WEDNESDAY, Sept. 25, 2002 (HealthDayNews) -- The agency that regulates drugs in the United States is approving them at a faster pace, but it's recalling more of them, too.
A 1992 law that has companies financing regulatory reviews of new drug applications caused this two-edged sword, according to a report from the U.S. General Accounting Office.
The GAO report, released yesterday, found that under the Prescription Drug User Fee Act (PDUFA) the average review time for standard new drug applications fell from 27 months in 1993 to 14 months in 2001.
Even more noticeable is the period for giving the go-ahead for priority drugs, down from 20 months to six months. A good example of this is the rapid push-through of Gleevec in 2001, a drug that had shown spectacular results in the treatment of certain types of adult leukemia.
That's the positive finding.
On the other side is the fact that the number of drugs having to be recalled has also spiked. For example, 5.34 percent of drugs OK'd between 1997 and 2000 were withdrawn from the market, compared with 1.56 percent of those approved between 1993 and 1996.
The Food and Drug Administration, which regulates drugs in the United States, maintains that the recall rate for the eight years before and after the law was enacted is essentially identical -- 3.1 vs. 3.5 percent. But Jane Heinrich, the GAO official who led the study, said taking such a long look obscures the more recent trend.
In addition, the report found that as the FDA works harder to meet the demands of reviewing new drug petitions, its ability to carry out the rest of its functions -- from monitoring the safety of medical devices to policing food and blood -- has suffered.
Training and professional development have lagged. Meanwhile, workloads are up under PDUFA, despite an increase in drug review staff of 77 percent, from 1,300 to 2,300 full-time posts between 1993 and 2001. At the same time, about 1,000 fewer staffers are performing other agency functions.
"The drug and biologic review processes have increased while other FDA activities have decreased somewhat," Heinrich said.
Perhaps a reflection of the strain, the report showed that attrition rates for jobs involved in drug review, like biologists and medical officers, are running higher than in other federal agencies. The document quoted FDA officials blaming the turnover, in part, on better salaries in the private sector.
Since 1993, the share of the FDA's budget for reviewing drugs and biologic compounds that comes from PDUFA funds has risen from 7 percent to 51 percent, the report found. In 2002, the agency plans to spend $170 million in user fees for these reviews out of a total of $332 million.
The cost of reviewing a new drug application in 2002 was $313,000 for the most comprehensive petition, and $156,000 for those that didn't include clinical trial data, industry figures show. Those numbers are set to soar in 2003, to $265,000 for the basic review and $530,000 for the more detailed process.
A spokesperson for the FDA said the agency agrees that PDUFA strained its resources in recent years. The law had rigid timetables for meetings and hearings that had to be scheduled.
Jeff Trewhitt, a spokesman for the drug industry group PhRMA, said that between 2 and 3 percent of drugs approved in the 1980s and 1990s, before and after PDUFA, were recalled for safety reasons. "That gives the FDA one of the best safety records, if not the best record, of all regulatory agencies that approve drugs worldwide," Trewhitt said.
Trewhitt said that "on balance, PDUFA is very important to the drug approval process" and has been a success.
The new report was requested by Sen. Edward Kennedy D-Mass, who chairs the Senate's Health, Education, Labor, and Pensions Committee, which oversees the FDA. Congress has renewed PDUFA twice since 1992, with the current version running for five years starting next month.
Under PDUFA III, user fees will run about $1.2 billion over five years, compared with $700 million for the previous incarnation of the law, Trewhitt said. Included in that sum are funds to double the number of post-approval reviewers, to 200, a change the FDA has sought.
John Hansen, a GAO researcher and a co-author of the report, said that that change and other items in the new law that give the FDA more flexibility in its budget should ease some of the strain from previous versions of PDUFA.
Also Tuesday, President Bush nominated Dr. Mark McClellan, a physician and a member of the White House's Council of Economic Advisers, to head the FDA. The agency has been without a permanent leader since Bush took office in 2001.
McClellan's brother is administration spokesman Scott McClellan.
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