President Obama Announces More Key Administration Posts

WASHINGTON, DC – Today, President Barack Obama announced his intent to nominate the following individuals to key Administration posts:

• Rebecca M. Blank – Deputy Secretary, Department of Commerce
• Larry Leon Palmer -Ambassador to Barbados, St. Kitts and Nevis, Saint Lucia, Antigua and Barbuda, the Commonwealth of Dominica, Grenada, and Saint Vincent and the Grenadines, Department of State
• Coral Pietsch - Judge, United States Court of Appeals for Veterans Claims
• Jessica Rosenworcel– Commissioner, Federal Communications Commission
• Michael A. Sheehan -Assistant Secretary of Defense for Special Operations and Low Intensity Conflict, Department of Defense

President Obamasaid, “I am confident that these outstanding men and women will greatly serve the American people in their new roles and I look forward to working with them in the months and years ahead.”

President Obama announced his intent to nominate the following individuals to key Administration posts:

Dr. Rebecca M. Blank, Nominee for Deputy Secretary, Department of Commerce
Dr. Rebecca M. Blank is the Acting Deputy Secretary of Commerce. In May 2009, Dr. Blank was appointed Under Secretary of Commerce for Economic Affairs.  As Under Secretary, Dr. Blank runs the Economic and Statistics Administration and is responsible for managing the two top statistical agencies in the United States, the Census Bureau and the Bureau of Economic Analysis. She was designated Acting Deputy Secretary on November 18, 2010 and subsequently Acting Secretary on August 1, 2011, a position she held until the confirmation of John Bryson as Secretary of Commerce.  Prior to joining the Obama administration, she was dean of the Gerald R. Ford School of Public Policy at the University of Michigan and co-director of the National Poverty Center.  Dr. Blank served as a member of the Council of Economic Advisers.  Prior to her service in the Clinton Administration, Dr. Blank taught economics at Northwestern University and Princeton.  She is a member of the American Academy of Arts and Sciences and a Lifetime Associate at the National Academies of Science. Dr. Blank holds a degree in Economics from the University of Minnesota, summa cum laude, and a Ph.D. in Economics from MIT. 

Larry Leon Palmer, Nominee for Ambassador to Barbados, St. Kitts and Nevis, Saint Lucia, Antigua and Barbuda, the Commonwealth of Dominica, Grenada, and Saint Vincent and the Grenadines, Department of State
Larry Leon Palmer, a career member of the Senior Foreign Service, served as President and CEO of the Inter-American Foundation from 2005 to 2010.  Previously, he was U.S. Ambassador to the Republic of Honduras from 2002 to 2005 and Charge D'Affaires in Quito, Ecuador.  Additional overseas posts have included the Dominican Republic, Uruguay, Paraguay, Korea, and Sierra Leone.  Ambassador Palmer served as Assistant to the President of the University of Texas at El Paso and President of the 41st Senior Seminar, a senior management course for Senior Foreign Service officers. Prior to joining the Foreign Service, Ambassador Palmer served as a Peace Corps volunteer in Liberia.  Ambassador Palmer received a B.A from Emory University, an M. Ed. from Texas Southern University and a Doctorate in Higher Education Administration and African Studies from Indiana University, Bloomington.  

Coral Pietsch, Nominee for Judge, United States Court of Appeals for Veterans Claims
Coral Pietsch currently serves as the Senior Civilian Attorney and Special Assistant in the Office of the Staff Judge Advocate for the U.S. Army Pacific.  She is a retired Brigadier General in the U.S. Army Judge Advocate General's Corps.  From 2005 to 2011, she was the Chair of the Hawaii Civil Rights Commission, and from 2007 to 2008, she served as the Deputy Rule of Law Coordinator for the Department of State's Baghdad Provincial Reconstruction Team.  Ms. Pietsch served as an Attorney-Advisor and Labor Counselor to U.S. Army Hawaii from 1986 to 1991.  From 1980 to 1986, she was a Deputy Attorney General for the State of Hawaii.  Ms. Pietsch was an active duty member of the U.S. Army Judge Advocate General Corps from 1974 to 1980.  While a member of the U.S. Army Reserve, she was promoted to Brigadier General and became the first female General officer in the Judge Advocate General's Corps as well as the first female Asian-American General officer in the U.S. Army.   She holds a B.A. from the College of St. Teresa, an M.A. from Marquette University and a J.D. from the Catholic University of America.

