Open Season on FDA - Pharmaceutical Executive

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Open Season on FDA
Congress is firing plenty of ammunition at pharma companies—and the regulators


Pharmaceutical Executive



Jill Wechsler
Even though federal legislators approved a significant expansion of prescription-drug regulation last fall, there has been no let-up in accusations against and investigations of the pharmaceutical industry—or criticism of the Food and Drug Administration. An article in the New England Journal of Medicine (Jan. 17, 2008) reignited concerns about the loss of valuable information from clinical studies on antidepressants that were never published—the "wastebasket effect." Even FDA action halting marketing of cold medicines to young children generated questions about the value of other pediatric treatments.

The latest big eruption involves the combo anticholesterol drug Vytorin (ezetimibe/simvastatin). Comarketers Merck and Schering-Plough ran into a buzz saw when they released less-than-stellar efficacy results after what seemed an unreasonable delay. Heavy DTC marketing for the drug was pulled in an attempt to quell the storm, as trial lawyers filed suits charging consumer fraud from Vytorin claims of being more effective than low-cost generics. Congressional critics even raised questions about whether FDA should rely on cholesterol levels as a biomarker for preventing heart disease.

And the Ketek (telithromycin) controversy, like the battery-powered bunny, just keeps going and going. The House Energy and Commerce Committee subpoenaed testimony from FDA criminal investigators on what they knew about research fraud related to testing the Sanofi-Aventis antibiotic—and when they and the company knew it. The legislators are demanding volumes of FDA documents to see if Commissioner Andrew von Eschenbach presented misinformation in testimony last year on Ketek safety concerns.

Funding Foibles


Boost for Biosimilars
Von Eschenbach is spending a lot of time on Capitol Hill addressing these issues and charges that FDA's paltry resources have made it ineffective and unable to protect public health. Members of the E&C Oversight subcommittee drilled von Eschenbach in January on how he was (or was not) responding to charges by the agency's Science Board that FDA is vastly underfunded and in danger of breaking down. The commissioner would not estimate the cost of remedying these problems, so Rep. Henry Waxman (D-CA) and Sen. Edward Kennedy (D-MA) asked the Government Accountability Office (GAO) to examine FDA's staffing, IT, and resource needs. In addition, E&C leaders asked Gail Cassell of Eli Lilly, who chaired the Science Board subcommittee, to have her panel determine whether the administration's 2009 FDA budget plan will address the funding problems raised in the Board's report.

It's unlikely that Cassell's group will have much praise for the FDA budget proposal. Attorney Peter Barton Hutt, who calculated FDA's funding shortfall for the Science panel, told the House panel that FDA needs to double its appropriations over the next two years and to increase staff by 50 percent.

Although FDA got nearly a 6 percent increase in 2009 funding to $2.4 billion, most of the gain is from rising user fees that support select programs. FDA appropriations are only $1.8 billion—way below the $2.1 billion level sought by the Alliance for a Stronger FDA. The administration's budget, said former FDA official and Alliance spokesman Bill Hubbard, provides "barely half of what FDA needs just to keep pace with inflation."

Moreover, the $628 million in user fees includes $16 million from generics makers, which that industry opposes without a number of regulatory reforms. It also includes $6 million in fees to support pre-review of DTC TV ads, a program FDA wants to revive after Congress refused to appropriate it for this year. While critics fulminate about FDA's increased reliance on industry payments, the user fees keep going up to fill in the gaps created by funding shortfalls.


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