Last week, FDA revised one of its two guidances relating to nitrosamines, Control of Nitrosamine Impurities in Human Drugs. Nitrosamines are impurities that can form during drug manufacturing and are considered potentially potent carcinogens. One specific kind of nitrosamines called N-nitrosamine drug substance-related impurities, or …
Tell me doctor, where are we going this time? Is this the 90s, or 2025? Apologies to both Robert Zemeckis, who directed the 1985 classic “Back to the Future,” and to Huey Lewis and the News, which played “Back in Time” for the feature film, …
As readers of this blog know (see, e.g., here), the Affordable Generics (and Biosimilars) Act has been floating around in Congress for the better part of two decades. That bill, addressing drug (and later biological product) patent settlement agreements (pejoratively referred to as “reverse payment …
The American Conference Institute (“ACI”) will hold (virtually) its 4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA from October 8-24, 2024. This virtual three-week program is designed to give new lawyers and executives a solid foundation in the essentials and intricacies of …
Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceutical manufacturers. In addition to the widely publicized drug price negotiation program, the IRA established inflation rebate programs under Medicare Part B …
FDA’s Office of Prescription Drug Promotion (OPDP) has issued two new Untitled Letters this summer after 5 months without any letter activity. The letters are vastly different from one another in subject matter, but together they make a cruel summer of OPDP enforcement against industry. …
Increasingly the subject of induced infringement litigation, the viability of the carve-out has been questioned for several years now. But recently, a new challenge was filed in the District Court for the District of Columbia questioning whether modifications to labeling as a result of patent …
On July 17, 2024, FDA announced the establishment of a Rare Disease Innovation Hub (the “Hub”) to enhance and improve outcomes for patients with rare diseases and conditions by focusing on rare disease drug and biological product development across the Agency’s Center for Drug Evaluation …
The Supreme Court’s recent decision in Loper Bright v. Raimondo has done away with Chevron deference to federal agencies’ interpretation of ambiguous statutes, including the FDA. The decision commands that federal judges must make their own decisions in suits against FDA, considering—but not deferring to—the …
The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. § 360j(g)(9)(A)). For drugs, …
This afternoon Hyman, Phelps & McNamara, P.C. (HPM) Director Dara Katcher Levy will present an informative webinar on the newly released AMCP Format for Formulary Submissions version 5.0. The event, titled “New and Improved – AMCP Format for Formulary Submissions v5.0,” aims to educate pharmaceutical …
FDA’s Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) is charged with assuring that drugs marketed in the U.S. are safe, effective, and meet appropriate quality standards. While no office at FDA truly works in a vacuum, we can …
Hyman, Phelps & McNamara (HPM) would like to congratulate the 7 rare disease programs selected for the inaugural class of the FDA’s “Support for clinical Trials Advancing Rare disease Treatment” (START) pilot program. The START pilot program was announced last September as a way to …
FDA’s Office of Women’s Health (OWH) recently celebrated its 30th anniversary. This office was formed in 1994 to promote the inclusion of women in clinical trials and to provide leadership on topics related to the health of women. Given that FDA was founded in 1906 and …
Last week, the United States Court of Appeals for the District of Columbia ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program. In United …
