FDA Signals More Oversight of Compounders in Drug Ads Crackdown
Healthcare & Life Sciences attorney Melissa Wong was interviewed by Bloomberg Law about the federal government's efforts to rein in pharmaceutical advertising and increase oversight of compounded products. President Donald Trump issued an executive order (EO) this week calling for concerted efforts to "ensure transparency and accuracy in direct-to-consumer prescription drug advertising." The U.S. Food and Drug Administration (FDA) subsequently sent letters to a number of drug companies warning them about deceptive advertising practices, including those involving compounded drugs, which are copies of FDA-approved treatments for specific patients and often cost less than brand-name products. Historically, these drugs have fallen into a regulatory gray area: Organizations marketing them argue promotion falls under Federal Trade Commission (FTC) purview because that agency regulates ads for over-the-counter drugs, but the EO signals the government's intent to apply the FDA's stricter rules covering prescription medications. Ms. Wong summarized the debate and provided examples showing the complicated nature of the issue.
"If there are clear-cut violations related to, for example, off-label use or messaging that omits discussion of potential side effects, these issues are more likely to continue to reside with FDA enforcement," she explained. "If there is an issue with how telehealth companies or pharmacies sell their products and services to the general public, it may make more sense for the FTC to lead the charge."
Regardless of how the oversight question is answered, she said, companies should take note of the announcement and review their advertising strategy to avoid unwanted federal scrutiny.
"The FDA is clearly looking to take a more aggressive stance with deceptive advertising practices, and that will include non-traditional targets," Ms. Wong cautioned. "...[T]he FDA is putting the entire industry and those non-traditional stakeholders on notice."
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