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Making Sense of Drug Safety
Henry Miller, M.S., M.D., Washington Times, 12-7-05

The next time your doctor prescribes a drug for you, try reading the “label” (package insert) that comes with it. You’ll find it a confusing, unhelpful mass of technical jargon that seems designed to prevent the transmission of helpful information.

Miller praises recent FDA initiatives to revise drug labeling and improve how the agency communicates with doctors, while also wondering why it continues to flood doctors and patients with scientifically dubious information about potential side effects.

These initiatives will be a marked improvement over the current, antiquated drug labeling. However, all the FDA innovations are not so inspired. Much criticized lately for supposed deficiencies in the surveillance and reporting on the safety of drugs, the agency is carrying out a wrongheaded scheme for releasing data on drugs' adverse reactions.

In May, the FDA announced its new Drug Watch program, which will make "emerging safety information" publicly available. According to the FDA, this program "is intended to identify drugs for which FDA is actively evaluating early safety signals. The Drug Watch is not intended to be a list of drugs that are particularly risky or dangerous for use; listing of a drug on Drug Watch should not be construed as a statement by FDA that the drug is dangerous or that it is inappropriate for use. Rather, inclusion on the Drug Watch signifies that FDA is attempting to assess the meaning and potential consequences of emerging safety information."
FDA further "clarifies" in the same document that Drug Watch is intended "to share emerging safety information before we have fully determined its significance or taken final regulatory action so that patients and health-care professionals will have the most current information concerning the potential risks and benefits of a marketed drug product upon which to make individual treatment choices."

The FDA’s Drug Watch program is, in effect, trying to head off criticism by data-dumping every conceivable shred of side-effect information into the public domain.

While the agency means well, it will inevitably fan public fears and uncertainties about prescription medicines, and play into the hands of trial lawyers who will dredge the Web site looking for promising lawsuits. Ultimately, this tactic will play against the FDA, by making it look like every drug it approves is dangerous. Miller thinks that this is one policy the FDA should jettison post haste.

Project FDA.
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