By Jeffrey K. Shapiro – We are beginning to suspect that the new transparency of this Administration is a lot like the old transparency. Or, as The Who sang in We Won’t Get Fooled Again, “meet the new boss / same as the old boss.” The …
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Hyman Phelps McNamara
- Meet The New Transparency – Same as The Old TransparencyApril 7th, 2010
- Judge Kozinski: Argument that Once State Allows Slaughter of Pigs it Cannot Further Regulate what Types of Pigs may be Slaughtered for Human Consumption is “Hogwash”April 7th, 2010
By Riëtte van Laack – Late last month, the U.S. Court of Appeals for the Ninth Circuit vacated a district court’s injunction against California’s prohibition of the use of non-ambulatory pigs for use in human consumption, Cal. Pen. Code § 599f. Last year, the district …
- The Rarely Used Exception to the First Permitted Commercial Marketing/Use PTE CriterionApril 6th, 2010
By Kurt R. Karst – [We interrupt this blog posting to bring you some breaking news . . . . For those of you following the battle over generic COZAAR/HYZAAR 180-day exclusivity, we updated our April 5th post with information on a D.C. Circuit decision. …
- Generic COZAAR/HYZAAR 180-Day Exclusivity – Teva Wins, FDA Too (Despite Itself) in the DC District Court; Appeals AboundApril 5th, 2010
By Kurt R. Karst – When we last blogged on the issue of 180-day exclusivity for generic versions of Merck & Co., Inc.’s blockbuster drugs COZAAR (losartan potassium) Tablets and HYZAAR (hydrochlorothiazide; losartan potassium) Tablets, FDA had issued an 8-page decision concluding that Teva …
- Mass Forfeiture of 180-Day Exclusivity!April 1st, 2010
By Kurt R. Karst – FDA’s recently posted approval letter for Orchid Healthcare’s (“Orchid’s”) ANDA No. 78-357 for a generic version of Schering-Plough Corp.’s (“Schering’s”) blockbuster drug CLARINEX (desloratadine) Tablets, 5 mg, reads like any run-of-the-mill ANDA approval letter; however, it’s what is not said …
- Presenting Risk Information in DTC Ads: FDA Issues Proposed Rule That Allows for FlexibilityMarch 31st, 2010
By Carrie S. Martin & Dara Katcher Levy – On March 29, 2010, FDA published a proposed rule to amend its direct-to-consumer (“DTC”) regulations to require that prescription drug advertisements present information about side effects and contraindications in a “clear, conspicuous, and neutral manner.” Current …
- Up In Smoke: Federal Court Supports Local Authority to Restrict Smokeless Tobacco Sales More Strictly than Under Existing Federal LawMarch 31st, 2010
By Peter M. Jaensch – On March 23, 2010, Judge McMahon of the U.S. District Court for the Eastern District of New York issued a memorandum decision in U.S. Smokeless Tobacco Manufacturing Company, LLC, and U.S. Smokeless Tobacco Brands, Inc. v. City of New York denying …
- The MDR Reporting System Badly Needs Reform: As A First Step, Malfunction MDRs Should Be EliminatedMarch 30th, 2010
By Jeffrey K. Shapiro – In October 2009, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a report entitled, “Adverse Event Reporting for Medical Devices” (“OIG Report”). The OIG’s Report has not received the attention it deserves. The OIG report …
- FSIS Proposes Rule Concerning Recall ProceduresMarch 30th, 2010
By Riëtte van Laack – On March 25, 2010, the Food Safety and Inspection Service (“FSIS”) of the USDA published a proposed rule requiring poultry and meat establishments subject to FSIS inspection to promptly notify the authorities when an adulterated or misbranded meat or poultry …
- In Health Care Reform, a Nod to the Role of NutritionMarch 29th, 2010
By Ricardo Carvajal – Earlier we blogged on the provisions of the Patient Protection and Affordable Care Act (“PPACA”) that most directly affect pharmaceutical and device manufacturers. The PPACA also contains a number of provisions that will directly and indirectly affect the food industry. Most …
- FDA Rules Against Patent Expiration 180-Day Exclusivity Forfeiture for Generic COZAAR/HYZAAR, But in Doing So FDA Repudiates Its Own Decision and Asks to be SuedMarch 29th, 2010
By Kurt R. Karst – Late last Friday, FDA teed up the next battle over 180-day exclusivity for generic versions of Merck & Co., Inc.’s blockbuster drugs COZAAR (losartan potassium) Tablets and HYZAAR (hydrochlorothiazide; losartan potassium) Tablets when the Agency issued its 8-page decision …
- Proposed Food Labeling Changes May be Hard for Pharmaceuticals to SwallowMarch 28th, 2010
By Peter M. Jaensch – On March 23, 2010, Congressman Jason Chaffetz (R-UT) introduced H.R. 4913 – the Free Speech About Science Act of 2010. The bill proposes several amendments to FDC Act § 403(r) concerning the misbranding of foods, which would have the effect …
- Here We Go Again! MDCO Launches Another Lawsuit Against the PTO Over ANGIOMAX PTEMarch 26th, 2010
By Kurt R. Karst – Earlier today, The Medicines Company (“MDCO”) announced that the company filed a new Administrative Procedure Act (“APA”) lawsuit in the U.S. District Court for the Eastern District of Virginia (Alexandria Division) challenging the Patent and Trademark Office’s (“PTO”) March 19, 2010 …
- FDA Tweaks Reportable Food Registry Reporting for Companies with Multiple FacilitiesMarch 25th, 2010
By Ricardo Carvajal – In a recently issued guidance document, FDA makes clear that a company with a reportable food located in multiple facilities can submit a single report to the Reportable Food Registry (RFR) instead of individual reports for each facility (a reportable food …
- Health Care Reform Becomes Law – HP&M Issues Summary of Drug and Device ProvisionsMarch 24th, 2010
By Alan M. Kirschenbaum & Kurt R. Karst – On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act (“PPACA”) (Pub. L. No. 111-148 ). A companion bill, the Health Care Education Affordability Reconciliation Act of 2010 (H.R. 4872), which …