In this post, I summarize some of the comments submitted by the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents the country‘s leading pharmaceutical research and biotechnology companies.
Novartis may be "cheeky" in suggesting that the FDA delete this and delete that, but PhRMA takes a decidedly litigious stance and suggests that the FDA is overstepping its authority under the Federal Food, Drug and Cosmetic Act (FDCA) and the First Amendment.
Instead of asking the FDA to clarify what it means by drug firms having "influence" over third-party sites -- which is what most other commenters asked -- PhRMA said that holding a biopharmaceutical manufacturer accountable for content written by third-parties on third-party web sites if the company merely "influences" the third-party is
"overbroad and is inconsistent with the FDCA. Put simply," said PhRMA, "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 Second, the Draft Guidance erroneously assumes that all manufacturer statements about prescription medicines on social media constitute promotional labeling or advertising. This expansive interpretation of labeling and advertising adopted in the Draft Guidance could chill truthful and non-misleading communication protected by the First Amendment. Thus, it is critical that FDA address these fundamental issues in the Final Guidance."And that's the end of that! But PhRMA had plenty more to say about the Draft Guidance.
"The breadth of the proposed 'influence' concept would sweep in materials that could not properly be considered within the scope of FDA‘s regulation of 'labeling' and 'advertising'," said PhRMA.
"As written," said PhRMA, "the Draft Guidance will severely chill a manufacturer‘s First Amendment right of association [my emphasis]; if a manufacturer 'collaborates' with a third-party on any aspect of a third-party site, the manufacturer will become potentially responsible for all speech by that third-party. Manufacturers could then subject to burdensome regulatory requirements and the threat of criminal penalties for speech that they do not even control. FDA should therefore remove the 'influence' test from the Draft Guidance."
Another interesting point made by PhRMA concerns user-generated content (UGC) on a drug company's site. PhRMA believes that manufacturers "should only be held responsible for promotional communications that are controlled or caused by the firm, which should be defined as content that is controlled entirely by the manufacturer or its agents and that the manufacturer or its agents are authorized to edit or delete in the manufacturer‘s sole discretion."
It cited this example:
"For example, if an independent third-party posts a statement about an unapproved use of an approved drug for diabetes on the firm's site, the firm should not be held responsible for the content of the statement if the firm only made a neutral call for comments about diabetes. Similarly, if a firm creates a discussion board inviting comments on patient experiences with diabetes, it should not be deemed to have prompted the content of the posts made by independent, third-party users."Personally, I believe that if a firm has the "sole discretion" to delete or not delete such content, this would be an open door to gaming the system whereby "anonymous" users -- who actually may be agents of the company or its agency of record -- will post off-label information that remains on the site for an indefinite amount of time. For more on this issue, read "Accountability for Pharma Content on Social Media Sites."
With regard to the First Amendment, PhRMA believes the Draft Guidance "threatens to subject manufacturers to criminal penalties not only for their truthful and non-misleading speech in social media outlets under some circumstances, but also for some such statements by third-parties, in plain violation of the First Amendment." In addition, PhRMA reminds FDA that "even though the term advertising is not defined in the FDCA, the assumption that all online communications constitute advertising is inconsistent with FDA regulations."
What about the free speech of pharma employees? PhRMA also has something to say about that, but in a nice way:
"While a firm should be responsible for comments by an employee, agent, advisor, or paid speaker acting on behalf of the firm, the Final Guidance should clarify that such agents may be speaking on their own behalf, in which case their content should be treated as independent of a manufacturer."As an example, PhRMA talks about key opinion leaders (KOLs) and patient/consumer bloggers.
"For example," said PhRMA, "some paid speakers may be experts in therapeutic areas, and although a firm might engage a speaker to speak on the firm‘s behalf on occasion, the individual may frequently speak independently about his or her areas of expertise, without the firm‘s knowledge or control. Similarly, a firm might engage with a third-party, such as a consumer health advocate, to develop content for the firm-owned site. The health advocate may also speak independently about their specific area of interest without the firm‘s knowledge or control. Likewise, a firm may maintain policies, training and education for employees about appropriate use of interactive social media. Nevertheless, that employee may act outside the scope of his employment and independently post information about a personal experience with a medicine or some other event without the firm‘s knowledge or control."There is some ambiguity in the Draft Guidance regarding the phrase “acting on behalf of the firm.” IMHO, it is best to instruct your paid spokespeople NOT to mention product names or engage in such conversations on their personal social media pages or other independent sites. At least not without prior approval from legal/regulatory. This prohibition should remain in effect even for some period of time AFTER the contract runs out and the person is no longer an “active” spokesperson but is a “latent spokesperson” as described in this Pharma Marketing News article: "Social Media, Latent Spokespersons & Native Advertising."
PhRMA was not a fan of forcing drug companies to submit Form FDA 2253 or 2301 submissions on a monthly basis as suggested in the Draft Guidance. "Providing monthly reports including the site name, URL, date range, and cross-references to the dates of the most recent submission of the site would impose an unnecessary burden on firms and discourage firms from participating in a broad variety of interactive forums," said PhRMA. "Moreover, such reports would provide little public health benefits nor significantly assist the agency in its mission compared to quarterly reports containing the same information." Quarterly submissions would "strike a more appropriate balance between the agency‘s mission and burdens on industry," said PhRMA.
With regard to restricted sites owned by pharma companies, PhRMA suggests that FDA give firms the option to provide FDA with user credentials to restricted sites rather than continuing to submit the relevant content of the restricted site in its entirety on a regular basis. "This may provide FDA with a more complete review in some instances because screenshots do not always accurately capture all of the content on a dynamic interactive platform," said PhRMA. Amen to that!