Monday, September 19, 2011

FDA Restrictions On Free Speech

Gregory Conko and CEI have published a detailed article on FDA restrictions of free speech.

From their blog post:
What can you do if you learn you have a life-threatening illness but there is no Food and Drug Administration-approved medicine to treat it? Sometimes, there is nothing to do but hope. Very often, though, your doctor will be able to prescribe a drug or medical device that has been approved by the Food and Drug Administration (FDA) for a different condition. This practice, called "off-label" prescribing, is perfectly legal, commonly practiced within the medical community, viewed as an essential component of good medical care, and offers greater choice in treatment options for millions of American patients. It is not without controversy, however.

Because the safety and efficacy of off-label uses have not been certified by the FDA, some in government and the public health community have long criticized the practice. And the FDA has long forbidden drug and device makers from disseminating most information about off-label uses, often making it difficult for doctors and their patients to learn about important therapeutic options.

No federal statute explicitly forbids manufacturers from promoting or otherwise disseminating information about off-label uses of their drugs and devices. The FDA has, however, extended its authority over product labeling to encompass manufacturers’ speech in other contexts—including print and broadcast advertisements, brochures and pamphlets, websites, conferences and seminars, and face-to-face communication. The agency bars nearly all speech promoting an off-label use regardless of its veracity, and vigorously enforces this restriction even when the information is not being broadcast to lay audiences, but is provided directly to physicians with sophisticated medical training...

[A]s legal scholars have noted, if two physicians were to provide identical truthful and non-misleading information about off-label uses to an identical audience, one of them can be hailed as a medical pioneer and the other convicted of a federal crime solely on the basis of the second doctor's financial ties to a drug or medical device company. Naturally, this inconsistency has raised questions about the constitutionality of the FDA's treatment of off-label promotion.
In other words, there can be factually true, scientifically vetted, medically useful information that would benefit doctors and patients. Yet drugmakers (and sometimes physicians) are forbidden by law from telling treating physicians this information. In the name of "protecting" us.

For more information, see the full CEI article (PDF) "Hidden Truth: The Perils and Protection of Off-Label Drug and Medical Device Promotion".