Understanding Pharmaceutical Relations and the Limits of Regulatory Reform

SmithKline & French pharmaceuticals

In the Organic Chemistry Section of SmithKline & French Laboratories, Dr. Wilfred H. Lindell, Professor of Pharmaceutical Chemistry of the University of London, England, (right), examines the yield of a new pharmaceutical with Dr. Maurice L. Moore, Director of the Research Laboratories of SKF (center), and Dr. Glenn E. Ullyot, Director of Organic Chemistry (left). Professor Lindell was on a four-week scientific visit to the United States as a guest of SmithKline & French.

It was the shared interests of academic researchers and the drug industry and the industry’s responsiveness to the needs of the biomedical community in the post-war decades that led the AMA, the drug industry, and certain leading academic physicians to join forces against pharmaceutical reformers in the 1960s and 1970s. These same networks continue to influence pharmaceutical policy today.

In addition, the federal government’s perpetual failure since the early 1960s to commit financially to drug regulation mars current reform efforts. Indeed, each time Congress has passed significant drug reform it has failed to give the FDA the necessary funds to secure the manpower and resources needed to fulfill the agency’s new regulatory burden. As a result the FDA has resorted to solutions that have invited drug companies into the center of the regulatory process. Take, for instance, the 1962 Drug Amendments. Passed in the wake of the thalidomide tragedy in Europe, these amendments for the first time required drug manufacturers to provide evidence of their drugs’ effectiveness. They also required firms to provide much more extensive safety data on their new drugs. Yet, even as President John F. Kennedy sought to bolster America’s drug regulatory system by increasing the FDA’s staff by 25%, Congress refused to grant the necessary increase in the FDA’s budget. Left without the manpower and resources to perform its new regulatory functions, the agency called on experts from academia—many of whom had ties with drug companies—to perform some of that regulatory work.

In 1992, when Congress authorized the fast tracking of drug approvals—a measure intended to increase access to new drugs for AIDS patients—it again failed to guarantee the FDA the necessary federal funds to cope with the greater workload. Instead Congress introduced a system of user fees to be paid by drug firms who wanted their new drug applications fast tracked. The result has been that pharmaceutical companies can now pay the FDA to expedite drug approval, and the relationship between drug firms and regulators is further intensified.

Today’s regulatory system, as well as the limits of that system, are the products of Congress, the FDA, universities, medical schools, physicians, and researchers being politically, socially, and financially invested in maintaining the status quo in pharmaceutical and health policy. The first step toward resolving the current problems in America’s system of drug development and regulation is to recognize the historical roots of—and the social and political reasons for—the extensive and intertwined relationships between the drug industry, the FDA, researchers, and physicians. Only after we fully understand this complicated network can we begin to address its deficiencies.

 

Dominique Tobbell is former acting program manager for biotechnology at CHF’s Center for Contemporary History and Policy. She is now assistant professor in the Program in the History of Medicine at the University of Minnesota.