Washington Editor

WASHINGTON Members of a House subcommittee told FDA leaders Wednesday the agency’s failure to submit its “goals letter” for the pending Prescription Drug User Fee Act III could hold up reauthorization of the act.

The Prescription Drug User Fee Act (PDUFA) II, which allows the FDA to charge biotechnology and pharmaceutical companies fees for drug applications, expires in September. During the last year, industry and agency leaders negotiated terms for PDUFA III, but apparently failed to compile and complete a list of goals needed as part of the package for Congress.

The FDA has long threatened that if a lapse occurs between the expiration of the current act and reauthorization of the next, the agency will be forced to lay off highly qualified scientists who are responsible for reviewing drug and biologics license applications. Last year PDUFA generated about $140 million to help pay salaries.

But in the House Energy and Commerce Subcommittee on Health hearing Wednesday, members of Congress turned the tables on the agency, essentially telling them without cooperation, PDUFA could end up on the bottom of the “things to do” list.

Rep. Anna Eshoo (D-Calif.) went so far as to remind FDA leaders that 2002 is an election year, and “this session will be over in October. We need your goals letter.”

The Washington-based Biotechnology Industry Organization has been quoted as saying the goal for PDUFA reauthorization is June.

On behalf of the FDA, Lester Crawford, a veterinarian tapped by the Bush administration last week to serve as FDA deputy commissioner and now the agency’s senior official, said the agency should have the goals prepared within a few days. (See BioWorld Today, Feb. 28, 2002.)

Aside from the letter issue, the FDA and the drug industry may be fighting an uphill battle when attempting to convince some members of Congress that PDUFA is good for the industry, agency and public.

“With all due respect, the Republicans jump when the drug industry says jump, and they race to pass legislation when the drug industry wants to pass it,” Rep. Sherrod Brown (D-Ohio) said. “We need to make sure the legislation and related agreements strike the proper balance between speedier drug approvals and drug safety. We need to evaluate whether the FDA is overreaching in its performance goals and ensure that the agency is devoting sufficient resources to pre- and post-market safety activities.”

Since PDUFA I was approved in 1992, the FDA said drug review times have dropped from a high of 30 months to less than 18 months, in some cases. The fees have enabled the agency to hire additional staff (about 2,500 reviewers now, compared to 1,277 in 1992), leading to swifter review periods.

Industry leaders were nervous a few weeks ago when President George Bush released a $2.13 trillion national budget that includes a 133 percent fee increase meaning an application filing fee could cost up to $700,000. In fiscal year 2001, the fee was about $309,647 per application.

Subcommittee Chairman Michael Bilirakis (R-Fla.) characterized PDUFA as a partnership of the agency, industry and patients. “I think it is important to state that this program was not created to ensure approvals. The FDA and Congress strongly believe that products should only be approved by the agency when they prove to be safe and effective. Payment of user fees in no way guarantees approval of a product.”

However, Brown and Rep. Bart Stupak (D-Mich.) were not so easily convinced by the chairman’s statement.

“We need to make sure this law strikes the proper balance between speedier drug approvals and drug efficacy,” Brown said. “We need to make sure that drug companies are completing all the clinical studies they commit to. Absent complete data and proper drug labeling, faster drug approvals could simply hasten improper use or inappropriate substitution of new drugs for existing ones.”

Stupak added that if Congress appropriated enough money for the FDA, the agency wouldn’t have to rely on industry fees, and therefore, would owe allegiance to no one but patients.

“What have we compromised with these fees?” he asked.