Lawmakers still debating PDUFA IV

Key Points

There has been considerable congressional action with regard to FDA-related legislation. The Senate recently approved the FDA Revitalization Act, setting the stage for further deliberations in the House over drug safety and FDA user fees.

The House Energy and Commerce Committee has been holding hearings on drug safety, user fees for drugs and medical devices, follow-on biologics, and food safety.

Members of the Senate Committee on Health, Education, Labor and Pensions (HELP) have promised to complete work on legislation that would allow for follow-on biologics, which could be included in a larger FDA measure during House-Senate negations on a final bill.

Although legislators and FDA are confident a user fee bill will be approved this year, final deliberations could move into the fall if issues surrounding generic drugs and drug reimportation create an impasse.

Senate HELP committee chairman Edward Kennedy (D–Massachusetts) and ranking Republican Michael Enzi (Wyoming) avoided a stalemate in the Senate by engineering compromises on a number of controversial amendments. The most prominent was an effort by Democrats to add a measure that would permit drugs to be imported from Canada. President Bush threatened to veto suchlegislation, prompting Sen Kennedy to support a second amendment that radically changes the amendment by restricting imports to drugs that FDA has deemed safe and more cost effective to Americans.

The final Senate PDUFA bill is a massive piece of legislation that includes provisions to ensure food safety and to renew medical device user fees. The bill also allows the renewal of pediatric research incentives and requirements, but reduces exclusivity to 3 months for drugs with sales of more than $1 billion.

Just before the bill moved to the Senate floor for approval, Sen Kennedy and Sen Enzi agreed to modify some of the earlier drug safety provisions, namely adding a requirement of a special risk evaluation and mitigation strategy (REMS) only for new drugs that are associated with serious adverse events during clinical trials or postapproval. The final bill also drops the 2-year waiting period for direct-to-consumer advertising of new drugs, opting instead for required presubmission of planned ads and substantial fines for marketers that run false or misleading promotions. One late change to the bill would double maximum fines to $2 million for violations of safety provisions.

The Senate also approved provisions that would curb abuses of citizen petitions to delay generic drug marketing and encourage development of new antibiotics and therapies for treatment of certain diseases.

The bill calls for FDA to manage the full life cycle of drugs, as opposed to its traditional focus on preapproval testing. The legislation includes provisions that would make it easier for FDA to mandate label changes and postapproval studies; FDA would also be required to post information regarding ongoing clinical trials and study results. The bill also allows for expansion of the electronic information systems FDA uses to evaluate adverse events and greater capacity to monitor potential safety problems associated with marketed drugs.

The final bill calls for an immediate $25 million increase in drug user fees (in addition to the $443 million in fees already expected in 2008) to support additional drug safety requirements; subsequent increases are also included in the bill.

FDA advocates say the additional funds aren't enough to meet the agency's objectives outlined in the PDUFA bill; they seek $2 billion in appropriated funds, in addition to the user fees, for 2008.