WASHINGTON Even though the FDA continues running without a permanent leader, agency reviewers said they are hitting goals set 10 years ago to reduce the time it takes a drug to make it through the approval process.
The agency released a talk paper Friday showing that in 2001 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. Two of the BLAs were classified as priority products, and reviewed in a median time of 11.5 months and approved in 13.2 months.
The report referred to BLAs as “complex” compared to the new drug applications (NDAs) reviewed by the Center for Drug Evaluation and Research (CDER). Last year the FDA approved 66 NDAs, including 10 priority products that made it through in a median time of six months. The median review time for the others was 12 months, and there was a median of 14 months for approval.
Those figures represent an improvement for an agency that was taking 20.1 months to approve drugs in 1994. And if things continue to progress at a steady pace, median approval times should drop to 10 months this year, Linda Suydam, senior associate commissioner at the FDA, told a House subcommittee last year. (See BioWorld Today, May 7, 2001.)
The agency has met goals set by the Prescription Drug User Fee Act (PDUFA) as reauthorized in 1997, according to the report. In 1999, the median review time was 11.6 months and in 2000 it was 12.5 months for standard applications (six months for priority applications).
Whether the slight slow-up is a result of too much work, not enough reviewers or reviewers who are leaning toward caution, most industry watchers say any problems brewing will start to simmer once a director is appointed.
Among points in a list of legislative priorities sent to President George Bush, the Washington-based Biotechnology Industry Organization said that an FDA commissioner is needed as soon as possible. “A new commissioner must reverse the trend of increased review times, demonstrate to Congress how the agency needs additional appropriations, lead on bioterrorism issues and insist on quick action to extend PDUFA,” BIO said.
Others within the industry, such as the Cambridge, Mass.-based Massachusetts Biotechnology Council (MBC), have contacted the White House and requested quick action on the FDA appointment.
Stephen Mulloney, director of government relations and communications for MBC, said the council’s letter to the White House was signed by 21 industry leaders, including James Mullen, president and CEO of Cambridge-based Biogen Inc.; Henri Termeer, president and CEO of Cambridge-based Genzyme Corp.; and Michael Astrue, senior vice president of administration and general council for Cambridge-based Transkaryotic Therapeutics Inc. and chair of the MBC.
Astrue made the short list of candidates for FDA commissioner, but ended up dropping out after it was reported that Sen. Edward Kennedy (D-Mass.) would not support him. Kennedy chairs the Senate Health, Education and Labor Committee, which oversees the FDA. (See BioWorld Today, Dec. 28, 2001.)
The top two rumored candidates are Lester Crawford, a veterinarian, who heads Virginia Tech’s Center for Food and Nutrition Policy in Alexandria, Va., and Alastair J.J. Wood, vice chancellor and professor of medicine and pharmacology at Vanderbilt University in Nashville.
While it’s been about a year since Jane Henney left the helm at the FDA, it’s been almost two years since Harold Varmus vacated his position as director of the National Institutes of Health. (Ruth Kirschstein was named acting director during the Clinton administration.)
Both Mulloney and Sharon Cohen, BIO’s vice president for government affairs, said the FDA position should be appointed first.
“Priority one is the FDA position; the NIH is priority 1-A,” Mulloney said. “I know individuals and companies that have called on that [NIH] position as well. Obviously, bigger companies that are developed to the point where they have a drug in clinical trials or awaiting FDA approval have a certain clout whereas some of the companies that may be interested in the NIH position might be some of the smaller companies that might not feel that they have the clout in Washington, so they hold back.”
The FDA talk paper is available at www.fda.gov.