FDA STRATEGY TO HEAD OFF LEGISLATIVE FIXES TO BE SHAPED BY PDUFA
Pending industry user fee reauthorization will strongly shape the FDA's likely effort to use regulatory action to preempt legislative fixes for a number of issues in the next Congress, sources say.
The agency has recently taken a number of steps to address lawmakers' and other parties' concerns with a variety of official actions immediately before and after the midterm elections. These efforts include: a recent speech by a high-ranking official laying out the FDA's position on drug safety; scheduling a workshop on unapproved drugs; issuing a flurry of warning letters to companies selling unapproved products; and releasing two documents outlining agency enforcement priorities and further defining who is covered by the new pedigree requirement.
The incoming Democratic leadership has targeted a number of issues involving the agency. Critics such as Reps. John Dingell (D-Mich.), Henry Waxman (D-Calif.) and Rosa DeLauro (D-Conn.) will now be in the majority and want to improve the agency's drug safety oversight and address its committee conflict of interest policies and clinical trial protocols. New Senate leaders, including Sens. Edward Kennedy (D-Mass.), Max Baucus (D-Mont.), Patrick Leahy (D-Vt.) and Herb Kohl (D-Wis.), are targeting drug safety oversight, drug prices, generics and intellectual property protections.
"The FDA has that pattern of trying to eclipse legislation" through regulatory steps, Marc Scheineson, a partner at the law firm Alston & Bird and former FDA associate commissioner for legislative affairs, said. The FDA is "laying down a baseline" of what changes are not necessary, Paul Kim, former deputy staff director for health policy for Kennedy, said. The agency is hoping to "shape what Congress is thinking" going into the next session, he added.