Black Box Panic

Full document available in pdf

President Barack Obama has designated overhauling American health care as a priority of his administration, and he has indicated that whomever he appoints to head the U.S. Food and Drug Administration (FDA) must implement “a stricter regulatory structure” and redouble the agency’s focus on food and drug safety. With mounting pressure for the incoming FDA Commissioner to dramatically reform the agency, it is worth noting that when regulators are pushed to err on the side of safety, they often make society less safe, not more. A good example is the FDA’s recent crackdown on prescription antidepressants, which has led to a drop in their use and a corresponding increase in suicides among teenagers and young adults.

Critics in Congress and in the news media often accuse agency regulators of having too cozy a relationship with the drug industry and favoring industry profits over patient safety. This chorus has grown in the past few years, as the agency has come under increasing scrutiny for a host of perceived blunders in approving new medicines and for being too slow to withdraw dangerous ones from the market. FDA regulates products representing approximately one-quarter of the American economy, so even small mistakes can have huge consequences.

The problem, which many critics fail to understand, is that no drug is absolutely safe. Even the most important life-saving medicines will often have potentially dangerous side effects that are not discovered until after the drugs have been approved. And many drugs later found to be dangerous provide tremendous health benefits to the vast majority of patients who use them. So, when deciding whether any given drug should be approved in the first place, or pulled from the market once potentially harmful side effects begin to emerge, the FDA must carefully balance its benefits against its risks.

Still, as early evidence of negative side effects begins to arise, politicians and the news media demand that the FDA “err on the side of caution.” The agency is often called upon to issue warnings or withdraw a drug based solely on preliminary and highly suspect information. When faced with this mounting political pressure, there is a real danger that the FDA will overreact—either by warning doctors and patients away from beneficial treatments or by withdrawing a drug from the market too quickly.