We previously reported that it has been unclear whether a company submitting an ANDA containing the results of an in vivo bioequivalence study must certify on Form FDA 3674 that new Public Health Service Act (“PHS Act”) § 402(j), as added by Title VIII of the …
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 …
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. …
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 …
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 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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
