WASHINGTON Now that the Prescription Drug User Fee Act has been in effect for 10 years, industry and government leaders have had the chance to analyze and identify sections in need of repair.
If all goes well, major and minor deficiencies that have surfaced will be corrected before Congress votes on whether to reauthorize the Prescription Drug User Fee Act (PDUFA) later this year.
At the request of the House Energy and Commerce Subcommittee on Health, Tommy Thompson, secretary of Health and Human Services, a week ago submitted to Congress a letter of goals prepared by the FDA and the drug industry designed to resolve some of the weaknesses in current law. (See BioWorld Today, March 7, 2002.)
As for the impact on the industry, Steve Lawton, vice president for regulatory affairs and general counsel of the Washington-based Biotechnology Industry Organization (BIO), called the goals “a major victory,” saying issues dear to the business side were included.
All this comes with a price, however. PDUFA, approved in 1992 and reauthorized in 1997, allows the FDA to charge biotechnology and pharmaceutical companies fees when they submit drug applications.
PDUFA II expires in September and during the last year, industry leaders such as BIO have been negotiating with the FDA to craft legislation that will be friendly to companies as well as the government.
In these give-and-take negotiations, the industry agreed to pay more money (fees will increase from about $300,000 in 2001 to $400,000 per application next year), but in exchange the industry particularly the biotechnology industry expects better service. (See BioWorld Today, March 15, 2002.)
“We feel like we’ve put a good package together,” Lawton said, “but it is up to Congress to review it and to react to it as they see fit.”
While user fees likely will jump about $100,000 per application upon Congressional approval, eventually companies will pay out about $500,000 per submission. Last year, the FDA collected about $160 million in user fees, and under the new proposal, the amount would reach $223 million in 2003 and continue to increase to $260 million in 2007. Since 1992, the agency has hired over 1,000 reviewers with PDUFA funds.
In return for higher fees, the FDA has agreed to a number of initiatives.
First, the agency agreed to BIO’s proposal that gives companies the option of requesting an outside independent consultant (selected by the agency) to participate in the review of protocol for clinical trials. One consultant for each drug will be permitted.
The need for an independent consultant truly is the outgrowth of other problems between the agency and industry. For instance, by the FDA’s own admission, it takes longer to navigate a product through the Center for Biologics Evaluation and Research (CBER) than it takes to make it through the Center for Drug Evaluation and Research (CDER). According to the agency, the reason for the bottleneck in CBER is directly related to the complexity of the biologics applications. (See BioWorld Today, Jan. 29, 2002.)
But Lawton said it’s not that simple. “The problem could be a combination of four, five or seven factors the way the two centers are organized, money, greater need at CBER to work on complex [investigational new drug applications], lots of issues,” he said. “We’re not slamming CBER, were saying, Let’s try to get this stuff straightened out and get the review times and the response to the performance goals more in line with each other.’”
The agency said it will spend $7 million over the five-year life of PDUFA III to pay for initiatives targeted at improving the review process.
Most biotechnology companies that have filed new drug applications or biologics license applications can attest that oftentimes it takes two or three review cycles to get an agency approval (or rejection) or a panel hearing.
In PDUFA III, the agency said it will report substantive deficiencies in an initial filing within 14 calendar days of the 60-day filing date.
Furthermore, the agency will develop Good Review Management Principles that include a commit to ongoing communication with a company throughout the review process.
Lawton said Congress is expected to take up PDUFA after Easter.