The Food and Drug Administration (FDA) docket recently closed on the "Draft Guidance for Industry on Fulfilling Regulatory Requirements for Post Marketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics" (Social Media Guidance), and the comments are significant. (See our prior post here). Collectively, the comments submitted to the FDA suggest FDA's Draft Guidance denies due process, violates the First Amendment, is ultra vires to FDA's power, and that FDA's interpretation of vague rules is not entitled to court deference. In light of those hurdles, the FDA's Social Media Guidance may not simply chill manufacturer's online speech, it may freeze it.
Since the advent of the Internet in the 1990's, the FDA has been flummoxed over how to regulate the expression of ideas without trampling the Constitution, and has been bobbing and weaving while dancing around the impossibility of crafting a coherent and reliable regime for regulating Internet content. The Social Media Guidancerecognizes four categories of content for FDA regulated industry: 1) approved labeling; 2) advertising; 3) "scientific exchange"; and 4) promotional labeling. By fiat, FDA characterizes content that is not FDA approved labeling, advertising or scientific exchange as "promotional labeling." Once content is characterized as "labeling" it becomes subject to FDA oversight and enforcement. Promotional labeling is not defined by Congress in the Food Drug and Cosmetic Act (FDCA), nor is it a term defined in FDA's regulations.
The Supreme Court has added to the FDA's difficulty in crafting coherent guidance because it no longer rubber stamps agency determinations interpreting its own rules. Increasingly, the Court looks to determine whether the agency has created a rule that is so vague that industry must guess whether its conduct is in compliance.
As the District Court observed in 1998 in Washington Legal Foundation v. Friedman, when it enjoined for FDA from enforcing its restrictions on manufacturer dissemination of scientific materials, the FDA is not entitled to unfettered discretion in establishing and interpreting its rules free from Constitutional constraints: "FDA exaggerates its overall place in the universe" WLF v. Friedman, 13 F.Supp. 2d 51, 67 (DDC 1998).
Due Process and the First Amendment have proven to be highly problematic stumbling blocks to the FDA's fashioning comprehensive guidance. FDA has deftly ignored the courts on First Amendment issues when it suits its purpose (see WLF v Friedman; Thompson v. Western States and US v. Caronia). Neither has the FDA taken heed of opinions on Due Process or the degree of deference to be afforded the agency in crafting and enforcing its rules (Christopher v. Smithkline, U.S. v. Alvarez and Citizens United v. FEC). Notwithstanding these unsettled issues, the government has had extraordinary success in exacting penalties under threat of severe criminal and civil enforcement.
A number of stakeholders submitted comments to the FDA on the draft Social Media Guidance. The Pharmaceutical Research and Manufacturers of America (PhRMA) comments put the crux of the issue at center stage:
PhRMA member companies have the most complete and up-to-date information about the medicines they research, develop and manufacture. Given the extraordinary growth of the Internet as a source of health information— and the enormous amount of inaccurate and non-regulated information about medical products online—FDA should avoid chilling manufacturers' responsible communication of medical information about their products and should allow manufacturers to take advantage of the same technologies that FDA and the White House use, including blogs, video, search, and social networking sites such as Twitter.
With respect to FDA seeking to impose responsibility on manufacturers for third-party sites and content, PhRMA states:
First, the Draft Guidance assumes that a biopharmaceutical manufacturer can be held accountable for content written by third-parties on third-party websites if the company merely "influences" the third-party. This premise is overbroad and is inconsistent with the FDCA. Put simply, third-party statements not caused or controlled by a manufacturer do not fall within the statutory or regulatory scope of FDA's authority to regulate promotional labeling or advertising.
Second, the Draft Guidance erroneously assumes that all manufacturer statements about prescription medicines on social media constitute promotional labeling or advertising. This expansive interpretation of labeling and advertising adopted in the Draft Guidance could chill truthful and non-misleading communication protected by the First Amendment.
PhRMA generally maintains that the FDA purports to regulate the undefined catchall category of manufacturer on-line content known as "promotional labeling," relegating everything that is not FDA-approved labeling, advertising, or scientific exchange to regulated "promotional labeling."
The Medical Information Working Group (Industry Coalition), a coalition of more than a dozen major pharmaceutical manufacturers, also filed comments. . The Industry Coalition takes a targeted approach, challenging the proposed draft guidance as: 1) a vague and overbroad interpretation of FDA's power to regulate speech; and 2) establishing a requirement that would make manufacturers responsible for the on-line content produced by others. The Industry Coalition provides a detailed analysis of the statutory parameters of FDA's power to define "labeling" stating that "there is a line to be drawn" and concluding that the "FDA cannot regulate communication – or 'activities' – that fall outside the scope of the 'labeling' and 'advertising' definitions [under the FDCA]".
The FDA has been monitoring regulated industry's on-line content and social media since the advent of the Internet. Yet, there is still no clear set of rules guiding industry's participation in the on-line information revolution. In FDA's defense, technology is a moving target and new media continue to evolve and revolutionize how society behaves and shares information on-line. As society moves dramatically forward toward more and greater depth in information sharing, FDA demands retreat and has remained tied to arcane rules governing print and broadcast media. With industry reticent to participate and a consuming public waiting, the Supreme Court is slowly peeling away the decades-old judicial appendages to Due Process and the First Amendment that have enabled regulatory constraints to industry's participation in the free flow of ideas in the marketplace. In the interim, and as regulated industry inches towards realization of a regime accommodating the advantages of new and emerging technology, industry will need to avoid running afoul of agency enforcement through adherence to old rules ill-suited for a new technological age.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
