The White House

Office of the Press Secretary

Presidential Proclamation -- To Modify the Harmonized Tariff Schedule of the United States

TO MODIFY THE HARMONIZED TARIFF SCHEDULE OF THE UNITED STATES

BY THE PRESIDENT OF THE UNITED STATES OF AMERICA

A PROCLAMATION

1. Section 1205(a) of the Omnibus Trade and Competitiveness Act of 1988 (the "1988 Act") (19 U.S.C. 3005(a)) directs the United States International Trade Commission (the "Commission") to keep the Harmonized Tariff Schedule of the United States (HTS) under continuous review and periodically to recommend to the President such modifications to the HTS as the Commission considers necessary or appropriate to accomplish the purposes set forth in that subsection.  Among those purposes are to promote the uniform application of the International Convention on the Harmonized Commodity Description and Coding System (the "Convention") and to alleviate unnecessary administrative burdens.

2. The Commission conducted an investigation pursuant to section 1205 of the 1988 Act (Investigation No. 1205-8) in response to a request from the Department of the Treasury regarding certain footwear featuring outer soles of rubber or plastic to which a layer of textile material has been added.  The request stated that changes to the HTS would promote the uniform application of the Convention as well as alleviate unnecessary administrative burdens.

3. On August 9, 2010, the Commission issued a report in Investigation No. 1205-8, recommending certain changes to the HTS.  The report and layover requirements of section 1206(b) of the 1988 Act (19 U.S.C. 3006(b)) were satisfied as of March 30, 2011.

4. On November 8, 2010, the United States Trade Representative (the "USTR") requested that the Commission make further recommendations consistent with section 1205(d) of the 1988 Act concerning particular provisions of the HTS that the Commission had recommended in its August report be replaced by new tariff lines.  The USTR also asked the Commission to consider whether, in response to requests made by interested parties in the course of the original investigation, additional tariff lines should be inserted in the HTS.

5. On February 18, 2011, the Commission issued an addendum to its report, recommending additional modifications to the HTS.  The report and layover requirements of section 1206(b) were satisfied as of June 30, 2011.

6. Section 1206(a) of the 1988 Act (19 U.S.C. 3006(a)) authorizes the President to proclaim modifications to the HTS based on recommendations made by the Commission pursuant to section 1205 of the 1988 Act, if he determines that the modifications are in conformity with United States obligations under the Convention and do not run counter to the national economic interest of the United States.  I have determined that the modifications to the HTS set forth in Annex I to this proclamation are in conformity with United States obligations under the Convention and do not run counter to the national economic interest of the United States.

7. On June 6, 2003, the United States and Chile entered into the United States-Chile Free Trade Agreement (USCFTA).  The Congress approved the USCFTA in section 101(a) of the United States-Chile Free Trade Agreement Implementation Act (the "USCFTA Act") (19 U.S.C. 3805 note).  Presidential Proclamation 7746 of December 30, 2003, implemented the USCFTA with respect to the United States, and incorporated in the HTS the tariff modifications and rules of origin necessary or appropriate to carry out the USCFTA.

8. Section 202 of the USCFTA Act provides rules for determining whether goods imported into the United States originate in the territory of a USCFTA Party and thus are eligible for the tariff and other treatment contemplated under the USCFTA.  Section 202(o)(2)(A) authorizes the President to proclaim, subject to the consultation and layover requirements of section 103(a) of the USCFTA Act, modifications to such previously proclaimed rules of origin.

9. The United States and Chile have agreed to modify certain rules of origin and to add certain other rules of origin in the USCFTA.  I have determined that further modification of the USCFTA rules of origin set forth in Proclamation 7746, and subsequently modified, is therefore necessary.

10. The consultation and layover requirements of section 103(a) of the USCFTA Act were satisfied as of July 10, 2010.

11. On April 15, 1994, the United States entered into trade agreements resulting from the Uruguay Round of multilateral trade negotiations (the "Uruguay Round Agreements").  In section 101(a) of the Uruguay Round Agreements Act (the "URAA") (19 U.S.C. 3511(a)), the Congress approved the Uruguay Round Agreements listed in section 101(d) of that Act, including the Agreement on Agriculture in section 101(d)(2).  To implement section 4.2 of the Agreement on Agriculture, section 401(b)(2) of the URAA amended section 103B of the Agricultural Act of 1949 (7 U.S.C. 1444-2) by converting the special import quotas on cotton provided for under section 103B to tariff-rate quotas.

12. Proclamation 6301 of June 7, 1991, and Proclamation 6948 of October 29, 1996, modified U.S. note 6 to subchapter III of chapter 99 of the HTS and created tariff lines in the HTS for reporting entries under a special import quota for upland cotton.  Note 6 sets out the conditions under which a special import quota for upland cotton takes effect.

13. Section 1207(a)(2)(B) of the Food Conservation and Energy Act of 2008 (7 U.S.C. 8737(a)(2)(B)) changed the conditions under which a special import quota for upland cotton takes effect.  U.S. note 6 to subchapter III of chapter 99 needs to be modified to reflect those changes.

14. Section 604 of the Trade Act of 1974, as amended (the "Trade Act") (19 U.S.C. 2483), authorizes the President to embody in the HTS the substance of the relevant provisions of that Act, and of other Acts, affecting import treatment, and actions thereunder, including the removal, modification, continuance, or imposition of any rate of duty or other import restriction.

NOW, THEREFORE, I, BARACK OBAMA, President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States of America, including but not limited to section 1206 of the 1988 Act, section 202 of the USCFTA Act, and section 604 of the Trade Act, do proclaim that:

(1)  In order to modify the HTS to promote the uniform application of the Convention and to alleviate unnecessary administrative burdens, the HTS is modified as set forth in Annex I to this proclamation.

(2)  The modifications to the HTS set forth in Annex I to this proclamation shall be effective with respect to goods that are entered, or withdrawn from warehouse for consumption, on or after the later of September 1, 2011, or the thirtieth day after publication of this proclamation in the Federal Register.

(3)  In order to modify the rules of origin under the USCFTA, general note 26 to the HTS is modified as provided in Annex II to this proclamation.

(4)  The modifications made by Annex II to this proclamation shall be effective with respect to goods of Chile under the terms of general note 26 to the HTS that are entered, or withdrawn from warehouse for consumption, on or after November 1, 2011.

(5)  In order to reflect the modified requirements under which a special import quota for upland cotton takes effect, the HTS is modified as set forth in Annex III to this proclamation.

(6)  The modifications made by Annex III to this proclamation, shall be effective with respect to goods entered, or withdrawn from warehouse for consumption, on or after June 18, 2008.

(7)  Any provisions of previous proclamations and Executive Orders that are inconsistent with the actions taken in this proclamation are superseded to the extent of such inconsistency.

IN WITNESS WHEREOF, I have hereunto set my hand this thirty-first day of October, in the year of our Lord two thousand eleven, and of the Independence of the United States of America the two hundred and thirty-sixth.

BARACK OBAMA

President Obama Speaks on Preventing Drug Shortages

October 31, 2011 | 4:28 | Public Domain

Today, the President signed an Executive Order to prevent drug shortages and protect consumers.

