By Kurt R. Karst – In a September 10, 2015 Response to a September 2, 2011 Citizen Petition (Docket No. FDA-2011-P-0657) submitted by the National Organization for Rare Disorders (“NORD”), FDA refuses to add a statement to guidance documents concerning orphan drugs that the Agency’s official …
By Riëtte van Laack & Etan J. Yeshua – As we previously reported, when FDA announced a new compliance date for the menu labeling rule, it also announced that it would issue guidance. On Friday, September 11, FDA issued the promised draft guidance. The draft guidance is …
By Kurt R. Karst – Last week, Senators Amy Klobuchar (D-MN) and Charles Grassley (R-IA) announced the introduction of S. 2019, the Preserve Access to Affordable Generics Act. The bill is the latest attempt to pass legislation to address pharmaceutical patent settlement agreements (aka “reverse payment …
By Ricardo Carvajal & Riëtte van Laack – FDA released pre-publication versions of the two final rules on current good manufacturing practice and preventive controls requirements – one governing human food (here), and the other animal food (here). The pre-publication versions total over 1,500 pages, so will …
The Expert Institute recently informed us that the organization is holding a “Best Legal Blog Competition” and that the FDA Law Blog has been selected to participate in the competition. From a field of more than 2,000 potential nominees, FDA Law Blog has received enough …
By Kurt R. Karst – It’s been a while since we peeked in on the appeals Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”) and Elliott Associates, L.P., Elliott International, L.P. and Knollwood Investments, L.P. (collectively “Elliott”) filed with the U.S. Court of Appeals for the District of Columbia …
By Kurt R. Karst – The Order handed down last week by the U.S. Court of Appeals for the Federal Circuit denying Amgen Inc.’s (“Amgen’s”) Emergency Motion For An Injunction Pending En Banc Consideration and Review and Sandoz Inc.’s (“Sandoz’s”) September 3, 2015 launch of the …
By Kurt R. Karst – Finger through the “Discontinued Drug Product List” section of the Orange Book and youl’ll quickly realize that there are a lot of drug products no longer marketed. The “Discontinued Drug Product List” spans 337 pages in the current annual edition of …
By Alan M. Kirschenbaum, Michelle L. Butler & David C. Gibbons – On August 28, 2015, the Health Resources and Services Administration (HRSA) of the Department of Health and Human Services published an omnibus guidance document to implement the 340B Drug Discount Program (the Proposed Guidance). Since …
By James C. Shehan & Andrew J. Hull – The U.S. Court of Appeals for the Eighth Circuit recently issued an opinion in the case of Lytle v. U.S. Department of Health and Human Services, Nos. 14-3715, 15-1214 (8th Cir. Aug. 21, 2015), affirming that private membership …
By Ricardo Carvajal – FDA issued a warning letter to Hampton Creek alleging that its Just Mayo products are misbranded, in part because they purport to be a food governed by a standard of identity – namely, mayonnaise – that the products fail to meet. This alleged …
By David C. Gibbons – An August 28, 2015 letter to Judge Paul Engelmayer, U.S. District Court for the Southern District of New York, from the attorneys representing Amarin, Inc. (“Amarin”) indicated that the parties on both sides of Amarin Pharma, Inc. v. FDA, No. 15-3588 …
By Alexander J. Varond – Hardly a week goes by without news of FDA’s priority review voucher (“PRV”) programs. The last several weeks are no exception. In this blog post, we focus on five key updates related to FDA’s tropical disease and rare pediatric disease (“Pediatric”) …
By James C. Shehan – On August 27, 2015, FDA published its much–anticipated views on the non-proprietary naming of biological products. Set forth in a proposed rule, a draft guidance, and a blog post, FDA proposes that a four letter suffix “devoid of meaning” be part …
By David C. Gibbons – As we reported in a previous post, the House Committee on Energy and Commerce requested that FDA answer a number of questions regarding how FDA Centers issue and publicly disclose Untitled Letters (“ULs”). As readers may recall, the letter to FDA …
