By Alan M. Kirschenbaum – The October 30, 2015 Texas Register contained a proposed regulation published by the Health and Human Services Commission (HHSC) that would repeal a burdensome price reporting requirement for drug manufacturers. In order to have a drug included on the Texas fee-for-service …
By Kurt R. Karst – There are several important dates in the history of the Orange Book – FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations – some of which are the result of advancements in technology, and some of which occur (curiously) around the end …
By Riëtte van Laack – As we previously reported, POM Wonderful (“POM”) petitioned the U.S. Court of Appeals for the D.C. Circuit for en banc review of that Court’s earlier decision which had largely upheld the FTC’s cease and desist order issued against POM. That petition was …
By Ricardo Carvajal – FDA has established a web page that “alerts consumers to companies fraudulently marketing products for the treatment or prevention of serious diseases.” If a company receives a warning letter challenging such claims and fails to correct its marketing practices within 30 days, …
By Kurt R. Karst – Earlier this week FDA finally released its Manual of Policies and Procedures (“MAPP”) on NDA Classification Codes (MAPP 5018.2) – formerly called “Chemistry Classification Codes.” The MAPP has been under development for quite some time . . . . and there’s …
By Wes Siegner – Effective October 30, 2015, FDA issued a stay on certain food provisions of the final guidance, “Investigational New Drug Applications—Determining Whether Human Research Studies Can Be Conducted Without an IND” (IND Guidance). FDA announced the stay in the Federal Register notice, 80 …
FDA recently announced that it has submitted the FSMA final rules on produce safety, foreign supplier verification, and third party accreditation to the Federal Register – just in time for the third and fourth installments in the Food and Drug Law Institute’s (FDLI’s) FDA Food Safety …
By Jeffrey K. Shapiro – For more than 10 years, FDA has regulated human cells, tissues, and cellular and tissue-based products (“HCT/Ps”) under 21 C.F.R. Part 1271. Under § 1271.10(a), if four criteria are met, the HCT/P qualifies for regulation exclusively under Part 1271. This status …
By Diane B. McColl – On October 28, 2015, FDA announced that a food additive petition (FAP) submitted by the Grocery Manufacturers Association (GMA) for minor uses of partially hydrogenated vegetable oils (PHOs) was accepted for filing on October 1, 2015 (Docket No. FDA-2015-F-3663). GMA’s FAP …
By David C. Gibbons & Alan M. Kirschenbaum – At 3 am on October 30, 2015, the Senate passed H.R. 1314, the Bipartisan Budget Act of 2015 (“BBA”), which had already passed the House on October 28, and is expected to be signed imminently by the …
By David C. Gibbons & Anne K. Walsh – Background In a previous post we described the recent challenge by Pacira Pharmaceuticals, Inc. (“Pacira”) to FDA’s authority to restrict a manufacturer’s promotional activities. See Pacira Pharms., Inc. v. FDA, No. 15-7055 (S.D.N.Y. Sept. 8, 2015). Pacira’s allegations …
By James C. Shehan – On October 27th, the FTC submitted comments objecting to the FDA’s draft guidance on Nonproprietary Naming of Biological Products. In the comments and an accompanying press release, the FTC asserts that the proposal may reduce price competition in biologic drug markets, …
By Karla L. Palmer – FDA announced (here and here) earlier this week the availability of two draft guidances (here and here) for compounders using bulk substances under FDCA Sections 503A and 503B. FDA also published final guidance for compounders under Section 503A (see our previous post addressing that …
By Kurt R. Karst – Hatch-Waxman Patent Term Extension (“PTE”) disputes never get old for this blogger. There’s often some new twist for FDA or the U.S. Patent and Trademark Office (“PTO”) to consider, as shown in a recent PTE denial for a patent concerning the …
By James R. Phelps – Last Thursday, at the 16th Pharmaceutical Compliance Congress and Best Practices Forum, Principal Deputy Assistant Attorney General for the Justice Department’s Civil Division, Benjamin Mizer, reviewed enforcement policies that the Department of Justice will follow. Appropriate to the forum, he focused …
