By James C. Shehan – In a bluntly-worded warning letter to contract manufacturer Sri Krishna Pharmaceuticals Ltd. issued April 1, 2016, we see another example of increasing FDA concern over data integrity issues at non-US drug manufacturing facilities, particularly those in India. This rather remarkable letter contains …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is proud to announce the publication of its FDA Deskbook, incorporating more than a century of experience of HP&M’s attorneys from positions in the government and regulated industry. The FDA Deskbook provides a comprehensive resource that details the ins-and-outs …
By Andrew J. Hull – FDA often seeks permanent injunctions against FDA-regulated companies that allegedly run seriously afoul of FDA’s cGMP requirements. FDA usually asks courts, in granting a permanent injunction (the agency’s most powerful civil enforcement tool against U.S. facilities), to order the complete shutdown …
By Mark I. Schwartz – One of the pre-eminent rules in QSR and cGMP compliance is to document one’s activities. In the eyes of FDA, the “failure to document” is often equated with the failure to perform the underlying regulated activity. FDA takes this position principally …
By David C. Gibbons & Jeffrey N. Wasserstein – On March 16, 2016, the Feinstein Institute for Medical Research, located in Manhasset, New York, (“Feinstein”) entered into an agreement with the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) to pay $3.9 …
By Jenifer R. Stach & Wes Siegner – If you weren’t aware that the Department of Justice (DOJ) has unsafe dietary supplements on its list of enforcement priorities, you should take notice. On Tuesday March 8th, 2016 as part of National Consumer Protection Week, United States Attorney …
By David C. Gibbons & John R. Fleder – On March 8, 2016, Amarin Pharma, Inc. (“Amarin” or “the Company”) and FDA filed a proposed Stipulation And Order Of Settlement (“Proposed Settlement Order”) with Judge Paul Engelmayer in the U.S. District Court for the Southern District of …
Over the past few years, the Food and Drug Administration has dramatically increased its inspections of foreign manufacturing facilities for Active Pharmaceutical Ingredients (APIs) and finished dosage form drugs, with potentially cataclysmic consequences for U.S. parent companies, distributors, and manufacturers relying on foreign APIs or …
By Jennifer D. Newberger – Judge Royce Lamberth, a Senior Judge in the United States District Court for the District of Columbia and sitting by designation in the United States District Court for the Western District of Texas, is no stranger to First Amendment cases involving …
By Mark I. Schwartz – Unlike solid oral dosage form drugs that don’t require sterilization, generally, parenteral drug products must be sterilized and, due to their nature, many parenteral drug products cannot be terminally sterilized. This leaves aseptic manufacturing. In the aseptic process, the drug product and …
By Mark I. Schwartz – [1] According to our calculations, 2015 was a banner year, from CDER’s perspective, for foreign drug facilities receiving cGMP Warning Letters citing data integrity issues. While the overall number of cGMP Warning Letters issued by CDER was only 23 (compared, for …
By Ricardo Carvajal & JP Ellison – According to public communications by the restaurant chain Chipotle, the company has been served with subpoenas in a federal criminal investigation apparently arising out of one or more outbreaks of foodborne illness that appear to implicate certain of the …
In November 2013, the Drug Quality and Security Act (“DQSA”) was signed into law in an effort to increase the quality of the United States drug supply. The law contains two separate acts: the Compounding Quality Act (Title I), and the Drug Supply Chain Security …
By John R. Fleder & Mark I. Schwartz – We all know that under the so-called “Park Doctrine”, corporate executives can be criminally prosecuted under the FDC Act for violations of that Act even absent any showing that the executives acted with any wrongful intent. A prosecution …
By Riëtte van Laack & John R. Fleder – In hockey parlance, a player gets a “hat trick” when the player scores three goals in one game. In the FDA enforcement world, a “hat trick” – and perhaps a “Gordie Howe hat trick” – would be the …
