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  • Prescription Drugs and Biologics

    • Vanda Isn’t Dropping This Bone Despite Negative Court DecisionFebruary 21st, 2020

      Blog readers may be thinking, “HPM, didn’t you just blog about the Vanda case last week?”  We certainly did (and had previously here and here).  You will recall that Vanda Pharmaceuticals did not prevail in its quest to have the Court find that FDA’s imposition …

    • Paw Shucks: Court Defers to FDA’s Request for Additional Animal StudiesFebruary 18th, 2020

      Animals, shmanimals.  Or so says FDA.  Well, FDA didn’t actually say that, but that’s the effect of the District Court of D.C.’s recent ruling in Vanda Pharmaceuticals v. FDA.  In a case we have been following for the last year or so, the District Court …

    • Does Your Unapproved Device, Drug or Biologic Qualify for an Emergency Use Authorization (EUA)?February 14th, 2020

      The FDA is taking very seriously the threat of the coronavirus from China (2019‑nCoV).  Makers of medical devices, drugs and biologics should consider whether their products can contribute to countering this threat. In late January, FDA announced its strategy to advance development of medical countermeasures to …

    • Acetris Case – Federal Circuit Rules that a Drug Tableted in the U.S. is Manufactured in the U.S. and Eligible for Government ProcurementFebruary 14th, 2020

      On February 10, the Court of Appeals for the Federal Circuit ruled that the Department of Veterans Affairs (“VA”) erred in interpreting the Trade Agreements Act of 1979 (“TAA”) and the Federal Acquisition Regulation (“FAR”) to exclude from procurement pharmaceutical products that are manufactured in …

    • Knives Out: Carving Up an aBLAFebruary 12th, 2020

      As more biosimilars are approved (we’re up to 26 now!), FDA has been rolling out guidance documents under the Biosimilars Action Plan (“BAP”).  The most recent guidance has been long awaited.  While the Hatch-Waxman Act explicitly provides that an applicant can seek approval for only …

    • The Value of Priority Review Vouchers – GAO’s Two CentsFebruary 11th, 2020

      Congress enacted several priority review voucher (“PRV”) programs in the past fifteen or so years with the goal of incentivizing drug companies to develop new drugs for diseases that ordinarily may not be attractive because the potential market is small or otherwise unlikely to produce …

    • FDA Law Alert – February 2020February 10th, 2020

      Hyman, Phelps & McNamara, P.C. is pleased to publish the first FDA Law Alert of the new year. This is the fourth installment of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog.  Please subscribe to the FDA Law Blog to …

    • Dueling It Out with FDA over NCE ExclusivityFebruary 7th, 2020

      Those familiar with the Hatch-Waxman Act and its various incentives to stimulate drug innovation know that New Chemical Entity (“NCE”) exclusivity is the holy grail of small molecule exclusivity.  Though orphan drug may give a sponsor two more years of exclusivity than NCE, it only …

    • FDA and FTC Announce New Steps Under the Biosimilars Action Plan, Which Include Targeting False and Misleading Statements About BiosimilarsFebruary 5th, 2020

      On February 3rd, FDA announced several new actions as part of its Biosimilars Action Plan (BAP).  If you recall, back in July 2018 when FDA first unveiled the BAP, four key elements were identified:  improving efficiency of biosimilar and interchangeable product development; maximizing scientific and …

    • FDA’s Getting Its Priorities Straight: Revised ANDA Priority MAPPFebruary 3rd, 2020

      Only about 2 years after its last revision (which was only 5 months after its previous revision), FDA decided this week that MAPP 5240.3, Prioritization of Original ANDAs, Amendments, and Supplements, just wasn’t working.  With too many ANDA submissions designated as priority, and thereby entitled …

    • ACI’s 35th FDA Boot Camp – New York EditionJanuary 31st, 2020

      The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 35th iteration – is scheduled to take place from March 24- 25, 2020 at DoubleTree By Hilton Metropolitan, New York, NY.  The conference is billed as the premier event to provide folks with …

    • California Dreaming Part 2: The Constitutional ChallengeJanuary 29th, 2020

      Back in September 2019, California passed AB 824: Preserving Access to Affordable Drugs.  That law sought to discourage “reverse-payment agreements” in which a brand manufacturer enters into a patent settlement agreement with a potential generic sponsor that involves a transfer of value from the brand …

    • HP&M’s Serra Schlanger to Present on State Drug Price Reporting LawsJanuary 24th, 2020

      Hyman, Phelps & McNamara, P.C. is pleased to announce that Serra Schlanger will present at this year’s Drug Pricing Transparency Congress, to be held in Philadelphia, PA on March 30-31, 2020.  This conference gathers stakeholders to examine the evolving landscape of state drug price reporting …

    • Fostering Oncology Product Development for Kids with CancerJanuary 9th, 2020

      Too often, children are not included in clinical trials for new drugs, even though children may eventually be prescribed those very same drugs. This forces physicians who treat children to try and extrapolate information collected from adult trials to determine if and how to use …

    • PhRMA Challenges Oregon Drug Pricing Transparency LawsJanuary 2nd, 2020

      On December 9, 2019, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed a civil action in the United States District Court for the District of Oregon seeking declaratory and injunctive relief against the Acting Director of the Oregon Department of Consumer and Business Services …