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 http://energycommerce.house.gov], which will keep a lot of lawyers and policy analysts very busy.