Jessica Rosenworcel, Nominee for Commissioner, Federal Communications Commission
Jessica Rosenworcel is the Senior Communications Counsel for the United States Senate Committee on Commerce, Science, and Transportation, working for Senator Jay Rockefeller IV since 2009, and previously for Senator Daniel K. Inouye from 2007 to 2008.  Before joining the Committee, she worked at the Federal Communications Commission from 1999 to 2007, serving as Legal Advisor and then Senior Legal Advisor to Commissioner Michael J. Copps (2003-2007), Legal Counsel to the Bureau Chief of the Wireline Competition Bureau (2002-2003), and as an Attorney-Advisor in the Policy Division of the Common Carrier Bureau (1999-2002).  From 1997 to 1999, Ms. Rosenworcel was a communications associate at Drinker Biddle and Reath.  Ms. Rosenworcel received a B.A. from Wesleyan University and a J.D. from New York University School of Law.   

Michael A. Sheehan, Nominee for Assistant Secretary of Defense for Special Operations and Low Intensity Conflict, Department of Defense
Michael A. Sheehan is currently a Fellow at the Combating Terrorism Center at West Point and has recently been a terrorism analyst for NBC News.  From 2003 to 2006, he served as the Deputy Commissioner for Counter Terrorism in the New York City Police Department.  From 2001 to 2003, he was the Assistant Secretary General of Mission Support in the United Nations Department of Peacekeeping Operations.  Mr. Sheehan was appointed as Coordinator for Counter Terrorism at the U.S. Department of State (1998-2000) and was confirmed by the Senate as Ambassador-at-Large in 1999.    Mr. Sheehan is a retired U.S. Army Special Forces officer; in this capacity he served on many overseas assignments including Panama, Korea, El Salvador, and Somalia.  He was awarded the Combat Infantry Badge for his service. While on active duty, he served at the White House on the National Security Council from 1989 to 1992 and again from 1995 to 1997. He holds a B.S. from the United States Military Academy at West Point, and an M.S. from Georgetown University School of Foreign Service.

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.

Fact Sheet: Obama Administration Takes Action to Reduce Prescription Drug Shortages in the U.S.

While the Food and Drug Administration has successfully prevented 137 drug shortages since the beginning of 2010, drug shortages have been increasing in frequency and severity in recent years and adversely affecting patient care.  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, going from 61 to 178. There are many causes and potential solutions to this challenge and addressing this significant public health problem will require the urgent attention of industry, other stakeholders, and government.

Today, President Obama will issue an Executive Order directing the FDA and Department of Justice to take action to help further reduce and prevent drug shortages, protect consumers, and prevent price gouging. These additional steps for early notification will help achieve some of the goals of bipartisan legislation in Congress, which the President supports, that will strengthen the FDA’s ability to prevent prescription drug shortages in the future.

The Executive Order is one in a series of steps that will help address the shortage of prescription drugs and ensure patients have access to the lifesaving medicines they need. Today, the Obama Administration will also:

• Send a letter to drug manufacturers reminding them of their legal responsibility to report the discontinuation of certain drugs to the FDA. The letter also encourages companies to voluntarily notify FDA about potential prescription drug shortages in cases where notification is not currently required.
• Increase 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.
• Release 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 its role in monitoring, preventing, and responding to these shortages.

President Obama’s Executive Order
Early notification of potential drug shortages can help FDA work with drug manufacturers, hospitals, doctors, and patients to prevent or mitigate a shortage before it becomes a crisis. Currently, Federal law requires drug manufacturers to notify FDA when production of critical drugs provided by only one manufacturer is being discontinued. The President’s order directs FDA to broaden reporting of potential shortages of certain prescription drugs. Additionally, the Executive Order requires FDA to expand its current efforts to expedite review of new manufacturing sites, drug suppliers, and manufacturing changes to help prevent shortages. 

