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Editorial

FDA's off-label rule under attack

Some drug makers are arguing in court that the FDA's marketing limits violate their 1st Amendment rights.

November 07, 2011

Prescription drugs and medical devices are frequently used to treat conditions other than those the Food and Drug Administration has specifically approved them for. The main guidance the FDA gives to doctors is to be well informed, have good scientific and medical reasons, and maintain records of any off-label use. The agency bars drug and device manufacturers, however, from promoting their products for more than their approved uses — for example, by giving doctors unsolicited advice about potential off-label applications.

Now some drug makers are pushing back in court, arguing that the FDA's marketing limits violate their 1st Amendment rights. The government's approach to off-label uses has some weaknesses that deter research and make it harder for doctors to learn about new, effective treatments, but simply throwing out the restraints on off-label marketing would only encourage a less formal and rigorous process for drugs and devices entering the market.

The Pharmaceutical Manufacturers Assn. says that neither it nor its members are seeking to expand off-label marketing. You wouldn't know that from the legal filings by GlaxoSmithKlein, among others, in court cases challenging the constitutionality of the FDA's labeling and misbranding regulations. The drug makers contend that the regulations improperly "censor" them, preventing them from speaking truthfully in ways that promote off-label uses.

Off-label uses can help close the gap between the time when research demonstrates the effectiveness of a drug and the formal FDA approval. But there's a fine line between supplying information about how a product is being used off-label and promoting such a use. And the more widespread an off-label use becomes, the more it circumvents the FDA's process for ensuring that drugs and devices are safe and effective before they reach patients.

Rather than loosening the restraints on marketing, policymakers should try to correct flaws in the FDA's current system that slow the spread of useful information and treatments. One approach would be to make it easier for manufacturers to obtain the FDA's permission to market specific off-label uses for approved drugs, possibly by setting a lower bar for provisional approval of new uses. At the same time, the FDA could require drug and device manufacturers to collect and report data on off-label uses of their drugs, so that the agency could provide more oversight of those that become widespread. There shouldn't be a trade-off between manufacturers' free-speech rights and the public's safety.

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