Congress Approves User Fees, Safety Policies for FDA

September 27, 2007
Jill Wechsler

Jill Wechsler is ACT's Washington Editor

Applied Clinical Trials

Congress Approves User Fees, Safety Policies for FDA

WASHINGTON, DC, September 2007-House and Senate leaders finally agreed on compromise legislation to renew prescription user fees late last month, just a few days before the funding program was set to expire. The 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, biotech and medical device companies that already raised fees considerably. There’s also a new fee program to support FDA pre-review of DTC TV 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 block-buster 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 post-approval studies could be hit with new fines. And the final bill includes language that could undermine FDA authority to pre-empt 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 [available at], which will keep a lot of lawyers and policy analysts very busy.