“Jurisdictional creep.”  “Overbroad.”  “May be unforeseen consequences.” Months before FDA’s expected main venture this summer into regulating medical marketers’ activities in social media, the industry reacted sharply to the agency’s preliminary move—a draft guidance it issued in January on requirements for submitting interactive promotional media to regulators. 

While the response period ended in mid-April, the draft guidance continued to draw feedback, and some of the most strongly worded comments weren’t posted until the last day of the month.

Comments on the draft from the Coalition for Healthcare Communication tell FDA that the question of how medical marketer influence or “control” is defined for the purposes of the submissions guidance “is perhaps the most important one to medical publishers, agencies and life science companies.” 

“In particular,” the coalition writes, “it appears the FDA is defining control to include company influence over the placement of advertising—a common practice in all advertising, including print, broadcast and online advertising.”

It points out that if FDA interprets advertiser selection of adjacent editorial content as influence or control requiring submissions to the agency, this would make “virtually all media buying an exercise in control, and thus renders all of the material on sites the responsibility of the advertiser from the point of view of FDA.” 

That would violate the traditional journalism ethic of having “a virtual Chinese wall between editorial content and advertising,” and lead to the “unforeseen consequence” of swamping FDA with “hundreds—and maybe thousands—of Form 2253 submissions that could overwhelm its capacity to review and might end up inhibiting—not facilitating—good FDA marketing review practice.”

The coalition says that some of its members also are concerned that under a broad interpretation, “collaborates on” in the guidance could mean that a firm cannot hold public relations workshops for any media that it supports with advertising or unrestricted educational grants. 

“If this were the case,” it says, “any PR department assistance in the development of a story—e.g., even connecting a New York Times reporter with the appropriate spokesperson for a particular issue or providing background information on a topic—could conceivably be covered under this provision.

“Is it the FDA’s intention that if these PR activities were to occur, a company would be obligated to file a 2253 and provide a copy of the related article to the agency? We don’t think so, but believe the FDA should clarify this point, because this interpretation would chill the practice of companies speaking to the media, which certainly cannot be the outcome the agency intends.” 

Slamming it as “worse than no guidance at all,” the Washington Legal Foundation (WLF) says, in comments posted April 30, that the document fails to recognize that the courts have repeatedly said that the agency is subject to First Amendment free speech protections.

WLF’s comment urges FDA to withdraw Section 4 of the guidance because it is based on the premise that everything a manufacturer posts online qualifies as promotional material, falls within FDA statutory purview, and is not protected from FDA regulation by the First Amendment. 

“Agency policy in this area ought to begin with guidance regarding where FDA draws the line between speech that it is and is not permitted to regulate,” WLF says. “The draft guidance brushes aside such concerns and makes clear that FDA intends to regulate everything that a manufacturer says regarding its products on social media sites.”

This “chills manufacturer speech by requiring all such speech to be submitted for agency review, yet failing to provide manufacturers with any assurance that at least some of the submitted material is not subject to FDA regulation.” 

Manufacturer-based interests are also criticizing what they see as FDA’s overbroad stretch of authority in the draft guidance.

In its comment letter, the Pharmaceutical Research and Manufacturers of America (PhRMA) highlights two fundamental concerns—an agency assumption 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, and an agency assumption that all manufacturer statements about prescription medicines on social media constitute promotional labeling or advertising. 

The Biotechnology Industry Organization (BIO) says that because of the uniqueness and rapid evolution of social media, it is important for FDA to be flexible in its regulatory approach.

As an example, it cites a healthcare professional who has a specific service arrangement with a firm (such as a paid promotional speaker). Such a person may not be acting on behalf of a firm when he or she generates content at his or her own initiation outside the scope of the contracted services. 

“In such an instance,” BIO says, “the healthcare professional is representing his or her opinion as a medical professional and engaging in medical or scientific dialogue, not within the limited scope of his or her arrangement with the firm, and thus not acting on a firm’s behalf.”

Pfizer faults the draft guidance for language that “could be read as jurisdictional creep requiring submission of materials that are neither advertising nor labeling.” To lessen this risk, Pfizer supports PhRMA and BIO recommendations that the guidance be changed in favor of quarterly rather than monthly submissions to FDA. 

Also calling for more flexibility by FDA, Eli Lilly in its comments asks FDA to make clear in the final guidance that the term “interactive promotional media” necessarily means two-way communication of written text.

This would exclude, Lilly says, such one-way techniques as “links or rollover features leading to additional content, video or flash display, advertising or content that moves/scrolls with or without user assistance, and downloadable tools that allow users to provide inputs with a resulting display of information viewable only by the individual user.” 

The Medical Information Working Group, meanwhile, says the document “advances legally impermissible interpretations of FDA authority that must be corrected in the final version.” Its comment letter says the draft sets forth an ambiguous and overly broad interpretation of the agency’s authority to regulate manufacturer speech and also describes manufacturer “influence and control” in a manner that is not consistent with and broader than both the governing law and earlier FDA statements.

“FDA can better respect constitutional limitations by interpreting the scope of its regulatory authority in a clear manner that is consistent with the Federal Food, Drug, and Cosmetic Act,” the coalition of medical manufacturers says.