Caelen Caspers, MJLST Staffer
The television shows a sunny day, birds chirping, and kids skipping. A journal staffer attempts to join in, but winces in remembrance of cite checks. The narrator sighs and explains that life’s moments should not be interrupted by the discomfort of bluebooking. Loudly, the narrator cuts in, “That’s why there’s LawRizzy—clinically proven to relieve the racking pain of cite checks.” The narrator directs you to talk to your healthcare provider and rambles off a few side effects.
Sound familiar? Direct-to-consumer (“DTC”) drug broadcasts have become prolific on our television, social media, podcasts, etc. The rise of DTC advertising is attributed mainly to the “adequate provision loophole”[1]—a regulatory text utilized by drug companies to minimize risk disclosures and instead refer viewers to a secondary source for additional information.[2]
On September 9, 2025, the Food and Drug Administration (“FDA”) announced plans to rescind the loophole.[3] Without it, pharmaceutical companies would have to provide a disclosure of all necessary information related to a drug’s side effects and contraindications in their advertisements.[4] Controversy has since ensued.
Statutory Context
Currently, the law requires that broadcast advertisements must include a “major statement” of “information relating to major side effects and contraindications . . . of the advertised drugs.”[5] Additionally, the advertisements must contain a “brief summary of all necessary information related to [the major statement], unless adequate provision is made for dissemination of the approved or permitted product labeling in connection with the broadcast presentation.”[6]
The provision did not garner loophole status until 1997, following guidance by the FDA,[7] wherein a drug company provides an adequate provision by presenting “reasonably convenient access” to the product’s labeling.[8] This can be accomplished by disclosing a toll-free number, print page, webpage, and a directive to speak to a medical professional.[9] Lucy Rose, a former FDA employee involved in drafting the guidance, explained that the purpose of the is regulation not as a loophole, but rather to balance “the demands for marketing new drugs and informing patients.”[10]
The Controversy
Indeed, there are many persuasive arguments in favor of the adequate provision loophole. First, proponents argue that it is essential to avoid burdening the consumer with bulky risk information.[11] The mass of information merely functions to fearmonger, desensitize, and dilute more serious risks among minor issues.[12] Second, proponents underscore the benefits to public health, such as public awareness and market competition.[13] Moreover, standards for disclosure and fair balance are well-established, hence, if the administration were to enforce the existing law, then there would be no need for eliminating the provision.[14] Finally, proponents warn that the FDA’s proposed action will have a chilling effect on drug companies’ First Amendment rights.[15]
Those adverse to the provision argue that it is “used to conceal critical safety risks in broadcast and digital ads, fueling inappropriate drug use and eroding public trust.”[16] The FDA contends that DTC ads lead to more prescription requests and inappropriate prescribing.[17] FDA Commissioner, Marty Makary, stressed that the 25% of drug companies’ budget towards advertising could be “better spent on lowering drug prices for everyday Americans.”[18] Furthermore, the FDA admitted to difficulty in regulating DTC advertising in social media, making it “increasingly difficult for patients to distinguish between evidence-based information and promotional material.”[19]
The Future
It is easy to envision the provision in practice, given the unavoidability of DTC advertisements on our screens. You anticipate the statement “ask your health provider about LawRizzy! Side effects include panic attacks, failing journal, or dizziness.” Without it, advertisers would be required to include a “brief summary of all necessary information related to the major side effects and contraindications.”[20]
But what constitutes a brief summary? Health and Human Services (“HHS”) Secretary Robert F. Kennedy proclaimed “[o]nly radical transparency will break the cycle of over-medicalization that drives America’s chronic disease epidemic.”[21] Thus, on one extreme, it appears that the purpose of the rescission is part of a larger effort to ban DTC drug advertisements altogether.
Is it realistic that the FDA can curtail all drug advertisements? Before to 1997, drug advertising in the United States was virtually non-existent.[22] However, given that DTC ads have become industry standard, it might be too difficult to put the mouse back in the bag. And, Big Pharma is unlikely to go quietly, likely to give rise to immense litigation.[23]
The FDA has yet to release guidance on what constitutes presentation of a “brief summary.”[24] One might expect subsequent guidance from the FDA, as done prior with “major statement” in 2023[25] and “adequate provision” in 1999.[26] Until it does, the future landscape of DTC drug advertising will remain uncertain.
