On August 3rd, FDA issued 11 warning letters to foreign facilities registered as OTC drug manufacturers. For each of these facilities, FDA did not conduct an on-site inspection of the facility prior to issuing the warning letter. Instead, FDA issued a request for records pursuant …
Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here). FDA now seeks comments on this very program to support its continued collection of information as …
After about a year without any untitled letters from OPDP, Xeris Pharmaceuticals received an untitled letter for their promotion for Recorlev (levoketoconazole) for misleading safety and efficacy claims. To quote everyone’s favorite flautist (and TikTok sensation) Lizzo, “it’s about d@mn time!” (Sorry for the bowdlerization, …
As we move into the heat of the summer, we can look forward to the annual June deluge of opinions coming from the Supreme Court. Last week, the Court ruled on a pair of combined cases that potentially impacts many of our blog readers in …
We were listening to a radio interview last week with Lina Khan, the Chair of the Federal Trade Commission (“FTC”). In the interview, Khan spoke about the Commission’s efforts to regulate geolocation data trackers so that they don’t abuse their abilities. The risks she described …
On April 13, the Federal Trade Commission (“FTC” or “Commission”) issued a press release that it had sent letters to “almost 700 marketing companies that they could face civil penalties if they can’t back up their product claims.” FTC indicates that the notices were sent to companies …
On Thursday, April 20, from 1:30-3:00pm, John Claud of Hyman, Phelps & McNamara, P.C. will present a webinar entitled “Medical Device Enforcement: Latest Developments from the FDA, DOJ and FTC.” John will provide participants with a greater understanding of new guidance implications, as well as recent …
On April 18, the Supreme Court will hear oral argument in two consolidated cases that present the question of whether a defendant can “knowingly” submit a false claim under the Federal False Claims Act when the alleged falsity is based on an objectively reasonable legal …
The annual ABA White Collar Crime Institute is a popular venue for prominent Department of Justice officials to make speeches announcing new policies. This year, Deputy Attorney General Lisa Monaco took the stage, and her speech included many of the well-known past hits from the …
GoodRx is a digital health platform familiar to many, and a prime example of a single player that operates in several different realms of the evolving and growing digital health marketplace. Among its services are prescription drug discounts, telehealth visits, and other health services. The Federal …
A recent analysis of statistics on FDA’s website, prepared for a presentation at a good manufacturing practices (GMP) conference in San Diego next week, shows a dramatic increase in the percentage of FDA drug manufacturing facility inspections that result in an “Official Action Indicated” classification. …
(Caution: Links in the first paragraph are a wild musical ride. Click at your own risk) For those of you that review Rx ad/promo materials, it’s a familiar scenario: Marketing has come to the Legal Department with significant concerns about competitor activities – consumers are being …
As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. In 2022, the chief regulating entities—FDA, FTC, and DOJ—all continued to forge policies to help bridge …
Sentencing for defendants convicted in federal court of felony offenses that involve fraud, including violations of the Federal Food, Drug, and Cosmetic Act, may be dramatically reduced based on an opinion issued last week by a panel of the Third Circuit Court of Appeals. The …
Anne Walsh of Hyman, Phelps & McNamara PC will be presenting on “The Relationship Between Outside Counsel Investigations and Quality System Investigations, and What to Do when they Conflict” as part of the Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference on December …
