By Allyson B. Mullen & Jeffrey N. Gibbs – The end of 2013 marked the first anniversary of CDRH’s Refuse to Accept Policy for 510(k)s (the “RTA”). FDA, Guidance for Industry and FDA Staff, Refuse to Accept Policy for 510(k)s (December 2012). Therefore, we thought it …
By Wes Siegner – The following organizations filed joint comments on November 26, 2013 voicing strong opposition to the food provisions of FDA’s final IND Guidance and requesting that FDA reopen the comment period to permit comment on the food provisions of the guidance, which FDA …
By Ricardo Carvajal, Diane B. McColl & JP Ellison – The Center for Food Safety filed suit in the DC District Court challenging FDA’s allegedly “unlawful action of exempting substances that are [GRAS] from regulation as food additives under a proposed rule for more than fifteen …
By Kurt R. Karst – Even before FDA gave up an appeal of Judge Edward R. Korman’s April 2013 Judgment and Order that Teva Branded Pharmaceutical Products R&D, Inc.’s (“Teva’s”) PLAN B One-Step (levonorgestrel) Tablets, 1.5 mg (“PBOS”), be made available Over-the-Counter (“OTC”) without age or …
By JP Ellison – On February 24, 2014, the U.S. Department of Justice announced a civil lawsuit and partial settlement arising out of alleged violations of statutes enforced by the Consumer Product Safety Commission (the “CPSC”). According to the press release, the complaint alleges that four California companies …
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 …
