Julie Dohm’s comments at the Food and Drug Law Institute’s Medical Products Advertising and Promotion Conference were featured in an article in The Pink Sheet examining the U.S. Department of Health and Human Services’ enforcement discretion policy on peptide compounding.
“There [are] no conditions related to advertising and promotion of those peptides in the list of conditions that would have to be met in order for a peptide to be eligible for the policy,” Julie said.
“A number of those peptides are widely advertised currently … sometimes in combination with GLP-1s, and so I thought that that was a notable omission,” Julie added.
Julie also discussed the pharmaceutical industry’s response to the FDA’s enforcement actions targeting advertising claims by telehealth platforms, med spas, and weight loss clinics. To date, many of the claims targeted have been relatively straightforward, including assertions that a compounded drug is FDA-approved, is a generic version of an approved product, or contains the same active ingredient.
“But as a practical matter, there are some bigger advertising and promotion issues that I think industry would love to see more done about,” Julie said, specifically citing the presentation of risk information.
“A lot of the telehealth advertising for compounded drugs has minimal to no risk information, which is obviously a concern because if you’re claiming all the benefit and not the risk, then the patient and prescribers don’t know what the balance is,” Julie said.
Julie also addressed the FDA’s legislative proposal concerning misleading advertising practices.
“I think that the agency put that legislative proposal forward, hopefully, just as a clarification of what they can already determine to be misleading under their existing authorities,” Julie said.
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