Sponsored Influencer Database

Generation Patient issue brief on a sponsored influencer open payments database

Influencers are increasingly advertising prescription medicines on social media, and the financial relationships behind these promotions are largely invisible to regulators and the public. This brief discusses how Congress and federal regulators can address this issue, including:

  1. Passing the Protecting Patients from Deceptive Drug Ads Act. A bipartisan solution to require manufacturers and telehealth companies to report payments made to influencers.
  2. Utilizing lessons learned from the Physician Payments Sunshine Act. An open-payments database model that can be extended to include payments made to all social media influencers receiving payments from the pharmaceutical industry.
  3. Designing an Influencer Open Payments Database that Works. Payments made to influencers and the campaigns they fund differ in important ways from payments made to healthcare providers, requiring distinct choices on definitions, reporting timing, identification, and enforcement.
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Pharmaceutical companies increasingly rely on social media influencers as a major marketing tool to promote their products and services to American young adults. Social media influencers are very effective at steering consumer behavior because of the trust and credibility they have established.1 Influencer promotions of prescription pharmaceutical products carry many risks including the amplification of misleading information and the blurry and often hidden distinctions between personal testimonials and paid promotions.2 The absence of any transparency requirement for these payments compounds these risks, because neither users nor regulators can confirm which testimonials are paid.

The Federal Trade Commission (FTC) has long required influencers to disclose paid relationships, and it has brought enforcement actions against those who do not.3 FDA, which has separate statutory authority over prescription drug advertising,4 has issued draft guidance on drug promotion on social media but their guidance is not as comprehensive when it comes to influencer promotions.5 Its enforcement depends on seeing the promotion in the first place. In 2024, FDA sent an untitled letter to Kaleo, Inc. over a paid Instagram post by Brittany Mahomes promoting AUVI-Q without safety information. FDA reviewed that post because Kaleo had submitted it on Form FDA 2253 (required for submission by the drug's application holder for promotional materials it disseminates) and the post was labeled a paid partnership.6 However, a payment that is not disclosed in the post or on a Form 2253 leaves no trace for either agency to find. Disclosure in the post is itself rare: a 2025 review of three classes of prescription drugs found that fewer than 15 percent of promotional posts carried a clear sponsorship disclosure.7 Regulators and the public need a record of these financial relationships, and the Physician Payments Sunshine Act Database offers a blueprint for one.8

Lawmakers have begun to recognize the need for greater transparency around pharmaceutical payments made in exchange for influencer endorsements. In 2024, Senators Dick Durbin (D-IL) and Mike Braun (R-IN) introduced the Protecting Patients from Deceptive Drug Ads Online Act, which was later reintroduced as the Protecting Patients from Deceptive Drug Ads Act by Senators Durbin and Roger Marshall (R-KS).9 If enacted, the bill would require drug manufacturers and health care providers, including telehealth companies, to report the payments they make to social media influencers for promoting a “covered drug,” and would make those reports public through the Sunshine Act’s existing Open Payments system.10 A covered drug is one for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program.11 This brief examines the precedent for an influencer open payments database, the lessons offered by the Physician Payments Sunshine Act Database, and the key design considerations for building a database that delivers meaningful transparency for the public and regulators.

1The Physician Payments Sunshine Act Database

The idea of an open payments database for increased transparency is far from novel in the United States. A similar database for healthcare professionals who receive payments from pharmaceutical manufacturers has existed for well over a decade. This database was formed under the Physician Payments Sunshine Act,12 enacted under the Affordable Care Act in 201013 and implemented by the Centers for Medicare and Medicaid Services (CMS).14 The need for the database stemmed from an environment in which manufacturers provided healthcare professionals and other organizations with payments, gifts, travel, and other forms of payment that influence prescriber decision-making.15 Patients and regulators needed to understand the potential provider conflicts of interest created by payments received from the medical industry.

Over the years, Congress has expanded the Sunshine Act to include a broader range of payment recipients. When first enacted, the Sunshine Act’s reporting mandate covered only payments made to physicians and teaching hospitals.16 The reporting mandate was later expanded to include payments made to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and anesthesiologist assistants, and certified nurse-midwives under the SUPPORT Act of 2018, with reporting beginning for payments made in 2021.17 These recipient additions from what was originally mandated demonstrate that additional payment recipients (including social media influencers) can be easily included in the required reporting on this database or a similarly functioning database.

