A Second Century Initiative (2CI) faculty member recently talked to Bloomberg about the legal gray area that online drug startups like “Hims” and “Kick” are wading into.
Patricia Zettler, a former Food and Drug Administration lawyer and faculty member in the College of Law’s Center for Law, Health & Society, weighed in on companies which are using Instagram and other social media platforms to sell prescription medications for off-label uses. Such uses include generic Zoloft (sertraline), an antidepressant, for premature ejaculation, and propranolol, a blood pressure medication, for use against anxiety.
While some doctors will prescribe the two drugs for those uses, and both drugs have clinical data showing they may help some patients with the conditions, sertraline and propranolol haven’t been cleared by the U.S. Food and Drug Administration for those purposes. With some of their ads, marketing copy and social media posts, the startups are pushing the boundaries of how prescription drugs can be marketed, according to pharmaceutical and legal experts interviewed by Bloomberg.
“It’s not clear to me that this is totally kosher,” said Patricia Zettler, a former FDA lawyer and a law professor at Georgia State University.
Under FDA rules, pharmaceutical companies and distributors can’t make claims that haven’t been approved by drug regulators. Known as off-label marketing, the practice has led to hundreds of millions of dollars in fines and legal settlements from companies. Doctors, however, can legally prescribe whatever they want off-label — including using a blood-pressure drug to treat nerves, or an antidepressant for premature ejaculation — even if the FDA hasn’t cleared those uses.
Zettler also said:
“If they were saying, ‘We’ll connect you to the best doctors to treat social anxiety, that’s one thing,” said Zettler, the law professor, referring to Kick. “It’s another to say, ‘We’ll connect you to a doctor to prescribe a specific drug, and ship you that drug.’”
Read the complete article at https://www.bloomberg.com/news/articles/2019-04-02/startups-are-hawking-zoloft-and-beta-blockers-for-off-label-uses. Learn more about Zettler and her research/scholarly interests at https://nextgen.gsu.edu/2018/06/26/2ci-qa-patricia-j-zettler/.