Foley & Lardner LLP partner Kyle Faget is quoted in the Inside Health Policy article, “Legal Experts Contradict Califf, Say FDA Can Regulate Misleading Telehealth Ads,” offering insight on the U.S. Food and Drug Administration’s (FDA) authority to regulate online clinics advertising drugs without affiliations to drug companies.
Faget, who is co-chair of Foley’s Health Practice, noted that the Federal Food, Drug, and Cosmetic Act provisions that “enable FDA’s actions are not necessarily restricted to manufacturers, packagers and distributors.”
Faget explained that the FDA’s guidance document on drug advertising and promotion was written in a way to keep manufacturers, packagers, and distributors in mind, as historically these were the sole entities advertising and promoting prescription drugs before the emergence of telehealth companies.
“Now, there’s this whole telehealth industry, and FDA has remained largely silent on this front,” Faget said. “FDA has yet to actually weigh in on that.”
Faget emphasized that clarity from Congress would alleviate much of the confusion surrounding whether FDA possesses the authority to regulate telehealth advertisements of drugs.
“Congress would be very important here because there is so much confusion in the marketplace,” she added.
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