FDA’s Crackdown on Deceptive Ads: What Happens When FDA’s Representations May Be False Or Misleading?

As an avid reader of OPDP Warning and Untitled Letters that routinely allege pharma companies have engaged in false or misleading Rx drug promotion, this blogger read with interest FDA’s press release on its crackdown on deceptive DTC drug advertising.  As I dug into the press release and the example industry letter, I couldn’t help but wonder, what happens when FDA’s own representations could be viewed as “false or misleading.”

As background, late in the day on September 9^th, President Trump signed a presidential memorandum addressing misleading direct to consumer prescription drug advertisements and instructing the Secretary of Health and Human services to take appropriate action “to ensure transparency and accuracy in direct-to-consumer prescription drug advertising including by increasing the amount of information regarding any risks associated with the use of any such prescription drug.”  Along with this presidential memorandum, FDA issued its own press release announcing a crackdown on deceptive drug advertising.  The press release states that “FDA is sending thousands of letters warning pharmaceutical companies to remove misleading ads and issuing approximately 100 cease-and-desist letters to companies with deceptive ads.”

In addition to the letters, FDA states that it is “initiating rulemaking to close the ‘adequate provision’ loophole created in 1997, which drug companies have used to conceal critical safety risks in broadcast and digital ads.”

To support these initiatives, the FDA press release and letter to industry cite to a 2024 review article published by Oxford University Press’s academic research platform – a platform based in the UK where DTC Rx drug promotion is prohibited.  FDA cites to the 2024 review article from the Journal of Pharmaceutical Health Services Research which “reveals that while 100% of pharmaceutical social media posts highlight drug benefits, only 33% mentioned potential harms.”  This statement is attributed to a study published in 2015 that looked at social media activity in 2013 and 2014.  In addition, FDA states that, ”88% of advertisements for top-selling drugs are posted by individuals and organizations that fail to adhere to FDA ‘fair balance’ guidelines.”  This statement cites to another study published in 2012 that evaluated YouTube “advertisements” posted during a 1 month time period in September 2009.  Geez, FDA.  This is far from the “scientifically appropriate and statistically sound” evidentiary standard expected of pharma.

Beyond this woefully outdated and likely inaccurate information is the seeming attempt to obfuscate the entities/individuals that may in reality be responsible for the “misleading direct-to-consumer pharmaceutical advertisements” referenced in the press release.  While FDA is sending letters to “all application holders,” it is not clear that the application holders are the ones responsible for what FDA views as objectionable content.

FDA’s press release also hearkens back to the good ole days, when “FDA used to send more than a hundred warning letters each year, and misleading ads were rare.”  Huh?  What was FDA sending the warning letters about then?  Does anyone else see the seeming contradiction in that statement?

This “crackdown” comes at a time when pharmaceutical companies have, arguably, been working to include the greatest amount and clearest delivery of safety information related to their drugs.  With the recently implemented “clear, conspicuous, and neutral rule” that went into effect in late 2024, modifying 21 C.F.R. §202.1(e)(1), FDA requires that a company present a  drug’s “major statement” (the “fair balance” of safety in a DTC broadcast ad) in a “clear, conspicuous, and neutral” manner, with consumer-friendly terminology and, if in television format, in both audio and text.  During the major statement, the ad must not include audio or visual elements likely to interfere with comprehension of the major statement.

The press release reference to FDA’s new rulemaking intended to close the “adequate provision loophole” is also interesting.  Given the Office of Prescription Drug Promotion’s efforts over the years to conduct research on meaningful ways to convey safety information to consumers, including proposals in Draft Guidance that would reduce the quantity of content but improve the quality of delivery of risk information in consumer print promotion, one has to wonder about the true intent behind this rulemaking.  Is it truly to deliver meaningful risk information about Rx drugs?  Or is this a back door attempt to ban DTC broadcast drug ads by making it virtually impossible for a pharmaceutical company to comply with these new requirements.

This latest attempt to villainize pharmaceutical companies is falling flat with this blogger.  If there was truly such concern over prescription drug ads, one has to wonder why OPDP was subject to such a significant Reduction in Force back in April?  We previously reported on  Senator Durbin’s questions about FDA’s “Operational Capacity” to oversee DTC Rx drug advertising given these workforce reductions.  Is FDA’s use of “AI and other tech-enabled tools to proactively surveil and review drug ads” really supposed to take the place of the FDA employees that worked for years, dedicated to helping ensure prescription drug promotional compliance?  Will the letter to application holders and rulemaking really bring about meaningful changes that will protect the public health or is this simply more PR about big bad pharma?  This blogger’s money is on the latter.