Download mp4 (43MB) | mp3 (4MB)

The White House

Office of the Press Secretary

Press Gaggle to Preview the President's Trip to Cannes, France for the G20 Summit

James S. Brady Press Briefing Room

10:36 A.M. EDT

        MR. CARNEY:  Good morning, everyone.  Happy Halloween.  Thanks for being here for our off-camera gaggle previewing the President's trip later this week to the G20.  I have with me today someone you all know, Ben Rhodes, the Deputy National Security Advisor for Strategic Communications.  I also have on my left the Under Secretary of Treasury for International Affairs Lael Brainard; and on my right the Deputy National Security Advisor for International Economic Affairs Mike Froman.

        I have them here to discuss, as I said, the President's upcoming trip, take your questions on that trip.  I will remain after they leave to take your questions on other issues if you have any.  

        And with that, Ben, I'll turn it over to you.

        MR. RHODES:  Good morning, everybody.  Trick or treat there.  Feel free to take two pieces.

        So we want to talk a little bit about the President's trip to the G20 today.  I'll just start by giving a bit of an overview of the schedule as it currently stands, and then turn it over to these guys to dig deeper into the issues that will be discussed in Cannes.

        We'll be leaving here Wednesday night to fly to France.  After we arrive, we'll have two bilateral meetings in the morning, first with President Sarkozy of France, and then with Chancellor Merkel of Germany.  These are obviously the two largest economies in the eurozone and two leaders that the President has been in very close contact with over the last weeks and months about the issues that will be discussed at the G20 and about the situation in the eurozone.  So these will be important meetings for him to have consultations with these leaders before the G20 commences.  And Mike and Lael can speak a little bit more about those issues.

        Following those meetings he will also have a meeting with the L20, the international labor leaders who will be in Cannes as a part of the G20 program.  And then that afternoon we head directly into the G20 schedule.  And the G20 schedule for that afternoon includes a working lunch and then a number of sessions and a working dinner.  So the rest of the day on Thursday will be taken up with the G20 schedule.

        Then Friday morning, we will complete the G20 with a number of sessions in the morning and early afternoon.  Following the conclusion of the G20, the President will be able to meet with President Kirchner of Argentina.  She was recently reelected, as you may know, and this is an important opportunity for the U.S. and Argentina to discuss our relationship going forward and to congratulate her on her reelection.

        Following that meeting, the President will have a press conference, as he usually does at the end of the G20.  And then we may have additional opportunities to spend some time with President Sarkozy.  We're working that out as well.

        If there are additional meetings that emerge on the margins of the G20, we'll, of course, let you know about them either before or during the sessions.  The President often has opportunities to speak to his counterparts at these summits.

        And with that, I'll turn it over to Mike to talk through some of the issues, and then we'll go to Lael, and then we'll take your questions.

        MR. FROMAN:  Thanks, Ben.

        Well, as you all know, this is the -- Cannes will be the fifth G20 that President Obama attends.  In Pittsburgh, the leaders agreed to make the G20 the premiere forum for global economic cooperation and it's already established a solid track record of action.  

        In London, as you may recall, the G20 countries deployed their combined fire power to deal with the crisis of 2008-2009.  In Pittsburgh, the G20 launched the framework for strong, balanced and sustainable growth.  In Toronto and Seoul, the G20 elaborated on that framework and launched work programs into new areas like anticorruption and development.

        The G20 agenda is critical to growing our economy here back at home, to strengthening the recovery, to increase exports and to create jobs.  And as the President said in his op-ed last week, the U.S. plays a leadership role in strengthening the global recovery.  To promote near-term growth and job creation, the President of course has proposed the American Jobs Act, but he's also proposed the framework to put our medium-term public finances in stronger, more sustainable footing as well.  And together we think this approach of spurring job creation and growth in the near term and meaningful deficit reduction in the medium term represents the best insurance policy to protect the U.S. economy.

        In Cannes, we expect the eurozone to be the primary focus of discussion, but in addition, the leaders will focus on mechanisms that have been put in place to ensure strong, balanced and sustainable growth.  They'll talk about the next stages of financial regulatory reform, and they'll talk about how to keep momentum going on G20 priorities on common global challenges -- everything from development for security and infrastructure, as well as the phasing out of fossil fuel subsidies, fighting corruption, and strengthening the multilateral trading system consistent with our interest.

        These summits, like any summits, really have three purposes:  One, they're action-forcing events to make decisions; they are ongoing processes for getting work done below the leader level; and they’re an opportunity for leaders to engage directly with their counterparts on the issues of the day.  

        And let me say, in many respects, the Cannes G20 has already been an important success as being a catalyst for the decisions that Europe took last week to deal with its crisis.  Obviously, there's more discussion to be had among leaders about the next steps in that process to include the fleshing out of the details and their full implementation.  But that’s the context in which the President goes to Cannes.

        And let me turn it over to Under Secretary Brainard.

        UNDER SECRETARY BRAINARD:  Against a backdrop of renewed global risks, there is growing agreement around the world that the focus at Cannes needs to be on growth, safeguarding the fragile recovery, and laying the foundation for stronger, more balanced growth will, therefore, be the core of our economic agenda in Cannes.

        President Obama remains intensely focused on putting Americans back to work.  Recovery in the U.S. remains fragile and still too vulnerable to disruption beyond our shores.  Pro-growth policies in the near term and meaningful deficit reduction in the medium term provide the best insurance policy to protect the U.S. recovery from global risks.

        President Obama goes into Cannes on the heels of signing three new trade agreements that are at the center of our growth agenda by securing new markets for U.S. goods and services exports.  And we’re going to continue in the weeks ahead seeking opportunities to capitalize on the export-led engine of growth and job creation that’s central to the recovery, advancing the President’s national export initiative goal of doubling exports in five years.

        President Obama will also continue his close engagement with European leaders in Cannes, working together to safeguard the global recovery.  The comprehensive plan agreed by European leaders last week will lay a critical foundation for a durable solution to the euro area crisis.  The plan contains all the right elements:  building a more powerful firewall to overwhelm the markets and protect sovereigns so they have access to affordable financing as they reform; ensuring European banks have the liquidity and the capital cushions they need to maintain the full confidence of depositors and creditors; charting a sustainable path forward for Greece to support crucial fiscal and structural reforms; and ensuring member states are pursuing sound economic policies to address the root causes of today’s crisis.  We are looking forward to hearing more at Cannes about the further elaboration and implementation of these elements.  

        Obviously, the challenges facing Europe have significant implications for the U.S. economy and for the global economy.  The EU is a critical anchor of global stability, and our single-largest trading partner.  Fortunately, Europe has the resources and the capacity to overcome these risks.  We’ll continue to support our European allies in their efforts to address this crisis, alongside the IMF and our G20 partners.  We also welcome Japan’s recent initiatives to support growth by accelerating expenditures in its third supplemental budget, and through implementation of its national growth strategy.

        With weak demand in advanced economies, emerging markets, especially those with large surpluses, have substantial capacity to support growth by pivoting more rapidly to a pro-growth strategy driven by domestic consumption.  Recall in Pittsburgh, the leaders of the G20 recognized that an unbalanced global recovery will be neither strong nor durable.

        In China and other surplus emerging-market economies, allowing exchange rates to appreciate to reflect market forces is the most powerful near-term tool to accelerate the shift to domestic consumption, while countering inflationary pressures.

