Safety, workload cited for perceived FDA backlog
By Deena Beasley
TORONTO, June 11 (Reuters) - The U.S. drug approval process may meet legislated limits, but safety concerns combined with a growing workload have slowed the regulatory pace at the Food and Drug Administration, industry experts said on Tuesday.
"I think the FDA numbers are misleading. There is a lot of time between when an application is being designed and when it receives an answer -- follow-up times are longer, there are requests for more patients in trials and more tests," said Una Ryan, chief executive at vaccine developer Avant Immunotherapeutics Inc. (NasdaqNM:AVAN - News).
Speaking at a meeting here of the Biotechnology Industry Organization (BIO), Cynthia Rask, Medical Officer at the FDA's Center for Biologics Evaluation and Research, said the perception that the agency is approving fewer drugs is inaccurate, but a "complete review letter" from the agency does not always mean that the application process is finished.
"The problem is the timelines assigned to activities besides reviewing licensed applications," she said, citing as examples a 30-day limit on requests for meetings with companies.
"These are not funded by PDUFA (Prescription Drug User Fee Act)," Rask added.
Under PDUFA, first passed in 1992, the FDA has a 12-month review clock on applications for drugs that treat diseases where alternative therapies are available and a 6-month limit on applications for so-called "priority" drugs.
"I think that the FDA really needs more staff to handle this," Rask said. She cited a lack of space at the agency -- some new staffers are sharing offices or even working in hallways -- as well as funding constraints for the backlog.
OVER-EMPHASIZING RISK OF DRUG SIDE EFFECTS
For 2000-2001, the FDA took longer than 12 months to approve 29 new drug applications -- safety was the issue in 38 percent of those, she said.
President Bush is expected this week to sign the latest update of PDUFA -- which also sets user fees that biotechnology and pharmaceutical companies are required to pay to the FDA.
BIO, and its drug company members, have also urged Bush to appoint a new FDA commissioner -- a post that has gone unfilled since the Administration took office some 18 months ago.
U.S. Health and Human Services Secretary Tommy Thompson said here on Monday that a new commissioner could be named "within a few weeks."
"The commissioner needs to be a courageous leader -- an M.D. at the head of the agency is important, because ultimately it is a clinical decision," Ryan said.
She said regulators have "fallen into a trap" of over-emphasizing the risk of drug side effects to the detriment of patients who could ultimately benefit from new treatments.
"It is difficult for pre-marketing studies to detect all a a drug's potential problems," Rask said.
As a result, the FDA emphasizes the monitoring of adverse drug reactions, particularly in patient populations where other therapies are available and for drugs that treat non-life-threatening conditions.
"The number of drug withdrawals hasn't changed since PDUFA was enacted in 1992. What has changed is that more than half of all new drugs are now being launched in the United States," the FDA's Rask said. |
