Pharmaceutical Direct to Consumer Programs: OIG's Low-Risk Roadmap for Drug Discounts & Congressional Concerns on TrumpRx Compliance

On January 27, 2026, the Department of Health and Human Services, Office of Inspector General (“OIG”) published a Special Advisory Bulletin (the “SAB”) addressing key considerations for pharmaceutical manufacturers' offering direct-to-consumer (“DTC”) programs to allow patients to obtain lower priced prescription drugs. These DTC initiatives offer discounted prices to cash-paying patients, including patients enrolled in Federal health care programs like Medicare and Medicaid. The SAB recognizes the importance of drug affordability while continuing to safeguard against fraud and abuse under the Federal Anti-Kickback Statute (“AKS”). The SAB underscores the OIG's support for drug affordability efforts but stresses the requirement to adhere to overarching AKS requirements. 

The OIG identifies two main ways DTC sales to Federal health care program enrollees could violate the AKS: (1) using discounted drugs as a marketing tool to induce purchases of other manufacturer products billable to Federal programs, and (2) employing "seeding" programs to encourage drug use in anticipation of future Federal billing if coverage improves.

Subject to OIG’s ongoing assessment of these evolving DTC programs, the SAB lists the following as characteristics of  DTC programs that could minimize the risk of fraud and abuse under the AKS:

• The individual has a valid prescription from an independent, third-party prescriber. 

• When an individual purchases prescription drugs through a pharmaceutical manufacturer’s DTC program, no claims for these drugs are submitted to any insurer, including any Federal health care program. 

• The pharmaceutical manufacturer does not use the DTC program for one product as a vehicle to market other federally reimbursable products it manufactures or services it provides.

• The pharmaceutical manufacturer does not condition the DTC program price for any drugs offered through its DTC program on any future purchases (of that drug or any other items or services).

• The pharmaceutical manufacturer makes the prescription drug available to the Federal health care program enrollee through its DTC program for at least one full plan year. 

• The prescription drugs offered by the pharmaceutical manufacturer through the DTC program do not include controlled substances.

Interplay with FDA and FTC Drug Advertising Rules

While the SAB primarily addresses remuneration risks under AKS, pharmaceutical manufacturers offering DTC programs should also consider overlapping regulations from the Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”). For prescription drugs, the FDA holds primary authority over advertising and promotion, requiring that DTC communications be truthful, not misleading, and present a fair balance of benefits and risks under the Federal Food, Drug, and Cosmetic Act. The FTC enforces general truth-in-advertising laws under Section 5 of the FTC Act, which prohibits deceptive or unfair practices in commerce and would also apply to DTC drug marketing. 

In addition to the above, pharmaceutical manufacturers should account for self-regulatory oversight from the BBB's National Advertising Division (NAD), which operates as an independent forum to promote truthful and accurate advertising across industries, including prescription drugs. NAD reviews national advertising claims for substantiation, often in response to challenges from competitors, consumers, trade associations, or its own monitoring initiatives. While NAD's process is voluntary, its standards align closely with FTC guidelines on truthfulness and non-misleading claims, and has increasingly addressed prescription drug promotions, including DTC ads.

In practice, this interplay means that while a DTC program's pricing structure may comply with AKS per OIG guidance, any advertising of the DTC program, such as website promotions, social media campaigns, or direct mail should also avoid unsubstantiated claims about the drug’s efficacy or safety. In short, DTC marketing risks scrutiny not only under the AKS, but also by the FDA, FTC, and self-regulatory bodies, such as the NAD. To ensure compliance, companies should integrate legal reviews across these frameworks.

Congressional Concerns and Key Highlights from Oversight Inquiries

Following the release of the SAB, U.S. Senators Richard J. Durbin and Peter Welch expressed significant concerns in a January 29, 2026, letter to OIG Inspector General T. March Bell (the “Durbin Letter”) regarding the guidance's application to the upcoming TrumpRx website, a government-backed platform set to integrate manufacturers' DTC programs. The senators highlighted that the SAB was issued just days before the planned launch of TrumpRx.gov, which they argued "clears the path" for the initiative without sufficient assurance of compliance with federal laws, including the AKS. They emphasized the need for further OIG review to address potential fraud, abuse, and conflicts of interest, particularly given the White House's promotion of the site and its affiliations.

Key highlights and concerns from the Durbin Letter include:

Compliance of Existing DTC Platforms: According to the Durbin Letter, not all current manufacturer DTC platforms appear to meet the SAB's low-risk criteria. For instance, a prior congressional investigation into existing manufacturer DTC platforms revealed partnerships with telehealth companies costing up to $3 million combined, where patients were steered toward high-cost medications. The Durbin Letter states that manufacturer use of “affiliated telehealth companies for their DTC platforms under TrumpRx, it is not clear whether these prescriptions could be considered, ‘from an independent, third-party prescriber.’”

Advertising and Marketing Risks: Pharmaceutical manufacturers have spent billions on DTC advertising, which could fuel demand for medications later reimbursed by federal programs like Medicare, potentially leading to wasteful spending. The senators question whether promotions touting TrumpRx participation must adhere to the SAB principles.

Telehealth Fraud Alignment: Referencing OIG's 2022 Special Fraud Alert on telehealth schemes involving kickbacks and fraudulent prescriptions, the Durbin Letter asks if TrumpRx will vet manufacturers' telehealth arrangements for consistency and how OIG will ensure prescriptions come from independent prescribers amid known risks like limited patient interaction or directives to prescribe specific items.

Prohibitions on Claims and "Seeding": The SAB's caution against submitting claims to insurers (including federal programs) should be prominently noticed on TrumpRx and manufacturer sites. Additionally, for drugs like GLP-1 medications, offering discounted starting doses via DTC could conflict with guidance if patients later seek federal reimbursement for higher maintenance doses, potentially using the program to market other reimbursable products.

The Durbin Letter requests responses by February 15, 2026, or before TrumpRx's launch, underscoring unanswered congressional requests for information on the program's scope, structure, and legal authority. The Durbin Letter argues that additional safeguards and transparency are essential for a ".gov" website promoted by the White House and manufacturers, to prevent fraud and ensure patient protection.