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 …
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 …
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 …
We are still parsing through the May 12 Executive Order (EO), “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” and impacts this may have on the pharmaceutical industry. We’ve blogged about Most-Favored-Nation (MFN) drug pricing and how the new EO goes well beyond the 2020 …
Who among us, upon reading FDA’s draft guidance on the distribution of off label information and their coining of the acronym SIUU (standing for Scientific Information on Unapproved Uses) did not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 …
Today’s email brings an interesting, and somewhat confusing settlement of what should have been an ordinary antikickback statute case, and may bring about a clash between what many companies do and what the government may be objecting to. Or, perhaps your loyal blogger is reading …
The U.S. District Court for the District of Columbia has vacated the Notice of Benefits and Payment Parameters (NBPP) rule issued in May 2020 (2020 NBPP Rule) which allowed health insurers and pharmacy benefit managers to use copay accumulators to exclude drug manufacturers’ copay assistance when …
After about a year without any untitled letters from OPDP, Xeris Pharmaceuticals received an untitled letter for their promotion for Recorlev (levoketoconazole) for misleading safety and efficacy claims. To quote everyone’s favorite flautist (and TikTok sensation) Lizzo, “it’s about d@mn time!” (Sorry for the bowdlerization, …
We were listening to a radio interview last week with Lina Khan, the Chair of the Federal Trade Commission (“FTC”). In the interview, Khan spoke about the Commission’s efforts to regulate geolocation data trackers so that they don’t abuse their abilities. The risks she described …
GoodRx is a digital health platform familiar to many, and a prime example of a single player that operates in several different realms of the evolving and growing digital health marketplace. Among its services are prescription drug discounts, telehealth visits, and other health services. The Federal …
On September 26, 2022, Biogen Inc. agreed to pay $900 million to the United States and various states to settle a False Claims Act (FCA) lawsuit. This lawsuit was brought to the U.S. district court of Massachusetts by former employee and whistleblower Michael Bawduniak in …
In a recent JAMA editorial (unfortunately behind a paywall), three authors called for increased use of the Park Responsible Corporate Officer doctrine, under which senior level officials at a company can be held liable under a strict liability theory even if they were not involved …
Three patient advocate groups have sued the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), challenging HHS’s 2020 Notice of Benefits and Payment Parameters (NBPP) rule. As it stands, the rule allows insurers and pharmacy benefit managers …
While the Jackson 5 hit “ABC” predates even these rapidly aging bloggers (first performed on Dick Clark’s American Bandstand in 1970, and we challenge you to name all five members of the Jackson 5, we tap out after Michael, Tito, and Jermaine), its basic wisdom …
