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Bob Carroll
Bob Carroll
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Limited-Time Drug Licensure – An Incentive Badly Needed

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Drugmakers need an incentive to study safety after products hit the market – Marsha N. Cohen, The Washington Post. Her proposal is a limited-time drug licensure. It is a great idea!

A License for Safer Drugs

Our confidence has been shaken in recent years by revelations about risks emerging in such drugs as Vioxx, Ketek, Baycol and all the antidepressants. Each was licensed by the Food and Drug Administration, and at the time each was approved, its effectiveness in treating conditions for which it was marketed outweighed its safety risks.

But all that the FDA knew at the time of approval came from clinical testing on just a few hundred to a few thousand people. Dangerous, even deadly, side effects that might arise only once in a thousand uses are extremely unlikely to be revealed in pre-market testing.

Drug development is extremely expensive; the investment is largely returned in the early years of marketing, when patent protection rules out price competition. Why would a rational drug company voluntarily look for reasons that its drug should be removed from the market?

Under current practices, drug companies, while they need to be responsive to reports of adverse events, are not required to go looking for them.

Limited-time drug licensure would furnish incentives to ensure that all new drugs are properly scrutinized. Companies would need to formulate post-marketing surveillance plans as well as promotional plans when a drug is approved. The FDA would be subject to firm deadlines in reviewing post-marketing information, because prescribers and patients would be relying upon a seamless system of licensure renewal in the absence of negative information.