Bill would reauthorize FDA fees for drugmakers

As the House and Senate work to resolve differences on legislation that also includes drug-safety provisions, FDA employees are handed a reprieve on lay-off notices.

By Susan J. Landers, AMNews staff. Aug. 20, 2007.

Washington -- Drug safety continues to be a hot topic on Capitol Hill.

Congress has been crafting legislation to reauthorize the Food and Drug Administration's prescription drug user fee program, which is set to expire at the end of September. The measure also contains several drug-safety upgrades.

Separate bills have been passed by each chamber, and differences between them are being ironed out.

FDA officials and others have been eagerly awaiting a final law, warning legislators that without the reauthorization measure in place, employees would have to be laid off because the user fees pay their salaries.

But in something of a reprieve, FDA Commissioner Andrew von Eschenbach, MD, told reporters during an Aug. 2 meeting that "carry-over" funds are available to pay salaries. These reserve funds should last until September, said Dr. von Eschenbach.

Congress was scheduled to adjourn at the beginning of August and not return until September, when conferees are expected to renew their reconciliation efforts.

In addition to continuing the user fee program -- in which pharmaceutical companies are expected to pay the agency about $390 million next year to have their products reviewed promptly -- both measures contain several provisions intended to improve postmarketing surveillance of drugs, and dedicate funds to that effort.