Lexology September 11, 2025
The U.S. Food and Drug Administration (FDA) announced it is changing its approach to direct-to-consumer (DTC) drug advertisements after a directive from a White House Memo instructing FDA and HHS to “to ensure transparency and accuracy.” The agency says it plans to close a “loophole” that allows drug sponsors to omit a brief summary of risk information from broadcast ads in certain circumstances that were prescribed in FDA guidance first issued in 1997. Simultaneously, FDA sent thousands of letters warning pharmaceutical companies, which demand that they evaluate their compliance with the statute. Below we analyze the impact of these Trump administration statements – including whether they effectively constitute a rescission of agency guidance – and we consider what additional enforcement...
Today's Sponsors
Today's Sponsor