WEDNESDAY, Dec. 17, 2003 (HealthDayNews) -- The fees paid by drug companies to the U.S. Food and Drug Administration do not buy the companies special treatment from the federal agency, a new study concludes.
"There was absolutely no evidence that money coming from industry did anything more than provide resources to speed up approval time," says Dr. Mark Fendrick, senior author of the report, which is published online Dec. 17 in Health Affairs. "There was no evidence of preferential treatment."
Ever since the Prescription Drug User Fee Act (PDUFA) was passed in 1992, critics have charged that the FDA has become a "servant of industry." The act requires companies with drugs in the pipeline to pay fees to the FDA to take care of the cost of hiring additional staff to complete the review process.
The study points out that, in the decade since the act was passed, about $1 billion has been paid by companies to the FDA.
And while the speed of drug approvals has unquestioningly improved -- from 27 months to 14 months for nonpriority drugs, a 2001 U.S. General Accounting Office report also found there had been more withdrawals of approved drugs since the passage of PDUFA. Those recalls increased from 1.56 percent to 5.34 percent.
Critics of PDUFA contend that the increase in recalls is inexorably tied to the swifter approval process.
Those critics include Dr. Sidney Wolfe, the director of Public Citizen's Health Research Group in Washington, D.C., who was quoted in the new study.
"GAO showed that concomitant with reduced approval time was an increase in the rate of drug recalls. There's no dispute of that," Wolfe told HealthDayNews. "We're not criticizing the study. We're criticizing the direction the FDA has taken when the review of drug function went largely in the direction of industry funding."
For the study, the researchers looked at the effect of FDA staffing patterns and the characteristics of the drug companies (how big, how much money paid to the FDA) on approval times for 843 new drug applications that were submitted between 1977 and 2000.
The average time from a drug's initial submission to its approval decreased dramatically over the time frame studied, while the number of FDA reviewing staff increased. In fact, the study found, the approval time speeded up by 3.3 months for every 100 new hires.
However, the authors point out, those staffing levels were already increasing for about five years before PDUFA took effect. So effectively, the speedier approval times would have come about no matter where the funds came from, the authors contend.
"We believe that it is the amount of funds, not their source, that impact [new drug application] approval times," says study author Dr. Mark Fendrick, a professor of internal medicine at the University of Michigan School of Medicine, and editor-in-chief of the American Journal of Managed Care.
As for the increase in drug recalls since PDUFA's passage, Fendrick says: "There might have been a trend toward more recalls, but we believe that's more of a statistical chance than anything else ... We could not establish if there was a relationship between the passage of PDUFA and withdrawals."
Wolfe, though, remains unconvinced.
"It's not a matter of how much money. We agree with the finding of the study that, if you provide more funds from public sources or from industry, you can hire more staff, and hiring more staff generally is a good idea," he says.
"We don't have data from before PDUFA, but our impression is that if we had done a survey 10 years earlier, we wouldn't have found as many examples of drugs that had been thought to be too dangerous but which had been approved over the objections of physicians in the agency [FDA]," Wolfe adds.
A Public Citizen survey of FDA medical officers found that many of them thought that physician judgments were being overruled when it came to drug approvals, he says.
"The remedy, which is more likely to happen when Congress finally starts waking up, is just to go back to the way it was. It's safer," Wolfe says. "It needs the extra staff but the FDA is too important to leave to pharmaceutical industry funding, which is basically what we have now. It's too dangerous."
More information
To learn more about the Prescription Drug User Fee Act, visit the Food and Drug Administration. Visit Public Citizen to see their comments on PDUFA.
