In a surprising and likely controversial decision regarding so-called “Section 340B covered entities,” the U.S. Court of Appeals for the Ninth Circuit in County of Santa Clara v. Astra U.S.A., Inc. recently reversed the U.S. District Court for the Northern District of California’s dismissal of …
More than one might guess. On September 26, 2008, the Government Accountability Office (“GAO”) released a report, titled "Food Safety: Improvements Needed in FDA Oversight of Fresh Produce." As the title suggests, the report is somewhat critical in tone, although it does acknowledge FDA’s efforts …
Earlier this week, Senator Sherrod Brown (D-OH) announced the introduction of S. 3633, the “Transparency in Drug Labeling Act.” The bill, also know as the “COOL Pharmaceutical Bill,” would amend the FDC Act to require Country-Of-Origin (“COO”) labeling on prescription and Over-The-Counter (“OTC”) drug products. …
Section 920 of the FDA Amendments Act (“FDAAA”) amended the FDC Act to create new § 505(t) – “Database for Authorized Generic Drugs” – that requires FDA to compile and publish a complete list of all authorized generic drugs identified in annual reports submitted to …
We previously reported (April 25, 2007, May 22, 2007, August 14, 2007) on a trend in policing promotional and advertising claims by FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”), in which DDMAC has focused on ensuring that all claims are supported by substantial …
In response to an urgent request of the European Commission, Health and Consumers Directorate, the European Food Safety Authority ("EFSA") conducted an exposure assessment for biscuits and confectionery contaminated with melamine. Although milk and milk products originating from China currently are prohibited from importation into …
Yesterday, the U.S. Senate passed S. 3560, the “QI Program Supplemental Funding Act of 2008.” Section 4 of the bill would amend the FDC Act to add new subsection 505(v) – “Antibiotic Drugs Submitted Before November 21, 1997” – to create Hatch-Waxman benefits for so-called …
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 …
