James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg Law Health Law & Business, in “FDA Signals More Oversight of Compounders in Drug Ads Crackdown,” by Nyah Phengsitthy. (Read the full version – subscription required.)
Following is an excerpt:
The FDA is signaling fresh control over the promotion of copycat drugs under President Donald Trump’s executive order to rein in pharmaceutical advertising, staking a position in a regulatory gray area around so-called compounded products.
On Tuesday, Trump’s executive order called for “action to ensure transparency and accuracy in direct-to-consumer prescription drug advertising.”
The Food and Drug Administration then sent hundreds of letters to drug companies warning of deceptive promotions, which included notices to online telehealth companies that market the compounded products, a spokesperson for the US Department of Health and Human Services said in an email. …
Reviving a Debate
The FDA’s move is significant as it is wades into an industry debate on which ads the agency or the FTC can regulate.
The FDA oversees prescription drug advertisements and requires them not to be false or misleading, have a balance between efficacy and risk information, and be truthful.
The FTC, meanwhile, primarily oversees advertisements for over-the-counter drugs to ensure claims are truthful and non-deceptive. …
Still, the FDA has taken some authority over compounded drug ads in the past, sharing that if the agency has concerns that compounders’ promotional materials are false or misleading, it may seek voluntary compliance. …
“For pharma manufacturers, it’s pretty clear because all of their advertising is regulated by the FDA,” said James Boiani, a member of Epstein Becker & Green PC. “For compounders, it’s more nebulous.”
