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    • Alliance for Natural Health Asks FDA to Fix IND GuidanceMarch 30th, 2018

      In September 2013, FDA issued a final guidance addressing when, according to FDA, companies need an Investigational New Drug Application (IND) for clinical studies in humans. The final guidance created quite a stir, as it included several sections that had not been included in the …

    • DC District Court Sets the Record Straight on Standing to Sue FDAMarch 29th, 2018

      Last week, the U.S. District Court for the District of Columbia dismissed a lawsuit filed by the Environmental Working Group (EWG) and Women’s Voices for Earth (WVE) against the Food and Drug Administration (FDA) and the Commissioner of the FDA. The facts of this case …

    • Least Burdensome – The Third Time’s the Charm?March 28th, 2018

      In 1997, Congress directed FDA to use the “least burdensome” approach in reviewing device applications. This legislation resulted in little change in behavior.  In 2012, Congress enacted new legislation with the same outcome. In 21st Century Cures, Congress addressed the “least burdensome” approach for the third …

    • FDA’s (Re) (Re) (Re) Evaluation of Bulk Drug Substances for Outsourcing Facilities Under 503B: Is the Third Time a Charm, or Three Strikes, You’re Out?March 26th, 2018

      After President Obama signed into law Title I of the Drug Quality and Security Act (the Compounding Quality Act), which created a new breed of drug compounders (deemed “outsourcing facilities”), FDA also came up with a plan to evaluate bulk substances outsourcing facilities could use …

    • “Sham” Citizen Petition Case Opinion Calls FTC’s Litigation Authority Into QuestionMarch 26th, 2018

      Last February we reported on FTC v. Shire ViroPharma, in which the Federal Trade Commission (FTC) took the relatively unusual (although not unprecedented) step of suing a brand drug company for anti-competitive use of the Food and Drug Administration’s (FDA’s) citizen petition process to delay …

    • CMS Finalizes New Medicaid Rebate AgreementMarch 23rd, 2018

      In order for their outpatient drugs to be covered under Medicaid and Medicare Part B, drug manufacturers must enter into a National Drug Rebate Agreement (“Agreement”) with the Department of Health and Human Services. The Agreement requires the manufacturer to pay quarterly rebates to state …

    • DePuy Petitions Supreme Court to Weigh in on FCA Pleading StandardsMarch 22nd, 2018

      Last year, the First Circuit reversed the dismissal of a False Claim Act (FCA) case brought against DePuy Orthopaedics, Inc., holding that the district court had wrongly dismissed the relators’ complaint for failing to plead with particularity under Federal Rule of Civil Procedure 9(b) (see …

    • The Wait is Over: USDA Withdraws the Organic Livestock and Poultry Practices RuleMarch 21st, 2018

      On March 12, 2018, the USDA announced its decision to withdraw the Organic Livestock and Poultry Practices (OLPP) final rule that was published on January 19, 2017. As previously discussed, the OLPP was essentially an animal welfare rule, establishing minimum indoor and outdoor space requirements for …

    • CMS Finalizes National Coverage Determination for Next Generation Sequencing TestsMarch 20th, 2018

      On March 16, 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a new National Coverage Determination (NCD) for Next Generation Sequencing (NGS) tests.  The granting of the new NCD resulted from the FDA – CMS Parallel Review of Foundation Medicine, Inc.’s FoundationOne CDx™ …

    • FDA’s Quality Metrics Program: The Sound of SilenceMarch 19th, 2018

      Back in 2015, FDA stated its intention of initiating a voluntary quality metrics reporting program (a cornerstone of FDA’s framework for building quality into drug products) and, in July of that year, announced the publication of a draft Quality Metrics Guidance. We blogged about the …

    • Guidance on Guidance on GuidanceMarch 16th, 2018

      As one of her final acts before leaving DOJ, Associate Attorney General Rachel Brand announced that DOJ would no longer permit its lawyers to use guidance documents issued by its “client” agencies as a basis for civil enforcement. The “Brand Memo” provides guidance about DOJ’s use …

    • Oregon Jumps on the Drug Pricing Transparency BandwagonMarch 15th, 2018

      On March 13, 2018, Oregon became the latest state to enact a law focused on transparency in drug pricing (see our roundup of other recent state laws). The Prescription Drug Price Transparency Act, H.B. 4005, places new reporting requirements on drug manufacturers related to price …

    • Will the Supreme Court Take on the False Claims Act Materiality Standard?March 14th, 2018

      The saga continues in United States ex rel. Campie v. Gilead Sciences, Inc., 862 F.3d 890 (9th Cir. 2017), a False Claims Act case alleging that Gilead concealed information from FDA regarding the contamination of certain drugs, leading to false claims being paid by the …

    • GAO Report Confirms the Obvious: Food Safety Has Been Driving the Bus at FDA’s FVM ProgramMarch 13th, 2018

      On March 5, 2018, GAO released to the public a report titled “Food Safety and Nutrition: FDA Can Build on Existing Efforts to Measure Progress and Implement Key Activities.” The report confirms that FDA’s Food and Veterinary Medicine (FVM) Program has been primarily preoccupied with …

    • FDA Releases DSCSA Draft Guidance on Standardization of Data and Documentation Practices for Product TracingMarch 12th, 2018

      As stated in our post last week, on February 28, 2018, Commissioner Gottlieb announced FDA’s release of a draft guidance document addressing certain requirements under the 2013 Drug Supply Chain Security Act (DSCSA) concerning standardization of data and documentation practices for product tracing. The purpose …

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