        And finally, the G20 will press forward with financial reform.  In Cannes, we’ll seek agreement on a new global margin standard on uncleared derivatives trades to create incentives for central clearing while pushing forward on standardization of derivatives, exchange trading and trade reporting.  These efforts are critical to ensure international coherence and greater oversight of capital markets.

        We also expect the G20 leaders to move forward on important reforms for the largest, most interconnected financial institutions, including adopting a new standard for resolution regimes so that large cross-border firms can be resolved without severe disruption or taxpayer exposure to loss.  We’ll also ask these firms to hold higher capital buffers so that they can withstand future shocks without imposing costs on the economy.  

        This builds on a host of initiatives to ensure the largest financial institutions bear their fair share of the burden and are discouraged from the risky behavior that led to the crisis.

        Stronger and more balanced growth, financial stability, these will be the key touchstones for the G20.

        MR. CARNEY:  Great.  If we can take your questions.  Ben?

        Q    Thanks, Jay.  I had two questions for Lael, please.  The firewall that you mentioned, how confident is the United States that the European countries will be able to achieve that? It’s expected to be $1.4 trillion.  And will the United States either directly or indirectly be contributing any money to that?

        UNDER SECRETARY BRAINARD:  Let me just say that the announcements that European leaders made last week were very significant.  We are going to hear more about the details of how they move forward on the four elements, including on the firewall.  So we look forward to hearing more about the elaboration and implementation of those initiatives at Cannes.  And of course, we are, along with other members of the G20, going to stand with Europe and support Europe.  Europe has substantial resources that it can bring to bear to address the challenge and we have a lot of confidence that they will do so.

        Q    When you say you stand with them and support them, will there be any U.S. financial commitment?

        UNDER SECRETARY BRAINARD:  The U.S., as you know, went through a number of important decisions on its own during our financial crisis, and we have been very engaged with Europeans, sharing our experiences during the crisis where we, ourselves, took quite decisive and overwhelming action to address the financial disruptions to our own economy.  And so we'll continue talking with Europe about those.

        The IMF also has played an important role, and through it the United States will continue to support Europe.  The IMF, as you know, received substantially greater resources, at our behest and with our support, back in 2009, and those resources are largely available today to support Europe and other countries as they confront financial volatility and as they mount plan to restore stability in the euro area.

        Q    -- if I could follow up.  Do the Europeans really have the luxury of spending weeks, if not months, to flesh out the details of this plan, is my first question.  And I'd like to follow up on something else as well.

        UNDER SECRETARY BRAINARD:  Well, I think as Mike noted earlier, European leaders came together.  They used the G20 summit in Cannes as a action-forcing event.  They came together on a comprehensive plan with the four key elements to address their crisis, and they will continue, I believe, moving quickly to elaborate and implement the four elements.  And we expect to hear more about those details and the implementation at Cannes.

        Q    Okay.  And to follow up, the Bank of Japan was intervening in currency markets overnight.  You talked about the need for currencies to appreciate for emerging economies that have surpluses.  But are you concerned over Japan intervening to prevent the rise of the yen?  That sends a potentially conflicting signal to that desire to see currency fluctuate freely.

        UNDER SECRETARY BRAINARD:  So the G7 reaffirmed in September its commitment to market-determined exchange rates.  In the absence of disorderly conditions or excessive volatility, that remains our position.  And in the G20 discussions, we do expect that as we look at the rebalancing agenda, emerging market economies that have surpluses will continue to move forward on their commitments to rebalance demand by allowing their exchange rates to appreciate in line with market forces, which is the most powerful tool they have to encourage the pivot to domestic consumption-led growth.

        Q    Dr. Brainard, what -- or, Mr. Froman, what message will the U.S. deliver to Europe about their interest in China helping to make up some of the bailout fund?

        UNDER SECRETARY BRAINARD:  So let me just broaden out that question a little bit.  You'll remember that, in Pittsburgh, it was President Obama that led the initiative to make the G20 the premiere forum for international cooperation to strengthen growth and to secure more balanced growth.  And that was because he saw then the importance that these economies, the emerging markets, would play in coming years in the global economy.  So it is, I think, important that we have all the countries around the table, including key emerging markets.  And China and other emerging markets -- like us -- have a tremendous interest in seeing European stability and confidence return, and European growth return.

        So all of us are going to work together to support European efforts.  It's very much in all of our interests to see them return to stability and growth.

        Q    The U.S. has made it clear that we want -- or this administration wants Europe to bail out Europe.  

        UNDER SECRETARY BRAINARD:  Well, let me just say again, we are all working with Europe.  It's very much in all of our interests.  But Europe has substantial capacity, substantial resources, and, indeed, they've indicated that they are going to bring those resources to bear.  So we will stand with other members of the G20.  We'll continue to support the IMF having a very important role working with Europe as Europe takes steps to address its own crisis.

        Q    Are you saying it's okay with the U.S. if China contributes a significant sum to that bailout fund?

        UNDER SECRETARY BRAINARD:  I think that we will have a variety of conversations in Cannes about steering the global economy to a stronger place, and we'll have members of the G20 sitting around the table that make contributions such as -- in the case, for instance, of some of the emerging market surplus economies, they have a tremendous contribution they can make through their own domestic consumption and through pivoting to domestic consumption-like growth.  We’ll all stand together with the IMF, but again, Europe has substantial resources to bring to bear to the problem.

        And the IMF is much better resourced than it was in 2009 because of our efforts in 2009.  Back in 2009, compared to today, I think the IMF has four times greater resources to deal with any crisis around the world than we saw back in 2009.  But we will have a set of conversations, and we will work together with other countries to support Europe and to support the global recovery.

        Q    This is for Ben.  You were talking about this meeting with President Kirchner.  So the relationship between the two countries has not been particularly good in the past months, so I would like to know what you are expecting there.  I mean, do you expect, for example, any engagement from Argentina concerning the point that has been the burden in the relationship in the past months?

        MR. RHODES:  Well, certainly there have been ups and downs in the U.S.-Argentina relationship over the last couple of years. But we believe very much that when you have an election and you have a new mandate for a leader, that presents an opportunity to put the relationship on a stronger footing and to establish a basis for cooperation going forward.

        So we very much view this as an opportunity following the reelection of President Kirchner to pivot on the relationship towards a more positive direction, and again, to cooperate with Argentina on issues in the hemisphere, our shared interest in economic growth and security in the Americas, as well as cooperating on global issues, Argentina, obviously, being a member of the G20 and many other forums where we have common interests.  

        So I do think it’s important to take advantage of this opportunity for the two leaders to come together after President Kirchner has won her new mandate and to, again, put the relationship on a stronger foundation and point a positive way forward coming out of the meeting between the two Presidents.

        Q    You talked about the shared experience you have with the Europeans.  Do you feel like you have been listened to enough?  And I would like also to know (inaudible) came out in support of the new transaction tax, the international financial transaction tax.  Would you support that (inaudible)?  And is that why you say that you need to see President Sarkozy again at the end of the G20, so is there a specific reason for that?  Thank you.

