Enforcement

As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs).  There is much to unpack, and we intend to do so in a series of blog posts. In this post, we focus on the …

DOJ has issued another “voluntary disclosure” policy intended to encourage companies to disclose misconduct it discovers as part of a merger and acquisition.  Under this new policy, a company will receive a “presumption of declination” of agency action – i.e., a safe harbor – if …

As readers of the FDA Law Blog know, the FDC Act is a strict liability criminal enforcement statute that can impose criminal misdemeanor penalties on a person without any showing of intent.  See some of our prior posts, here, here, and here.  If committed with …

A drug manufacturer’s bad post-inspection grade from the U.S. Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility.  Many …

OPDP is coming out!  On the heels of a nuanced and more complicated Warning Letter addressing CFL claims and statistical presentations comes a new Untitled Letter from OPDP going back to its roots!  This most recent Untitled Letter to Exeltis alleges omission of risk information …

Well, if you, like many within industry, felt emboldened to disseminate promotional materials that may push the envelope on efficacy (so long as your risk information was tight) think again!  OPDP is back in the game, letting all the people know that they are back …

Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here) Tuesday at the GMP by the Sea Conference.  He talked about regulatory discretion being exercised for drug …

At the GMP by the Sea Conference ongoing in Cambridge, Maryland, a presentation was made by a representative of FDA’s Center for Drug Evaluation and Research that shows some interesting trends in enforcement. Jennifer Maguire, the Director of the Office of Quality Surveillance within the Office …

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 …