FDA continues its crackdown on drug advertising with three untitled letters

The US Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has stepped up its enforcement efforts regarding prescription drug promotion, issuing three new untitled letters to Pfizer Inc., Amneal Pharmaceuticals LLC, and BioCorRx Pharmaceuticals Inc.

The heightened enforcement activity began in September, when the agency sent more than 100 warning and untitled letters to drug manufacturers regarding promotional claims made about their products (RELATED: FDA posts more than 100 warning and untitled letters, Regulatory Focus 16 September 2025;  FDA cracks down on drug ads, promises to end adequate provision ‘loophole’, Regulatory Focus 10 September 2025).

Agency calls Pfizer ads misleading

FDA took issue with Facebook video ads for Pfizer’s CD30-directed antibody-drug conjugate Adcentris. The ads include the claim that a patient was “Recently diagnosed with T-cell lymphoma?” and that “ADCETRIS plus CHP is an FDA-approved option for adults with certain CD30 expressing T-cell lymphomas.”

The agency called these ads “misleading” and noted that they do not provide full information about Adcetris’ uses.

FDA’s approved indication is that “ADCETRIS is indicated for the treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified (NOS), in combination with cyclophosphamide, doxorubicin, and prednisone.”

The agency took issue with the company’s claims that suggest the use of Adcetris for the general treatment of T-cell lymphoma or “certain” previously untreated CD30-expressing peripheral T-cell, but they do not specify the subtypes in the approved indication.

"By failing to adequately communicate the indication for Adcetris, the Facebook ads create a misleading impression about the drug’s FDA-approved indication,” FDA wrote in the untitled letter.

The agency further noted that while full FDA-approved indication is presented at the bottom of the ads, that is not enough to “correct the overall misleading impression created by these claims.”

Amneal omits information in patient brochures

FDA issued another untitled letter to Amneal for misleading ads in its patient brochures for Alymsys injection for intravenous use.

FDA said the patient brochure is misleading because it omits certain information on specific patient populations as well as its administration in combination with other chemotherapies.

This omission “misleadingly suggests that Alymsys can be used generally in different cancer types or as a single agent, when this is not the case,” according to the untitled letter.

In addition, FDA said the patient brochure is misleading because it fails to disclose information regarding the serious risks associated with Alymsys. “For example, page four of the patient brochure includes a presentation regarding the administration of Alymsys by intravenous infusion, but fails to disclose any material information that bevacizumab products, including Alymsys, can cause infusion-related reactions (IRR), including hypertension, hypertensive crises associated with neurologic signs and symptoms, wheezing, oxygen desaturation, Grade 3 hypersensitivity, chest pain, headaches, rigors, and diaphoresis.”

In addition, the limitations of use are not presented until page four, separate from the information on metastatic colorectal cancer. FDA wrote that “by failing to adequately disclose the full indications associated with Alymsys, the patient brochure creates a misleading impression about the drug’s FDA-approved indications.”

BioCorRx made misleading claims

BioCorRx also landed in the agency’s crosshairs for making “false or misleading” claims that its Lucemyra tablets are the only approved treatment for helping patients with symptoms of opioid withdrawal.

FDA states that “this claim misleadingly suggests that Lucemyra is the ‘only FDA-approved, non-opioid medicine proven to help with the symptoms of opioid withdrawal,’ when this is not the case. Specifically, there are other FDA-approved lofexidine products indicated for the mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.”

The companies have 15 days to respond to FDA.

Pfizer Inc., Amneal Pharmaceuticals LLC, BioCorRx Pharmaceuticals Inc.