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    • Another Blow to the Discount Safe Harbor in Massachusetts District CourtSeptember 29th, 2016

      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 …

    • Ninth Circuit Confounds Practice of Medicine and Off-Label Use IssuesSeptember 28th, 2016

      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 …

    • FDA Finalizes Guidance Regarding Patient Preference Information for Medical Device SubmissionsSeptember 27th, 2016

      By McKenzie E. Cato* & Allyson B. Mullen – In May 2015, FDA issued a draft guidance addressing how FDA might consider patient preference information (PPI) in review of premarket approval applications (PMA), humanitarian device exemption (HDE)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 …

    • Senate Votes to Extend Pediatric Voucher Program and Expand EligibilitySeptember 26th, 2016

      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 …

    • FDA Licenses First HUMIRA Biosimilar; Denies AbbVie Petition on Fifth Amendment TakingsSeptember 26th, 2016

      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 …

    • The Pediatric Voucher Program and Its Impending Renewal DeadlineSeptember 22nd, 2016

      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 …

    • The DeCosters Battle OnSeptember 20th, 2016

      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 …

    • FDA Electronic Registration for Human Drugs, Animal Drugs, and BLAsSeptember 19th, 2016

      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 …

    • FDA’s First Substantiation Guidance for a Conventional FoodSeptember 19th, 2016

      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, …

    • FDA Rolls Out a New Form—You May Want to Pay Attention to This OneSeptember 15th, 2016

      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.  …

    • Massachusetts District Court Guts Discount Safe HarborSeptember 14th, 2016

      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, …

    • FDA Issues Updated Draft Guidance Regarding 510(k) Third Party Review ProgramSeptember 13th, 2016

      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% …

    • On Second Thought: DC District Court Does a 180 on PREPOPIK NCE Exclusivity; Remands to FDASeptember 13th, 2016

      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 …

    • FDA Issues Final Rule on Safety and Effectiveness of Antibacterial Washes; Defers Action on Three Active IngredientsSeptember 12th, 2016

      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 …

    • How Many Federal Agencies Does it Take to Interpret the Industrial Hemp Law? USDA/DEA/FDA Weigh in on Industrial Hemp Research RequirementsSeptember 8th, 2016

      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 …

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