Congress approves user fees, safety policies for FDA

WASHINGTON, D.C.-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 television ads.

One important late compromise was to retain six-month 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 HAS LEEWAY

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-plus-page bill (available at http://energycommerce.house.gov/), which will keep a lot of lawyers and policy analysts very busy.