        MR. RHODES:  I’ll take the last question first.  Simply the fact that we are in France and President Sarkozy is the host, the President was interested in spending additional time with France as a key ally of the United States.  So that's the principal reason why.  

        They’ll obviously have the bilateral meeting at the beginning that will be intensely focused on the G20 agenda.  But again, we’ll keep you updated, but the thought was that the two Presidents, given their close personal relationship and the close alliance between the U.S. and France, would have some additional time together at the end of the summit.

        UNDER SECRETARY BRAINARD:  We’ve had very extensive engagement with Europe and, of course, we worked closely with them during our financial crisis.  I think President Obama has had a number of important conversations with his European counterparts, and we have shared back and forth some of the experiences we had during the crisis, and in particular, the need to move with overwhelming force.

        With regard to discussions about getting the financial sector to bear their fair share of the burden, we’re very much in sync with Europe on their goal of ensuring both that the financial sector -- large financial institutions -- bear their fair share of the burden, but also that they're discouraged from taking the kind of risky behavior that led to the crisis.  We’ve taken a number of steps and got started a little earlier here, as you know.  We undertook stress tests back in 2009 and asked our largest financial institutions to materially increase their capital buffers, and they have.  They’ve doubled their capital since that time.

        The President has also put forward a financial crisis responsibility fee that would be directed at the largest financial institutions that really impose the greatest costs on the economy.  We think it’s pretty well designed to both deter the kind of risky behavior that led to the crisis, and to ensure that these large financial institutions and not retail investors bear their fair share of the burden.

        MR. FROMAN:  I would just add to it that we’re looking forward to hearing the full Bill Gates report, but our understanding is in fact, he’s looked at development finance, broadly, including the importance of developing countries mobilizing domestic sources of finance and creating enabling environments for attracting private sector investment; countries upholding their commitments to aid where there is a varying degree of success; and then a series of innovative financing techniques -- that being just one of several that he is suggesting are worth consideration.  And we look forward to having that conversation about the array of things that could be done to support development.

        Q    You just partially answered the question I had.  I understand that the development portion of the agenda is going to come up on the first day.  What are President Obama’s goals for the issues of hunger, food security, the other humanitarian issues?  And what are the prospects of that just simply going to get overwhelmed by the overriding issue of the debt crisis?

        MR. FROMAN:  Well, as you may recall, in L’Aquila three years ago, the President launched a food security initiative -- here in the United States it’s called Feed the Future -- and it mobilized over $20 billion of commitments from around the world. But more importantly -- or equally importantly to the overall commitment, was the agreement to have countries align their assistance programs with country plans to focus on increasing agricultural productivity and leveraging the private sector that had as much to do with changing the way we do development assistance, consistent with the President’s own development policies that he laid out about a year or so ago at the U.N. as it does with the mobilization of finance itself.  So that will be very much on the agenda.  

        The Koreans added development to the G20 agenda last year.  The French focused on food security and infrastructure in developing countries as the two priorities for this year.  And the President looks forward to engaging with that, because he has been personally very much involved in both of those issues.

        MR. CARNEY:  Andrei.

        Q    Thank you.  My question is to Ben.  Ben, the Russians keep raising the possibility of the President’s visit to Moscow in December.  Is such a possibility even considered at the White House?  And if not, what are your plans for the upcoming bilaterals?

        MR. RHODES:  At this point, we don’t anticipate the President being able to travel to Russia this year, given a very aggressive schedule both domestically and then internationally. However, he will be, in addition to the G20, as you know, going to the -- hosting the APEC forum in Hawaii and then going to the EAS.  And we certainly anticipate that we will have the opportunity to have the bilateral meeting with President Medvedev at one of those stops on the Asia Pacific trip.  So we certainly believe he'll meet with President Medvedev bilaterally.  We think it's unlikely that he'll be able to get to Russia this year.

        Q    Are there specific things the President is seeking at the G20 and in the bilaterals that you can talk about, and more generally, how you would judge the success of this trip at the end of it?

        MR. RHODES:  I'd say a couple of things, and would just offer Lael or Mike the opportunity to add to this.  

        As Mike said, the G20 is both an ongoing process and an action-forcing mechanism.  The preeminent issue right now in the global economy has been the eurozone crisis.  The steps that the Europeans took in announcing a comprehensive package in advance of the G20 was an important marker leading into the G20 to give confidence and to provide a way forward that could help stabilize the situation in Europe.

        As Lael has said, there will be discussions about the ongoing implementation of that plan.  And I think what we want to see is a G20 as a forum where the leaders of the world's largest economies can come together behind that plan and in support of it, to project, again, confidence in the efforts to address the situation in the eurozone and to move forward.  

        At the same time, we also see the G20 as an important place to focus on steps that countries are taking to foster both growth in the immediate term that can stabilize the global economy, and then the type of fiscal consolidation in the medium and long term that the United States is pursuing at home as well.

        And then, lastly, it's, of course, an important forum to discuss a range of issues across the international agenda, be it development, be it the continued efforts to reform and modernize organizations like the G20 and others that address these global issues.  But I think, as we've led into it, the President's conversations with his counterparts, particularly his European counterparts, have really focused on this question of, how do we deal with the eurozone crisis; what lessons do we have to offer from our own financial crisis, in which the U.S. took very robust action, again, to address a financial crisis in our country and also to help stabilize the global economy.  And so those discussions will be ongoing as he talks to Chancellor Merkel, President Sarkozy, and then with his other leaders there.  

        So that's how I would frame it for you.

        MR. CARNEY:  Roger.

        Q    I'd like to go back to the transaction tax.  Europe is going to be pushing it.  I'm not clear on what the U.S. position is.

        UNDER SECRETARY BRAINARD:  Well, again, I think Europe is in the middle of their own discussions within not just the euro area but within the EU more broadly.  We're very much synched up with the goal of assuring that the largest financial institutions, whose risky behavior led to our financial crisis, bear the burden of the costs associated with it, and also have disincentives to engage in that kind of behavior.  So we've put in place a number of elements that we think are very powerful in that direction, including, as I mentioned earlier, asking them to hold much thicker capital cushions.  We'll have agreement, we think, at the G20 on additional capital buffers for the largest financial institutions.  But we've also put forward a financial responsibility fee.

        As Europe is thinking through how to go forward on its own goals, they'll be going through the same thought process that we went through.  And we put forward the fee because we think it's more important to put the burden on the largest financial institutions rather than shifting it to retail investors.  We think that the financial responsibility fee, which is on the liabilities of the largest financial institutions, is well targeted to make those institutions that are bearing greater risk pay more.  It is better targeted to prevent evasion.  And the IMF went through a similar assessment exercise and came, frankly, to a pretty similar conclusion.  But that said, looking forward to having the discussions with them; share very much the goal.

        Q    So the U.S. will not support it?

        UNDER SECRETARY BRAINARD:  Again, we very much support the goal and --

        Q    I understand that the goal is --

        UNDER SECRETARY BRAINARD:  -- look forward to having conversations about the best way to achieve that goal.

        MR. CARNEY:  Norah, then Jon-Christopher.

        Q    Hi.  Can I ask you about whether you're concerned at all that China is being asked for 100 billion euros to bail out Europe?  And will this G20 -- will the headline coming out of it be that this is a shift in economic power to Asia and Latin America?