Notes
[1] U.S. Dep’t Health & Hum. Servs., HHS, FDA to Require Full Safety Disclosure in Drug Ads (Sept. 9, 2025), https://www.hhs.gov/press-room/hhs-fda-drug-ad-transparency.html.
[2] See Login H. Merril, The FDA Just Killed Big Pharma’s Favorite Loophole, Freedom (Sept. 20, 2025), https://www.freedommag.org/news/the-fda-just-killed-big-pharmas-favorite-loophole-d87bf6 (explaining the adequate provision).
[3] U.S. Food & Drug Admin., FDA Launches Crackdown on Deceptive Drug Advertising (Sept. 9, 2025), https://www.fda.gov/news-events/press-announcements/fda-launches-crackdown-deceptive-drug-advertising.
[4] Id.
[5] 21 C.F.R. 202.1(e)(1)(i)(A).
[6] 21 C.F.R. 202.1(e)(1)(i)(B) (emphasis added).
[7] U.S. Food & Drug Admin., Guidance for Industry: Consumer Directed Broadcast Advertisements 2–3 (Aug. 1999), https://www.fda.gov/media/75406/download.
[8] Id. x
[9] Id.
[10] See Annalee Armstrong, In New DTC Ad Crackdown, FDA Trying to Close a Loophole That Isn’t, Biospace (Sept. 17, 2025), https://www.biospace.com/policy/in-new-dtc-ad-crackdown-fda-trying-to-close-a-loophole-that-isnt (citing Lucy Rose, A Response and Suggested Path Forward to FDA’s Fact Sheet, LinkedIn (Sept. 15, 2025), https://www.linkedin.com/pulse/response-suggested-path-forward-fdas-fact-sheet-ensuring-lucy-rose-jrple/?trackingId=h8%2BVIWXVSpKr4lMOeqQnQA%3D%3D).
[11] See James A. Boiani, et al., HHS, FDA Target Direct-to-Consumer Drug Advertising: A Paradigm Shift in Patient-Focused Communications, 15 Nat’l L. Rev. 278, 278 (Sept. 29, 2025), https://www.healthlawadvisor.com/hhs-fda-target-direct-to-consumer-drug-advertising-a-paradigm-shift-in-patient-focused-communications (explaining the importance the adequate provision).
[12] Id.
[13] Id.
[14] Id. (discussing enforcement of existing law).
[15] Joanne S. Eglovitch, FDA Cracks Down on Drug Ads, Promises to End the Adequate Provision ‘Loophole’, Regul, Focus (Sept. 10, 2025), https://www.raps.org/news-and-articles/news-articles/2025/9/fda-cracks-down-on-drugs-ads,-promises-to-end-adeq (“[T]ruthful and non-misleading DTC advertising is protected under the First Amendment and has documented evidence of advancing patient awareness and engagement.”)
[16] U.S. Food & Drug Admin., supra note 3 (citing Mor, et. al., Pharmaceutical Industry Promotional Activities on Social Media: A Scoping Review, 15 J. Pharm. Health Servs. Rsch. 1 (2024)).
[17] Id.
[18] Id.
[19] Id.
[20] 21 C.F.R. 202.1(e)(1)(i)(B).
[21] U.S. Food & Drug Admin., supra note 3 (emphasis added).
[22] Boiani, supra note 11.
[23] See Eglovitch, supra note 15 (discussing potential litigation on First Amendment grounds).
[24] See HHS and FDA Declare “Crackdown” on Drug Advertising and Promotion, King & Spalding (Sept. 10, 2025), https://www.kslaw.com/news-and-insights/hhs-and-fda-declare-crackdown-on-drug-advertising-and-promotion (“[The FDA] has not specifically addressed the presentation of the ‘brief summary’”).
[25] Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format, 88 Fed. Reg. 80958 (Nov. 21, 2023) (to be codified at 21 C.F.R. pt. 202).
[26] U.S. Food & Drug Admin., supra note 7.