The Prescription Drug User Fee Act: A Solution to Drug Lag?

Abstract

For decades, scholars criticized the United States Food and Drug Administration for delaying consumers’ access to vital new drug therapies. They argued that the FDA regulated system of drug development and approval was born out of disaster and therefore extremely overcautious. Critics alleged that pharmaceuticals available in other industrialized nations began saving lives years before the FDA would allow them onto the American market. “Drug Lag†as it came to be known, was blamed for killing thousands of Americans needlessly. In response, Congress passed The Prescription Drug User Fee Act of 1992. The act allowed the FDA to charge user fees to drug companies in order to generate a new influx of cash that would allow for faster approval of new pharmaceuticals. The legislation enumerated very specific new goals for the agency to meet in its review of various submissions. The legislation also required that the FDA submit an annual report to Congress outlining the agency’s progress in meeting the goals. The reports reveal that the FDA has achieved staggering success. In almost every category, the FDA met or exceeded aggressive goals outlined by Congress. Unfortunately for Congress, the FDA, and the American consumer, this success did not end drug lag. The time and money required to develop a new drug has ballooned dramatically. This occurred because Congress and the FDA crafted a statute that only deals with a small part of the problem. At its core, drug lag involves the amount of time and money required to take a drug from laboratory creation to store shelves. Since the drafters of the PDUFA did not fully address this problem, the legislation cannot solve it.