By Jennifer M. Thomas – The writers of this blog have often noted with dismay Relators’ attempts to enforce the FDCA and FDA regulations through the False Claims Act. Here, and here, for example. Last week, the Fourth Circuit confirmed that this is a losing strategy …
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 Ricardo Carvajal – FDA entered into a consent decree with the Center for Food Safety that specifies new deadlines for the agency’s submission of final rules implementing FSMA to the Federal Register for publication. The consent decree marks the latest chapter in a case that …
By Jeffrey N. Wasserstein – Either Senator Lamar Alexander (R-Tenn) reads the FDA Law Blog, or great minds truly think alike. On February 20, 2014, Senator Alexander wrote to Secretary of Health and Human Services (HHS) Kathleen Sebelius asking her to clarify HHS’s position regarding patient …
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 Allyson B. Mullen – On February 14, 2014, FDA issued a final rule amending 21 C.F.R. Part 803, Medical Device Reporting, to require medical device manufacturers and importers to submit MDRs in an electronic format (the “Final Rule”). 79 Fed. Reg. 8832 (Feb. 14, 2014). …
By Karla L. Palmer – Last week, the United States District Court for the District of Oregon ruled that the Drug Enforcement Administration’s (“DEA”) administrative subpoena powers are not unfettered when it comes to obtaining protected health information (“PHI”) submitted by pharmacies to Oregon’s Prescription Drug …
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 Ricardo Carvajal – FDA published a notice announcing the availability of a Draft Approach for Designating High-Risk Foods, and asking for comments and information to help the agency refine that approach. Designation of a food as a High-Risk Food (HRF) would trigger additional recordkeeping requirements intended …
By Jennifer D. Newberger – On February 5, 2014, CDRH released its 2014-2015 Strategic Priorities, in which it stated that the most important areas of focus over the next two years will be to “strengthen the clinical trials enterprise,” “strike the right balance between premarket and …
By Delia A. Deschaine & Alan M. Kirschenbaum – On January 31, 2014, the HHS Office of the Inspector General ("OIG") issued its Work Plan for FY 2014. The Work Plan sets forth OIG’s priorities for evaluations, inspections, and audits to be conducted in FY 2014 …
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 …
At the Food and Drug Law Institute’s (“FDLI’s”) 2014 Medical Device Conference – Key Legal and Regulatory Developments, which will take place in Washington, D.C. on February 27, 2014, top FDA officials will discuss their most significant recent activities and forecast upcoming medical device activities. …