        MR. FROMAN:  I would repeat something that Lael said earlier, which is that the whole idea of the G20 and the reason that President Obama insisted on it becoming the premiere forum for international cooperation is to recognize that emerging economies have an important role to play, commensurate with their size in the global economy; that they need to have a seat at the table, and that there are certain responsibilities that go along with having that seat at the table.  

        So the concept that China and other emerging economies are part of this discussion, that they will be there, along with ourselves and other industrialized countries, speaking with the Europeans, talking about the elaboration and the implementation of their plan, and expressing unity and support of what the Europeans are doing, we think is very much appropriate.

        The U.S. is the largest economy in the world.  We are a very important market to China and others.  We continue -- this is the place that parents all over the world want to send their kids to university.  We’re the center of innovation.  We have a great network of alliances around the world that no other country has. People continue -- I’m struck -- in the G20 and the other forums that we're involved in, I’m struck by the degree to which other countries very much look to the U.S. for leadership, thought leadership and leadership on action, to ensure a way to resolve global problems.

        Q    So it doesn’t matter that China is being asked for a hundred billion euros, and that they’re going to bail out Europe -- might bail out Europe?

        MR. FROMAN:  As I said, I think the U.S. plays a critical leadership role, and we believe that having all the major emerging and developing countries around the table, along with the industrialized countries, talking about what’s important for the global economy is what the G20 is all about.

        Q    In light of the recent vote in Parliament last week regarding the level of involvement Great Britain will be having in the EU, will the President be speaking to Prime Minister Cameron?  Will it be a bilateral?  Is the President aware of this particular issue that’s going on -- conflict that’s going on in the UK right now?

        MR. FROMAN:  The President is very much aware of it, and I’m sure will have an opportunity to speak with Prime Minister Cameron over the course of their time together there.

        Q    So there’s no bilateral set up at the moment?

        MR. FROMAN:  There’s no formal bilateral set up at the moment.

        MR. CARNEY:  If we can just take a couple more for Lael and Mike.  

        Yes, sir.

        Q    There is a push in Europe to regulate credit rating agencies and essentially shield countries -- there are going through bailouts from adverse credit ratings.  Is this going to be part of the regulatory reform discussion at the G20?  And if so, what’s the U.S. position on it?

        UNDER SECRETARY BRAINARD:  The G20 and the FSB have, to date, been very focused on credit rating agencies, but making sure that credit ratings don’t play an inappropriate role in terms of the supervisory process.  And we’ve made a number of very strong commitments there to ensure that credit ratings are not used in a mechanical way but that supervisors are actively engaged.  

        So I would anticipate that conversations will continue along those lines.  As you know, in the U.S., under the Dodd-Frank Act, the Dodd-Frank Act has very strong provisions so that supervisors need to assess risk weights without relying, as they had previously, on credit ratings.  So we’ve taken a number of very strong steps here to ensure that credit ratings play a more appropriate role.  And so that is, to date, where the G20 and FSB discussions have been, and I anticipate they’ll continue in that vein.

        Q    I have two important follow-ups.  First, my colleague from Bloomberg asked a pretty important question -- because the people on Wall Street do not know how to parse diplomatic-speak.  And so you will probably roil the markets if your wording is not clear and concise.  (Laughter.)  So could you please tell us if the U.S. supports or opposes a transaction tax, number one.

        Number two, to Norah’s question, Europe's relation with China has been reduced to mendicancy.  They’re mendicants to China.  You talk about talking about currency manipulation and China’s mercantilism.  It sounds like an empty agenda item if Europe is going to China hat in hand.  What kind of strong language can they expect out of the G20?

        UNDER SECRETARY BRAINARD:  So on the issue of how to get Wall Street to bear its fair share of the burden, how to ensure that the largest financial institutions do not again impose costs on the system through risky behavior, were very much in sync with Europe.  Europe is having its own conversations about this issue. They are looking at a financial transactions tax, but there is a debate within the European Union, as you know, on this issue.

        We’re very much aligned on the goal.  We went through our own analysis and assessment.  We put in place a number of things that we think are very tough and very effective, including having our institutions go through stress tests and requiring them to build capital, to double capital.  We’re now going to require the largest institutions to build additional capital buffers.  We put forward a fee -- a financial crisis responsibility fee that, again, we think is well targeted because it puts the burden on the largest institutions, yet disincents them from taking risky behavior that could be imposing costs on the economy.  And we think that's an approach that works better than putting the burden on retail investors.  We think it’s an approach that better addresses issues of evasion.

        So again, we’re going to have that conversation with European friends and more broadly.  

        On the issue of what role we would want to see various emerging markets playing, I think it is, again, very much with our support and leadership that the major emerging economies are sitting at the G20, which is now the premiere forum for steering the global economy.  They have critically important contributions to make in steering the global recovery.  

        And they have said in the G20, and we expect them to continue moving in their policies to contribute importantly by shifting to more domestic, consumption-led growth.  Why?  They're looking at the same numbers that we are.  Demand is likely to be weak in the advanced economies for some time, so it’s very much in China’s own interest, as they know, and as you see in their own policies, to shift to domestic consumption-led growth, rather than relying on an outdated growth model based on net exports to advanced economies where demand is likely to be weak for some time.  And the exchange rate plays the most powerful potential near-term role as a lever in helping that shift.

        They will also be -- parts of the conversation in how we make sure that the IMF continues to be as strong as it possibly can be.  And again, it has four times greater resources than it had going into the crisis in 2008-2009, when we moved forward on this very significant decision to up the resources.  

        So we look forward to having that conversation, and we think it’s very important that the emerging markets be central parts of that conversation.

        MR. CARNEY:  I want to thank Mike and Lael, and we’ll go on to other topics, if that's okay.

        Thank you.  Ann.

        Q    Tony Blair meeting, can you give us a --

        MR. CARNEY:  As we said when we announced it, there’s no set agenda.  They’ll obviously talk -- discuss a number of topics.  I don't have anything more specific on it for you.

        Q    And was the President aware that Qaddafi had kept his chemical weapons?  Or were reports of chemical weapons being found in Libya a surprise?

        MR. CARNEY:  I’m not aware of anything that's been reported that has surprised us out of Libya, but I can check on that for you.

        Q    Palestine is now a member of UNESCO.  What’s our thinking about this?  How does that affect Israel's relationship with the Palestinians --

        MR. CARNEY:  Today’s vote at UNESCO to admit the Palestinian Authority as a member is premature and undermines the international community’s shared goal of a comprehensive, just and lasting peace in the Middle East.

        Today’s vote distracts us from our shared goal of direct negotiations that result in a secure Israel and an independent Palestine living side by side in peace and security.  I mean, not unlike the issues of membership, as we discussed, the path to peace is through direct negotiations, and we support measures that -- and steps that bring the two sides closer to direct negotiations, which is the only way to resolve the differences between them.

        Anybody else?  Yes, Victoria.

        Q    What was the reason for putting both David Plouffe and David Axelrod on the Sunday shows yesterday?  I mean, generally speaking, if you're going to have --

        MR. CARNEY:  To see who did better.  (Laughter.)

        Q    Well, I mean, usually you put one political strategist out there, but to put two out -- I mean, it was like two guns.  It was just odd this early in the campaign to put two out there.

