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 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 …
By Ricardo Carvajal – The Food and Nutrition Board of the Institute of Medicine and the Board on Agriculture and Natural Resources of the National Research Council have established an ad hoc committee to examine FDA’s oversight of food safety and make recommendations to fill “gaps …
By David B. Clissold – It seems likely that the answer will be “yes.” The Family Smoking Prevention and Tobacco Control Act (H.R. 1256) is on a fast-track under the new administration. The bill passed the House Energy and Commerce Committee by an overwhelming margin …
When Hyman, Phelps & McNamara, P.C. launched the FDA Law Blog 2 years ago today – Is that 14 in “blog years”? It certainly seems like it, if not more! – we could hardly imagine how successful it would become and how our subscribers (and the …
By Cassandra A. Soltis – The Indiana Senate is currently reviewing House Bill No. 1207, passed by the House on February 25, 2009, which would require food establishments having 20 or more locations in Indiana to post both calorie and carbohydrate information “in a manner that …
By William T. Koustas – As we have previously reported, Title IX of the Food and Drug Administration Amendments Act of 2007 (“FDAAA” or “the Act”) provides a new statutory framework and authority for FDA (or “the Agency”) to require Risk Evaluation and Mitigation Strategy …
