FDA Proposes Rule That Would Loosen Restrictions On Off-Label Prescription Drug Promotion

Main Category: Pharma Industry / Biotech Industry
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 20 Feb 2008 - 5:00 PDT

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FDA on Friday proposed new guidelines that would allow pharmaceutical and medical device companies to market their products for off-label uses, the New York Times reports (Harris, New York Times, 2/16). Currently, physicians can prescribe medications and medical devices for off-label uses, but companies cannot market their products for such uses (Wilde Mathews/Johnson, Wall Street Journal, 2/16).

Under the guidelines, pharmaceutical and medical device companies could provide physicians with medical journal articles that address off-label uses for certain products. The guidelines would apply to peer-reviewed articles published in medical journals with an expert editorial board. Pharmaceutical and medical device companies would have to include prominent warnings to indicate that the articles address uses for their products not approved by FDA (New York Times, 2/16). In a news release, Randall Lutter, an FDA deputy commissioner, said that such articles "can contribute to the practice of medicine and may even constitute a medically recognized standard of care" (Wall Street Journal, 2/16). FDA will accept public comments on the guidelines for 60 days.

According to the Times, "FDA has for years struggled to find the appropriate balance between the need to inform doctors of experimental but hopeful drug and device uses and the need to guard against hucksters promoting dangerous products as cure-alls," and, to "complicate the issue, the drug agency's power to prevent companies from providing truthful, albeit uncertain, information to doctors has been questioned by federal courts as a possible infringement of commercial free-speech rights."

Reaction
Supporters maintain that because "FDA is so slow in assessing drug and device benefits," companies "need to be able to hand out medical journal articles so that doctors can learn immediately about lifesaving uses," the Times reports. Scott Gottlieb, a former FDA deputy commissioner, said, "The consequence of rapid disclosure of these benefits could be measured in lives." Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson said that "journal articles can offer physicians valuable insight that helps them make informed decisions regarding appropriate medical treatments for their patients" (New York Times, 2/16).

Catherine DeAngelis, editor-in-chief of the Journal of the American Medical Association, said the guidelines would provide a "way to assure at least some oversight of the off-label use of these publications" (Wall Street Journal, 2/16).

However, according to critics, "drug and device companies have a long history of promoting unapproved drug and device uses that later proved dangerous," and "allowing companies to talk about such unapproved uses removes incentives for companies to research adequately whether the new use is actually beneficial," the Times reports. Sidney Wolfe, director of the Health Research Group at Public Citizen, said, "People will die if they are getting drugs that don't have clear evidence that the benefits outweigh the risks."

Steven Nissen, chair of the department of cardiovascular medicine at the Cleveland Clinic, said, "Companies could openly promote products for unapproved indications without testing these drugs," adding, "I'm astonished that this rule would even be considered" (New York Times, 2/16). In a letter to FDA, Rep. Henry Waxman (D-Calif.) wrote, "It's a conflict of interest for the company to be promoting sales when they haven't been able to establish that a drug is safe and effective through the rigorous FDA process" (Wall Street Journal, 2/16).

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