Last week, FDA published a Request for Information (RFI) (here) seeking input from the public on its efforts to “to identify and eliminate outdated or unnecessary regulations.” The Announcement raises several questions and issues for the device industry. 10-for-1 Rule and its effect on de novos. …
On May 21, FDA announced “enhancements” to the Section 804 import program (SIP). Section 804 of the Federal Food, Drug, and Cosmetic Act provides a pathway for certain prescription drug imports from Canada. The FDA news release provides that FDA is offering to pre-review SIP …
Following up on Donald Trump’s May 12 Executive Order on Most Favored Nation Prescription Drug Pricing (see our post here), The Department of Health and Human Services today issued a brief press release answering a few of the multitude of questions raised by the Executive …
Last month the U.S. Attorney’s Office for the Northern District of Illinois announced that Walgreens agreed to pay up to $350,000,000 to resolve allegations that its pharmacies illegally filled millions of invalid prescriptions for opioids and other controlled substances in violation of the federal Controlled …
Operation Stork Speed is a go! On March 18, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) launched a significant initiative called Operation Stork Speed to bolster the availability and safety of infant formula in the United …
Dr. Marty Makary took the stage on Thursday at the Food and Drug Law Institute’s Annual Conference, continuing the tradition of Commissioners speaking at this event, but with a tone and tempo distinctly his own. Now firmly in the chair after the agency’s controversial RIFs—which he …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Sophia Gaulkin will be presenting and speaking on an expert panel at Informa Connect’s annual Life Sciences Pricing & Contracting USA Summit, which is being held virtually and in-person in Philadelphia on May 19-21. Ms. Gaulkin’s presentation, Product Price …
In early April, Cellares became the first company to announce receipt of an Advanced Manufacturing Technology (“AMT”) designation from FDA. The designation was granted by CBER to Cellares for its automated cell therapy platform, the Cell Shuttle. We were excited to see the news and …
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 …
On September 15, 2020, I posted an article in this blog entitled “Trump Embraces International Reference Pricing in Executive Order,” which described an order in Trump’s first administration to use most-favored-nation (“MFN”) pricing as a limit on Medicare payment. The article ended with the following …
On May 6, 2025, FDA announced that it planned to conduct more surprise inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for U.S. consumers. The stated goals are to ensure that “foreign companies will receive the same level …
There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. This scrutiny was enhanced after the Fourth Circuit’s ruling in United States v. Mallory, 988 F.3d 730 (4th …
Drug Enforcement Administration (“DEA”) civil monetary settlements involving listed chemicals that do not include pseudoephedrine are rare. Even more scarce are DEA civil settlements with non-registrants. (By my count there have been only ten since 2000). When one comes along, it is worthwhile to sit …
Thanks to everyone who joined us today. We are excited that you were able to join us for our discussion of enforcement under the new FDA. We hope you enjoyed a lively conversation. We appreciated all of the questions we received from the audience. If …
We have reached maximum capacity for this Thursday’s webinar! We are excited by the large interest in this topic, and are eager to share our insights about the latest changes impacting the FDA-regulated industry. Registration is closed, but if you would like to be put …
