OAKLAND, Calif., Feb. 10, 2010—The Food and Drug Administration (FDA) has requested a $4.03 billion budget for FY2011, a 23 percent increase over last year. Prompted by the FDA’s vast reach and alarming budget, a new report delves into the organization’s history, finding that a series of drug-related crises provided it with the political leverage to amass control over the nation’s food and drug industries, while showing the FDA’s repeated failures to protect the public.
Medical Disasters and the Growth of the FDA (February 2010) by Independent Institute Research Fellow Ronald Hamowy investigates the three major health crises that fostered the expansion of the FDA. Hamowy, Emeritus Professor of History at the University of Alberta, Canada, highlights the FDA’s power plays in the aftermath of each event, every one resulting in constricted protocol for producers and broader authority for government.
In 1901, it was discovered that a batch of diphtheria antitoxin contaminated by tetanus resulted in the deaths of thirteen children. Social reformers used the tragedy to push a bill through Congress establishing the Public Health Service, a forerunner of the FDA. Proponents of the bill weren’t bothered by the fact that, as Hamowy points outs, “the provisions of the law would have done nothing to prevent the tragedies.” Regardless, the stage had been set for ever-increasing intervention in this market.
The next disaster that bolstered the case for nationalized supervision of the food and drug industries was the 164 deaths caused in 1937 by a flavor additive in sulfanilamide, an anti-infective medication. As with the previous disaster, reformers “capitalized on the event to link the disaster to the absence of a new food and drug bill.” Although the measures then proposed to Congress “would have proved inadequate in dealing with the crisis,” the bill passed thanks to an FDA campaign that produced literature and two motion pictures fueling public distrust of private medicine and desire for expanded federal authority.
The event that solidified the FDA’s role as the national authority over food and drug safety was the thalidomide crisis of 1960. Thalidomide, a drug marketed to pregnant women suffering morning sickness, was discovered to be responsible for thousands of miscarriages, stillbirths, and birth defects in Europe, Australia, and Canada. While the manufacturer recalled the product before it was approved in the United States, the FDA illegitimately took credit for intentionally forestalling the drug’s distribution. The outcome was new legislation enacting controls on everything from drug names and prices to efficacy claims and pre-market testing.
Through each of these crises, the FDA was able to strengthen its hold on pharmaceutical companies and other medical innovators, “even though it likely meant that fewer new drugs would be developed.” Hamowy stresses that the FDA was consistently ineffective at averting disaster, while local authorities and private companies were immediately responsive to each situation. In spite of this, the FDA still “ultimately has the power of life and death over hundreds of thousands of people suffering from fatal illnesses.”
By tracing the FDA’s history of happenstance successes and subsequent power grabs, Medical Disasters and the Growth of the FDA demonstrates that the FDA is not solely interested in serving the public. Hamowy exposes the possibility that it may be too mired in bureaucratic inefficiency and the distractions of politicking to reliably ensure the safety and quality of the products that it has sought to monitor.
# # #
