West Coast Editor

With only a few adjustments, the House gave its blessing Wednesday by a vote of 425-1 to the renewal of the Prescription Drug User Fee Act, passing the measure as part of a bill that provides for counter-bioterrorism research as well.

The House "essentially codified all the recommendations from the joint agreement [between the Biotechnology Industry Organization, the FDA and the Pharmaceutical Research and Manufacturers of America (PhRMA), submitted in March]," said Wendy Taylor, director of regulatory affairs and bioethics for BIO.

"They took the recommendations intact, with a few minor changes here and there, and added some of their own," Taylor said. Carl Feldbaum, BIO's president, said the organization "fully supports" the bill passed by the House.

PDUFA, approved in 1992 and reauthorized in 1997 (it expires every five years), lets the FDA charge biotechnology and pharmaceutical companies fees when they submit drug applications. The Senate was scheduled to vote on PDUFA today.

Under the joint recommendations as formulated by BIO, the FDA and PhRMA, fees would increase from about $300,000 in 2001 to $400,000 per application. Income from fees would go up from approximately $160 million in 2001 to $223 million in 2003, with the amount expected to be near $260 million by 2007. (See BioWorld Today, March 26, 2002.)

Taylor told BioWorld Today the House "also specified spending in a few areas that are non-PDUFA-related." Those include post-market surveillance of drugs; the FDA's Division of Drug Marketing, Advertising, and Communications; and the office that oversees generic drugs.

"Those were not necessarily addressed under the recommendations," Taylor said.

"They tweaked the independent-consultant provision as well, which was extremely important to many of our biotech companies," she added, as part of an agreement. The issue is one that likely will be covered in the "goals" letter sent from the FDA to Congress after passage of PDUFA, she said.

"[The letter] is a commitment to do things," Taylor said. "It's been part of PDUFA at each round. A lot of what we think of as PDUFA is actually part of the goals letter."

The independent-consultant aspect "is going to be very important for companies dealing with cutting-edge science," she said, and it applies to all biologics.

"It allows a company, usually when they are entering into Phase III [trials], to ask that the FDA bring in an independent outside consultant to provide advice on a particular protocol or product," she said. "You may have individuals [in the FDA] who don't know everything on a particular issue, and this is an opportunity to bring in somebody else not tied to the company."

The consultant would be chosen by the FDA and screened for potential conflicts of interest, Taylor said.

"It's a one-time shot, and the FDA is not bound by any recommendation or advice," she added.

In 2003, some of the funding increase would be directed toward invigorating the review process at the Center for Biologics Evaluation and Research, which handles most recombinant biotechnology products that are especially in need, at least occasionally, of an outside expert. In the past, FDA critics have noted how long it takes for applications to pass through CBER as compared to the Center for Drug Evaluation and Research.

The bioterrorism portion of the measure provides funding to boost state and local preparedness, conduct research and development on antibioterrorism agents, and enhance controls on biological agents, food and drinking water.

A new set of tracking requirements will follow biologics and toxins, but those already approved are exempt, and a process for further exemptions covering investigational products will be devised by the Department of Health and Human Services.

Companies that import biologics or food for export also will be subject to new tracking burdens, but these requirements were modified in conference.

An issue unresolved by the bill has to do with regulating access to potential bioterrorism agents by holders of H1-B visas, which allow foreign workers into the U.S., but federal guidelines will be devised and BIO will be among those helping to draft them.