By Serra J. Schlanger & Alan M. Kirschenbaum – Judge Rya Zobel of the Federal District Court for the District of Massachusetts has dealt another blow to the Federal health care program antikickback statute (“AKS”) discount safe harbor, which drug and device manufacturers and their customers …
By Anne K. Walsh & Andrew J. Hull – A problematic decision from the Ninth Circuit appears to impermissibly grant FDA authority to regulate the practice of medicine, and to further muddy the regulatory morass governing off-label use of products. We hope other courts recognize this …
By McKenzie E. Cato* & Allyson B. Mullen – In May 2015, FDA issued a draft guidance addressing how FDA might consider patient preference information (PPI) in review of premarket approval applications (PMA), humanitarian device exemption (HDE) applications, and de novo requests; the types of data …
By Alexander J. Varond – Late last week, the Senate voted unanimously to extend the rare pediatric disease voucher program until December 31, 2016. In doing so, it also voted to amend the definition of “rare pediatric disease” set forth in Section 529 of the Federal …
By Kurt R. Karst – Last Friday, FDA announced that the Agency licensed the fourth biosimilar biological product under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”): Amgen, Inc.’s (“Amgen’s”) AMJEVITA (adalimumab-atto) (BLA 761024), a biosimilar version of AbbVie Inc.’s (“AbbVie’s”) (BLA 125057) blockbuster …
By Alexander J. Varond – FDA’s rare pediatric disease priority review voucher program is set to expire on October 1. If this happens, FDA will no longer award pediatric vouchers to otherwise eligible sponsors. Expiration of the pediatric voucher program would mean the end (at least …
By Jennifer M. Thomas – As predicted in our last post on the significant Park-related litigation arising out of the Quality Egg case, Austin (Jack) and Peter Decoster timely petitioned for panel or en banc rehearing of their Eighth Circuit challenge to three-month prison sentences imposed …
By Dara Katcher Levy & Jenifer R. Stach – Ten years and two days after FDA issued the proposed rule, the Agency published the final rule – Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a …
By Ricardo Carvajal – FDA’s issuance of a draft guidance for industry titled Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling marks the first issuance of a guidance that addresses structure/function (SF) claim substantiation for a conventional food. As FDA explains in the guidance, …
By JP Ellison & Wes Siegner – There are 12 pages of FDA forms on the FDA website covering everything from product topics (foods, drugs, cosmetics, etc.) to safety forms and FDA field operations forms. Unless we missed it, one of FDA’s newest forms isn’t on its website. …
By Serra J. Schlanger & Alan M. Kirschenbaum – For 25 years, drug and device manufacturers and their customers have relied on the discount safe harbor under the Federal health care program antikickback statute (“AKS”) to protect procompetitive discount arrangements that save money for purchasers, patients, …
By Allyson B. Mullen – As our blog readers know, the 510(k) Third Party Review Program has been a bit of a flop in terms of utilization and clearance times (see our previous post here). In Fiscal Years 2013, 2014, and 2015, only 3.2%, 2.2%, and 2.3% …
By Kurt R. Karst – What a difference a few precedents can make! In a rather surprising turn of events, Judge Rudolph Contreras of the U.S. District Court for the District of Columbia issued a Memorandum Opinion last Friday granting a Motion for Reconsideration filed by …
By Riëtte van Laack – Last week, FDA announced its final rule regarding over-the-counter (OTC) consumer antiseptic wash products. As we reported in 2013, FDA issued a proposal to declare all antimicrobial consumer hand wash products as not generally recognized as safe and effective but invited comments …
By John A. Gilbert, Jr. & Larry K. Houck – This is third in a series of in-depth reviews of the Drug Enforcement Administration’s (“DEA’s”) and other federal agencies’ recent decisions/notices on marijuana and industrial hemp issued on August 12, 2016. Previously, we reviewed DEA’s policy …