When designing the Sunshine Act database, lawmakers understood that payments could come in many different forms that may not be monetary in nature.18 When implementing the Sunshine Act, CMS identified common examples of non-monetary transfers of value that include entertainment, gifts, debt forgiveness, travel, dining, and others.19 These payments or transfers of value are required to be reported when they meet a minimum dollar amount (de minimis threshold), which is updated annually based on the Consumer Price Index for that particular year.20 Failure to report these payments is met with civil monetary penalties that increase in severity depending on the knowledge and frequency of non-compliance.21

In its first publication in September 2014, the Sunshine Act database disclosed 4.4 million records valued at nearly $3.5 billion.22 In the seven program years from 2019 through 2025, CMS published 93.87 million records accounting for $82.24 billion in payments and ownership interests.23 While one study suggests the Sunshine Act database itself may have low public awareness or interaction,24 the data reported has supported researchers and investigative journalists in shining a light on the prevalence and nature of manufacturer influence on clinical decision-making. Utilizing the Sunshine Act data, ProPublica found that more than 2,500 physicians received at least $500,000 from drug and device manufacturers between 2014 and 2018, and that more than 700 of those physicians were paid more than $1 million.25 The Sunshine Act data has also been used by researchers to suggest that even small payments may influence prescribing behavior. In a cross-sectional study, it was found that physicians who received even a single drug promotional meal, worth less than $20 on average, had significantly higher rates of prescribing the promoted drug.26

2Designing an Influencer Open Payments Database

Who is an Influencer?

Paid promotions take many forms, so implementers of an open payments database must define “influencer” broadly. Follower and engagement counts should not by themselves determine who is covered. Mega- and macro-influencers are common choices for advertising campaigns, but micro- and nano-influencers are also chosen because audiences perceive them as trustworthy and authentic.27 A threshold based on follower and engagement counts would also invite gaming, since a campaign can be split across accounts that each fall below it. Content categories should not limit the definition either. Pharmaceutical campaigns have used patients,28 healthcare professionals,29 athletes,30 and musicians31 as promoters. A definition that covers only accounts with large followings would miss much of the promotion that exists today and discount the unique parasocial relationships that can be found with micro- and nano-influencers.

What Transactions Should be Reported?

A transaction between an influencer and a manufacturer to induce a post, story mention, comment interaction, or other social media promotions does not always involve a direct transfer of money. Transactions can include gifts, paid trips, coupons, stock or ownership interests, commissions for affiliate codes used, and other forms of non-monetary payment, all of which can prompt an influencer to promote a prescription pharmaceutical product. Free product samples should also be reported. The Sunshine Act excludes samples intended for patient use from its reporting requirement32, but a sample given to an influencer can be used as a payment for promotion, so the influencer database should depart from that exclusion. These payments can be tracked similarly to the de minimis framework used in the Sunshine Act, which in 2026 set $13.82 as the reporting threshold for individual payments or transfers of value.33 Payments under the threshold amount are excluded from reporting unless total annual payments to a recipient exceed $138.13, in which case all payments, including the small ones, must be reported.34 Whether utilizing the de minimis framework or a similar framework, it is important that these transactions are clearly reported, displaying the type of payment and the value.

Required Reporters and Frequency of Reporting

Those who are making the payments to influencers should be responsible for reporting the payments to CMS. Tasking influencers themselves to report the payments they received would likely create many compliance oversight issues due to the sheer volume of influencers that are participating in prescription drug campaigns, along with difficulties that exist in determining what is paid promotion and what is a patient or caregiver experience independent of any financial ties to industry. Similar to the Sunshine Act, pharmaceutical manufacturers, telehealth companies, and affiliated organizations can be tasked with providing detailed reports of the influencer transactions they engaged in,35 including transactions that utilized intermediaries to deliver the payment, such as influencer marketing agencies. There should additionally be a requirement that a company officer attest to the completeness and accuracy of each submission. Influencer campaigns can both occur relatively quickly and have a large reach, requiring more frequent reporting than the Sunshine Act’s yearly reporting requirements.36

Reporting requirements (including post updates) should be set as real-time; at the time of the campaign launch, the transaction must be reported into the system. This is already a requirement of manufacturers when it comes to promotional content; FDA Form 2253 must be submitted at the time of initial public dissemination.37 In an environment where a single ad campaign can reach millions of people within hours or even minutes, real-time reporting is essential to ensuring that oversight keeps with the pace.

