In 1992, Congress passed the Prescription Drug User Fee Act (FDUFA), an initiative that allowed the Food and Drug Administration (FDA) to impose a fee on pharmaceutical companies producing new research-based drugs and biotechnology products (biologics). Previously, pharmaceutical companies lost valuable time and faced the threat of potential competition while awaiting FDA approval. Under this new act, however, the FDA would earn more revenue with which it could augment both its staff and resources— also accelerating the approval process for new drugs and certain biologics. From 1993-1996, the approval rate for new drug applications declined by 8.7 months and the number of new drugs nearly doubled. At outset, this seemed to be a positive change, but it was soon clear that the system was full of complicated ramifications.

While the review process was expedited for pharmaceutical companies, other regulatory departments responsible for monitoring safety, ensuring manufacturing standards, and verifying ads for accuracy languished. Inadequate staff and equipment obstructed the FDA’s ability to inspect for and detect potential health hazards in drugs. Such was the case with the story of Vioxx, a drug marketed to relieve pain for osteo- and rheumatoid arthritis that was found to increase the risk of cardiovascular complications in consumers. Many suspected that this could have been avoided if the Department of Drug Evaluation and Research had taken more time to examine the long-term effects of the drug; however, many FDA officials contended that Vioxx happened to be a medicine that slipped through the cracks. FDA spokeswoman Crystal Rice remarked, "No drug is fully safe. Our job is to appropriately balance our decisions, based on

the risk-benefit profile for a drug and the societal need and desire for new drugs. We believe that our actions regarding Vioxx are appropriate and consistent with our public health mission." By 2003, the FDA’s drug center budget had increased by almost 30 percent over the course of 11 years—from 53 percent in 1992 to nearly 80 percent in 2003. This meant that user funds were increasing, while appropriated dollars remained unchanged. Essentially, it appeared as if the FDA was driven by financial incentive to approve drugs without properly scrutinizing them.

Since the FDUFA only permitted user fees to be collected and used for the approval of new drug applications for research-based drugs, FDA offices dedicated to approving generic drugs continued to be understaffed as well. Thus, the approval rates of generic drugs were nearly twice as slow. As user fees were a big investment to the FDA, they proved to be a miniscule expenditure for pharmaceutical companies wishing to market their products before cheaper, more generic products were approved. It is possible that this aim for efficiency opened the door for a structural change in the relationship between the FDA and the pharmaceutical industry. Boston Globe journalist Marcia Angell commented, "In effect, the user fee act put the FDA on the payroll of the industry it regulates." As pharmaceutical companies become more involved in the actions of the FDA, there appears to be more of a complimentary alliance between the two than a regulatory relationship. Though the new monetary power wielded by the pharmaceutical industry appears largely economic in impact, it also stands as an indication of an impending encroachment on the intimate relationship between the doctor and his/her patients.