Two industry groups representing U.S. biopharmas said they are evaluating the guidances and reviewing them with members, in advance of comments to be submitted later this year to the website www.regulations.gov. FDA has set a 90-day period for feedback that ends September 16.
“We are encouraged that FDA is proceeding with providing us with much needed guidance in this area,” Tracy Cooley, a spokeswoman for the Biotechnology Industry Organization (BIO), told GEN.
Jeffrey K. Francer, vp and senior counsel with Pharmaceutical Research and Manufacturers of America (PhRMA), told GEN that his group had yet to fully vet the draft guidances with members, but did say the draft guidance for limited-character media was especially helpful.
“It’s been very challenging for companies to use Twitter in a way that the FDA prescribes, because the FDA wants to see both benefit and risk information everywhere, not just after the link, and this can be very challenging,” Francer said. “If the FDA is going to require the same type of fine print that you see in a magazine ad to be in a tweet, then the FDA is essentially taking that tool away from patients who may want to hear from companies as well as healthcare professionals.”
Francer said PhRMA has proposed in the past that companies be allowed to use graphic symbols to indicate risk, with a short statement about what the drug does, and a link to more detailed risk-benefit information.
Such character-limited messages would be along the lines of the FDA’s Twitter tweets every time the agency approves a new drug, which include links with the details about risks and benefits rather than embedding info within the tweets.
“The companies want to provide information that’s useful to physicians and that’s useful to patients, and they should be able to use all the different media that the government uses itself,” Francer said. “I assume that the FDA believes that its own tweets are truthful and not misleading. If they believe that, then why couldn’t a company use Twitter in the same way that the FDA is using Twitter?”
“It actually raises, I think, important First Amendment issues when the government is restricting the speech of a particular party, but kind of engaging in that same exact speech itself,” Francer added.
PhRMA also cited free-speech concerns with a January draft guidance in which FDA advised companies on regulatory requirements for post-marketing submissions for prescription human and animal drugs and biologics to “interactive promotional media”—not only social media but blogs and podcasts. Addressing the agency, PhRMA said that draft guidance “could chill truthful and nonmisleading communication protected by the First Amendment” by assuming that all manufacturer statements about prescription medicines on social media constituted promotional labeling or advertising.