Industry Blasts FDA Space-Limited Social Media Guidance as Too Restrictive
Drugmakers say they will be forced to abandon social media due to proposed FDA requirements to present both risk and benefit information in character-limited social media messages — a requirement they contend the agency doesn’t even follow.
Draft guidance released in June indicates that a drugmaker’s posts about a product on social media such as Twitter and sponsored links should include a description of serious risks, limitations to an indication and a link to a web page with more information.
There is no way, however, this information can all fit into a tweet’s140-character limit, making the use of Twitter and comparable platforms “impossible,” according to the Medical Information Working Group (MIWG), a coalition that includes Bayer, Novartis, Pfizer and other companies.
In comments to the guidance, manufacturers also expressed concern that the proposed policy would effectively end the use of Google’s sponsored links to advertise products. The guidance says such advertisements should include links to potential risks, and notes that Google allows up to six additional Sitelinks to be shown as part of an ad.
However, under Google’s policies Sitelinks are not always guaranteed to appear, meaning that the risk information may not always display, according to MIWG. The search engine warns advertisers that anywhere from two to six Sitelinks may appear on a computer desktop.
Without the guarantee of presenting such links, manufacturers will be forced to stop using the service, MIWG said in comments to the guidance.
The FDA should allow multiple product risks to be included in one link instead of separate links for each risk, Novartis wrote in comments.
PhRMA and the Biotechnology Industry Organization effectively called the FDA’s benefit-risk requirement hypocritical. Agency tweets often contain only benefit information about new products accompanied by a link to an FDA news release outlining some risks and benefits, PhRMA said in comments to the guidance.
The group pointed to a recent FDA tweet announcing the approval of Mannkind’s Afrezza (insulin) that doesn’t mention any risks. PhRMA and BIO said they didn’t want the FDA to change its Twitter policy, but rather grant manufacturers the same flexibility.
Another concern drugmakers expressed is whether the guidance is unconstitutional. MIWG noted the proposals violate manufacturers’ First Amendment rights because it imposes content and speaker-based restrictions. The group cites a Supreme Court decision in Sorrell v. IMS Health, where the court decided that pharmaceutical marketing speech is protected by the First Amendment.
The FDA received 20 comments on the guidance, the majority of which from trade groups and drugmakers.
Industry had similar concerns that a separate FDA guidance on using social media to correct third-party misinformation will also chill social media use. Industry groups believe that the guidance unfairly makes drugmakers responsible for third-party content they did not provide.No question about it: social media presents a host of problems for drug and device companies. Manage your presence successfully with Social Media Strategies for Drug and Device Companies.