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  • Prescription Drugs and Biologics

    • GAO Issues Report on Qualified Infectious Disease ProductsMarch 14th, 2017

      The U.S. Government Accountability Office (GAO) recently issued a January 2017 report to the Senate Committee on Health, Education, Labor, and Pensions.  The GAO report examines: The steps FDA has taken to encourage the development of antibiotics to treat serious or life-threatening infections since the enactment …

    • Orphan Drugs: The Current Firestorm, a Real Evergreening Issue, and a Possible SolutionMarch 12th, 2017

      Periodically, legislators and others become concerned about reports citing the high price of some orphan drugs, including drugs that achieve blockbuster status (earning more than $1 billion a year). Several proposals have been introduced in response to such concerns.  In 1990, Congress passed legislation that …

    • A New Rulemaking Is Needed for the Intended Use RegulationMarch 9th, 2017

      We recently blogged about whether FDA’s recent amendment to the intended use regulation could be considered essentially null and void based upon a failure to comply with the Congressional Review Act. Apparently, this suggestion caused quite a stir and even excitement in some quarters, as it …

    • How To Get Rid of The “Totality of the Evidence” Amendment to The Intended Use RegulationMarch 7th, 2017

      A few weeks ago, we blogged about FDA’s final rule amending the “intended use” regulation.  The final rule looks very different than the proposed rule, and adopts a new “totality of the evidence” standard that does not resolve the old problems with the regulation but …

    • Slower than Molasses in January, FDA Moves to Provide Guidance on Product Communications by Pharmaceutical and Device ManufacturersMarch 2nd, 2017

      In January 2017, FDA issued two Draft Guidance documents concerning communications made by medical device manufacturers about information not expressly contained within a product’s labeling: Medical Product Communications That Are Consistent With the FDA-Required Labeling – Questions and Answers: Guidance for Industry [Draft] (January 2017), hereinafter …

    • ACI’s 29th FDA Boot CampFebruary 28th, 2017

      The American Conference Institute’s (“ACI”) popular FDA Boot Camp, now in its 29th iteration, is back in New York at the Millennium Broadway Hotel on March 22-24, 2017. The conference is billed as the premier event to provide folks with a roadmap to navigate the …

    • Drug Debarment Actions: BewareFebruary 26th, 2017

      FDA recently released a report summarizing its enforcement activities for FY 2016 (October 1, 2015 to September 30, 2016). It shows, among other things, that the number of warning letters from the Center for Drug Evaluation and Research doubled (76 in FY 2015 to 151 …

    • FDA Defines the Scope of 3-Year Exclusivity for MORPHABOND After Wrestling With Different ApproachesFebruary 21st, 2017

      It was just a couple of weeks ago that we published a post titled “Abuse-Deterrence and 3-Year Exclusivity: FDA Decisions Further Elucidate Scope and a ‘Route of Abuse’ Approach to Exclusivity.” Among other things, we discussed Egalet US, Inc.’s ARYMO ER (morphine sulfate) Extended-release Tablets, …

    • Do President Trump’s Regulatory Freeze-Out and “1-in-2-Out” Orders Affect the Regulation of Compounding?February 20th, 2017

      On Inauguration Day (January 20, 2017) President Trump’s assistant Reince Priebus circulated a regulatory “freeze order” blogged here affecting regulations and guidance published in the Federal Register but that had not yet taken effect, postponing their effective date for 60 days (from January 20, 2017). The …

    • The Problem of the “Intended Use” Regulations Continues to FesterFebruary 19th, 2017

      In 2015, FDA proposed revising the so-called intended use regulation (21 CFR 201.128; id. § 801.4) to remove the famous “knowledge” sentence: “But if a manufacturer knows, or has knowledge of facts that would give him notice, that a [drug or device] introduced into interstate commerce …

    • Amgen and the BPCIA Patent Dance – ReduxFebruary 19th, 2017

      2017 is already shaping up to be a big year in court for Amgen and the Biologics Price Competition and Innovation Act (“BPCIA”). As regular readers know, Amgen’s challenge to Sandoz’s refusal to participate in the patent dance after filing of an aBLA relying on …

    • The Final Common Rule: Much Either Retained or Removed, But Not Much New AddedFebruary 17th, 2017

      On January 18, 2017, the U.S. Department of Health and Human Services along with 15 other federal agencies issued the Final Rule to revise the Federal Policy for the Protection of Human Subjects, known as the “Common Rule.”  This 1991 set of regulations created a …

    • Abuse-Deterrence and 3-Year Exclusivity: FDA Decisions Further Elucidate Scope and a “Route of Abuse” Approach to ExclusivityFebruary 9th, 2017

      Questions about the scope of 3-year exclusivity granted by FDA for an abuse-deterrent opioid have been on the rise over the past few years. Initially, FDA was able to punt on some decisions, either because companies exchanged waivers of 3-year exclusivity (e.g., single-entity, extended-release hydrocodone …

    • The FTC Takes Action for Alleged Anticompetitive Citizen Petitioning Activities Surrounding Generic VANCOCINFebruary 7th, 2017

      It is often said that companies have an absolute right to petition the government to take or not take action without fearing exposure to an antitrust suit.  This “right” is thought to be based on a series of Supreme Court decisions that are collectively commonly referred …

    • FDA’s 180-Day Exclusivity Q&A Guidance: Two Items of NoteFebruary 5th, 2017

      Earlier this month, FDA published much-needed draft guidance on 180-day exclusivity, titled “180-Day Exclusivity: Questions and Answers.”  We perused the document and promptly posted on it the next day, noting, among other things, that the draft guidance doesn’t reveal anything revolutionary, but rather,  provides a …