FDA Issues Draft Social Media Guidance for Drug, Device Makers

In draft guidance issued Tuesday, FDA outlined how drugmakers and medical device makers should highlight the benefits and risks of their products via social media and how they should address and correct misinformation regarding their products posted by third parties, the New York Times reports (Tavernise,  New York Times, 6/17).

FDA is accepting comments on the draft guidance. According to the Wall Street Journal's "Pharmalot," FDA must finalize the guidelines before a July deadline that was established under a 2012 law, which requires the agency to offer guidance on product promotion on the Internet (Silverman, "Pharmalot," Wall Street Journal, 6/17).

Draft Guidance Details

The draft guidance would require drug and medical device manufacturers to disclose the benefits and potential risks of their products when posting about the items on social media, even if the social media platform only offers limited character space, Reuters reports

For example, the manufacturer would have to specify whether a hypothetical memory loss drug was for "mild to moderate memory loss," rather than just for "memory loss." The draft guidance notes that there might be limitations in character space on some social media platforms, which "may not enable meaningful presentations of both benefit and risk," especially for products with "complex indications or extensive serious risks."

The draft guidance would permit simple "reminder" promotions, which feature only the name of the product (Clarke, Reuters, 6/17).

Thomas Abrams -- director of the Office of Prescription Drug Promotion at FDA's Center for Drug Evaluation and Research -- said, "The information should not be promotional and should be factually correct. This is not an opportunity for a company to tout its drugs" ("Pharmalot," Wall Street Journal, 6/17).

The draft guidance also would permit manufacturers to correct product misinformation posted by third parties or in chat rooms. In such instances, companies would not be required to detail all of a product's risks and benefits as long as they provide corrections that are clear, accurate and not misleading.

In addition, the guidance would allow companies to correct misinformation posted on online forums or submit a correction to an individual blogger or website. Under the guidance, companies would not be accountable for misinformation that a blogger or website creator failed to correct.

However, the guidance would not provide the same flexibility for corrections when the information is posted by a company employee or an affiliate firm. It also would not allow companies to monitor discussions on its own website or to edit comments that portray a product negatively while adding positive comments (Reuters, 6/17).

Comments

In a blog post about the draft guidance, Abrams wrote, "These documents strive to ensure that the information provided by drug and device companies is accurate and will help patients to make well-informed decisions in consultation with their health care providers" (Abrams, "FDA Voice," FDA, 6/17).

Separately, Abrams said the guidance is "intended to have a beneficial impact on public health," noting that the regulations were "not developed in a vacuum. They were developed with careful consideration and with input from industry and many other stakeholders. There was a lot of important consideration given to the issues" ("Pharmalot," Wall Street Journal, 6/17).