By JP Ellison – In a recent post we described the Generic Pharmaceutical Association’s amicus brief in the POM case, which urged the Supreme Court to “be cognizant of the differences” among FDA regulated products. In particular, GPhA urged that ‘[e]ven if petitioner is allowed to …
By Kurt R. Karst – It was only about a year ago when the topic du jour was generic drug labeling and whether federal law – the FDC Act and FDA’s implementing regulations – preempts state-law product liability claims (failure-to-warn, design defect, failure-to-conform/update, etc.) against generic …
By Jay W. Cormier & Anne K. Walsh – It was a big day in January 2009 when FDA finally issued guidance for manufacturers governing the distribution of medical journal articles and reference publications. While some guidance was better than no guidance, FDA received several comments …
By Kurt R. Karst – It’s “Exclusivity Week”! First there was FDA’s Draft Guidance that, if finalized, would reinterpret the 5-year New Chemical Entity (“NCE”) exclusivity provisions of the FDC Act to award NCE exclusivity to a newly approved Fixed-Dose Combination (“FDC”) drug containing an …
By Kurt R. Karst – In moves that may displease both brand-name and generic drug manufacturers, and that could lead to litigation from both sides, FDA has with one hand proposed to giveth New Chemical Entity (“NCE”) exclusivity to certain Fixed-Dose Combination Drugs (“FDCs”) and has …
By Alexander J. Varond – Purdue Pharma recently submitted a citizen petition challenging FDA’s decision to require labeling revisions and postmarket study requirements for extended-release and long acting opioid analgesic products but not immediate-release products. We discussed these revisions here. Purdue’s citizen petition, dated February 11, 2014, …
By James C. Shehan – Vermont law has banned manufacturers of prescription drug, device, and biologics products from providing most gifts to physicians and other healthcare professionals since 2009 and has required these manufacturers to report permitted gifts and payments to Vermont HCPs since 2002 (summarized …
By Kurt R. Karst – Last Friday, BioMarin Pharmaceutical Inc. (“BioMarin”) and FDA announced (here and here) the approval of a BLA for a new biological product for patients with Mucopolysaccharidosis type IVA, also known a “Morquio A syndrome”: VIMIZIM (elosulfase alfa) Injection. The approval of …
By Kurt R. Karst – Although it’s been more than 10 years since the December 8, 2003 enactment of the Medicare Modernization Act (“MMA”) – or, more accurately, The Medicare Prescription Drug, Improvement, and Modernization Act, Pub. L. No. 108-173 – which created a new regime …
By Kurt R. Karst – A couple of weeks ago we announced a massive and unprecedented undertaking by FDA’s Office of Generic Drugs (“OGD”) to address an outpouring of concern about, among other things, a Manual of Policies and Procedures (“MAPP”) – MAPP 5200.3 – titled “Responding …
By Kurt R. Karst – The Electronic Age has changed nearly every aspect of our daily lives, and the day-to-day operations of the U.S. Federal Government are no different. The government is no longer open for business from 9-5, but rather 24 hours a day by …
By William T. Koustas – The litigation between Regenerative Sciences, LLC (“Regenerative”) and FDA may have come to an end on Tuesday, February 4th, when the United States Court of Appeals for the District of Columbia Circuit ruled against Regenerative, concluding that FDA has the authority …
By Kurt R. Karst – The Wachowski Brothers’ Matrix Trilogy of movies depict a post-apocalyptic world in which reality is not what it seems. The reality most people perceive is actually a simulated reality created by sentient machines – a dream world created by virtue of …
By Kurt R. Karst – In a new paper published by The Petrie-Flom Center for Health Law Policy, BioTechnology, and BioEthics at Harvard Law School, and presented at a February 3, 2014 Health Law Workshop, Kevin Outterson, a Professor of Law at Boston University and member …
By Kurt R. Karst – The U.S. Patent and Trademark Office (“PTO”) has finally issued a final decision in the long-running dispute over eligibility for a Patent Term Extension (“PTE”) for U.S. Patent No. 5,674,860 (“the ‘860 patent”) covering AstraZeneca LP’s SYMBICORT (budesonide and formoterol fumarate …
