Congress Approves User Fees, Safety Policies for FDA

Washington, D.C. (Sept. 21)-House and Senate leaders finally agreed on compromise legislation to renew prescription user fees, just a few days before the funding program was set to expire. The US Food and Drug Administration legislation increases drug-user fees by $225 million over five years, in addition to adopting user-fee agreements negotiated with pharmaceutical, biotechnology and medical device companies that already raised fees considerably. There’s also a new fee program to support FDA prereview of direct-to-consumer television ads.

One important late compromise was to retain six-months exclusivity for sponsors that conduct studies providing pediatric labeling information, defeating a move to limit exclusivity to three months for blockbuster drugs. The legislation also continues a five-year “sunset” policy for a related rule that gives FDA authority to require pediatric studies under certain conditions, instead of making that authority permanent.

FDA retains some leeway in deciding when to require a Risk Evaluation and Mitigation Strategy (REMS) for a new drug, but the agency is expected to implement this drug-safety program broadly. Sponsors will have to post clinical trial results to a new database, but the details of that process-including disclosure of results for never-approved products-probably will take months, if not years, to finalize and implement. The final bill also gives FDA some flexibility in allowing conflicts-of-interest waivers for advisory committee members, another policy that will face increased scrutiny.

Manufacturers that violate REMS requirements or fail to complete postapproval studies could be hit with new fines. And the final bill includes language that could undermine FDA authority to preempt state laws imposing different disclosure and labeling policies than the federal agency, a very troubling provision for industry as well as FDA. It will take months to unravel all the details in this

400+-page bill

, which will keep a lot of lawyers and policy analysts very busy.