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Promoting Off-Label Uses of Approved Drugs: Green Light—or First Amendment Violation?

Promoting Off-Label Uses of Approved Drugs: Green Light—or First Amendment Violation?

The FDA recently released its long-awaited but highly controversial final guidance permitting drug and device manufacturers to distribute medical journal articles and medical or scientific texts that discuss off-label uses of approved products.

The guidance, “Good Reprint Practice for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drug and Approved or Cleared Medi­cal Devices,” is available on the FDA’s Web site: http://www.fda.gov/oc/op/ goodreprint.html.

A major critic of the guidance, Rep Henry Waxman (D-Calif), chair of the House Committee on Energy and Commerce, urged the Obama administration “to carefully reexamine” the policy. Waxman accused Bush’s political appointees of giving drug companies “a long-coveted parting gift.”

“Despite revelations that drug companies manipulate medical journal articles to exaggerate the benefits and downplay the risks of their drugs, the guidance gives companies a green light to promote unapproved uses of their products by handing out these journal articles,” he said. “This fun­da­mentally undermines the requirement that companies prove to the FDA that each new use is safe and effective.”

Others, however, perceive the guidance as highly restrictive. In 1998, the Washington Legal Foundation (WLF) obtained a federal court injunction (Washington Legal Foundation v Friedman) that prohibits the FDA from preventing manufacturers from disseminating peer-reviewed medical journal articles and medical texts that contain off-label information. When a draft of the guidance was released last year, the WLF contended that it raised serious First Amendment concerns regarding manufactur­ers’ rights to speak truthfully about important health care issues. The WLF pledged to initiate court action if the FDA adopted a final guidance that violated either the existing federal court injunction or the First Amendment.

When asked about the WLF’s stance on the final guidance, Richard Samp, the organization’s chief counsel, said that the WLF continues to have serious reservations about the reprint guidance.

“Despite what some ill-informed critics on the Left are saying, this guidance is a significant tightening of prior speech restrictions. Just how bad the guidance is depends to a certain extent on how strictly the FDA interprets an ‘adequate and well-controlled study,’” he said. “If the FDA means to limit studies that can be disseminated to those that are sufficient to warrant the granting of an NDA [New Drug Application], then the restriction is so tight that it cannot survive First Amendment scrutiny and the FDA is in contempt of the current federal court injunction that we won against them. We have no plans to pursue litigation at this point; there is no point in doing so until the Obama administration makes clear how it intends to address the issue.”

The guidance published in January encourages manufacturers to seek approvals and clearance for new indications and intended uses. It also acknowledges that health care pro­fes­sionals may lawfully use or prescribe an approved drug or cleared device for off-label treatment.

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