FDA’s Vague Rules Limiting Speech (i.e. Due Process and the First Amendment):
On September 29, 2014, the FDA reopened the comment period for two of its Social Media Guidance documents for FDA-regulated industry. Since the advent of the internet, the FDA has been plagued by its reliance on undefined terms while enforcing vaguely circumscribed regulations that criminalize First Amendment protected speech. During that time, the US has endured (at least) two wars, three two- term presidents and an entire generation has been born and raised, but no clear rules on how FDA regulated industry may use the internet have emerged. There is a now glimmer of hope as the Comment period has been reopened for the follow two draft Guidance documents:
The Internet/Social Media Scorecard:
There are eight relevant guidance documents that touch on the issues of industry use of the internet:
- Correcting Third-Party Content and User Generated Content (see above);
- Twitter Guidance (see above);
- Interactive Promotional Media (Fulfilling Regulatory Requirements for Post marketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics) January 2014;
- Presenting Risk Information (Draft Guidance: Presenting Risk Information in Prescription Drug and Medical Device Promotion) May 2009;
- Advertising and Promotional Labeling Guidance for Industry: Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling. Revised November 2013;
- Unsolicited Requests: Draft Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. December 2011;
- Scientific Exchange Notice was published in the Federal Register in December 2011 entitled Communications and Activities: Off-Label Uses of Marketed Products and Use of Products Not Yet Legally Marketed). A draft Guidance was issued on March 3, 2014 revising FDA’s Good Reprint Practice Guidance and that guidance was renamed and issued as a draft Guidance entitled “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices”; and
- .com Disclosures Federal Trade Commission “Dot Com Disclosures” Guidance Updated to Address Current Online and Mobile Advertising Environment. The 2000 .com Disclosures were updated in March 2013.
In addition, there are two relevant Citizen’s Petitions filed by the Medical Information Working Group that relate to these issues:
- Request a Review, Response and Modify in a Constitutionally Permissible Manner Statutory Limitations and Specific Requests Set Forth in the July 2011 Citizen Petition (FDA-2013-P-1079). This petition relates to a long pending July 2011 Citizens Petition; and
- Establish Comprehensive, Clear and Binding Regulations to Guide The Industry Relating to New Uses of Marketed Drugs and Medical Devices (FDA-2011-P-0512).
Third-Party Content and Space Limitations:
On September 16, 2014, a number of stakeholders filed responses to both draft guidance documents (Third-Party Content and Twitter). Permeating the responses to these proposed Draft Guidance documents is the concern that the emerging regime for on-line manufacturer content implicates Fifth Amendment due process concerns and infringes First Amendment speech rights. Despite decades of intransigence, there are encouraging signs as FDA has announced making “some ‘mid-course corrections’ in recognition of emerging case law, in particular the case law involving the First and Fifth Amendments of the United States Constitution.” This is no small concession for an agency that, reminiscent of the Black Knight in Monty Python’s Holy Grail, ignored the Supreme Court’s admonitions in Thompson v. Western States and Sorrell v. IMS, and shrugged off its 2012 First Amendment shellacking in the Second Circuit in US v. Caronia, touting all as a “mere flesh wounds.” In what portends to be the final limb of FDA’s rejection of Due Process and First Amendment challenges to how the FDA limits manufacturer content, the Constitutionality of FDA’s enforcement is once again working its way through the courts in Solis v Millennium, 2:09-cv-3013 (E.D. Cal.).
What “Speech” is at Issue?
There are five forms of manufacturer content for FDA regulated industry: FDA approved labeling; advertisements; “Promotional Labeling”; Scientific Exchange; and none of the above. Despite categories of content entitled to different levels of constitutional protection, the current enforcement regime renders all manufacturer online content as regulated labeling subject to the lowest level of court scrutiny. While there are pseudo safe harbors for certain content (for example, reprints and unsolicited requests), whether manufacturer’s affiliation, collaboration, or by-stander status concerning content is subject to FDA enforcement and the government’s overwhelming police power is largely left to the ipse dixit of the FDA itself.
What is emerging is recognition by the FDA that Due Process demands a clear set of rules and the First Amendment demands more, not less, information be disseminated by manufacturers who possess valuable information concerning their products. As FDA’s decades of analysis of manufacturer and consumer use of the internet has demonstrated, consumers and health care providers overwhelmingly search the internet for information about products. There is a health imperative where consumer education and reliable scientific and medical information are the cornerstone, and manufacturer participation needs to be encouraged not suppressed.
No regulation or guidance will prevent bad actors from circumventing the law for personal gain. While the federal government has proven itself highly successful and profitable in netting bad actors, too often it ensnares questionably culpable manufacturers. Due Process and Free Speech rights remain as vital and misunderstood as they were when ratified in 1791. Despite the controversy, applying the principles that flow from these rights to providing health information on the internet may ultimately prove to be among both the greatest challenges and accomplishments in advancing the public health for this generation.