Influencer Identifiable Information

A key aspect of this database is allowing the public and regulators to be aware of the influencers who are engaging in these campaigns, which creates unique challenges when compared to healthcare providers who utilize National Provider Identifiers (NPI).38 Influencers often operate many different accounts spread across multiple platforms, with various account names that can easily be changed. This reporting should include all known account names used by the influencer, identifying the account names directly associated with the campaign and those that are not being used in the campaign. For this database to be useful to regulators, the legal name of the influencer participating in the advertising campaign should be reported along with every associated alias, influencer stage name, and username used across social media. To protect the health information of influencers who may be patients themselves, upon first reporting, a unique registry identifier can be automatically assigned to the influencer. While the public would not be able to access legal names, they would be able to access the unique registry identifier, along with the associated account names and influencer aliases, which are often the only identifiable information known to the public.

Reporting the Advertising Campaign

Cataloging the advertising used in the campaign would be a crucial component of the database because it identifies what is specifically a paid endorsement versus what could be a personal opinion of the influencer. A key aspect of this process is identifying what specific therapeutic product or telehealth service is being promoted in the campaign. The cataloging process should also include key components of the campaign, including the active dates, the social media platforms engaged, and the mode of dissemination (e.g., post, story, commenting). As previously mentioned, manufacturers are already required to submit every promotional material to FDA utilizing Form 2253.39 For website and electronic content specifically, manufacturers are already required to report how the content will look and convey the messages to the end user, and resubmit Form 2253 as a new submission with cross-references for any updates not within the original submission.40 The influencer open payments database can be similarly modeled by requiring the downloading and reporting of the content created and public engagement as individual files, and requiring updated reporting of new engagement. This modeling would be a logical extension of the pre-existing mandate, directed at the modern age of influencer-based pharmaceutical advertising.

Ensuring the System is Publicly Accessible

The transparency provided by this database does not just inform regulators, but also serves as a tool to promote informed public engagement on social media, and the database should be fully accessible to the public. While some influencer endorsements may identify that they are ads in the post itself, these signals are often hidden in the advertisement to maintain a sense of “organic content,” and studies have shown that many users miss these disclosures entirely.41 It is important to acknowledge that many social media users may not directly go to the Open Payments system themselves, a limitation that also exists in the Sunshine Act database, with one study finding that only about 3% of patients knew whether their own physician had received payments.42 However, the social media communication environment is vastly more connected and informative than the physician-to-patient environment. Many researchers and investigative reporters engage with social media platforms to disseminate information to the public, and that information can include reporting on the influencer open payments database.

Federal Agency Collaboration in Administration

CMS should administer the influencer open payments database.43 CMS has spent more than a decade building the registration, dispute-resolution, publication, and penalty processes that a payments database requires, and it has already expanded the system to new categories of recipients.44 Other federal agencies should be granted access to the data in the influencer open payments database. FDA’s Office of Prescription Drug Promotion (OPDP) already reviews promotional materials submitted on Form 2253,45 and comparing those submissions against reported payments could be a direct approach to surface undisclosed campaigns. The statute should give FDA direct access to the data and a mandate to use it. FTC, which enforces influencer disclosure across all consumer products,46 should have the same access. The bill’s proposed FDA–FTC task force on monitoring and compliance can coordinate how the agencies use the data.47

Enforcement Mechanism

Reporting mandates must be paired with an enforcement mechanism. The Sunshine Act enforces reporting through civil monetary penalties imposed by CMS under a two-tier structure: (1) a failure to report and (2) a knowing failure to report.48 A failure to report covers unintentional omissions, errors, and late submissions.49 A knowing failure means the reporter had actual knowledge of the information, acted in deliberate ignorance of its truth or falsity, or acted in reckless disregard of its truth or falsity; none of these requires proof of specific intent to defraud.50 The statute sets the penalty at $1,000 to $10,000 for each unreported payment or transfer of value, and $10,000 to $100,000 for each knowing failure, subject to annual caps of $150,000 and $1,000,000 respectively.51 As adjusted for inflation in 2026, those figures are $1,443 to $14,432 per payment with a $216,490 annual cap, and $14,432 to $144,329 per payment with a $1,443,275 annual cap.52

The Protecting Patients from Deceptive Drug Ads Act would bring influencer payments under this same enforcement structure. The bill treats any payment for the promotion of a covered drug “as a payment from an applicable manufacturer to a covered recipient for purposes of section 1128G,” so a manufacturer or telehealth company that fails to report an influencer payment would face the Sunshine Act penalties described above, enforced by CMS.53 The bill separately creates a new civil penalty, administered by FDA, for influencers and health care providers who make false or misleading communications about a drug, at the amounts already set for deceptive direct-to-consumer advertising: up to $250,000 for a first violation in any three-year period and up to $500,000 for each subsequent violation.54 That penalty targets the content of a post, not the failure to disclose the payment behind it.

