By Kurt R. Karst – Last week, FDA announced the issuance of a long-anticipated draft guidance document, titled “Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules,” providing details on acceptable physical attribute differences between generic drugs and their NDA Reference Listed Drug (“RLD) …
By Kurt R. Karst – On December 12th, a group of bipartisan lawmakers led by Representatives Phil Gingrey (R-GA) and Gene Green (D-TX) introduced H.R. 3742, the Antibiotic Development to Advance Patient Treatment Act of 2013 (“ADAPT Act”). If enacted, the ADAPT Act would, among other …
By Kurt R. Karst – Congress has been silent on new legislation addressing drug patent settlement agreements (aka “reverse payment agreements” or “pay-for-delay agreements”) since the U.S. Supreme Court issued its June 2013 opinion in Federal Trade Commission v. Actavis, Inc., 570 U.S. ___ (2013). As …
It’s been quite a month for Hyman, Phelps & McNamara, P.C. (“HP&M”)! First, the American Bar Association named the FDA Law Blog to the 2013 ABA Journal Blawg 100 (see here). Now there are three more honors to report! Earlier this week at the Food and …
By Riëtte van Laack – In addition to the many (more than 20,000) comments to FDA on the draft rules regarding Produce and Preventive Controls implementing the Food Safety Modernization Act (“FSMA”) (Docket Nos. FDA-2011-N-0920 and FDA-2011-N-0921), FDA has received a flurry of letters from Congress …
By Jennifer M. Thomas – To the extent that Plaintiffs, or interested observers, hoped the District Court for the District of Columbia would seize an opportunity to take FDA to task for failing to prevent or stop drug shortages, they were disappointed by Judge Howell’s Thanksgiving …
By Kurt R. Karst – Our hopes that FDA might publish a proposed rule to implement at least some of the changes made to the Hatch-Waxman Amendments to the FDC Act by the Medicare Modernization Act (“MMA”), enacted on December 8, 2003, before the 10-year anniversary …
By Kurt R. Karst – A Complaint recently filed in the U.S. District Court for the District of Delaware by Otsuka Pharmaceutical Co., Ltd. (“Otsuka”) against Par Pharmaceutical, Inc. (“Par”) concerning notice of a Paragraph IV certification contained in an ANDA Par submitted to FDA for …
The Food and Drug Law Institute (“FDLI”) will hold is annual – and quite popular – Enforcement, Litigation and Compliance Conference from December 10-11, 2013 at The Westin Georgetown in Washington, DC. You can register for the conference here. A copy of the conference agenda …
By Delia A. Stubbs & John A. Gilbert – DEA didn’t waste time during its Thanksgiving break. Monday, in just shy of three weeks of the close of its comment period on its proposed rule, DEA issued a final rule placing perampanel in Schedule III. We …
By Dara Katcher Levy – We recently became aware of a lawsuit filed against FDA in the Eastern District of New York over the importation of bulk drug product. In this suit, which also names an individual FDA Compliance Officer, the importer argues that FDA’s actions …
Next Wednesday, December 12th, the ABA Section of Litigation, Products Liability Committee is sponsoring a live audio program titled “Understanding criminal prosecution of food and supplement companies (and their corporate officers) under the Food Drug and Cosmetic Act: Best practices to avoid becoming the next …
By Allyson B. Mullen & Jeffrey N. Gibbs – On November 25, 2013, CDRH issued the Final Guidance “Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions” (the “RUO Guidance”) (see our previous posts on the draft …
By Kurt R. Karst – Earlier this week, Representative Robert Hurt (R-VA) introduced new legislation – H.R. 3631, the Small Manufacturer Protection Act of 2013 – that, if enacted, would bring relief to some companies that are required to pay user fees under the Generic Drug …
By Douglas B. Farquhar – Well, that certainly didn’t take long. FDA has clearly been eager to initiate its new, clarified powers over compounding pharmacies. President Obama only signed the new act (the Drug Quality and Security Act) the day before Thanksgiving, and this morning we find …