While additional manufacturing capacity is necessary to fully address the drug shortage problem, early disclosure can have a significant, positive impact on the incidence and duration of drug shortages. This year alone, voluntary early notification by manufacturers allowed FDA to successfully prevent 99 drug shortages. Once FDA is notified of an existing shortage, the agency has multiple options to prevent or mitigate the drug shortage, and in many cases, takes more than one action.  In the shortages studied, the agency’s three most common actions were:

• Asking other firms to increase production (31%),
• Working with manufacturers to identify ways to mitigate quality issues, i.e. flexibility through regulatory discretion (28%), and
• Expediting review of regulatory submissions (26%).

FDA has also exercised regulatory discretion regarding controlled importation of similar products approved abroad but not approved in the United States in 5 percent of cases. 

Fighting Price Gouging
The President’s Executive Order also directs FDA to work with the Department of Justice to examine whether any secondary drug wholesalers or other market participants have responded to potential drug shortages by illegally hoarding medications or raising prices to gouge consumers.  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 shortage. 

Pending Legislation
These additional steps for early notification will help achieve some of the goals of bipartisan legislation sponsored by Senator Amy Klobuchar (S. 296) and Congresswoman Diana DeGette (D-CO) (H.R. 2245). Backed by the President, this legislation would require all prescription drug shortages to be disclosed and give the Food and Drug Administration new authority to enforce these requirements.  In the meantime, to complement the broadened notification and consistent with the goals of this legislation, the FDA will establish a voluntary notification process that will encourage manufacturers to disclose more potential shortages.

Increased Staffing Resources for the FDA Drug Shortages Program
Over the coming weeks, the FDA will tap six to eight members of a surge team with critical skills from across the Department to work in the Drug Shortage Program to enhance the Agency’s ability to prevent and mitigate drug shortages as a result of increased early notification by manufacturers.   When FDA becomes aware of a potential drug shortage, this Program works collaboratively with the affected firms to return the product to its usual market availability as quickly and as safely as possible while helping prevent any harm to patients.  It also encourages other firms that make the drug to ramp up production if they are willing to do so, expedites the review of submissions from manufacturers which may include requests to extend the expiration date of products, increase capacity, use a new raw material source, license new manufacturers, and permit changes in product specifications.  And, for manufacturing and quality problems, FDA works with the firm to address the issues. 

New Analyses from the Department of Health and Human Services
The HHS Assistant Secretary for Planning and Evaluation conducted an assessment of the underlying economic factors that lead to prescription drug shortages, particularly market factors that have contributed to shortages of sterile injectable oncology drugs.  The report finds that over the last several years,  growth in demand has occurred while the capacity of manufacturing facilities has remained stable, unable to keep up with demand.  Although sterile injectable drugs are a small percentage of the overall prescription drug market, they make up a disproportionate share of drugs in shortage and include critical drugs, such as oncology drugs.  Their report concludes that over time, entry of additional manufacturing facilities, and expansions in capacity should reduce the frequency of shortages due to supply disruptions.  The Administration plans on further outreach the industry, oncologists, and people with cancer to identify additional ideas on actions.

In addition, to better understand drug shortages, the FDA conducted a review of medical product shortage activities in its four medical product Centers, with an emphasis on reviewing what the agency has already done and is currently doing to address drug shortages.  FDA also spoke with external stakeholders to understand their perspectives on the current drug shortage problem.  Based on these conversations, a review of published and unpublished information on drug shortages, and analyses of databases either available or created for the report, the reports find that the shortage problem is complex and stems from economic, legal, regulatory, policy, and clinical decisions that are deeply interconnected.  FDA continues to work with manufacturers to help prevent and mitigate these shortages, but many potential solutions to drug shortages will require collaborative efforts among all relevant stakeholders.

