WASHINGTON If President Bush’s proposed Fiscal Year 2003 budget is approved as submitted, the fee biotechnology companies pay to file drug applications would more than double.
According to the Washington-based Biotechnology Industry Organization (BIO), the Bush budget indicates that user filing fees paid to the FDA under the Prescription Drug User Fee Act (PDUFA) would increase from about $300,000 to $700,000. BIO calculated the 133 percent increase based on “confidential discussions with the FDA.”
“This is a number that floated down from the administration and it came as a surprise. In some quarters, it was a rude shock,” Carl Feldbaum, BIO’s president, told BioWorld Today. “This is a much higher figure, and there’s been no effort from the FDA or the administration to justify it.”
The $2.13 trillion budget released last week by Bush includes $1.727 billion for the FDA next year. Of that amount, the FDA said it anticipates collecting $295 million in user fees, including $272 million from PDUFA. Additional user fees are proposed for the continued implementation of the Mammography Quality Standards Act ($16.4 million), export certification program ($1.6 million) and the color certification program ($5.1 million), according to the FDA. (See BioWorld Today, Feb. 6, 2002.)
Feldbaum isn’t the only one who raised his eyebrows over the proposed spectacular hike in user fees. Jeff Trewhitt, spokesman for the Washington-based Pharmaceutical Researchers and Manufacturers of America, said the proposed $295 million figure apparently is on someone’s wish list, but subject to ongoing discussions.
In the last few months, industry leaders have been negotiating terms of PDUFA III with the FDA (PDUFA II expires in September). Congress has final approval authority for PDUFA III.
Claiming that it underbid PDUFA II, the FDA has long said it would probably need to implement a higher fee structure to help the agency meet review-time goals.
And that doesn’t seem to be so bothersome.
“We don’t mind discussing and considering greater payment, but we always like to know what we are paying for and how any increased payments would be linked to future streamlining and reduction of review times,” Feldbaum said. “I think overall, the industry would say that the user fee program has been a distinct success, although lately review times have slowed. We’re willing to pay more, but only if paying more is linked to better performance.”
The application fee for new drug applications (NDAs) and biologics license applications (BLAs) includes a base cost of $267,606 plus an inflation adjustment (cumulative since 1997 at 15.71 percent) to total $309,647 in fiscal year 2001.
A few weeks ago, the FDA released a talk paper touting its success in moving drugs through the review process.
The agency said the Center for Biologics Evaluation and Research (CBER) reviewed 16 biologics license applications (BLAs) in a median time of 13.8 months and approved them in a median time of 20.3 months. Meanwhile, over at the Center for Drug Evaluation and Research (CDER), 66 NDAs, including 10 priority products, were reviewed in a median time of six months. For non-priority drugs, the median review time was 12 months, and 14 months for approval. (See BioWorld Today, Jan. 29, 2002.)
Comparatively, in 1994, the median review time at CDER was 20.1 months. Longer review times for biologics are justified because the FDA considers the applications “complex,” the agency said.
Even though most people agree that review times have been quicker since PDUFA initially was authorized in 1992, a report released by S.G. Cowen Securities last summer said the process began to slow a little in 1999. Specifically, the report said in 2000 the review time rose 34 percent to 15.6 months. Of the 27 drugs that were approved in 2000, more than half had been filed before 1998, it said.
And almost anyone who has dealt with the FDA is familiar with its last-minute “approvable,” “non-approvable,” or “complete response” (a demand for more information) letters. Typically, a company receives one of these letters just days before the PDUFA deadline (six months for accelerated review).
If the last-minute letter calls for additional trials, it can stall a launch by months or years.