        MR. CARNEY:  We make decisions about who appears on which show based on not just our desires, but on the requests.  Obviously, David Plouffe's role here in the White House is different from a role on the campaign, and he can address different subjects more broadly, and certainly did in his appearance.

        Q    Jay, you're announcing some new steps today on the We Can't Wait program regarding prescription drug shortages.  Given that there's pending legislation in Congress and, if I understand, only today is the White House actually endorsing that, why is it necessary to move forward unilaterally from this end if you're just now endorsing what Congress is doing?

        MR. CARNEY:  Well, our endorsement hasn't determined whether or not Congress acts on a piece of legislation, first of all.  As we have said throughout this initiative and in general, the President looks to ways he can use his executive authority to, broadly speaking, help Americans who can be helped through actions that this administration can take -- whether it's helping underwater homeowners refinance their loans, take advantage of these historically low mortgage rates, or students ease the burden of their student loans, or, in this case, speed access -- or ensure that there are not shortages of -- try to ensure that there are not shortages of very, very important drugs for Americans who may be in great need of them.  

        So we will continue to take these actions as the President determines them, because we can't wait for Congress to act -- whether it's on legislation to take on this problem or on the American Jobs Act, the provisions therein that the Congress, thus far, has refused to pass -- the Republicans in Congress have refused to pass in the Senate.  We hope that changes as more votes are taken in the Senate, because there is no more urgent priority than the need to grow the economy and create jobs here in America.

        Yes, Scott.

        Q    How is the White House going to keep that focus on the economy during this short G20 trip within the longer --

        MR. CARNEY:  Well, both of these trips are all about economic growth, global as well as domestic economic growth.  The President has said repeatedly, as have I and others, that the crisis in the eurozone has a direct effect on the American economy.  It is why it's so important that Europeans implement the important decisions that they made last week, and why the G20, as a forcing mechanism, was so important and continues to be so important.  The President is obviously a leader in that forum.

        That will be the case when he goes to the Asia Pacific region and participates in both APEC and the EAS and other -- has other meetings that are directly related to the need to expand global markets to grow the economy in that region of the world.  And that has great benefit to American markets and to American workers.

        And I would also simply say that we will continue to press the agenda on all fronts while the President travels, both from wherever he is and here back in the United States.

        Yes, Mark.

        Q    On the announcement -- I'm sorry -- are the Republicans obstructing this in some fashion?

        MR. CARNEY:  Well, the question here isn't -- it's not about a contrast, necessarily.  It's simply about action.  Action needs to be taken; action hasn't been taken on the Hill.  So the President has the authority to take this action, so he will take it because it's in the best interests of the American people and the many Americans who need these particular drugs.

        Q    There's no counterpoint -- it's not as if you're -- this is one or the other; it's not like the jobs package where there's specific votes that have been against it.

        MR. CARNEY:  No, but there is inaction.  There is a lack of action, so there is a need to move -- because we can move.  And again, this is not, broadly speaking -- the We Can't Wait actions, the executive actions that the President is taking and will take are not substitutes for legislative action.  He fully understands that the kinds of things that are contained within the American Jobs Act require congressional action, require laws being passed.  And that's why he's pressing for Congress to take action legislatively.

        But he can also act independently -- or, rather, administratively, and exercise his executive authority to benefit the American people in other ways.  And he will continue to do that.

        Yes.

        Q    Thank you, Jay.  Two questions.  The President is now going to --

        MR. CARNEY:  I’m sorry.  He’s not going to --

        Q    He’s going to APEC and East Asian Summit as well.  Will he hold any bilateral meetings with President Hu?

        MR. CARNEY:  I don't have any more meetings to announce beyond what Ben did at the top of this briefing.  As we have meetings to announce we’ll certainly make you aware of them.  

        Q    Are you arranging --

        MR. CARNEY:  I’m sorry?

        Q    Are you arranging the meeting right now?

        MR. CARNEY:  Well, that would be kind of announcing it, wouldn’t it?  (Laughter.)  Or announcing our intentions.  So you’ll have to wait for the announcement.

        Q    Jay, the House Speaker has expressed concerns over some of the We Can’t Wait legislation or executive action, and the RNC is suggesting its political expediency.  I don't know if you addressed this, but could you?

        MR. CARNEY:  I was asked about this concern, which I would just suggest is misplaced, because the President is acting well within his authority, well within his constitutional authority.  And he is simply acting to help the American people, whether it’s with their mortgages, their student loans, their access to vital drugs, assisting businesses to speed up the process by which they get either contracts with or payments from the federal government.  These are all measures he can take administratively, and he will continue to take them.  

        Again, one of the reasons why we can’t wait is because Congress won’t act.  So if the Speaker is concerned about the President acting administratively, he can certainly assist in the effort by allowing the provisions of the American Jobs Act, for example, to be voted on by the House of Representatives.

        Yes.  Paula.

        Q    The Keystone Excel Project -- I know you’ve been deferring that decision to the State Department.  There’s been a lot of reputable scientists and climatologists that have said that this would cause irreversible environmental damage if that pipeline is built, so -- and also, it’s a litmus test for the President as far as his commitment to climate change.  So what is the White House response to that?

        MR. CARNEY:  Well, I would say two things.  One, the President’s commitment to addressing these issues has been demonstrated by the actions he took for historic fuel efficiency standards, an action which by itself will have dramatic effect on the amount of fuel consumed in this country.  Great reduction -- great increase in our fuel efficiency; great reduction in our demand for foreign fuel from -- I mean, fuel from abroad, as well as savings for American consumers that are quite extensive.

        Secondly, I will return to the fact that this is a decision that will be made by the State Department, or is housed within the State Department.  And they are taking into -- they are in a phase now of taking into public account, public comment and comments certainly from experts, both environmental as well as energy experts.  So this process includes a full review of various concerns from all areas.

        MR. EARNEST:  Jay, let’s just do one more.

        MR. CARNEY:  One more.  

        Yes.

        Q    Can I ask one more question?

        MR. CARNEY:  Yes. Sorry.  And then you -- yes.

        Q    Well, I know one of the arguments for supporters is that it would create jobs as well as that there is a concern about the need for reducing foreign dependence on oil.  But those that oppose it are saying that there’s no guarantee that the oil would even go -- or stay within the United States, that it could be exported to other countries such as China.

        MR. CARNEY:  Oh, I understand.  You’re trying to get me to engage in something that’s being reviewed over at the State Department.  And my comments weren’t meant to address the Keystone issue, but to -- in response to the suggestion -- or the comment you made about the President’s environmental record.  

        Again, I would point to you that just one of his achievements, the fuel economy standards accomplished by this administration, with industry support and without the need of congressional action -- which, given our circumstance is always a good thing -- will reduce our reliance on foreign oil, saving a total of 12 billion barrels of oil, and by 2025, reduce oil consumption by 2.2 million barrels a day -- as much as half of the oil we import from OPEC every day.  These steps will save American families $1.7 trillion, and by 2025, result in an average fuel savings of over $8,000 per vehicle.

        Yes.

        Q    Yesterday, Mr. Plouffe on “Meet the Press” had strong words about Mr. Romney.  Would you say those are Mr. Plouffe’s opinions, or does that represent the White House’s opinion?

