GAO Report Backs Link Between Drug User Fees and Higher Rate of Drug Withdrawals

For years, Public Citizen has decried the Food and Drug Administration’s (FDA’s) shoddy performance in approving questionable new drugs and then having to yank them from the market, often after dozens of people are killed or injured. In part, we have attributed this to the Prescription Drug User Fee Act (PDUFA), landmark legislation that was adopted by Congress in 1992. Under PDUFA, pharmaceutical companies pay “users’ fees” to the FDA, expanding the number of drug reviewers and thereby bringing drugs to market more quickly. In return, the FDA has to complete new drug reviews within prescribed periods of time. (PDUFA assumes that many important therapeutic advances are being denied to U.S. consumers, an assertion for which there is no evidence since most drugs are, at best, minimal advances over already approved products.)

Clearly, this is a situation that invites conflict of interest. Intent on remaining in the good graces of industry, lest the industry pull the plug on the users’ fees, the FDA has an incentive to lower the bar for new drug approvals.

Now comes a report from the General Accounting Office (GAO), an investigative branch of Congress, that shows that since the Prescription Drug User Fee Act (PDUFA) was implemented in 1992, a higher percentage of newly approved drugs has been withdrawn than before. In the period 1993-1996, as PDUFA was being fully implemented, the drug withdrawal rate was 1.56 percent, compared to 5.34 percent in the period 1997-2000.

These findings echo criticisms of PDUFA we have made for years. In 1998, Public Citizen conducted a survey of the FDA physicians who review New Drug Applications and found that the reviewing physicians had opposed the approval of 27 drugs approved in the previous three years (see the January 1999 issue of Health Letter). One result of PDUFA, said the GAO, has been the diversion of agency funds to the review process from other areas, including postmarketing safety surveillance. Thus, even as more drugs are approved more quickly, there is no commensurate increase in the agency’s ability to monitor their safety.

The GAO report also documents that staff turnover is higher among FDA scientists than among scientists in other government agencies. Our 1998 report documented how physicians were precluded from presenting data adverse to the drugs they were reviewing at FDA Advisory Committee meetings and how they received harassing phone calls from the industry with whom they now have a “partnering” relationship, thanks to PDUFA. Even the Director of the FDA’s Center for Drug Evaluation and Research, Dr. Janet Woodcock, concedes that PDUFA has “create[d] a sweatshop environment that’s causing high staffing turnover.”

Unwise drug approvals by the FDA, in part because of increased workloads due to PDUFA, have led to unnecessary patient deaths and illnesses and poor morale among drug reviewers. Congress should immediately conduct meaningful oversight hearings on each of the drugs that has been withdrawn for safety reasons. Drug makers have benefited from PDUFA, making millions in profits off drugs that should never have been brought to the market. The government must revert to being the sole funder of the FDA, removing private influence from the equation. (See cover story for more information on this issue.)