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.