By Kurt R. Karst – One recent afternoon we returned to our office from a meeting to find the new (2012) nine-volume set of Title 21 of the Code of Federal Regulations (“CFR”) placed on our desk chair. There’s a special place on our desk …
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Hyman Phelps McNamara
- The Obesity Epidemic: FDA’s Growing Waistline!September 3rd, 2012
- FDA and OMB Sued Over Delays in FSMA ImplementationAugust 31st, 2012
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”). …
- Hot Ticket Item – Patent Settlement Agreement ChallengesAugust 30th, 2012
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 …
- D.C. Circuit Affirms District Court Decision Striking Down FDA Regulation Requiring Graphic Warnings on Cigarette PackagesAugust 28th, 2012
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). …
- IOM Issues Report on “Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network”August 27th, 2012
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 …
- The Rabbit Hole Runs Deep; CDRH “Whistleblower” Scandal Involves a Once-Secret qui tam LawsuitAugust 26th, 2012
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 …
- FDA Gears Up for GDUFA Implementation and ANDAgeddonAugust 23rd, 2012
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 …
- The Clock Ticks Away on AAFCO’s Ingredient Definition ProcessAugust 22nd, 2012
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 …
- In Litigation Over Animal Feed Antibiotic Withdrawals, District Court Says FDA Needs to Move ForwardAugust 22nd, 2012
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 …
- Congressional Interest in FDA Remains High, Even After the Enactment of FDASIAAugust 20th, 2012
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 …
- HP&M Attorneys to Present at Upcoming Conferences on Food LawAugust 20th, 2012
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 …
- A Solution in Search of a Problem, Part IIAugust 16th, 2012
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 …
- Push for 12-Year Biologics Exclusivity in TPP Agreement Continues as the Next Round of Negotiations ApproachesAugust 16th, 2012
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 …
- FDA is Sued Again Over Pre-MMA 180-Day Exclusivity; This Time the Drug is Generic ACTOSAugust 15th, 2012
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 …
- California Labeling Requirements for Organic Cosmetics Not PreemptedAugust 14th, 2012
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 …