Earmarks and Instructions
As usual, Congress utilizes the appropriation process to micromanage FDA operations. The agency will get an extra $56 million to bolster oversight of food products and imports, but only if FDA provides Congress with an acceptable food-safety performance plan. The legislation authorizes FDA to collect nearly $460 million in prescription drug user fees, but axes the new DTC ad review program (see sidebar). Congress specifies a $42 million budget for the Office of Generic Drugs, up $6 million, and earmarks half of the $20 million added for drug safety activities for FDA's drug safety office. The agency's Critical Path Initiative gets an extra $7 million—much less than initially proposed by the Senate—with the requirement that one-third of those funds have to be handed out in grants to universities and nonprofits. For example, Ray Woosley's Critical Path Institute and the University of Utah received $563,000 to support research on warfarin dosing.
And FDA has to produce a long list of studies and reports on everything from Ketek safety to microbial resistance. The final legislation omits an earlier provision to expand drug reimportation but still requires FDA to analyze how well it oversees foreign manufacture of active drug ingredients.
Several provisions reflect ongoing concerns on Capitol Hill about excessive pharmaceutical industry influence on FDA policies. Congress reminds FDA to reduce the number of advisory committee members with conflicts of interest. And it takes a big swipe at the nascent Reagan-Udall Foundation by stipulating that FDA cannot use any appropriated funds to support this new organization.
That curb reflects the concerns of Rep. Rosa DeLauro (D-CT), chair of the House Appropriations subcommittee that oversees FDA, that Reagan-Udall provides an avenue for manufacturers to shape FDA safety initiatives—similar to how The Tobacco Institute supported research refuting health concerns about cigarettes. The FDA Amendments Act (FDAAA) allowed FDA to provide up to $1.25 million for this public–private entity to advance drug development science, but DeLauro flexed her legislative muscle and inserted the funding hold in the final bill.
It didn't help politically that one of the newly named Reagan-Udall board members was Tachi Yamada, former GlaxoSmithKline R&D chief who now heads the Bill & Melinda Gates Foundation's global health program. Unfortunately, this eminent researcher recently came under fire on Capitol Hill for allegedly pressuring a researcher for Glaxo not to raise safety concerns about Avandia.
While FDA officials hope to assuage DeLauro's concerns, the rift is likely to delay Reagan-Udall projects: One possible initiative was to encourage collaboration on standards for a new pharmaceutical active-surveillance system that FDAAA also added to FDA's to-do list. Former FDA commissioner Mark McClellan, recently named to chair Reagan-Udall, is a strong advocate for using health system databases and advanced IT systems to detect and analyze safety problems earlier and faster and was poised to tackle this challenging task.