Congress should consider whether the Sunshine Act’s two categories and caps are adequate in the influencer context. A single national campaign can involve dozens of influencers and hundreds of individual transfers of value, and an annual cap of roughly $1.4 million is a modest cost against the marketing budget of a blockbuster drug. Two adjustments would close the gap. First, the annual cap should apply per campaign or per product rather than per reporting entity, so that a manufacturer running multiple campaigns cannot exhaust its exposure with a single omission. Second, an undisclosed paid relationship should also constitute a false or misleading communication.55 Treating concealment as deceptive in itself would ensure it is never cheaper than the post it paid for.

Conclusion

Pharmaceutical and other healthcare promotions have followed the broader consumer marketing shift into social media, but robust federal oversight has not kept pace. This has resulted in a growing volume of paid influencers promoting medications and other therapeutics, with financial underpinnings that are invisible to the followers who trust them, the researchers that study these ads, and the regulators responsible for ensuring the promotions are free from deception. An influencer open payments database is a practical solution to this issue. The Sunshine Act provides a blueprint because of its success in achieving transparency in the healthcare professional context. The Protecting Patients from Deceptive Drug Ads Act offers Congress the ability to establish this influencer open payments database. Young adult patients, who are increasingly turning to social media for health information, deserve to know the financial ties behind the medication and healthcare promotions they are exposed to.

Responsible Tech Youth Power Fund (RTYPF) supports Generation Patient's work on increasing oversight of pharmaceutical ads, including this brief. Generation Patient accepts no funding from pharmaceutical companies, device manufacturers, or technology developers.