Key Facts about Drug Shortages

• The number of reported drug shortages annually has tripled from 61 in 2005 to 178 in 2010.
• Of the 127 studied shortages in 2010-11, 80 percent involved drugs delivered to patients by sterile injection, including oncology drugs, antibiotics, and electrolyte/nutrition drugs.
• The leading reasons for the reported shortages were problems at the manufacturing facility (43%), delays in manufacturing or shipping (15%), and active pharmaceutical ingredient shortages (10%). 
• Manufacturing quality problems that have resulted in shortages can be serious, including findings of glass shards, metal filings, and fungal or other contamination in products meant for injection into patients.
• Sterile injectable drugs have unique manufacturing and market features which make shortages of these products more likely to occur and harder to prevent or mitigate,including:
  • Manufacturing them is complex and can more easily lead to problems that affect safety,
  • Dedicated manufacturing lines are often required,
  • The top three generic injectable manufacturers hold 71% of the market by volume,
  • Most sterile injectables have one manufacturer that produces at least 90% of the drug, and
  • “Just in time” manufacturing and inventorying practices leave little margin for error.

WEEKLY ADDRESS: "We Can't Wait" to Strengthen the Economy and Create Jobs

WASHINGTON—In this week’s address, President Obama told the American people that we can’t wait for Congress to take action to grow the economy and create jobs, and highlighted the executive actions he took this week to help families save thousands of dollars by refinancing their mortgages, put veterans to work, and lower the cost of student loans.  The President continued to urge Congress to do its part and pass the American Jobs Act now, which will put more money in the pockets of middle class families, create jobs and strengthen our economy right away.

Remarks of President Barack Obama
Weekly Address
The White House
Saturday, October 29, 2011

This week, a new economic report confirmed what most Americans already believe to be true: over the past three decades, the middle class has lost ground while the wealthiest few have become even wealthier.  In fact, the average income for the top one percent of Americans has risen almost seven times faster than the income of the average middle class family.  And this has happened during a period where the cost of everything from health care to college has skyrocketed.

Now, in this country, we don’t begrudge anyone wealth or success – we encourage it.  We celebrate it.  But America is better off when everyone has had the chance to get ahead – not just those at the top of the income scale.  The more Americans who prosper, the more America prospers.

Rebuilding an economy where everyone has the chance to succeed will take time.  Our economic problems were decades in the making, and they won’t be solved overnight.  But there are steps we can take right now to put people back to work and restore some of the security that middle-class Americans have lost over the last few decades.

Right now, Congress can pass a set of common-sense jobs proposals that independent economists tell us will boost the economy right away.  Proposals that will put more teachers, veterans, construction workers and first responders back on the job.  Proposals that will cut taxes for virtually every middle class family and small business in America. These are the same kinds of proposals that both Democrats and Republicans have supported in the past.  And they should stop playing politics and act on them now.

These jobs proposals are also paid for by asking folks who are making more than a million dollars a year to contribute a little more in taxes.  These are the same folks who have seen their incomes go up so much, and I believe this is a contribution they’re willing to make.  One survey found that nearly 7 in 10 millionaires are willing to step up and pay a little more in order to help the economy.

Unfortunately, Republicans in Congress aren’t paying attention.  They’re not getting the message.  Over and over, they have refused to even debate the same kind of jobs proposals that Republicans have supported in the past – proposals that today are supported, not just by Democrats, but by Independents and Republicans all across America.  And yet, somehow, they found time this week to debate things like whether or not we should mint coins to celebrate the Baseball Hall of Fame.  Meanwhile, they’re only scheduled to work three more weeks between now and the end of the year.

The truth is, we can no longer wait for Congress to do its job.  The middle-class families who’ve been struggling for years are tired of waiting.  They need help now.  So where Congress won’t act, I will.

This week, we announced a new policy that will help families whose home values have fallen refinance their mortgages and save thousands of dollars.  We’re making it easier for veterans to get jobs putting their skills to work in hospitals and community health centers.  We reformed the student loan process so more young people can get out of debt faster.  And we’re going to keep announcing more changes like these on a regular basis.

These steps will make a difference.  But they won’t take the place of the bold action we need from Congress to get this economy moving again.  That’s why I need all of you to make your voices heard.  Tell Congress to stop playing politics and start taking action on jobs.  If we want to rebuild an economy where every American has the chance to get ahead, we need every American to get involved.  That’s how real change has always happened, and that’s how it’ll happen today.

Thank you.