Alan Minsk Quoted in Bloomberg Law on FDA Oversight of Compounded Drug Advertising

AGG Food & Drug chair Alan Minsk was quoted in a Bloomberg Law article examining FDA’s stepped-up scrutiny of advertising for compounded drugs, following a new executive order aimed at increasing transparency and accuracy in prescription drug marketing.

FDA recently issued hundreds of letters to drug companies and telehealth providers warning against potentially deceptive practices, indicating greater control in the regulatory gray area of compounded medications, which are custom-prepared alternatives to FDA-approved drugs.

Alan explained that FDA has long asserted authority when promotional materials raise concerns. “Where FDA believes that there is written printed or graphic material for any FDA-regulated product, it will assert jurisdiction,” he said.

The debate highlights uncertainty over whether oversight of compounded drug promotions falls under FDA, which regulates prescription drug ads, or the Federal Trade Commission, which oversees over-the-counter promotions.

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