The House Energy and Commerce Committee released a draft of its 21st Century Cures Act (the Cures Act) on January 27, 2015, as a "starting point in the legislative process and to spur discussion." The draft is part of a 2014 initiative established to revamp some of what the Food and Drug Administration (FDA) regulates, including social media oversight, and establish a "path to 21st century cures."
The almost 400-page document touches on many subjects, but Sections 1141 and 1161, tucked away on page 92, discuss communication and distribution of scientific and medical developments. Section 1141, "Facilitating Responsible Communication of Scientific and Medical Developments" has no text, but serves as placeholder for a provision that may—finally—unshackle the flow of scientific and medical information.
Section 1161, "Modernizing the Regulation of Social Media," purports to overhaul FDA's social media regulations. We have written extensively over the years on FDA's rules regarding FDA-regulated industries' use of the internet. ( FDA, Social Media & Promotional Labeling: Frees Speech or Freeze Speech, FDA and Social Media: the FDA speaks, FDA Issues Draft Guidance on the Internet and Social Media and FDA Compliance and Social Media – Data Smog, Digital Strangers and FDA's Road Not Taken. While Congress might deserve one-handed applause for any attempt to address the existing rules discouraging industry participation in social media, it needs to do more than simply direct FDA "to review each regulation and guidance" and propose revisions.
The First and Fifth Amendments to the U.S. Constitution create barriers to social media regulation, particularly when disseminating "truthful, non-misleading information." FDA has persistently denied that constitutional free speech guarantees apply to the industries they regulate and, by doing so, has abridged those industries' due process rights. This Constitutional conundrum has been expanding since at least 1976, reaching a fever pitch in Sorrell v. IMS and US v. Caronia. Only recently has FDA begun to acknowledge that the Constitution applies to its enforcement regime.
While there are good reasons that FDA has struggled with balancing due process and First Amendment considerations, Congress should address the due process and First Amendment considerations that have hampered the free flow of important product information. There is no doubt that FDA brings considerable scientific expertise to creating artful rules and guidance on health and safety issues, but FDA is out of its element regulating speech and exercising judgment regarding constitutional requirements. The Constitution often demands Congress perform the heavy lifting, and it is past time for Congress to put pen to paper and straighten out this issue. Far too many physicians and patients have been denied important and truthful information about therapies they prescribe and ingest, while the government plays an outrageous and expensive game of regulatory whack-a-mole—often exacting massive fines and penalties from industry for the high crime of disseminating truthful scientific or medical information.
If enacted, the Cures Act would give FDA one year to review all regulations and guidance applying to the dissemination of information about medical products by means of the Internet (including social media platforms and character limited applications) and:
propose revisions to such regulations and guidance (in the form of proposed amended regulations and draft guidance, respectively) that—facilitate meaningful use, by the sponsors of medical products [defined as drugs, biological products, or medical devices], of the Internet, including Internet applications and social media, for dissemination of truthful, non-misleading information about medical products. Id at Sec 1161.
It is somewhat perplexing and disheartening that Congress used the term "Cure" in its proposal. After all, a manufacturer's use of the term "cure" in social media creates an invitation to regulatory hot water. Although Congress is late to the game and may be running the bases on a foul ball with this "discussion draft," it is clearly interested in what industry has been bemoaning for decades—criminalization of the "dissemination of truthful, non-misleading information about medical products." The definitions of "dissemination," "truthful" and "non-misleading" have been hotly litigated as well as the subject of bitter and expensive enforcement. These issues have arisen because the government categorizes every utterance or non-utterance as labeling and subjectively defines "truthful" and "misleading" on a case-by-case basis, creating a First Amendment infringement without due process. A review of the past decade's massive settlements involving disseminating truthful scientific and medical information reveals few, if any, consent decrees in which the manufacturer admits to wrongdoing. Congress, not FDA, must provide clarity and not leave it to FDA to define "truth" because—according to FDA— a statement is true only if it has been subjected to two randomized controlled clinical trials or received prior FDA approval.
One innovative and helpful suggestion in the proposed Cures Act concerns hyperlinks. The Act proposes to:
recognize that such sponsors may use the Internet—"B(i) to disseminate, in character-limited applications, truthful, introductory information about medical products, including the name of such products and their approved uses;" and "B(ii) to provide additional information about the safety and effectiveness of the medical products using information that is hyperlinked to such introductory information; and "(C) for regulatory purposes, treat hyperlinked information described in subparagraph (B)(ii) as if the information appeared in introductory information described in subparagraph (B)(i).
This proposal, if enacted, would represent a significant common sense change by legalizing hyperlinks that currently result in violations. Whatever form the Cures Act ultimately takes, it will certainly not be a "cure." Nevertheless, any legislation will be better than the current regime and will have a real impact on FDA, FTC, DOJ and states' attorneys' enforcement of the Food Drug and Cosmetic Act and its parallel state acts.
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