Final form of US drug user fee renewal bill still uncertain

15 March 2002 18:19  [Source: ICIS news]

WASHINGTON (CNI)--The US Food and Drug Administration (FDA) and the drug industry have agreed on renewal of the Prescription Drug User Fee Act (PDUFA), but a renewal bill's provisions are uncertain, sources said Friday.

Congressional aides note that the draft agreement sent to Capitol Hill earlier this week includes provisions that for the first time would allow FDA to use industry fees to expand its monitoring of drugs and biologic products for up to three years after they reach the market.

The draft agreement also gives FDA more flexibility in directing those fees to where they are needed the most within the agency.

But aides reviewing the proposal note that both Senate Health Committee Chairman Edward Kennedy (Democrat-Massachusetts) and House Energy and Commerce Committee Chairman Billy Tauzin (Republican-Louisiana) have expressed a desire for a "clean bill" that simply increases funding for the current program.

Aides indicate that the key committees are prepared to go along with the FDA/industry deal under which fees paid by drugmakers to speed FDA reviews of new products would rise from $160m (Euro180m) in fiscal 2001 to $223m in fiscal 2003 and $260m by fiscal 2007.

"We do not want a repeat of the FDA reform battle that took place in 1997," said a Kennedy spokesman, referring to the agency-wide overhaul that took nearly two years to complete the last time the user fee law was up for reauthorization.

He said Kennedy is "exploring all possibilities" for moving PDUFA legislation, but no hearings are expected until late April or early May, around the time Tauzin's committee plans to hold a vote on a reauthorization bill.

An Aide to Representative John Dingell of Michigan, ranking Democrat on the Energy and Commerce Committee, said he believes the panel should consider some broader FDA issues.

However, attempts to add amendments to the PDUFA bill concerning drug company advertising practices or antitrust provisions are not expected to succeed in the Republican-led House committee.

The new user fee plan would allow FDA to add 100 employees, doubling its drug review and approval staff by 2007. The system has been widely credited with cutting by 50% review and approval times for new drugs over the past 10 years.

Although the program has broad bipartisan support in Congress, Public Citizen and other consumer activists have charged that the user fees threaten to make FDA a captive of the industry it regulates.

For example, they complain that FDA's agreement with the drug industry would give manufacturers the option of requesting that independent consultants help design "Phase III" safety trials and provide guidance to companies on how to move their products through the approval pipeline.

However, the Biotechnology Industry Organization (BIO) dismisses such criticism, pointing out that FDA would select and screen the consultant and retain final decision-making authority.

By: Glenn Hess
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