WASHINGTON Biotechnology and pharmaceutical companies filing drug applications with the FDA can expect to pay higher fees by the end of the year.
While negotiations for reauthorization of the Prescription Drug User Fee Act (PDUFA) are ongoing, talks between the agency and industry leaders have leaned toward increased fees for better service.
“We have had discussions with the FDA and I would not characterize what we have come up with as a deal, but hopefully it will gel into a joint recommendation to be made to the administration and ultimately to Congress and that’s where we stand,” Carl Feldbaum, president of the Washington-based Biotechnology Industry Organization (BIO), told BioWorld Today.
“It does include a fee increase. While it is a substantial increase, it is not nearly the number that the administration had put out,” he said.
Feldbaum is speaking of President Bush’s proposed $2.13 trillion national budget that includes a 133 percent increase for drug applications (from about $300,000 to $700,000 per application).
Enacted in 1992 and reauthorized every five years, PDUFA gives the FDA the authority to charge companies filing fees for drug applications. PDUFA II expires Sept. 30.
Last year the agency collected about $140 million in fees alone. The money pays for the 1,000 or so additional reviewers who have been hired in the last decade.
Even though the biotechnology industry is paying its fair share, on average it takes a biologic longer than a pharmaceutical to make it through the drug approval process.
In a House subcommittee hearing on reauthorization Wednesday, a BIO representative told lawmakers that while the user fee act has been successful in getting drugs to patients more quickly, there are a few new items that should be considered in PDUFA III. (See BioWorld Today, March 7, 2001.)
“Prior to enactment of PDUFA, the FDA was often behind other nations of the world in approving new pharmaceutical products,” Mary Pendergast, executive vice president of government affairs for Elan Corp. plc, told the subcommittee on behalf of BIO. “What Congress and the FDA repeatedly heard was that American patients waited while patients elsewhere had access to important new therapies. The drug and biologic user fee program reversed that scenario.”
With that in mind, Pendergast told the House Energy and Commerce Subcommittee on Health that BIO’s recommended improvements to PDUFA III would not cost the agency any extra money.
For starters, she said the FDA should use its annual reporting system to find out why it takes reviewers at the Center for Biologics Evaluation and Research (CBER) longer to move a biologic through than it takes reviewers at the Center for Drug Evaluation and Research (CDER) to do the same.
The FDA isn’t shy about admitting Pendergast’s information is right. In fact, the agency released a talk paper a couple months ago touting its quick review times.
In 2001, CBER said it reviewed 16 biologics license applications in a median time of 13.8 months and approved or denied them in a median time of 20.3 months. Two of the BLAs were priority products, and were reviewed in a median time of 11.5 months and approved in 13.5 months. (See BioWorld Today, Jan. 29, 2002.)
Comparatively, CDER reviewed 66 new drug applications in a median time of 12 months, and approved or denied them in a median time of 14 months. Of the 66 applications, 10 were priority products that made it through in a median time of six months.
The difference? The agency says biologics are more complex and take longer to review.
In response, BIO says the agency should bring in experts to advise reviewers on cutting-edge technology.
“The biologics are not only more complex, but we are getting into novel combinations of biologics and devices and there may not be immediate expertise at the FDA,” Feldbaum said. “For that reason, we have asked for the option of bringing in outside advisers and experts who will not replace reviewers by any means, but who will help the FDA and sponsors design the clinical trials and explain the underlying science and technology.”
Even when the FDA meets its six-month PDUFA deadline for priority drugs or the 10-month deadline for non-priority products, Pendergast pointed out that “action” by the agency often comes in the form of a letter requesting more information, pushing approval back months or years.
Frequently it takes three or more cycles for a final decision by the agency.
Pendergast said there is a “striking” difference between the centers in their ability to get a product through in one cycle.