Two FDA guidance documents on how health product manufacturers may participate in social media have each drawn criticism from affected industry and consumer groups. Both documents, one on presenting risk/benefit information on Internet/social media platforms with space character limitations and the other on dealing with misinformation about products by third parties, were published in June.

Among comments on the character limitations draft guidance, the industry-funded Washington Legal Foundation (WLF) expressed “grave concerns” about several provisions in it.

“Although FDA does not say so explicitly,” WLF wrote, “the gist of the draft guidance is that manufacturers should rarely, if ever, attempt to use Internet/social media platforms with character space limitations because those limitations do not provide manufacturers with sufficient space to include all the risk and benefit information that FDA asserts is a necessary part of any such communications.

“The de facto prohibition on use of such Internet/social media platforms is inconsistent with FDA’s statutory mandate and raises serious First Amendment concerns regarding the rights of manufacturers to speak truthfully on important healthcare issues.”

WLF called on FDA to withdraw the document in its entirety and replace it with one that “respects statutory and constitutional constraints on FDA’s authority.”

Pharmaceutical Research and Manufacturers of America (PhRMA) blasted FDA for what it described as a double standard as regards dealing with character limitations. Specifically, PhRMA said FDA’s own Twitter posts don’t follow the restrictions that the agency is attempting to impose on industry in the draft document. “FDA’s own actions—including the use of links to present risk information and general descriptions of the benefits of drugs—provide reasonable standards for appropriate use of these media,” PhRMA wrote.

“Significantly, the limitations FDA recommends cannot withstand basic First Amendment scrutiny, because there are less restrictive means of ensuring that information presented on these platforms is truthful and non-misleading. Moreover, it cannot be truthful and non-misleading for FDA to use character-space-limited platforms in one way, but misleading for biopharmaceutical companies to do the same.”

Meanwhile, in separate comments on the related guidance about correcting third-party misinformation on the Internet, PhRMA faulted FDA for assuming that manufacturers can be held accountable for such content if a company merely influences the third party.

“By limiting the scope of the guidance in such a way, FDA‘s draft guidance, perversely, is likely to result in more inaccurate information about medicines online that will go uncorrected.”

PhRMA said the draft guidance also appears to recognize that some statements on social media correcting misinformation are neither labeling nor advertising, but fails to give guidance as to what kinds of statements would be regulated as such. “The draft guidance should expressly recognize that many statements on the Web are not labeling, that non-promotional statements are not advertising, and that many statements correcting misinformation will be neither,” it said.

Representing large medical-device manufacturers, AdvaMed commented that abbreviated format platforms are generally viewed as gateways for accessing additional information. “Such communications are an important means of providing information about device technologies, including those that are new and offer life-saving and life-enhancing therapies, to patients and healthcare professionals,” AdvaMed wrote.

It called on FDA to take a more flexible approach that supports truthful and non-misleading information while better reflecting the unique attributes and use of Internet and social media tools and appropriate use of links to support such communications.

The Biotechnology Industry Organization (BIO) complained that the character limitations draft document “imposes broad speaker-based restrictions on manufacturer communications” and reiterated its support for manufacturer First Amendment rights to truthful and non-misleading speech.

Separately addressing the third-party misinformation document, BIO called for assurance of FDA flexibility in terms of manufacturer participation in already existing conversations purporting to contain accurate information about biopharmaceutical products.

The Medical Information Working Group (MIWG) called the character limitations document tantamount to a ban on the use of space-limited platforms for product communications and said it runs afoul of the First Amendment protection of truthful manufacturer speech.

In separate comments on the third-party misinformation draft guidance, MIWG said FDA should reconsider its approach and hold manufacturers accountable only to the extent that the content was developed or posted by or on behalf of the manufacturer.

It asked the agency to provide more examples of when manufacturers are and are not responsible for correcting misinformation found online and on social media.

The draft as it stands “advances an impermissibly broad interpretation of FDA’s authority to regulate manufacturer speech by taking the position that manufacturers are accountable for third-party communications that they have influenced or with which they have been involved.”

Members of the Patient, Consumer and Public Health Coalition expressed concern that the guidance only applies to companies that “voluntarily choose” to correct misinformation appearing on the Internet or through social media platforms from third-party entities.

“Due to the fact that the guidance is voluntary in nature and that there are no enforcement mechanisms in place,” it wrote, “it will not do enough to protect individual patients or the public health more generally. Only a strict requirement to correct misinformation would ensure that patients are not misled.”