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 …
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- DOJ Makes History: On a Single Day It Files a Criminal Prosecution, a Consent Decree and a Criminal Forfeiture of Foods Involved in the Same IncidentJanuary 26th, 2016
- FDA Broadens Arsenal in Fight Against KratomJanuary 7th, 2016
By Ricardo Carvajal – FDA announced the seizure of dietary supplements purportedly containing kratom, which the agency describes as “a botanical substance that could pose a risk to public health and have the potential for abuse.” The seizure followed on the heels of an administrative detention – a …
- WARNING: GMP Problems No Excuse for Caraco’s Lack of WARN Act Layoff NotificationsJanuary 4th, 2016
By James C. Shehan – The worlds of FDA regulatory law and employment law rarely intersect, so when we came across a recent case in which they did, we thought it worthy of commentary. In that case, a federal appeals court held that GMP troubles leading …
- Pacira Settles and Heralds Changes to How FDA Will Regulate Off-Label Promotion in the New YearDecember 15th, 2015
By David C. Gibbons & Jeffrey N. Wasserstein – Pacira Pharmaceuticals, Inc. (“Pacira” or the “Company”) announced today that it had reached agreement with FDA to settle its First Amendment challenge regarding the promotion of its drug, EXPAREL. As we discussed in a previous post, Pacira …
- HP&M’s Karla Palmer to Speak at FDLI’s Drug Quality and Security in 2016 ConferenceDecember 4th, 2015
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 …
- The Government Really Means It This Time (Part II)November 22nd, 2015
By Anne K. Walsh & John R. Fleder – As we reported in September, DOJ’s Deputy Attorney General Sally Quillian Yates released a seven-page memorandum announcing DOJ’s reinforced efforts to bring cases against individuals. She anticipated that DOJ would revise the U.S. Attorney’s Manual (USAM) to …
- Sex, Drugs, and Rock & Roll (FDA Style): FDA’s Unapproved Drug Machine Continues to Dole Out Enforcement and Legal DecisionsNovember 18th, 2015
By Kurt R. Karst – In case you were under the impression that FDA’s interest in unapproved drug issues and the Agency’s broader Unapproved Drugs Initiative has been waning, or that the extent of FDA’s interest has merely been in sending out Warning Letters to companies …
- Warner-Chilcott Resolution Includes Indictment of PresidentNovember 12th, 2015
By Anne K. Walsh & John R. Fleder – It has been just over a month since the Department of Justice, via the “Yates Memorandum,” reemphasized its commitment to pursue individuals when dealing with corporate misconduct, reported here. Ever since then, FDA-regulated industry has been awaiting …
- FDA Spotlights Products “Fraudulently Marketed for Serious Diseases”November 6th, 2015
By Ricardo Carvajal – FDA has established a web page that “alerts consumers to companies fraudulently marketing products for the treatment or prevention of serious diseases.” If a company receives a warning letter challenging such claims and fails to correct its marketing practices within 30 days, …
- Warning Letter? What Warning Letter? . . . Latest Developments in Pacira and a Look at FDA’s History of Withdrawing Warning LettersOctober 30th, 2015
By David C. Gibbons & Anne K. Walsh – Background In a previous post we described the recent challenge by Pacira Pharmaceuticals, Inc. (“Pacira”) to FDA’s authority to restrict a manufacturer’s promotional activities. See Pacira Pharms., Inc. v. FDA, No. 15-7055 (S.D.N.Y. Sept. 8, 2015). Pacira’s allegations …
- Do You Really Want to Be An Executive In An FDA-Regulated Company?October 26th, 2015
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 …
- Sovereign Immunity in Texas for Warning Letters Sent by the Attorney General? The U.S. Court of Appeals for the 5th Circuit says, “Not so fast cowboy”October 14th, 2015
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 …
- A Court’s Contempt for the Government in BayerOctober 5th, 2015
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 …
- Bayer Scores a Big Win in Action Involving Dietary Supplement Claim SubstantiationOctober 1st, 2015
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 …
- Be Careful What You Wish For: Specialized FDA Inspectors Don’t Necessarily Mean Happier InspectionsOctober 1st, 2015
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 …