Hyman, Phelps & McNamara, P.C.

Recent reductions in force (RIFs) and leadership changes at FDA are already affecting key agency functions—and as the administration plans a broader reorganization, the impact will likely grow. Read our blog post written by John Claud and Michelle Butler where they take a look at the affect these changes will have on the drug development and review process. Link to blog post is: https://lnkd.in/eVm_HE3n #FDA #prescriptiondrugs #drugdevelopment #CDER

There is much change happening at FDA. In the wake of the April 1st reduction in force, there has been a great deal of uncertainty about what the impacts will be. This rings particularly true amongst the #raredisease patient community. Read our blog post written by James Valentine and Naomi Lowy, M.D. where they discuss what is known about what functions were and were not affected by the RIF, Dr. Makary's bold new mechanism-based ultra rare approval pathway, and a new policy that seems to elevate the role of patients and caregivers on FDA Advisory Committees. Link to blog post is here: https://lnkd.in/eBUuw-_X #orphandrugs #drugdevelopment #PFDD #FDA

It is that time again to clear our medicine cabinets of unwanted prescription drugs.  Read our recent blog post written by Larry Houck to find out how. Link to post: https://lnkd.in/ew-ceFN4 #fda #prescription #medicine #medication

Read our recent blog post written by Dara Katcher Levy and Sarah Wicks where they dig into FDA’s second untitled letter of 2025 — once again focusing on a provider-branded website for an oncology drug granted accelerated approval. In their post, they break down what caught OPDP’s attention this time, why it matters, and what sponsors should be thinking about when promoting products approved under accelerated approval. Link to blog post is here: https://lnkd.in/es36M9qW #fda #biologics #advertising #drugapproval #prescriptiondrugs

Enforcement Under the New FDA: HPM to Host a Q&A Webinar on FDC Act Enforcement with Three Former Federal Prosecutors Hyman, Phelps & McNamara, P.C. is hosting a free webinar on recent and forward-looking enforcement under the Federal Food, Drug & Cosmetic Act on Thursday, May 1, 2025, from 12:00 p.m. to 1:30 p.m. (ET) Join us as HPM’s Anne Walsh moderates a panel discussion with three former DOJ attorneys who all litigated extensively under the FDCA. The panel will include JP Ellison, a former trial attorney at DOJ’s Consumer Protection Branch (CPB), John Claud, a recent Assistant Director at CPB, and Andrew Hull, a former Assistant U.S. Attorney. Equipped with significant FDC Act prosecution experience from their years as federal prosecutors, the panelists will address questions about how an FDC Act case is prosecuted, recent FDC Act enforcement cases, and what to expect under the new administration. The panelists will also share their predictions on the increased role of state agencies and other prosecutions in the FDA space. We hope you will join us for this exciting and relevant discussion. Registration Link: https://lnkd.in/eG9ygREq #fda #enforcement #wellness #drugs #compliance #law

Last month, we blogged on the Department of Justice’s (DOJ) abrupt announcement that it had determined that removal restrictions protecting administrative law judges (ALJs) were “unconstitutional” and that DOJ would no longer defend those removal restrictions in court. We opined that while the impact of this statement was unclear, it was likely that this position would make it more difficult for litigants challenging the constitutionality of a proceeding presided by an ALJ. That’s precisely what happened in a recent decision out of the U.S. District Court for the District of Rhode Island in a case challenging a DEA ALJ’s authority to preside over a hearing as to whether the plaintiff’s application for a DEA registration should be granted or denied.  Read our recent blog post written by Andrew Hull about this recent case. Link to blog post is here: https://lnkd.in/eZ3wXMiB #fda #law

The recent and drastic Reduction In Force (RIF) at the U. S. Food and Drug Administration (FDA) is already having ripple effects not just internally, but across the broader regulatory and life sciences communities and the public at large. While much of the focus has been on how these cuts may impact application review timelines and industry engagement, another quieter consequence is emerging – a significant slowdown in the availability of information that FDA is required to produce under the Freedom of Information Act (FOIA). Anne Walsh and Sarah Wicks recently blogged about the consequences these RIFs will have on obtaining FDA information via FOIA requests. Read their post here: https://lnkd.in/eg_axDUd #fda #medicaldevices #biologics #dietarysupplements

The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs. Read our recent blog post written by Kurt Karst about one particular division in the Office of Generic Drugs (OGD),  The Division of Policy Development in the Office of Generic Drug Policy (OGDP), and how it was eradicated and what that might mean for the immediate future of generic drugs in America. Link to blog post is here: https://lnkd.in/eY2RNTsF #fda #biologics #genericdrugs

Promotional claims do not receive the most attention with respect to FDA enforcement these days, and veterinary promotion is no exception. Indeed, most Center for Veterinary Medicine (CVM) Warning Letters arise because products advertised are actually new animal drugs. But this year, CVM has issued two notable warning letters and one Untitled Letter concerning the promotion of animal drugs. Sara Wexler Koblitz and Dara Katcher Levy recently blogged about these letters, discussing them in more detail. Read their blog post here: https://lnkd.in/gCzgKWNZ #fda #enforcement #animalfeed

Recently The Supreme Court issued a unanimous decision in FDA v. Wages & White Lion Investments, LLC, No. 23-1038 (Apr. 2, 2025) that affirms FDA’s denial of authorization to market flavored vape products. Read our blog post written by Andrew Hull, David Clissold, Sophia Gaulkin and Esther Petrikovsky about this decision here: https://lnkd.in/grqq-KWF #fda #tobacco