FDA Issues New Guidance to Help Pharma Correct Misinformation on Social Media

Jul 9, 2024, 01:02 PM

The US FDA has issued new draft guidance aimed at helping pharmaceutical companies correct misinformation, particularly on social media. This guidance includes updates from 2014 and introduces terms like 'influencer' to address the growing spread of rumors. FDA Commissioner Dr. Robert Califf emphasized the need for the industry to 'promptly and proactively' tackle misinformation. The guidance allows prescription drug and medical device makers to directly correct claims made by social media influencers or other third parties about unapproved uses of medical products. Additionally, the FDA has created a new safe harbor to enable pharma companies to correct misinformation without violating advertising and promotion regulations. This move is part of a broader effort to ensure accurate information about medical products and to address false claims, such as those suggesting that lipid-lowering drugs cause Alzheimer’s. The FDA also advised manufacturers to pay attention to data received from CROs.