By Ricardo Carvajal – The Center for Food Safety and the Center for Environmental Health filed suit in the Northern District of California to compel FDA and the Office of Management and Budget (“OMB”) to implement several major provisions of the Food Safety Modernization Act (“FSMA”). …
By Kurt R. Karst – It seems that hardly a day goes by without something new happening concerning patent settlement agreements. They are generally referred to as “pay-for-delay” agreements; however, that’s a bit of a loaded term, and one we try to avoid. We just …
By Ricardo Carvajal & JP Ellison – A divided three-judge panel of the D.C. Circuit affirmed U.S. District Judge Richard Leon’s grant of summary judgment to plaintiffs in R.J. Reynolds et al v. FDA et al. (for our previous summary of that decision, see here). …
By Alexander J. Varond – The Institute of Medicine (“IOM”) recently issued a paper titled “Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary.” The IOM paper summarizes the “Maximizing the Goals of the Cures Acceleration Network to …
By James R. Phelps – According to recent reports concerning the widely reported “whistleblower” scandal at FDA’s Center for Devices and Radiological Health (“CDRH”), in 2009, the CDRH dissidents involved in the affair, while still employed at FDA, filed a “secret” Federal False Claims Act suit …
By John R. Fleder – We have previously reported about the Federal Trade Commission’s (“FTC”) case against POM Wonderful, the maker of pomegranate juice (here, here, here, and here). In the world of FTC advertising cases, this litigation is certainly “big league” litigation. On September 27, 2010, the …
By Kurt R. Karst – In a pair of Federal Register notices (here and here) set for publication on August 27, 2012, and in a pair of draft guidance documents released ahead of their announcement in the Federal Register next week (here and here), FDA …
By Ricardo Carvajal & Diane B. McColl – Back in April, FDA’s Center for Veterinary Medicine ("CVM") notified industry of its decision to extend the agency’s Memorandum of Understanding ("MOU") with the Association of American Feed Control Officials ("AAFCO") for one year (the MOU was scheduled to …
By Kurt R. Karst – The decades-long saga over the withdrawal of approval of certain uses of certain classes of antibiotics in food-producing animals is likely to continue for some time given an August 8, 2012 decision from the U.S. District Court for the Southern …
By Kurt R. Karst – Just before Congress recessed for the month of August, and less than a month after the July 9th enactment of the FDA Safety and Innovation Act, several FDA-related bills were placed in the hoppers in the U.S. Senate and U.S. House …
Hyman, Phelps & McNamara, P.C.’s Diane McColl will present at USP’s 2012 Science & Standards Symposium, which is dedicated to functional foods and dietary supplements. The conference will address scientific and regulatory issues from an international perspective, and will feature speakers from USP and NIH’s …
By Jennifer D. Newberger – Perseverance can be an admirable quality, except when it is misguided. So it seems to be with Representative Edward Markey and Senator Jeff Merkley, who seem intent on convincing the public that devices cleared through the 510(k) process pose great risks …
By Kurt R. Karst – Efforts to include a 12-year period of exclusivity for biological products in the Trans-Pacific Partnership (“TPP”) agreement chapter on intellectual property rights are alive and well as folks ramp up for the 14th negotiating round of the TPP, which will take …
By Kurt R. Karst – It’s been nearly nine years since the enactment of the Medicare Modernization Act (“MMA”), which, among other things, changed the regime for 180-day generic drug marketing exclusivity from a “patent-by-patent” approach (under which shared exclusivity can exist for cross-Paragraph IV filers …
By Riëtte van Laack – The Organic Food Products Act of 1990 (“OFPA”) established national standards for the marketing of certain agricultural products marketed as organically produced. It directed USDA to issue regulations specifying the requirements for certification and labeling of organic agricultural products. In promulgating …
