Summary: The FDA and the pharmaceutical industry are lobbying Congress heavily to reauthorize the 1992 Prescription Drug User Fee Act (PDUFA). Rather than bow to the will of industry or government bureaucrats, Congress should do what is best for patients: reform the FDA and give user fees the study they deserve.
For years, the Food and Drug Administration (FDA) has delayed the approval of life-saving therapies, forcing patients to suffer and even die unnecessarily while they wait for new medicines. Recognizing the need to speed up FDA approval of new drugs, Congress passed the 1992 Prescription Drug User Fee Act (PDUFA), which allows the FDA to collect “user fees” from pharmaceutical companies. Proponents hoped the added revenue from user fees would accelerate the FDA’s approval of new medicines. Unfortunately, PDUFA has failed to meet these expectations.
For its part, the FDA has declared PDUFA a success. In truth, the agency has shortened review times for new drug applications. Last year, Tufts University’s Center for the Study of Drug Development found that the average review time for new drugs was cut from 2.7 years for drugs approved in the 1990-1993 period, to 1.7 years for drugs approved in 1994 and 1995.1
However, review time is the smallest piece of the drug approval process, and by itself is a poor indicator of the FDA’s performance. From a patient’s perspective, the most important indicator is overall approval time: the time between a new drug’s discovery and FDA approval, not just FDA review time. Over the last thirty years, the FDA has caused average approval time to double. In the 1960s, patients waited only 8.1 years for FDA approval of a new drug. By the early 1990s, patients were forced to wait 15 years.2
Under PDUFA, average review time decreased by one year, but average clinical development time (when the FDA directs a drug through human testing) increased from 5.5 years (1990-1993) to 7.2 years (1994-1995).3 Thus, any gains made in cutting review times were more than swallowed up by losses elsewhere in the process. Patients are now waiting nearly one year longer for new drugs than before PDUFA was enacted.
Furthermore, an average review time of 1.7 years is no cause for congratulations. The Food, Drug and Cosmetic Act requires the FDA to approve or deny all new drug applications within 180 days (21 USC 355(c)(1)) — a deadline the FDA has flouted for years. At 1.7 years per review, the FDA still takes over three times as long as the law requires. User fees have done nothing to address the underlying problems at the FDA.
There are also reasons to question the FDA’s management of user fees. It is not clear that all user fee revenue has been applied to the review of drug applications. User fees give the FDA a revenue source independent from the traditional appropriations process. At the very least, Congress must apply added scrutiny to the FDA’s management of this special revenue source to ensure full accountability. With the FDA’s current accounting structure, Congress cannot be certain that prescription drug user fees are being used only for the approval of prescription drugs. It would be tantamount to fraud for the FDA to apply user fees to anything but review of a firm’s application.
Despite data that show user fees have failed, the FDA and the pharmaceutical industry are lobbying Congress to reauthorize PDUFA before taking any real steps to speed up the FDA’s drug approval process. (Congress must extend PDUFA’s authorization before September 30, or the FDA will lose the authority to collect user fees.)
Rather than bow to the will of the FDA and drug companies, Congress should do what is best for patients and consumers: enact reforms that accelerate FDA approval of life-saving therapies, and hold the FDA accountable for its budget. Because it is not clear that prescription drug user fees have been implemented effectively, Congress should extend PDUFA’s authorization for only one year to allow a more thorough examination of its implementation by the General Accounting Office. The patient is waiting.
1Joseph A. DiMasi, “A New Look At United States Drug Development and Approval Times,” American Journal of Therapeutics, 3(9), 1996, p.1.
2Joseph A DiMasi, Mark A. Seibring, and Louis Lasagna, “New Drug Development in the United States from 1963 to 1992,” Clinical Pharmacology & Therapeutics, 55(6):609-22, June 1994.
3DiMasi. p. 1.