Notes

  1. Delia C. Balaban, Julia Szambolics & Mihai Chirică, Parasocial relations and social media influencers' persuasive power. Exploring the moderating role of product involvement, 230 ACTA PSYCHOL. 103731 (2022) doi: 10.1016/j.actpsy.2022.103731. ↩
  2. Sascha Gell, Sneha Dave, et al., Prescription Drug Promotion by Social Media Influencers: A Systematic Scoping Review. JAMA Netw Open. 2026;9(3):e262738. doi:10.1001/jamanetworkopen.2026.2738. ↩
  3. FTC Endorsement Guides, 16 C.F.R. pt. 255; Trade Regulation Rule on the Use of Consumer Reviews and Testimonials, 16 C.F.R. pt. 465 (2024); Fed. Trade Comm’n, CSGO Lotto Owners Settle FTC’s First-Ever Complaint Against Individual Social Media Influencers (Sept. 7, 2017), https://www.ftc.gov/news-events/news/press-releases/2017/09/csgo-lotto-owners-settle-ftcs-first-ever-complaint-against-individual-social-media-influencers. ↩
  4. 21 U.S.C. § 352(n); see also 15 U.S.C. §§ 45, 52 (FTC authority over unfair or deceptive acts and false advertising). ↩
  5. U.S. Food & Drug Admin., Draft Guidance for Industry: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (June 2014), https://www.fda.gov/media/88545/download; U.S. Food & Drug Admin., Draft Guidance for Industry: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics (Jan. 2014), https://www.fda.gov/media/87685/download; U.S. Food & Drug Admin., Draft Guidance for Industry: Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (June 2014), https://www.fda.gov/media/88551/download; U.S. Food & Drug Admin., Draft Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (Dec. 2011), https://www.fda.gov/media/82660/download. ↩
  6. Food & Drug Admin., Untitled Letter to Kaleo, Inc. re: Auvi-Q, NDA 201739, MA 1021 (July 17, 2024), https://www.fda.gov/media/180350/download?attachment (noting that the post was submitted under cover of Form FDA 2253 and was labeled a paid partnership); see also Food & Drug Admin., Untitled Letter to Merz Pharmaceuticals, LLC re: Xeomin (Oct. 31, 2024). ↩
  7. Dianne Munevar et al., NORC at the Univ. of Chi., Strengthening Oversight of Prescription Drug Promotion on Social Media (Aug. 2025), https://www.norc.org/content/dam/norc-org/pdf2025/av-dtva-policy-brief-508.pdf (last visited Sept. 4, 2026). ↩
  8. 42 U.S.C. § 1320a-7h. ↩
  9. S. 652, 119th Cong. (2025). A predecessor bill, the Protecting Patients from Deceptive Drug Ads Online Act, S. 5040, 118th Cong., was introduced by Senators Durbin and Braun on September 12, 2024. ↩
  10. S. 652, 119th Cong. § 2(b)(1) (2025). ↩
  11. Id. § 2(b)(3)(B) (defining “covered drug” as “any drug, including a biological product (as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i))), for which payment is available under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) or a State plan under title XIX or XXI of such Act (42 U.S.C. 1396 et seq.; 42 U.S.C. 1397aa et seq.) (or a waiver of such a plan)”). ↩
  12. Hereinafter “the Sunshine Act”. ↩
  13. 42 U.S.C. § 1320a-7h. ↩
  14. 78 Fed. Reg. 9458 (Feb. 8, 2013), 42 C.F.R. Parts 402 and 403. ↩
  15. Grassley, Kohl Say public should know when pharmaceutical makers give money to doctors, U.S. Senate Comm. on Fin. (Sept. 6, 2007), https://www.finance.senate.gov/ranking-members-news/grassley-kohl-say-public-should-know-when-pharmaceutical-makers-give-money-to-doctors. ↩
  16. 42 U.S.C. § 1320a-7h. ↩
  17. Pub. L. No. 115-271, 132 Stat. 3894 (codified in scattered sections of 21, 26, 42 U.S.C.). ↩
  18. Paid to Prescribe?: Exploring the Relationship Between Doctors and the Drug Industry: Hearing Before the S. Spec. Comm. on Aging, 110th Cong. (2007) (statement of Sen., Herb Kohl, Chairman, S. Spec., Comm. on Aging). ↩
  19. Centers for Medicare & Medicaid Services, Natures of Payment, Open Payments, https://www.cms.gov/priorities/key-initiatives/open-payments/natures (last visited Sept. 4, 2026). ↩
  20. Centers for Medicare & Medicaid Services, Data Collection, Open Payments, https://www.cms.gov/openpayments/program-participants/reporting-entities/data-collection (last visited Sept. 4, 2026). ↩
  21. 42 U.S.C. § 1320a-7h; 78 FR 9521. ↩
  22. Centers for Medicare & Medicaid Services, CMS makes first wave of drug & device company payments to teaching hospitals and physicians public (Sept. 30, 2014), https://www.cms.gov/newsroom/press-releases/cms-makes-first-wave-drug-device-company-payments-teaching-hospitals-physicians-public (last visited Sept. 4, 2026) (consisting of reports made in the last five months of 2013). ↩
  23. Centers for Medicare & Medicaid Servs., Open Payments Data Overview, https://www.cms.gov/priorities/key-initiatives/open-payments/data (last visited Sept. 4, 2026). ↩
