On June 14, 2022, the Senate Health, Education, Labor and Pensions Committee voted to pass the FDA Safety and Landmark Advancements (FDASLA) Act (S.4348). While FDASLA focuses on user fees and includes several other provisions regarding drugs and devices, it also includes provisions related to …
Oh what a feeling, we’ll be dancing on the ceiling as they say. One day. As the drug distribution industry is well aware, and as blogged about here, on February 4, 2022, FDA published its long-awaited proposed rule titled “National Standards for the Licensure of …
Last week, FDA issued a draft guidance entitled “Considerations for Rescinding Breakthrough Therapy Designation” (the Draft Guidance), authored by CDER, CBER, and the Oncology Center of Excellence (it is interesting, though not surprising, to see the OCE as an author on this document, given the …
On June 27, 2022, in one of the last opinions issued during its current term, a majority of the U.S. Supreme Court (six justices) issued a noteworthy opinion on criminal liability related to prescribers of controlled substances. This consolidated case has implications not only for …
We have blogged before (for example, here and here) on amendments to the Federal health care program antikickback law safe harbor regulations that were finalized by the Trump Department of Health and Human Services in November 2020. If and when implemented, the amendments will likely …
The American Conference Institute and Council for Responsible Nutrition are hosting the 10th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements live in New York next week, June 29-30. The conference will feature speakers from government and industry who will provide updates on the …
On June 8, 2022, the U.S. Attorney’s Office for the Western District of Virginia, announced that Sovah Health (“Sovah”), a two-campus health system in Danville and Martinsville in southern Virginia, had entered into a non-prosecution agreement (“NPA”) and $4.36 million civil settlement due in large …
There is a lot to unpack in the 430 pages of FDASLA, which means that some provisions are falling a little under the radar. One of those provisions is an unusual one in which Congress directs FDA to issue final rules concerning Over-the-Counter hearing aids. …
Readers of this blog surely are familiar with FDA’s repeated efforts to rein in Congress’s 180-day exclusivity reward to the first generic applicant that challenges an NDA holder’s patent monopoly (most recently by lobbying Congress to effectively end 180-day exclusivity together – see our prior …
Last month, the FTC announced and posted a prepublication of its proposed changes to its guides concerning the use of endorsements in advertising (Endorsement Guides). The Endorsement Guides date back several decades. Since the publication of the original Endorsement Guides in 1975, FTC has made several …
In 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule to significantly decrease the rate the government will reimburse 340B hospitals in 2018 for outpatient prescription drugs from average sales price (“ASP”) plus 6% to ASP minus 22.5%. 82 Fed. Reg. …
Hyman, Phelps & McNamara, P.C.’s Dara Katcher Levy will be presenting at the DIA 2022 Global Annual Meeting being held this June 19-23 in Chicago, IL. Dara will be joining an expert panel as part of the Medical Affairs and Scientific Communications Track to discuss manufacturer communications …
Market exclusivities—patent or otherwise—are a critical part of the Hatch-Waxman compromise, intended to encourage continued innovation in spite of the introduction of generic competition. Even a month of market exclusivity is financially lucrative enough to fight for, so it is no surprise that a company …
Legal doctrines can be like parrots. Sometimes it is hard to know if they are dead or just resting. Under the False Claims Act (FCA), if a company’s fraudulent conduct induces a governmental entity to enter into a contract with the company, then any claims for …
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 …
