As any blogger can tell you, writing a blog is a labor of love. It takes a lot of time to put together thoughtful and informative posts – and before the news gets stale. So, when our blog is mentioned as one of the top …
Menu
Hyman Phelps McNamara
- FDA Law Blog Named One of the Best Health Care Policy BlogsSeptember 22nd, 2008
- A Noteworthy Fraud and Abuse Compliance Event for the Medical Device IndustrySeptember 22nd, 2008
Jeffrey K. Shapiro of Hyman, Phelps & McNamara, P.C. will be speaking at American Conference Institute’s 8th National Conference on Reducing Legal Risks in the Sale and Marketing of Medical Devices, November 17-18, 2008 at the Allerton Hotel on the Magnificent Mile in Chicago, IL. …
- FDLI Update Article Discusses State and Federal Enforcement Actions Against Cosmetics CompaniesSeptember 21st, 2008
The latest FDLI Update “Enforcement Corner” article by Hyman, Phelps & McNamara, P.C. discusses the fact that government entities, including FDA, are taking enforcement actions against companies that market cosmetics and cosmetic-like products. The article highlights recent enforcement actions in this area, and also notes …
- Dingell and Stupak’s Investigation of Wyeth’s Centrum Cardio: Much Ado About Nothing?September 18th, 2008
Representatives John Dingell and Bart Stupak are investigating advertising claims made for Wyeth Pharmaceuticals’ Centrum Cardio multi-vitamin. The inquiry stems from a review of direct-to-consumer advertising for pharmaceutical products by the Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations. In a …
- FDA Holds the Line on Green Tea Qualified Health ClaimsSeptember 17th, 2008
FDA has denied a petition for administrative reconsideration of its June 2005 decision on qualified health claims for green tea and certain cancers. In that decision, FDA stated its intent to consider the exercise of enforcement discretion for two weakly worded qualified health claims for …
- The Skinny on “Skinny Labeling” – A Generic Drug Labeling Carve-Out Citizen Petition ScorecardSeptember 16th, 2008
Over the past several months, FDA has responded to or companies have submitted citizen petitions to FDA requesting that the Agency refrain from approving ANDAs for generic drugs with less than complete labeling – so-called “skinny labeling.” That got us thinking – what is the …
- D.C. Circuit Vacates Teva’s 180-Day Exclusivity on Generic RISPERDALSeptember 15th, 2008
On September 12, 2008, the U.S. Court of Appeals for the District of Columbia heard oral argument and ruled in Teva Pharmaceuticals USA, Inc. v. Leavitt, which concerns the availability of 180-day exclusivity for a generic version of Janssen Phaemaceutica’s schizophrenia drug RISPERDAL (risperidone) Tablets …
- FDA Issues Animal Efficacy Rule Concept Paper; Provides Essential Animal Model ElementsSeptember 11th, 2008
Human history is replete with examples of the use of lethal or debilitating agents in war and by terrorists. As early as the 6th Century B.C., the Assyrians are reported to have poisoned the wells of their enemies with ergot of rye (causing ergotism), and …
- Second Circuit Upholds Dismissal of Case Against Former KPMG EmployeesSeptember 10th, 2008
In United States v. Stein, the United States Court of Appeals for the Second Circuit recently upheld a lower court’s decision to dismiss charges against former employees of KPMG on the basis that the prosecutors interfered with the employees’ constitutional right to counsel. Ex-employees of …
- FDA Clarifies that FDAAA Clinical Trial Certification Requirement Applies to IND Submissions; Questions Remain About ANDA Bioequivalence Study RegistrationSeptember 8th, 2008
On March 5, 2008, FDA published a notice in the Federal Register announcing an opportunity for public comment on a proposed collection of information concerning the new clinical trial certification requirement created by Title VIII of the FDA Amendments Act (“FDAAA”). We previously reported on …
- CBI’s Pharmaceutical Congress on Paragraph IV DisputesSeptember 3rd, 2008
Kurt R. Karst of Hyman, Phelps & McNamara, P.C. (and co-chief blogger of FDALawBlog.net) will be speaking at the Center for Business Intelligence’s Pharmaceutical Congress on Paragraph IV Disputes, October 15 – 16, 2008, at the Marriott Philadelphia Downtown in Philadelphia, Pennsylvania. A copy of …
- “Male Enhancement” Dietary Supplement Distributor Gets Sentencing Enhancement — 25 Years for FraudAugust 28th, 2008
According to the Associated Press, a federal court has sentenced Steven Warshak, founder of Berkeley Premium Nutraceuticals, to 25 years in prison for crimes including mail fraud, conspiracy to commit fraud, and money laundering. In addition, Warshak and other defendants must forfeit money and assets …
- FTC Announces Workshop and Study on Follow-On Biologic Patent and Non-Patent Exclusivity IssuesAugust 28th, 2008
2009 is shaping up to be a big year for debate on Follow-On Biologics (“FOBs”). Earlier this year, Representative Anna Eshoo introduced FOB legislation and the House Energy and Commerce Committee Subcommittee on Health requested comment on various FOB issues. The legislation and comments submitted …
- DEA Actions Upheld by D.C. Court of AppealsAugust 27th, 2008
A recent decision by the U.S. Court of Appeals for the District of Columbia in Chein v. DEA demonstrates the Court’s deference to agency expertise and a registrant’s heavy burden in overturning final action by the Drug Enforcement Administration (“DEA”) absent a “flagrant departure from …
- District Court Rules on Jurisdiction and Non-Final Agency ActionAugust 26th, 2008
In Novelty Distributors, Inc. v. Leonhart, the U.S. District Court for the District of Columbia recently confronted the issue of whether district courts have jurisdiction over a challenge to an agency action that is admittedly not final. Novelty Distributors, Inc. (“Novelty”), a distributor of controlled …