By Kurt R. Karst – Late yesterday, Rep. Anna Eshoo (D-CA), along with Reps. Jay Inslee (D-WA), and Joe Barton (R- TX), announced the introduction of the Pathway for Biosimilars Act (H.R. 1548). (A copy of the bill should be available soon). The introduction of …
By Kurt R. Karst – FDA has issued its highly anticipated decision concerning whether the QI Program Supplemental Funding Act of 2008 (“QI Act”) imposes a 30-month stay of approval of an ANDA referencing an old antibiotic drug product if that ANDA contains a Paragraph IV certification …
By Riëtte van Laack – In 2004, the State of California sued three tuna companies, Tri-Union Seafoods, LLC, Del Monte Corporation, and Bumble Bee Seafoods, LLC, for violation of California’s Proposition 65 because they failed to provide the required clear and reasonable warning that their …
Hyman, Phelps & McNamara, P.C. (“HP&M”) has issued a detailed analysis of the Supreme Court’s recent ruling in Wyeth v. Levine. A copy of the analysis, written by James P. Ellison and Carrie S. Martin, is available here. In Wyeth, the Court ruled that, based …
By Ricardo Carvajal– In an address highlighting the need to tackle problems with the nation’s food safety system, President Obama today announced the appointments of Dr. Margaret Hamburg as the new FDA Commissioner and Dr. Joshua Sharfstein as Principal Deputy Commissioner with primary responsibility for …
By Bryon F. Powell – On March 11, 2009, the Massachusetts Department of Public Health ("DPH") Public Health Council unanimously approved a final rule on Pharmaceutical and Medical Device Manufacturer Conduct. This vote came just seven months after Massachusetts’ Governor Deval Patrick signed into law …
By James P. Ellison – Despite the Supreme Court’s 2008 ruling in Riegel v. Medtronic, in which the Court found express preemption for devices subject to premarket approval based on express statutory language, the judge in Minnesota overseeing multi-district device litigation granted the plaintiffs’ motion to …
By Kurt R. Karst – Earlier this week, FDA announced that the Agency will reverse course and grant Amyotrophic Lateral Sclerosis (“ALS”) patients “compassionate use” access to IPLEX (mecasermin rinfabate [rDNA origin] injection). FDC Act § 561, which was added to the statute in 1997 …
By Kurt R. Karst – Earlier today, Representative Henry Waxman (D-CA) (along with Representatives Nathan Deal (R-GA), Frank Pallone (D-NJ), and Jo Ann Emerson (R-MO)) announced the introduction of H.R. 1427, the Promoting Innovation and Access to Life-Saving Medicine Act, which authorizes FDA to approve …
By James P. Ellison – The relationship between the federal government and qui tam relators is defined in part by statute and case law, but that law does not fully capture the often complex and varying relationship between qui tam relators and the government on …
By Ricardo Carvajal – The USDA Animal and Plant Health Inspection Service (“APHIS”) plans to hold public meetings in the Washington D.C. area in April to address issues raised by its proposal to revise its regulations on the importation, interstate movement, and environmental release of …
By Ricardo Carvajal – In response to the recent outbreak of Salmonella in peanut-derived products, FDA has issued a Guidance for Industry targeted to manufacturers who use peanut-derived ingredients in their products. (The guidance does not target producers of those ingredients.) The guidance addresses different …
By Ricardo Carvajal – FDA has announced a collaboration with the Alliance for NanoHealth ("ANH") that will aim to “expand knowledge of how nanoparticles behave and affect biologic systems, and to facilitate the development of tests and processes that might mitigate the risks associated with nanoengineered …
By John R. Fleder & Kurt R. Karst – Last week, the United States District Court for the Eastern District of Pennsylvania entered a Consent Decree against giant home shopping retailer QVC, Inc. The Consent Decree stems from a June 14, 2000 Federal Trade Commission (“FTC”) decision …
By Riëtte van Laack – The U.S. Government Accountability Office ("GAO") has released a report that calls for FDA to take further actions to improve oversight and consumer understanding of dietary supplements. In its 2009 Report, GAO reviews developments since its previous report in 2000. Significant …
