Political and organizational influences in the side effects of FDA approved drugs.

Using data consisting of drug/side-effect pairs attached to information on the FDA approval process, contemporaneous congressional politics, and media coverage, this study explores the predictive power of political and organizational processes on the frequency of side effects among approved drugs. The results point to medical innovation as a strong interest that yields unanticipated consequences, consistent with Robert K. Merton's famous formulation. When a drug is approved quickly, under priority review, or fills a significant and unoccupied therapeutic niche, it involves more side effects. The association is substantial. The association with priority review, for instance, is comparable to the causal effect of the drug itself, as indicated by the difference between the effect of a drug and a placebo. In addition, the frequency of side effects is sensitive to agenda-setting factors at the time of approval, suggesting that a growing interest in health can overwhelm risk aversion. When the media reports more on health, the frequency of side effects increases, whereas when the media reports more on the FDA, the frequency of side effects declines. In addition, more conservative leaning congressional committees with jurisdiction over the FDA are associated with more side effects among approved drugs, though the association with politics is conditioned by the prevailing regulatory approach to health. The association increases when Congress holds more hearings on disease prevention, producing more side effects, but decreases when Congress holds more hearings on the FDA. Side effects are an unanticipated consequence of purposeful social action. An interest in disease prevention yields a more risk-tolerant approach to pharmaceutical regulation, even as it also leads to the approval of therapeutically beneficial drugs.