  24. Genevieve P. Kanter, Daniel Carpenter, Lisa Lehmann, et al., Effect of the public disclosure of industry payments information on patients: results from a population-based natural experiment, 9 BMJ Open e024020 (2019), https://doi.org/10.1136/bmjopen-2018-024020. ↩
  25. Charles Ornstein, Tracy Weber & Ryann Grochowski Jones, We Found Over 700 Doctors Who Were Paid More Than a Million Dollars by Drug and Medical Device Companies, ProPublica (Oct. 17, 2019), https://www.propublica.org/article/we-found-over-700-doctors-who-were-paid-more-than-a-million-dollars-by-drug-and-medical-device-companies (last visited Sept. 4, 2026). ↩
  26. Colette DeJong, Thomas Aguilar, Chien-Wen Tseng, et al., Pharmaceutical Industry–Sponsored Meals and Physician Prescribing Patterns for Medicare Beneficiaries, 176 JAMA Internal Medicine 1114-1122 (2016), https://doi.org/10.1001/jamainternmed.2016.2765 (the study authors noted the finding represents an association rather than a cause-and-effect relationship). ↩
  27. Rita Conde & Beatriz Casais, Micro, Macro and Mega-Influencers on Instagram: The Power of Persuasion via the Parasocial Relationship, 158 J. Bus. Res. 113708 (2023); Pawel Korzynski et al., Opinion Leadership in a Digital Age: The Rise of Nano and Micro-Influencers, 102 Telematics & Informatics 102328 (2025). ↩
  28. Erin Willis & Marjorie Delbaere, Patient Influencers: The Next Frontier in Direct-to-Consumer Pharmaceutical Marketing, 24 J. Med. Internet Res. e29422 (2022), https://pmc.ncbi.nlm.nih.gov/articles/PMC8924782/. ↩
  29. Ben Adams, Salix Taps TikTok for the First Time in Constipation Campaign Push, Fierce Pharma (Dec. 13, 2021), https://www.fiercepharma.com/marketing/salix-taps-tiktok-for-first-time-constipation-campaign-push. ↩
  30. Beth Snyder Bulik, AbbVie Serves up Grand Slam Tennis Champion Serena Williams as New Ubrelvy Spokesperson, Fierce Pharma (Aug. 5, 2020), https://www.fiercepharma.com/marketing/abbvie-serves-up-grand-slam-tennis-champion-serena-williams-as-new-ubrelvy-migraine-med. ↩
  31. Andrea Park, Lady Gaga Goes Behind the Camera in ‘Next Chapter’ of Nurtec ODT Campaign with Pfizer, Fierce Pharma (Apr. 10, 2024), https://www.fiercepharma.com/marketing/lady-gaga-goes-behind-camera-next-chapter-nurtec-odt-campaign-pfizer. ↩
  32. 42 U.S.C. § 1320a-7h(e)(10)(B)(ii) (excluding product samples intended for patient use from the definition of “payment or other transfer of value”). ↩
  33. Centers for Medicare & Medicaid Services, Data Collection, supra note 20. ↩
  34. Id. ↩
  35. Centers for Medicare & Medicaid Services, Open Payments Data, https://openpaymentsdata.cms.gov/ (last visited Sept. 4, 2026). ↩
  36. 78 F.R. 9458 (Feb. 8, 2013). ↩
  37. See 21 CFR 314.81(b)(3)(i); see also U.S. Food & Drug Admin., Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs: Guidance for Industry (Apr. 2022), https://www.fda.gov/media/128163/download. ↩
  38. Centers for Medicare & Medicaid Services, National Provider Identifier Standard (NPI), https://www.cms.gov/regulations-and-guidance/administrative-simplification/nationalprovidentstand (last visited Sept. 4, 2026). ↩
  39. See 21 C.F.R. § 314.81(b)(3)(i); U.S. Food & Drug Admin., Providing Regulatory Submissions, supra note 37. ↩
  40. U.S. Food & Drug Admin., Providing Regulatory Submissions, supra note 37. ↩
  41. Maike Hübner, Julia Thalmann & Jörg Henseler, Blending in or Standing Out? The Disclosure Dilemma of Ad Cues of Social Media Native Advertising, 16 Frontiers in Psychology 1636910 (2025), https://doi.org/10.3389/fpsyg.2025.1636910. ↩
  42. Kanter et al., supra note 24. ↩
  43. See 42 C.F.R. pt. 403, subpt. I; S. 652, 119th Cong. § 2(b)(1) (2025) (treating influencer payments as payments reportable under 42 U.S.C. § 1320a-7h). ↩
  44. Pub. L. No. 115-271, § 6111, 132 Stat. 3894 (2018). ↩
  45. Ctr. for Drug Evaluation & Rsch., U.S. Food & Drug Admin., OPDP eCTD, https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/opdp-ectd (last visited Sept. 4, 2026). ↩
  46. 16 C.F.R. pt. 255. ↩
  47. S. 652, 119th Cong. § 2(c)(1)(C) (2025). ↩
  48. 42 U.S.C. § 1320a-7h(b); 78 Fed. Reg. 9458 (Feb. 8, 2013). ↩
  49. 78 Fed. Reg. 9458 (Feb. 8, 2013). ↩
  50. 42 U.S.C. § 1320a-7h(e)(8) (adopting the definition of “knowingly” in 31 U.S.C. § 3729(b)). ↩
  51. 42 U.S.C. § 1320a-7h(b)(1)–(2). ↩
  52. 91 Fed. Reg. 3665 (Jan. 28, 2026) (annual inflation adjustment of civil monetary penalties under 45 C.F.R. § 102.3). ↩
  53. S. 652, 119th Cong. § 2(b)(1) (2025). ↩
  54. S. 652, 119th Cong. § 2(a)(1) (2025) (adding 21 U.S.C. § 333(h)); see 21 U.S.C. § 333(g)(1). ↩
  55. S. 652, 119th Cong. § 2(a)(1) (2025) (defining “false or misleading communications” to include a “material omission of fact”). ↩
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