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Friday, May 16, 2008

Why Von Eschenbach Bucked Bush: The Fight Over FDA Funding

As the New York Times reported earlier this week, FDA commissioner Andrew von Eschenbach did what has never been done before in the 100-plus years of the agency: he wrote a letter to Congress asking for more appropriated dollars for FDA.

Given the number of unfunded mandates handed to FDA over the years—and the recent demands on drug safety and overseas inspections—it should come as a surprise to no one that the agency is underfunded.

But for the FDA commissioner to make such a direct request to Congress for more money is an earth-shattering move: especially this commissioner who has shown a willingness to take a lot of criticism and abuse for defending Administration positions.

FDA has historically remained in lock-step with senior Administration officials over budget requests. The agency traditionally defers to a number of higher power centers on budget issues, including the budget enforcers at the Office of Management and Budget. Never before has an FDA commissioner publicly asked for anything from Congress that is at odds with what is in the president’s congressional budget request, in this case a 3% increase for fiscal year 2009.

But in a May 5 letter responding to a request from Sen. Arlen Specter (R-Penn.), von Eschenbach broke ranks with the White House and did just that. Specter is the ranking member of the Senate appropriations subcommittee that oversees HHS’ budget.

Using carefully worded language, von Eschenbach said that in his “professional judgment” and “without regard to the competing priorities,” FDA could use an additional $275 million in funding. The letter creates a new version of the Washington ruse of “plausible deniability.” By stressing that it is his professional judgment, von Eschenbach can continue to sound like a committed (professional) manager of FDA while denying that he is second-guessing his bosses.

Much has been made of the letter, but as earth-shattering as the request was, it didn’t come out of nowhere. Rather, it was the culmination of a series of baby steps taken by von Eschenbach over the last several months.

To Steven Grossman, deputy executive director for government relations and communications at the Alliance for a Stronger FDA, the “visible transition point” came during an Energy & Commerce Oversight & Investigations Subcommittee hearing January 30. The 180-member Alliance for a Stronger FDA has been lobbying for additional dollars for FDA; we wrote about the group in a story in The RPM Report here.

The hearing was called in response to an FDA Science Board report that detailed numerous deficiencies in the agency’s ability to meet its scientific mission. As we reported in an earlier post on the IN VIVO Blog, subcommittee chairman Bart Stupak repeatedly asked von Eschenbach whether the Administration’s budget proposal for FY 2009 was sufficient to meet FDA’s needs.

The commissioner demurred, noting that at the time, President Bush had yet to release the budget request. But as Grossman points out, von Eschenbach showed some fissures in his resolve to stick to the party line: he acknowledged that the budget was less than what he had requested from the Administration for FDA.

A month later, von Eschenbach conducted an interview with Wall Street Journal, in which he sought to correct a misperception that he didn’t think FDA needed more resources. That story was followed two days later by a keynote address at the National Press Club. (We wrote about that shift in von Eschenbach’s public comments about FDA resources in an earlier blog post here.)

After that, von Eschenbach appeared to take a couple steps backwards, first telling the Senate appropriations subcommittee on April 15 that FDA couldn’t absorb the $375 million in funding included in the Senate budget resolution. A week later, it took a long and heated exchange with Rep. John Dingell during an Oversight & Investigations hearing for von Eschenbach to acknowledge that FDA needed $70 million for overseas inspections.

So what made von Eschenbach finally publicly admit what everyone else seems to have known for a long time? We don’t claim to have any specific insight into what the commissioner was thinking, but there are a few things worth pointing out.

First, von Eschenbach and Sen. Specter had an amiable relationship long before the commissioner moved to FDA. Specter served as the chairman of the appropriations subcommittee while von Eschenbach was head of the National Cancer Institute. The two are also cancer survivors: Specter was diagnosed with Hodgkin’s disease in 1995, and von Eschenbach is a survivor of melanoma and prostate cancer.

Given that relationship, Sen. Specter may have been one of the few congressmen able to give von Eschenbach a way out of FDA’s budget crunch. In his letter to the commissioner, Specter wrote by hand in the margin, “Andy, I know the situation is extreme. I want to get you financial help now,” according to the Times.

And it’s also worth mentioning that other federal agencies have recently broken ranks with the Administration over budget requests. Last year, Julie Gerberding, head of the Centers for Disease Control & Prevention, issued a strongly-worded letter to Congress about its budgetary needs—in language much less diplomatic than von Eschenbach’s.

Much has been already written about how the letter marks the waning influence of the Bush Administration. While that may be true, it’s just as likely that von Eschenbach simply grew tried of trying to defend an indefensible situation. To the growing number of groups seeking more funding for FDA, it would be nice if von Eschenbach’s letter leads to some real money.

Boehm bucking broncho at Madison Antiques and Gifts.

2 comments:

Margaret Anderson, COO, Fastercures said...

The FDA's ability to harness advances in medical research has been significantly hampered because of budget shortfalls. We ask a lot of the FDA and we expect a lot. But we don’t support it a lot. The FDA, charged with protecting 300 million people, has a budget that is the same in real dollars as in 1996 and that mirrors Montgomery County Maryland's school budget.

The budget is holding the FDA back and preventing the agency from maximizing the benefits of historical advances in science for the American public. Yes, it would be nice if this letter leads to some real money.

-Margaret Anderson, Chief Operating Officer, FasterCures and board member, Alliance for a Stronger FDA

Margaret Anderson, COO, Fastercures said...

The FDA's ability to harness advances in medical research has been significantly hampered because of budget shortfalls. We ask a lot of the FDA and we expect a lot. But we don’t support it a lot. The FDA, charged with protecting 300 million people, has a budget that is the same in real dollars as in 1996 and that mirrors Montgomery County Maryland's school budget.



The budget is holding the FDA back and preventing the agency from maximizing the benefits of historical advances in science for the American public. Yes, it would be nice if this letter leads to some real money.



-Margaret Anderson, Chief Operating Officer, FasterCures and board member, Alliance for a Stronger FDA


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