On August 29, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to AbbVie, Inc. (AbbVie) regarding a promotional, direct-to-consumer (DTC) television...more
In a previous blog on the use of psychedelics to treat mental health disorders, we reported that the US Food and Drug Administration (FDA) granted breakthrough therapy designation to MDMA (a.k.a., ecstasy) in 2017 as part of...more
Polypharmacy is Medspeak for taking more than one prescription medication at a time. About one in five Americans over age 49 is a polypharmicist, of sorts....more
The recent Supreme Court decisions of SEC v. Jarkesy and Loper Bright Enterprises v. Raimondo have the potential to meaningfully impact the implementation and enforcement of the Drug Supply Chain Security Act (“DSCSA”) as...more
The Food and Drug Administration ("FDA") recently issued its first warning letter to a domestic entity after conducting a remote regulatory assessment ("RRA"), indicating increased confidence and likely broader use of RRAs in...more
On December 17, 2024, recent amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) relating to the recall of drugs and medical devices will come into force....more
In June 2024, the U.S. Food and Drug Administration ("FDA") clarified, with respect to the Drug Supply Chain Security Act (“DSCSA”), that it will not extend the one-year stabilization period for the enhanced drug distribution...more
A recent US Supreme Court decision, which grabbed headlines because it involved an abortion-related drug, with potential repercussions in litigation far-removed from health care due to the decision hinging on “standing,”...more
In 2019, KFC dropped the unexpected into a frier and forever changed the quick-serve restaurant (QSR) industry. They teamed up with Beyond Meat, a leading plant-based meat company, to create a vegan chicken offering, which...more
Mifepristone is safe for now. On June 13, 2024, the Supreme Court unanimously held that the plaintiffs — doctors and medical associations alike — lacked standing to challenge 2000 and 2019 FDA approvals of mifepristone (brand...more
Think you’re being healthy when you reach for that KIND bar in the middle of your workday? We won’t say yes or no—since the U.S. Court of Appeals for the Second Circuit has recently declined to opine on what “all...more
On February 23, the Food and Drug Administration (FDA) withdrew approval of Pepaxto (melphalan flufenamide), a drug that it had previously granted accelerated approval for treatment of multiple myeloma. The decision came...more
The Federal Trade Commission (FTC) has been busy scrutinizing patent listings in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the...more
On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the...more
Manufacturers of dietary supplements, food, beverages, and even medical devices can breathe a little easier following the Supreme Court’s denial of certiorari this week in a case seeking to overturn a First Circuit decision...more
On March 20, 2024, the US Food & Drug Administration (FDA) issued a proposed rule titled Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the...more
On March 21, 2024, the Health Subcommittee of the House Energy & Commerce Committee held a hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” In the wake of...more
On March 5, 2024, the Food and Drug Administration (FDA) issued its “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry” (“Final Guidance”). The purpose of the Final...more
As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more
Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....more
COMPETITION - - Non-opposition to a notified concentration (Case M.11420 - Blackstone / Vista / Adapt2)... - Non-opposition to a notified concentration (Case M.11411 - BPIFrance / Meridiam / Exoes)...more
On February 1, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule revising 42 CFR Part 8, which regulates opioid treatment programs (OTPs). The final rule is the first update to...more
FDA’s January 3, 2024, Federal Register notice soliciting comments on the agency’s plan to implement best practices for guidance development got me thinking. What do the data show regarding FDA’s performance in moving...more
Rare Disease Day took place on February 29, 2024. Created in 2008, Rare Disease Day is observed on the “rarest day of the year”—February 29 in leap years (February 28 in non-leap years)—as a way to galvanize the global rare...more
Legislators worked late into the night on Thursday to ensure legislation made the Crossover Day deadline. This #GoldDomeReport offers a recap of all the measures that passed out of the House and Senate and live on to seek...more