        MR. CARNEY:  Well, I mean, Mr. Plouffe works for the White House, so I would say that his views represent the White House’s views.  You have to be more specific if there is a -- that is my broad statement, but is there one in particular that you --

        Q    That he has no core?

        Q    Exactly.

        MR. CARNEY:  Look, I think as anybody who’s watched this campaign and watched Mr. Romney’s previous campaigns, it is always a question as to where he was and where he is and where he might be on any given issue.

        Thank you very much.  

END 11:29 A.M. EDT

The White House

Office of the Press Secretary

Remarks by the President at Signing of Executive Order

Oval Office

12:50 P.M. EDT

THE PRESIDENT: Well, thank you all for being here.

The United States, I think rightly, takes pride on having the most innovative and most successful drug industry in the world, and as a consequence the health of a lot of people, both here in the United States and around the world, is actively promoted. But as we also know, occasionally there are problems in our manufacture and distribution of drugs and how accessible they are to people.

And recently, we have seen how the potential of drug shortages for vital drugs, including some cancers, can really have a adverse impact on patients and those who are caring for patients. Sometimes we run out of or run low on certain types of drugs, and that drives up prices and it increases patient risk.

And I've got a couple of people here beside me who have had to navigate this problem. Jay Cuetara knows what it's like. In August, the center where he was receiving chemotherapy ran out of the drug being used to treat his cancer. And when that happens, you have pharmacy managers like Bonnie Frawley who have to scramble to make sure that their patients can somehow find the lifesaving medications that are necessary.

So over the last five years, the number of these drug shortages has nearly tripled. And even though the FDA has successfully prevented an actual crisis, this is one of those slow-rolling problems that could end up resulting in disaster for patients and health care facilities all across the country.

Congress has been trying since February to do something about this. It has not yet been able to get it done. And it is the belief of this administration, as well as folks like Bonnie and Jay, that we can't wait for action on the Hill -- we've got to go ahead and move forward.

So, as a consequence, I'm going to be signing an executive order today that directs the FDA to step up work to reduce the drug shortages and protect consumers. We'll still be calling on Congress to pass a bipartisan bill that will provide additional tools to the FDA and others that can make a difference. But until they act, we will go ahead and move.

As part of this, we're going to require that drug companies let us know earlier about the potential for drug shortages so that we can respond successfully. We're going to make sure that if we find out that prices are being driven up because shortages are being made worse by manipulations of companies or distributors, that we are making sure that we stop those practices. We're going to further empower the FDA and the Department of Justice to investigate any kinds of abuses that would lead to drug shortages.

So there's a combination of tools that are going to be contained in this executive order that can make sure that lifesaving drugs are available, and if we start seeing shortages, that we're able to catch those ahead of time so that Bonnie doesn't have to try to scramble as a pharmacy manager, and Jay, obviously, doesn't have to scramble as a patient.

This is something that needs to be done. I want to thank the leadership of both our FDA Administrator and our Health and Human Services Secretary for having done outstanding work in preparing this executive order. And again, I still urge Congress to move forward and build on this executive order so that we can provide even more tools for our agencies. And I want to thank Bonnie and Jay for being here and for helping inspire us to get this done.

All right. With that I'm going to sign this bill -- or this executive order -- excuse me.

(The executive order is signed.)

There you go. Thank you very much, everybody. Appreciate it.

Q Tony Blair -- can you tell us anything about the meeting with Tony Blair this morning?

THE PRESIDENT: I enjoyed our meeting with Tony Blair.

Thank you, guys.

END
12:55 P.M. EDT

The White House

Office of the Press Secretary

Statement by the President on the Presidential Elections in Kyrgyzstan

I congratulate the people and government of Kyrgyzstan for yesterday’s democratic and peaceful presidential election. In casting their ballots, the Kyrgyz people have taken an important and courageous step on the path of democracy and demonstrated their commitment to an orderly and open transition of power. I commend President Otunbayeva for her leadership and for her dedication to a vision of peaceful, democratic change. I also congratulate the many Kyrgyz leaders in government and civil society who worked to realize this moment of promise. The people of Kyrgyzstan will have a partner in the United States as they undertake the hard work of building upon the democratic gains of the past eighteen months and realizing a democratic, prosperous and just future for all Kyrgyz citizens.

The White House

Office of the Press Secretary

Executive Order 13588 -- Reducing Prescription Drug Shortages

EXECUTIVE ORDER

REDUCING PRESCRIPTION DRUG SHORTAGES

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:

Section 1. Policy. Shortages of pharmaceutical drugs pose a serious and growing threat to public health. While a very small number of drugs in the United States experience a shortage in any given year, the number of prescription drug shortages in the United States nearly tripled between 2005 and 2010, and shortages are becoming more severe as well as more frequent. The affected medicines include cancer treatments, anesthesia drugs, and other drugs that are critical to the treatment and prevention of serious diseases and life threatening conditions.

For example, over approximately the last 5 years, data indicates that the use of sterile injectable cancer treatments has increased by about 20 percent, without a corresponding increase in production capacity. While manufacturers are currently in the process of expanding capacity, it may be several years before production capacity has been significantly increased. Interruptions in the supplies of these drugs endanger patient safety and burden doctors, hospitals, pharmacists, and patients. They also increase health care costs, particularly because some participants in the market may use shortages as opportunities to hoard scarce drugs or charge exorbitant prices.

The Food and Drug Administration (FDA) in the Department of Health and Human Services has been working diligently to address this problem through its existing regulatory framework. While the root problems and many of their solutions are outside of the FDA's control, the agency has worked cooperatively with manufacturers to prevent or mitigate shortages by expediting review of certain regulatory submissions and adopting a flexible approach to drug manufacturing and importation regulations where appropriate. As a result, the FDA prevented 137 drug shortages in 2010 and 2011. Despite these successes, however, the problem of drug shortages has continued to grow.

Many different factors contribute to drug shortages, and solving this critical public health problem will require a multifaceted approach. An important factor in many of the recent shortages appears to be an increase in demand that exceeds current manufacturing capacity. While manufacturers are in the process of expanding capacity, one important step is ensuring that the FDA and the public receive adequate advance notice of shortages whenever possible. The FDA cannot begin to work with manufacturers or use the other tools at its disposal until it knows there is a potential problem. Similarly, early disclosure of a shortage can help hospitals, doctors, and patients make alternative arrangements before a shortage becomes a crisis. However, drug manufacturers have not consistently provided the FDA with adequate notice of potential shortages.

As part of my Administration's broader effort to work with manufacturers, health care providers, and other stakeholders to prevent drug shortages, this order directs the FDA to take steps that will help to prevent and reduce current and future disruptions in the supply of lifesaving medicines.

Sec. 2. Broader Reporting of Manufacturing Discontinuances. To the extent permitted by law, the FDA shall use all appropriate administrative tools, including its authority to interpret and administer the reporting requirements in 21 U.S.C. 356c, to require drug manufacturers to provide adequate advance notice of manufacturing discontinuances that could lead to shortages of drugs that are life supporting or life sustaining, or that prevent debilitating disease.

