The Trump Administration dropped its fiscal 2027 budget request this past week. The 90-page document released for the Department of Health and Human Services (HHS) includes some legislative proposals for the Food and Drug Administration (FDA) that the healthcare marketing industry should take note of as HHS looks to build on the Make America Healthy Again agenda heading into the midterm elections.
However, the budget request is not binding. Last year, congressional appropriators rejected many of the same changes proposed in the FY 2027 budget request and funded the agencies at or around their current levels. Some policy-driven requests might end up in a spending package that is expected to be the final major opportunity for legislative changes to FDA authority this year. Any new legislation concerning Rx advertising will be difficult given the narrow margins currently in Congress unless it has large bipartisan support – not as likely before the highly contentious midterm elections.
FDA Legislative Request on Drug Advertising
The first item under the “Legislative Proposals” (page 16) is focused on prescription and compounded drug advertising. Specifically, the FDA is seeking a two-part authority to:
- Deem a drug misbranded if a direct-to-consumer prescription drug advertisement “lacks fair balance and creates a misleading impression” about its approval, including the scope of the FDA-backed indication and the drug’s benefits; and
- Clarify that a compounded drug is misbranded if an advertisement fails to “clearly and prominently disclose” that the compounded product has not been evaluated by FDA for safety, effectiveness, or quality. Compounded products would also be deemed misbranded if an advertisement makes claims about the compounded drug based on clinical data for FDA-approved drugs containing the same active ingredients, making misleading comparative claims to a particular FDA-approved drug or class of drugs, and claims without evidence that a compounded drug is safe and effective, or omits risk information.
Part 1: Drug Ads that Create a Misleading Impression
The first part of the legislative proposal clarifies that the FDA thinks that it needs to codify in some form the gist of its untitled and warning letters on ‘creating a misleading impression’ in its enhanced enforcement since September 9th for prescription drug advertising and marketing.
This proposal would update FDA’s authorities with respect to direct-to-consumer (DTC) advertising. Specifically, this proposal would deem a drug to be misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352) if a DTC drug advertisement lacks fair balance and creates a misleading impression regarding FDA approval, the scope of the FDA-approved indication(s) and the limitations of use, or the drug’s efficacy and benefits, including by making or suggesting overstated representations that are not supported.
Why is the FDA making this legislative request? In brief, the series of some 50+ letters focusing on DTC ads, promotional websites and materials are, in fact, individual communications to a specific pharmaceutical company. While almost all of these letters have been closed out by the FDA, the individual letters in themselves do not represent a formal policy directive to the industry, and FDA enforcement could fade with the changing of an FDA Commissioner, HHS Secretary or Administration.
Many legal scholars would argue that FDA currently that the authority under the FD&C Act and 2007 Food and Drug Amendments Act (FDAA) to more tightly regulate pharmaceutical advertising as it has done through enforcement letters since last September. With this in mind, it also should be noted that codifying FDA enforcement letter actions also could be done – and still might be proposed this year – as a new or add-on guidance or regulations related to the 1999 FDA Consumer-Directed Broadcast Advertising with Questions & Answers industry guidance or 2023 “clear, conspicuous and neutral” (CCN) final rule. If a more regulatory approach does not occur, it may be a sign that FDA or White House lawyers believe that codifying the “creates a misleading impression” enforcement actions may be challenged in the courts.
Part 2: FDA Compounding Pharmacy Advertising Oversight
More importantly to FDA, the forementioned proposal’s first part sets up a parallel construction for the second half of this proposal that has eluded the FDA over compounding pharmacies’ advertising and marketing practices. Opposite of what has occurred with DTC drug advertising untitled letters, the agency has not received response letters for any of the warning letters sent to compounding pharmacies, nor have those letters been closed out. Due to a Supreme Court ruling at the turn of the century, this is really where FDA would likely need new adopted law by Congress to be able to pursue compounding pharmacy advertising drug claims that are misleading or do not present a fair balance of the compounded drug’s benefits and risks.
It would also update the FD&C Act to clarify that a compounded drug is deemed to be misbranded if an advertisement’s representation is false or misleading or creates a misleading impression by failing to clearly and prominently disclose that the FDA has not approved or evaluated these products for safety, effectiveness, or quality prior to marketing; representing or suggesting the compounded drugs are safe and effective without any evidence; making misleading comparative claims to a particular FDA-approved drug or class of drugs; misrepresenting the data available about the compounded drug or its active ingredients for particular indications based on clinical trials of FDA-approved drugs containing the same active ingredients; or omitting risk information or otherwise failing to provide fair balance.
FDA is seeking more authority from Congress to crack down on direct-to-consumer advertising of compounded drug products – a move signaling the agency believes it needs stronger legal grounding after sending 50+ warning letters to compounding pharmacy telehealth companies not to compare compounded drugs to FDA-approved formulations and targeting their more recent Superbowl ads. Compounding itself is regulated by states, not FDA. And prior administrations have said that FDA lacked authority to target telehealth compounder’s advertising. This legislative request is the clearest signal to congressional lawmakers that FDA needs their help by passing new law.
At the same time, however, HHS Secretary Robert F. Kennedy Jr. has been sending a mixed message on the issue by touting the efficacy of peptide products offered by compounders and promising laxer FDA enforcement for those products. Peptides like BPC-157 and CJC-1295 are popular, including among acolytes of Kennedy’s “Make America Healthy Again” movements, because of their supposed ability to build muscles and slow aging, although there is little data supporting these claims.
Last week, Sens. Dick Durbin (D-IL) and Roger Marshall (R-KS) urged FDA in a letter to begin reviewing compounders’ ads before they air to ensure disclosure of all relevant safety information. They introduced the Protecting Patients from Deceptive Drug Ads Act last year, which would instruct FDA to issue warning letters and fines to address false and misleading prescription drug ads by social media influencers and telehealth companies.
For questions or more information, please contact Jim Potter, CHC Executive Director, at [email protected].
