The “21st Century Cures Act” Draft Legislation Includes Welcome Support for First Amendment Rights

FDAThe House Energy and Commerce Committee released a 400-page “discussion draft” of its proposed “21st Century Cures Act” late last month. The bill includes a broad range of reforms governing the regulation of drugs and medical devices, most of which have been warmly received by broad segments of those industries. The bill is particularly welcome to supporters of commercial speech rights; it includes several provisions designed to ensure that government regulators do not prevent manufacturers from speaking truthfully about their medical products.

Social Media

One particular area of concern has been Food and Drug Administration (FDA) restrictions on manufacturer use of social media. Subtitle I of Title I of the bill would overturn those restrictions. One characteristic of social media is that it places a premium on brevity. For example, Twitter limits messages to 140 characters or less. In a Draft Guidance issued on June 18, 2014, FDA concluded that drug/device manufacturers should rarely, if ever, attempt to use social media platforms with character space limitations because those limitations deprives manufacturers of sufficient space to include all the risk and benefit information that the agency asserts is a necessary part of any such communications. It is not sufficient, FDA concluded, for a Twitter message to include the name of the drug and its intended uses, and then provide a hyperlink where detailed risk and benefit information is available. But as Washington Legal Foundation (WLF) pointed out in comments urging withdrawal of the Draft Guidance, a de facto prohibition on use of social media platforms raises serious First Amendment concerns. The First Amendment does not allow the government to prohibit an entire method of communication simply because other methods of communications are available to the speaker, at least not where the government’s goals can be achieved through more narrowly tailored means.

The proposed 21st Century Cures Act would reverse this particular FDA speech restriction. Title I, Subtitle I provides that manufacturers may “disseminate, in character-limited applications, truthful, introductory information about medical products, including the name of such products and their approved uses.” It further provides that the manufacturer may use a hyperlink to refer readers to “additional information about . . . safety and effectiveness of medical products,” and that “for regulatory purposes,” the hyperlinked information should be deemed to have appeared in conjunction with the “introductory information.”

The Sunshine Act

The bill also would revise a provision of the Physician Payment Sunshine Act that, in the view of many commentators (including WLF), has severely inhibited valuable, truthful speech. The Sunshine Act requires drug and device companies to report annually to the Centers for Medicare and Medicaid Services (CMS) all “payments or other transfers of value” they make to physicians. The statute exempts from the reporting requirement “educational materials that directly benefit patients.” The purpose of the Sunshine Act is to shame doctors into not accepting gifts that could be construed as bribes intended to encourage them to prescribe the gift-giver’s products. The idea was that doctors would not accept lavish gifts if they knew that their names would appear on public lists of gift-acceptors.

But a problem arose when CMS applied an extremely narrow interpretation of “educational materials.” In 2013, CMS determined that gifts of medical textbooks and journals were not educational materials and thus were reportable under the Sunshine Act. That odd decision led numerous doctors to cease accepting such gifts (so as to avoid having their names reported), even though it is widely acknowledged that the receipt of such materials from drug companies has long been a principal means by which doctors have kept abreast of medical advances within their areas of specialty. As WLF pointed out in a petition it filed with CMS, the government’s narrow construction of the “educational materials” exception raises serious First Amendment concerns by inhibiting dissemination of truthful medical information. CMS compounded its error in 2014 when it revised Sunshine Act rules to provide for the reporting of manufacturer payments made to the organizers of a continuing medical education event if (to the knowledge of the manufacturer) some portion of the payment is ultimately transferred to a doctor who attends the event.

Title IV, Subtitle S of the bill would reverse these misguided CMS policies. It would amend the Sunshine Act to explicitly exempt from reporting requirements all gifts to doctors of “peer-reviewed journals, journal reprints, journal supplements, and medical textbooks,” as well as payments “intended solely for purposes of providing continuing medical education to the physician.”

Off-Label Communications

FDA does, of course, impose numerous other restrictions on the speech rights of drug and device manufacturers, such as the ban on truthful manufacturer speech regarding medically-accepted off-label uses of FDA-approved products. The bill apparently intends to address at least some of those restrictions. However, the proposed statutory language is not yet ready for release. Title I, Subtitle H of the bill is entitled, AFacilitating Responsible Communication of Scientific and Medical Development,@ but for now the bill simply states that specific statutory language is “to be supplied.” Judging from the speech-friendly provisions discussed above, however, there is reason to hope that the language ultimately proposed will bring additional cheer to First Amendment advocates.

Also published by Forbes.com at WLF’s contributor page

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