For anyone who thought FDA’s Office of Prescription Drug Promotion (OPDP) had lost interest in pre-approval promotion, think again. On August 21, 2026, OPDP issued an Untitled Letter to Alar Pharmaceuticals concerning promotional claims for ALA-3000 injection, an investigational extended-release ketamine product being developed for treatment-resistant …
Keeping with the 2026 pace of issuing at least two letters a month, the Office of Prescription Drug Promotion (OPDP) has issued letters 20 and 21 this July, and it’s pretty clear to these bloggers that these summer letters are the “filler” to keep up …
Well, it’s here, it’s happening. The Unified Agenda of Regulations has been updated to include a proposed rule, “Transparency in Direct-to-Consumer Advertising” to remove the (so-called) “adequate provision loophole” from the prescription drug advertising regulations in 21 C.F.R. §202.1(e)(1)(i)(B). The proposal appears to be set …
As many of our blog readers already know, direct-to-consumer (“DTC”) prescription drug promotion has been a regulatory flashpoint for years, and especially recently with FDA’s DTC crackdown (see our previous posts here, here, and here), but a new bipartisan push suggests the conversation may be …
On January 27, 2026, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a Special Advisory Bulletin addressing direct-to-consumer (“DTC”) prescription drug programs. These DTC programs allow cash-paying patients, including those enrolled in Federal health care programs such as Medicare …
The American Conference Institute’s (“ACI”) FDA Boot Camp returns March 25-26, 2026, at the New York City Bar, New York, NY. This foundational training brings together life sciences attorneys, in-house counsel, and compliance professionals to dissect FDA law, policy, and enforcement trends. What You’ll Gain: A clear …
In a follow-up to FDA’s September 9 announcement that it would crackdown on deceptive direct-to-consumer (DTC) advertising, including issuing approximately 100 cease-and-desist letters, FDA has now (at the time of this blog drafting – September 16) posted 40 Untitled Letters and 35 Warning Letters, all …
Note: This HPM Fact Sheet, like HHS’s recently issued Fact Sheet, is intended to bring some radical transparency to the discussion around the recently announced DTC Rx drug ad “crackdown.” These bloggers thought it would be helpful to clarify some issues. On September 9, 2025, President …
As an avid reader of OPDP Warning and Untitled Letters that routinely allege pharma companies have engaged in false or misleading Rx drug promotion, this blogger read with interest FDA’s press release on its crackdown on deceptive DTC drug advertising. As I dug into the …
A recent Warning Letter to a dental laboratory offering direct-to-consumer dental prosthetics highlights the ambiguous regulatory position occupied by dental laboratories and the products they produce for patients. In June 2025, the dental laboratory Reset Technology Corporation received a Warning Letter identifying several areas of …
At the end of June, HHS Secretary Robert F. Kennedy told a House congressional committee that he would like to see all Americans make use of wearable products, such as Apple Watch, Oura Rings, Fitbits, and WHOOP, to “take control of their health.” Less than …
In a recent letter to FDA Commissioner Dr. Martin Makary, U.S. Senator Dick Durbin (D-IL) expressed concerns over the agency’s ability to regulate direct-to-consumer (“DTC”) prescription drug advertisements following recent workforce reductions. In his letter, Senator Durbin highlighted FDA’s critical role in ensuring that pharmaceutical …
FDA’s Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter of 2025 to Taiho Oncology (Taiho) for a healthcare provider branded website for its drug LYTGOBI (futibatinib). This letter, dated March 21, 2025, cites Taiho’s false or misleading representations about the benefits of …
Who among us, upon reading FDA’s draft guidance on the distribution of off label information and their coining of the acronym SIUU (standing for Scientific Information on Unapproved Uses) did not automatically think of Phil Collins’ classic song Sussudio? (Other than anyone under 50, that …
We recently saw an interesting Instagram post aimed at Swifties disappointed in the election results. It noted that Tay Tay released four albums during the first Trump administration and only two during the Biden administration, so there’s reason to hope for the next four years …
