The FDA and the Court
Libertarian law professor Richard Epstein's column this week says the Supreme Court should make it clear that the Food and Drug Administration shouldn't be able to stop drug companies from circulating information about "off-label" uses of their products:
On high principle, the FDA has long insisted that any drug company promotion of off-label uses undermines the integrity of its preapproval system. But even as the FDA criminally prosecutes drug companies for such promotion, information about the off-label uses still gets around. Thus, between 25 and 60 percent of drugs are prescribed for off-label uses. For cancer patients, that number may be as high as 65 percent; patients on dialysis or those with AIDS are also high consumers of off-label products.
Given that widespread use, the FDA's position has at least two serious downsides. The first is this: if the off-label uses are indeed beneficial, anything that slows down their dissemination could mean the difference between disease or recovery—life or death—in thousands of sick individuals. The second is that the prohibition against promotion cuts so deeply that drug companies are not allowed even to warn doctors about the bad side-effects from unauthorized uses, lest that warning be construed as an implicit approval for an off-label use.
by Editor | Dec 11, 2012 at 10:28 am
Related Topics: Health Care, Regulation
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