By JP Ellison – In Dickens’ A Christmas Carol, the main character is visited by three ghosts who by scaring him with visions of his past, present and future, seek to change him. On December 13, 2010, in the form of a U.S. District Court for …
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Enforcement
- Court Upholds Exclusion of Former Purdue ExecutivesDecember 20th, 2010
- FDA Steps Up Efforts Against “Tainted” Products Masquerading as Dietary SupplementsDecember 19th, 2010
By Riëtte van Laack – On December 15, 2010, FDA took several steps to increase its enforcement against products that are marketed as dietary supplements but contain analogs of, or the same active ingredients as, FDA-approved drugs, or other substances that do not qualify as dietary …
- FDA and FTC Target Caffeinated Alcoholic Malt BeveragesNovember 23rd, 2010
By Ricardo Carvajal & Diane B. McColl – FDA issued warning letters to the manufacturers of certain caffeinated alcoholic malt beverages contending that the products are adulterated under the Federal Food, Drug, and Cosmetic Act (“FDC Act”) because caffeine is not an approved food additive for …
- Former Pharma Company Attorney Indicted for Her Role in FDA Investigation of Her EmployerNovember 9th, 2010
By John R. Fleder, Douglas B. Farquhar & Peter M. Jaensch – The U.S. Department of Justice announced on November 9, 2010, the government version of a six-count indictment filed in the District of Maryland against Lauren Stevens, a former Vice President and Associate General Counsel for a brand …
- OIG Exclusion and FDA Debarment – New Use of Old ToolsNovember 8th, 2010
In the September/October 2010 edition of the Food and Drug Law Institute’s Update publication, HP&M attorney Jennifer B. Davis authored an article, titled “New Use of Old Tools: Career-Ending OIG Exclusion and FDA Debarment.” The article focuses on the Department of Health and Human Service’s …
- WLF Cautions FDA Regarding Park DoctrineNovember 1st, 2010
By Peter M. Jaensch – Over the last seven months, officials at FDA, including the FDA Commissioner, Margaret Hamburg, MD, and the Deputy Chief Counsel for Litigation, Eric Blumberg, have been promising to resume use of the individual criminal liability doctrine known as the Park Doctrine …
- GAO Report Blasts FDA for Failure to Implement 2008 RecommendationsOctober 31st, 2010
By Jennifer B. Davis – Earlier this week, the Government Accountability Office (“GAO”) publicly released its September 2010 Report to the House Committee on Oversight and Government Reform concerning Drug Safety, titled “DRUG SAFETY – FDA Has Conducted More Foreign Inspections and Begun to Improve Its …
- For Whistleblowers, Complaining to the Government Pays: GlaxoSmithKline Pays $750 Million to Resolve Criminal and Civil Liability for Alleged cGMP FailuresOctober 27th, 2010
By Peter M. Jaensch & John R. Fleder – A company has “current Good Manufacturing Practice” (“cGMP”) issues. FDA learns about the issues and engages in dialogue with the company regarding the purported violations. No big deal and no news story! Add in a terminated employee who files …
- Watch Out! At FDLI Conference, Government Says More People Will Be Convicted of CrimesOctober 14th, 2010
By Douglas B. Farquhar – At a trade industry conference this week, a cadre of government officials unanimously predicted a dramatic increase in the number of criminal prosecutions of individuals for violations of laws governing FDA-regulated industries. They also discussed how the types of prosecutions may …
- Final Reminder for HP&M’s Free Webinar – The Evolution and Resurgence of Strict Liability Criminal Prosecutions Under the Park DoctrineOctober 7th, 2010
Hundreds of you have already signed up for Hyman, Phelps & McNamara, P.C.’s free webinar – The Evolution and Resurgence of Strict Liability Criminal Prosecutions Under the Park Doctrine – scheduled for Friday, October 8, 12:00 p.m. – 1:30 p.m. For those last minute stragglers, …
- HP&M Presents the Evolution of FDA and the Park Doctrine for Criminal Prosecutions of Corporate ExecutivesOctober 4th, 2010
Join Hyman, Phelps & McNamara, P.C. attorneys on October 8, 12:00 p.m. – 1:30 p.m. for a free webinar on a very important, timely topic. You can register for the free webinar here. The webinar will feature attorneys with decades of experience in FDA’s application of …
- FTC Complaint Charges POM Wonderful LLC’s Advertising Not Supported by Competent and Reliable EvidenceSeptember 29th, 2010
By Riëtte van Laack – On September 27, 2010, less than two week after POM Wonderful LLC (“POM”) filed a complaint against the Federal Trade Commission (“FTC”) (see our previous post here), the Agency filed a Complaint against POM, its sister corporation Roll International Corp. and …
- HPM Attorneys to Present at FDLI’s Enforcement and Litigation ConferenceSeptember 29th, 2010
Hyman, Phelps & McNamara, P.C.’s Douglas Farquhar and Ricardo Carvajal will be presenting at FDLI’s upcoming two-day conference on FDA enforcement and litigation. Mr. Farquhar will moderate a panel on elements of proof in an injunction case, and will present on misdemeanors, debarment, and exclusion. …
- HP&M Presents the Evolution of FDA and the Park DoctrineSeptember 21st, 2010
Join Hyman, Phelps & McNamara, P.C. attorneys on October 8, 12:00 p.m. – 1:30 p.m. for a free webinar on a very important, timely topic. You can register for the free webinar here. (Please register by September 29th.) In criminal prosecutions of corporate executives, ignorance of …
- Cody/Lannett Unapproved Morphine Sulfate Litigation Gets New Legs; But FDA Motion to Dismiss Tries to Pull the Rug Out From Under ThemSeptember 6th, 2010
By Kurt R. Karst – The dispute between Cody Laboratories, Inc. and Lannett Co., Inc. (collectively “Cody/Lannett”) and FDA over marketed unapproved Morphine Sulfate Solution Immediate-Release 20mg/mL drug products did not end with the July 26, 2010 decision from the U.S. District Court for the District …