FDA Head Faces Reality, Asks Congress for More Funding

Beleaguered Food and Drug Commissioner (FDA) Dr. Andrew C. von Eschenbach has finally written Congress saying the FDA needs an immediate $275 million to ensure the safety of imported foods, <"http://www.yourlawyer.com/practice_areas/defective_drugs">drugs, and medical devices.  The May 5 request was sent to Senator Arlen Specter—Republican-Pennsylvania—and provides a detailed spending plan:  $125MM to finance food safety activities, $100MM for medical product and drug safety activities, $40MM for modernizing the FDA’s science and work force, and $10MM to upgrade agency facilities and laboratories.

Presidential appointees do not generally deviate from the president’s spending plans and, if so, not in writing.  von Eschenbach’s move surprised many and was seen as a sign of the president’s fading authority in the closing months of his presidency.  “In 30 years at the agency, I never saw anything like this happen before,” said William Hubbard, a former deputy FDA commissioner.

On May 1, Specter wrote von Eschenbach asking for how much the FDA needed “to protect the public’s health.”  In a handwritten note in the margin, Specter wrote, “Andy, I know the situation is extreme.  I want to get you financial help now.”  von Eschenbach wrote that he was providing his budget “without regard to the competing priorities that the agency, the president, and their advisors must consider as budget submissions to the Congress are developed.”

Bush asked Congress to provide an allocated budget for fiscal year 2009 of $1.77 billion, an increase of $50.7 million over 2006, which was seen as insufficient to cover increased FDA salary expenses.  von Eschenbach has suffered unrelenting criticism from the House and Senate Democrats following repeated scandals and on Capitol Hill, there is a bipartisan consensus the FDA must conduct increased inspections of foreign drug plants and imported food.

In April, at a House Energy and Commerce Subcommittee on Investigations, Representative John D. Dingell—Democrat-Michigan and chairman of the commerce committee—repeatedly asked von Eschenbach for a figure that would enable the FDA to conduct adequate inspections saying, “You cannot do your job, you are not doing your job, how much money do you need to do it?”  von Eschenbach did not give an amount.  A week earlier, Senator Robert F. Bennett—Republican-Utah—looked for a figure from von Eschenbach who only said that the FDA could not efficiently absorb a $375 million increase in its budget next year.  In this week’s letter, von Eschenbach said the FDA could absorb an additional $275 million in the next few months.

Last week, Senator Herb Kohl—Democrat-Wisconsin and Senate appropriations subcommittee Chairman—sponsored a measure to give the FDA an additional $275 million this year as part of an emergency supplemental appropriations bill largely intended to finance the war in Iraq.  The subcommittee has jurisdiction over the FDA and this may be the only way to provide additional FDA funding as appropriations bills are expected to be delayed.  The bill echoes von Eschenbach’s financial breakdown.

When told of von Eschenbach’s letter to Specter, Dingell said he wondered “why the commissioner is beginning to finally recognize what has been painfully obvious to everyone else.”

This entry was posted in Legal News, Pharmaceuticals. Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.