At this point in 2024, there were countless unknowns about how the medical device industry would be impacted in 2025. Did the year unfold as you expected? Did your company prepare for impacts to the foreign supply chain? Did you predict the government was going …
A few months ago, we blogged about a Texas U.S. District Court’s Wulferic ruling that FDA’s civil monetary penalty (CMP) provision for tobacco products contained at 21 U.S.C. § 333(f)(9) is unconstitutional under the Seventh Amendment and SEC v. Jarkesy, 603 U.S. 109 (2024). Wulferic, LLC …
Hyman, Phelps & McNamara, P.C. (HPM) is hosting a complimentary webinar, titled “Medical Device Update, 2025 Year in Review.” The webinar is scheduled for December 10, 2025 (11:00am to 12:00pm ET). Don’t miss this essential briefing. Our experts will unpack the year’s top FDA regulatory changes, …
Hyman, Phelps & McNamara, P.C. (“HPM”) Director Larry Houck will moderate “New Rules, New Risks: Inside the Changing World of Federal Inspections” at the Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference in Washington, D.C., December 4-5, 2025. The session will explore the …
No company wants to be on the receiving end of a Warning Letter, which is FDA’s primary tool for communicating to a company that it has been found to be in significant violation of regulatory requirements. Typically, a company who receives a Warning Letter must …
On October 3, 2025, FDLI published an article analyzing Warning Letters (WLs) issued since January 9, 2020 by Hyman, Phelps & McNamara P.C.’s Véronique Li and Jeff Gibbs. The in-depth analysis identified posting and issuance patterns, the length of time between milestone activities such as the …
On September 26, 2025, the Department of Commerce published a notice requesting public comment on “an investigation to determine the effects on the national security of imports of personal protective equipment (PPE), medical consumables, and medical equipment including devices.” 90 Fed. Reg. 46383 (Sept. 26, …
In a case involving international horse-doping conspiracies, racetracks, and state horse racing regulators, the Second Circuit expanded the application of the FDC Act’s felony provisions. There are two forms of criminal penalties for violations of the FDC Act contained in 21 U.S.C. § 333(a): a strict …
In a follow-up to FDA’s September 9 announcement that it would crackdown on deceptive direct-to-consumer (DTC) advertising, including issuing approximately 100 cease-and-desist letters, FDA has now (at the time of this blog drafting – September 16) posted 40 Untitled Letters and 35 Warning Letters, all …
Note: This HPM Fact Sheet, like HHS’s recently issued Fact Sheet, is intended to bring some radical transparency to the discussion around the recently announced DTC Rx drug ad “crackdown.” These bloggers thought it would be helpful to clarify some issues. On September 9, 2025, President …
As an avid reader of OPDP Warning and Untitled Letters that routinely allege pharma companies have engaged in false or misleading Rx drug promotion, this blogger read with interest FDA’s press release on its crackdown on deceptive DTC drug advertising. As I dug into the …
The authors of this post are both avid bibliophiles, and keenly appreciate the hook of a good title or first sentence that draws you right in. Usually the titles of government press releases do not share this allure, but there was one recently that caught …
At the end of June, HHS Secretary Robert F. Kennedy told a House congressional committee that he would like to see all Americans make use of wearable products, such as Apple Watch, Oura Rings, Fitbits, and WHOOP, to “take control of their health.” Less than …
At our webinar earlier this month, we talked about Administration priorities as they relate to the FDC Act and noted that we expect much to remain the same with respect to enforcement. One notable exception has been the Administration’s targeting of certain surgical procedures and …
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 …
