Bill would reauthorize FDA fees for drugmakers

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.

The Senate approved its bill in May, while the House passed legislation in July. Although both bills would require the same basic measures, namely establishment of a computerized network to scan public and private health insurance and pharmacy records for possible safety problems, the House version does not include a timetable for implementing the network. The bills also differ on the amounts of fines that can be levied against drug companies that violate safety regulations. The House would fine companies up to $10 million for a single violation, while the Senate would impose a $1 million fine.

Only the Senate bill contains a controversial provision that would allow the FDA to approve generic versions of biologic drugs. Biologics are derived from living cells, and some observers argue that they would be difficult to duplicate in generic versions.

The AMA has worked on both bills with the intention of preserving "physicians' ability to prescribe drugs that are necessary for the care of their patients without onerous government-imposed restrictions," said Cecil B. Wilson, MD, immediate past chair of the AMA Board of Trustees.