By Karla L. Palmer – FDA posted a “Notice” on July 12, 2016, advising compounding pharmacies regulated under Section 503A that, effective August 1, 2016, FDA is changing inspection procedures for Section 503A pharmacies (see Notice here). FDA announced that it now will make a “preliminary assessment” whether compounders …
By Jennifer M. Thomas & John R. Fleder – On July 6, 2016, the Eighth Circuit upheld a district court ruling in United States v. DeCoster that imposed three-month prison sentences and $100,000 fines on Austin “Jack” and Peter Decoster, the owner and chief operating officer, …
By Kurt R. Karst – It’s been a little more than 4.5 years since we first revealed in a December 11, 2011 FDA Law Blog post the fruits of our hunt for the mythical list of pending proceedings under the Drug Efficacy Study Implementation …
By Riëtte van Laack As we reported previously, in 2013, Health Science Funding, LLC (HSF) filed what might be the first medical food lawsuit against FDA. Plaintiff markets a medical food for women with lupus, Prastera® DHEA. Medical foods may be marketed without pre-market approval by …
In recent years, the level of scrutiny on foreign pharmaceutical manufacturing facilities in countries like China and India has skyrocketed—along with the demand and dependence of western countries on the supply of goods coming from those facilities. With the international pharmaceutical supply chain imperiled …
By Anne K. Walsh & John R. Fleder – DOJ Deputy Attorney General Sally Q. Yates spoke last week before the New York City Bar Association White Collar Crime Institute to provide an update on the DOJ policy she announced in September 2015, about which we …
The short answer to that question is “No,” says Hyman, Phelps & McNamara, P.C.’s Jeffrey K. Shapiro in an article published in the March/April 2016 issue of the Food and Drug Law Institute’s Update Magazine. Mr. Shapiro examines the Department of Justice’s recent criminal prosecution of …
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 …
