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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.

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