Medical Device Daily Washington Editor

WASHINGTON — The FDA funding merry-go-round has been in the works for better than a decade and a half, but that has not stopped the often outspoken Rep. John Dingell (D-Michigan) and others on Capitol Hill from lambasting the current FDA commissioner, Andrew von Eschenbach, MD, for his failure to play the squeaky wheel (Medical Device Daily, April 24, 2008).

However, von Eschenbach has reversed field and, in a break with past FDA commissioners, requested additional funding from Congress in a professional judgment letter as Congress pastes together a comprehensive spending bill of roughly $3 trillion.

In response to a letter from Sen. Arlen Specter (R-Pennsylvania), the FDA chief has requested a bolus of $275 million, which FDA would dedicate to programs that ensure the safety of food, drugs and medical devices. Roughly $100 million would go for drug and device safety while $125 million would go toward food safety. The balance would go toward facilities and personnel.

The move took observers by surprise, with some speculating that von Eschenbach decided to unilaterally make the request because he saw the influence of the Bush Administration waning. Others have suggested the possibility that he made the request with the tacit or expressed — but not publicized — approval of the administration.

Perhaps the most difficult question to answer is whether this will become a precedent or a one-time event, but another question that is difficult to ignore is why Congress took so many years to pay attention to FDA other than to pile on mandates.

Former associate FDA commissioner Bill Hubbard is widely quoted as having said "[i]n 30 years at the agency, I never saw anything like this happen before." Hubbard now serves as a senior adviser to the Coalition for a Stronger FDA (Washington).

In response to von Eschenbach's letter, Sen. Herbert Kohl (D-Wisconsin) has inked in $275 million for FDA in the current fiscal year's budget as part of the emergency supplemental appropriations bill now working its way through Congress. Kohl chairs the Senate Appropriations subcommittee that has jurisdiction over FDA, the clumsily named Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies.

Hubbard told Medical Device Daily that because von Eschenbach "has been increasingly criticized about not talking about FDA's needs ... I guess he felt he had to step forward" with a position.

He also reiterated that the move is at least "somewhat unusual, and I don't know if he did it with the tacit approval of the Secretary [of Health and Human Services Mike Leavitt] or OMB [the Office of Management and Budget]." Hubbard said von Eschenbach's reluctance to argue for a boost was destroying his credibility. "Group after group has been saying FDA is underfunded," and the FDA chief "was becoming increasingly incredible on that" point, Hubbard said.

"It's [also] possible the administration said 'our budget is out, if you want to get more from Congress, go at it,'" Hubbard said. Von Eschenbach may also have had an eye on the short calendar left to the 110th Congress. The August recess will be followed by the distractions of congressional and presidential campaigns, and "von Eschenbach might have said to himself 'if I'm going to get any money, I need to ask for it now,'" Hubbard said.

Physician Rx for FDA: less slamming

It's no longer just journalists who are making the argument that FDA's critics need a dose of reality. Now physicians are beginning to have the same questions, as a recent edition of the New England Journal of Medicine makes clear.

Writing in the April 4 edition of NEJM, Alastair Wood, MD, a professor of medicine at Weill College of Medicine (New York), states that public opinion polls indicate that the press treatment of the agency has brought public confidence in FDA "from 80% in the 1970s to 36% in 2006 — ratings usually reserved for tobacco companies and used car dealers."

Wood said that the Vioxx and tainted heparin episodes fuel much of the skepticism, but said the agency's critics have ignored "the responsibilities of others and the fact that the agency's federal funding is grossly inadequate." Wood also made the case that "[k]icking the FDA has become a popular sport for the press and legislators, but by failing to hold others accountable, it puts the public health at serious risk while carrying no personal risk for those who play it."

Wood stated that more than 80% of FDA's computer servers "are more than five years old" and that many clinical trial records are recorded on hardcopy "in warehouses, largely inaccessible for analysis," and pointed out that FDA's information technology budget "is about 40% of that for the Centers for Disease Control and Prevention."

Wood criticized the media for its reports of "legislators' criticisms of the agency without providing any analysis of their voting records on FDA appropriations," but said "the bigger scandal is Congress' grossly inadequate funding of the agency." Wood argued that "no longer should our legislators be able to publicly excoriate FDA employees while ignoring their own complicity," adding that "[n]o longer should any of us berate the FDA while failing to acknowledge that we are asking it to do more and more work with fewer and fewer resources."