Sec. 3. Expedited Regulatory Review. To the extent practicable, and consistent with its statutory responsibility to ensure the safety and effectiveness of the drug supply, the FDA shall take steps to expand its current efforts to expedite its regulatory reviews, including reviews of new drug suppliers, manufacturing sites, and manufacturing changes, whenever it determines that expedited review would help to avoid or mitigate existing or potential drug shortages. In prioritizing and allocating its limited resources, the FDA should consider both the severity of the shortage and the importance of the affected drug to public health.

Sec. 4. Review of Certain Behaviors by Market Participants. The FDA shall communicate to the Department of Justice (DOJ) any findings that shortages have led market participants to stockpile the affected drugs or sell them at exorbitant prices. The DOJ shall then determine whether these activities are consistent with applicable law. Based on its determination, DOJ, in coordination with other State and Federal regulatory agencies as appropriate, should undertake whatever enforcement actions, if any, it deems appropriate.

Sec. 5. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:

(i) authority granted by law to an agency, or the head thereof; or

(ii) functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

BARACK OBAMA

THE WHITE HOUSE,
         October 31, 2011.

The White House

Office of the Press Secretary

We Can’t Wait: Obama Administration Takes Action to Reduce Prescription Drug Shortages, Fight Price Gouging

President Issues Executive Order, Backs Legislation to Require Drug Companies to Report Shortages

President Obama today will sign an Executive Order directing the Food and Drug Administration (FDA) to take action to help further prevent and reduce prescription drug shortages, protect consumers and prevent price gouging. The President’s order directs FDA to broaden reporting of potential shortages of certain prescription drugs and to further expedite regulatory reviews that can help prevent or respond to shortages. Under the President’s order, FDA will also work with to the Department of Justice, which will examine whether potential shortages have led to illegal price gouging or stockpiling of life-saving medications.

In addition to signing the Executive Order, the White House announced the President’s support for bipartisan legislation (H.R. 2245 and S. 296) that will build on today’s actions to strengthen the FDA’s ability to prevent prescription drug shortages.

A small number of drugs in the U.S. experience a shortage in any given year, but the number of reported prescription drug shortages in the United States nearly tripled between 2005 and 2010. While FDA successfully prevented 137 drug shortages between January 1, 2010 and September 26, 2011, prescription drug shortages continue to threaten the health and safety of the American people.

These shortages could lead to price gouging, which has raised serious concerns. For example, the ranking member of the House Committee on Oversight and Government Reforms, when announcing his investigation into so-called gray markets, expressed concerns about a report that a leukemia drug whose typical contract price is about $12 per vial was being sold at $990 per vial – 80 times higher. A Premier healthcare alliance report released in August estimated that the typical gray market vendor marks up prices by an averaged 650 percent. At the extreme, a drug used to treat high blood pressure that was normally priced at $25.90 was being sold at $1,200 due to a drug shortage.

“The shortage of prescription drugs drives up costs, leaves consumers vulnerable to price gouging and threatens our health and safety,” said President Obama. “This is a problem we can’t wait to fix. That’s why today, I am directing my administration to take steps to protect consumers from drug shortages, and I’m committed to working with Congress and industry to keep tackling this problem going forward.”
 
Early notification of potential drug shortages can help prevent a shortage from becoming a crisis by allowing hospitals, doctors and manufacturers to take action to ensure medications remain available. Currently, the FDA can only require drug manufacturers to disclose the discontinuation of a critical drug when the drug is available through a single manufacturer. The President’s Executive Order directs the FDA to take additional steps to require drug manufacturers to provide adequate advance notice of manufacturing discontinuances or other actions that could lead to critical shortages. These additional steps to increase early notification will help achieve some of the goals of bipartisan legislation supported by the President that would require all prescription drug shortages to be disclosed to the FDA in advance and give the FDA new authority to enforce these requirements.

The Executive Order also requires FDA to expand its current efforts to expedite review of new manufacturing sites, drug suppliers, and manufacturing changes to help prevent shortages.

These actions are just some of the steps the Obama Administration is taking to ensure patients have access to the lifesaving medicines they need. Today, the Obama Administration also:

  • Sent a letter to drug manufacturers reminding them of their responsibility to report the discontinuation of certain drugs to the FDA. The letter also encourages companies to voluntarily disclose to FDA potential prescription drug shortages in cases where disclosure is not currently required by law.
  • Increased staffing resources for the FDA’s Drug Shortages Program to address the increased workload that will result from additional early notification of potential shortages by manufacturers.
  • Released a report from the Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation (ASPE) that assesses the underlying factors that lead to drug shortages, and an FDA report on their role in monitoring, preventing, and responding to these shortages.

While the causes and many of the solutions are outside of the FDA’s authority, including the need for additional manufacturing capacity in the private sector, the Administration will continue its ongoing work with manufacturers and other stakeholders to help address drug shortages.

View a fact sheet to learn more about prescription drug shortages and the Obama Administration’s announcements.

Trick-or-Treat with the President and First Lady

Watch the White House get a Halloween makeover here.

President Barack Obama and First Lady Michelle Obama welcomed area students and the children of military families to the White House for the annual Halloween celebration and trick-or-treating on Saturday night.

The President and First Lady handed out cookies, White House M&M's and dried fruit mix to trick-or-treaters at the North Portico of the White House. Check out these videos for the behind the scenes preparations and watch the main event with the President, Mrs Obama and all the costumed kids.

Watch President Obama and First Lady Michelle Obama hand out treats to area students and the children of military families here

The White House and the surrounding grounds were decorated in celebration of Halloween. As the trick-or-treaters made their way across the North Lawn to the North Portico they were entertained by the Marine Band playing Halloween music and spooked by in-costume actors from Washington-area theatres, brought together by theatreWashington.

Check out the White House Halloween recipes below.

The White House Sweet Dough Butter Cookie Recipe

1 lb Sugar                                                      1 tsp Vanilla
2 lbs Butter                                                    1 tsp Salt
3 Eggs                                                            3 lbs All Purpose Flour
                                                                       
Mix the butter and sugar till soft and well beaten. Then add eggs, vanilla, salt and half the flour. Beat on slow speed till mixed, then add the rest of the flour and mix until incorporated.

Push flat onto a cookie sheet and refrigerate overnight. Roll out to one quarter inch thick and cut out cookie shapes with cookie cutter.

Bake at 350F for 14 minutes and then allow to cool. 

Make Your Own Dried Fruit Mix

Dried Apples                                                             Dried Pineapple
Dried Apricots                                                           Dried Papayas
Dried Pears                                                              Dried Cherries
Dried Blueberries                                                    Banana Chips

Combine ingredients and serve.

Download the recipes and make these treats yourself. (pdf)

Related Topics: Pennsylvania

President Obama at National Italian American Foundation Gala

October 29, 2011 | 11:52 | Public Domain

At the National Italian American Heritage Foundation Gala, President Obama said, "We’ve always been and we will always be a nation of immigrants from all over the world. And out of many, somehow we’re able to forge ourselves into one people; and this is the place where the highest hopes can be reached, and the deepest and most sincere dreams can be made real."

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Trick-or-Treat with the President and First Lady

October 29, 2011 | 19:02 | Public Domain

President Barack Obama and First Lady Michelle Obama welcome area students and the children of military families to the White House for trick-or-treating on Halloween.

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