By James R. Phelps – Last Thursday, at the 16th Pharmaceutical Compliance Congress and Best Practices Forum, Principal Deputy Assistant Attorney General for the Justice Department’s Civil Division, Benjamin Mizer, reviewed enforcement policies that the Department of Justice will follow. Appropriate to the forum, he focused …
By Jenifer R. Stach* – There have been a number of recent battles between Attorneys General (AG)in various states and dietary supplement manufacturers. These battles have generally been triggered by AG letters which have alleged that manufacturers have marketed supplements that contain drug-like ingredients in violation …
By Jennifer M. Thomas – As we indicated in our post last week, the District Court’s opinion in United States v. Bayer, unsealed on October 1, 2015, reads as a serious loss for the government. It is certainly a clear victory for Bayer. The Court’s opinion …
By Jennifer M. Thomas – On October 1, 2015, the U.S. District Court for the District of New Jersey unsealed its opinion in United States v. Bayer Corp., No. 07-cv-00001 (D.N.J. Sept. 24, 2015), confirming a significant defeat for the government, and a clear victory for …
By Douglas B. Farquhar – Industry newsletter The Pink Sheet reports that, at a conference Monday, FDA said that investigators performing FDA inspections will likely be divided into “subspecialties within the various product groups.” Thanks for reporting that news, but we are not sure we agree …
By James C. Shehan – Aficionados of pro wrestling can regale you with the exploits of tag teams like The Bruiser and the Crusher, The Wild Samoans and The Fabulous Freebirds. The moniker FDA-IRS-FTC is far less colorful and mellifluous than those of WWE stars, but …
By Anne K. Walsh & John R. Fleder – The government has long repeated the mantra that it will hold individuals personally liable for the activities of their corporate employer. In the FDA-regulated arena, the government has been bolstered by the U.S. Supreme Court precedents set …
By Ricardo Carvajal – FDA issued a warning letter to Hampton Creek alleging that its Just Mayo products are misbranded, in part because they purport to be a food governed by a standard of identity – namely, mayonnaise – that the products fail to meet. This alleged …
By David C. Gibbons – As we reported in a previous post, the House Committee on Energy and Commerce requested that FDA answer a number of questions regarding how FDA Centers issue and publicly disclose Untitled Letters (“ULs”). As readers may recall, the letter to FDA …
By Jenifer R. Stach* – After Stewart Parnell’s conviction for selling salmonella-tainted peanut products, causing many deaths and illnesses, he could be facing life in prison. Attorneys on both sides called the recommendation for a life sentence “unprecedented” for a food-poisoning case. We wrote about the convictions …
By Jay W. Cormier – On Monday, after seeking input from a number of large industry stakeholders and floating the idea for some time, FDA announced the availability of a Draft Guidance entitled “Request for Quality Metrics.” The Draft Guidance formally presents FDA’s current thinking and intentions …
By John R. Fleder – Although there are many areas where practitioners and others disagree regarding the FDC Act, there is at least one subject that seems to generate universal agreement: FDA has the authority to issue a Form 482 to a companies subject to inspection …
By Andrew J. Hull* – Only one day before the product-tracing provisions of the Drug Supply Chain Security Act (“DSCSA”) were set to take effect for dispensers, FDA issued a Guidance Document for immediate implementation that signals FDA’s intention to delay any use of enforcement for …
By Jay W. Cormier, David C. Gibbons & Roger C. Thies – Having assisted clients with FDA inspections, 483 responses, and Warning Letter responses associated with cGMP for aseptic fill operations, we can imagine the nightmares many quality and manufacturing personnel would have with the observations …
By John R. Fleder – When companies and individuals are “asked” (or told by a court) to pay money to FDA/DOJ as part of a resolution of a civil case, the sting of making the payment can be severe. A question many ask is, “Can we …
