WASHINGTON, DC.— The Washington Legal Foundation (WLF) today warned the Food and Drug Administration (FDA) that it would violate the terms of a federal court injunction were it to adopt its revised draft guidance on reprint practices regarding articles/medical texts that contain off-label information concerning FDA-approved products. In formal comments filed in response to the Draft Guidance, WLF reminded FDA that a federal court injunction (issued in 1998 in Washington Legal Found. v. Friedman) prohibits FDA from preventing manufacturers from disseminating peer-reviewed medical journal articles and medical texts that contain truthful off-label information. It asserted that FDA officials could be held in contempt of court if they attempt to enforce speech restrictions outlined in the Draft Guidance.
WLF argued that the Draft Guidance, which never mentions the First Amendment, will violate both the injunction and the Constitution unless it substantially broadens the types of studies that may be the subject of a distributable journal article or medical text. The Draft Guidance purports to limit dissemination to materials that report on “adequate and well-controlled clinical investigations,” a standard that would eliminate virtually all dissemination. WLF also argued that the Draft Guidance imposes so many burdens on those seeking to disseminate articles and medical texts (such as that they be accompanied by an extensive bibliography) that many manufacturers would be dissuaded from speaking because they would find those burdens too onerous.
FDA has long recognized that off-label treatments play a vital role in medical care. WLF noted that patients will not receive state-of-the-art, off-label therapies if their doctors are not informed about those therapies. It argued that manufacturers—who possess both the necessary resources and the incentive to exert the necessary effort—have traditionally played a large and beneficial role in supporting the dissemination of information about new uses of FDA-approved products.
Following the filing, WLF issued the following statement by Chief Counsel Richard Samp:
“The Draft Guidance appears to violate the terms of a permanent injunction WLF obtained against FDA in 1999. Moreover, it raises serious First Amendment concerns regarding the rights of manufacturers to speak truthfully on important health care issues. By attempting to restrict truthful speech, FDA is endangering public health.”
WLF is a public interest law firm and policy center that regularly litigates in support of the free speech rights of the business community.