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    • FDA Updates the Regulatory Definitions of Certain Software Types for Consistency with 21st Century Cures Act ExclusionsApril 21st, 2021

      The 21st Century Cures Act (“Cures Act”), which was enacted in 2016 (see our blog post here), excluded from the statutory definition of “device” five categories of software: Software for administrative support of a health care facility; Software for maintaining or encouraging a healthy lifestyle and is …

    • Hyman, Phelps & McNamara, P.C. Seeks a 2nd to 4th Year AssociateApril 16th, 2021

      Hyman, Phelps & McNamara, P.C. seeks a 2nd to 4th year associate to join our team and work on a wide variety of FDA-related matters.  The ideal candidate must have a demonstrated interest in FDA law, possess strong research and writing skills, and fit into the …

    • AMG v. FTC: A Moot Court-Worthy Conflict at the Supreme CourtJanuary 15th, 2021

      With a legal question that led to a classic oral argument where all nine Justices refused to tip their hands on how the case will turn out, the U.S. Supreme Court this week heard oral arguments in AMG Capital Management v. Federal Trade Commission.  The …

    • No Longer “Waiting for Godot,” Godot has arrived. DEA Finally Issues a Proposed Rule on Suspicious OrdersNovember 3rd, 2020

      Today, more than two years after Congress passed the Preventing Drug Diversion Act of 2018 (PDDA) and after more than a decade of industry requests for regulations addressing the Drug Enforcement Administration’s (DEA) interpretation of suspicious order requirements under 21 C.F.R. § 1301.74(b), DEA has …

    • Ogden Nash’s Rule of Thumb Ignored: Group of 8 Face Criminal Indictment for Falsifying Clinical Trial RecordsAugust 18th, 2020

      “Here’s a rule of thumb; too clever is dumb.” Unfortunately, eight people didn’t follow Ogden Nash’s rule of thumb and are now facing a 19-count criminal indictment for falsifying records of clinical trials of investigational drugs and lying about it to FDA. The 60-page indictment was …

    • Everyone’s a Critic: FDA Under Fire for High Drug Approval NumbersFebruary 6th, 2020

      Lately, FDA has been subject to criticism on almost every front.  A recent NY Times Op-Ed alleging political interference, the popular theory that FDA fueled the opioid crisis, and the quality and inspection concerns raised in the 2019 book Bottle of Lies are all emblematic …

    • HP&M Attorneys Recognized by LMG Life Sciences AwardsSeptember 20th, 2019

      Awards season is now underway and we are delighted to announce that LMG Life Sciences has named Josephine Torrente the 2019 “Regulatory Attorney of the Year: FDA Pharmaceuticals.” Now in its seventh year, the LMG Life Sciences Awards are presented to the firms and individuals “behind …

    • Trump Administration Takes a Turn at Medicare Part B Payment ReformNovember 7th, 2018

      On October 30, 2018, the Centers for Medicare and Medicaid Services (CMS) issued an Advanced Notice of Proposed Rulemaking (ANPRM) soliciting public feedback on a potential International Pricing Index (IPI) Model for payment of certain drugs covered under Medicare Part B. 83 Fed. Reg. 54546 …

    • Dead Men Tell No Tales . . . and They Don’t Violate the FTC Act, EitherOctober 17th, 2018

      Earlier this year, we blogged on an interesting case out of the District of Delaware, FTC v. Shire ViroPharma, No. 17-cv-00131 (D. Del. Feb. 7, 2017), which called into question the FTC’s authority to litigate pursuant to section 13(b) of the FTC Act (15 U.S.C. …

    • FDA’s Insanitary Conditions Revised Draft Guidance: Required Reading for Compounding FacilitiesOctober 11th, 2018

      Late last month, FDA published revised draft guidance, titled “Insanitary Conditions at Compounding Facilities: Guidance for Industry.”  The revised guidance comes two years after FDA released its August 2016 draft guidance addressing what it considers “insanitary conditions” during inspections of both Section 503A pharmacies and Section …

    • Following Regulation, PhRMA and BIO Drop Challenge to State Drug Pricing LawJuly 11th, 2018

      By Alan M. Kirschenbaum & Eliot Markman* – On Thursday, June 28, 2018, two industry trade associations, Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Innovation Organization (“BIO”), agreed to drop a lawsuit against Nevada related to S.B. 539, a 2017 diabetes drug price increase …

    • FDA Plays Hardball With Two Stem Cell ClinicsMay 15th, 2018

      The U.S. Food and Drug Administration, in two complaints (here and here) filed last week in federal court, is seeking permanent injunctions to prevent two stem cell clinics from marketing stem cell products without FDA approval. Specifically, a permanent injunction is being sought against US Stem …

    • How Safe is the Safe Harbor?April 18th, 2018

      As the breadth of the “patent safe harbor” continues to expand under the Federal Circuit’s growing body of relevant case law, some patent holders are looking to the Supreme Court to push back. In a Petition for Certiorari filed last week in Classen Immunotherapies v. Elan …

    • Fourth Circuit Finds Maryland Price Gouging Law UnconstitutionalApril 16th, 2018

      On Friday, April 13, 2018, the U.S. Court of Appeals for the Fourth Circuit ruled that Maryland’s law prohibiting “price gouging” by generic pharmaceutical manufacturers (HB 631) is unconstitutional because it violates the dormant commerce clause by directly regulating transactions that occur outside of Maryland. …

    • “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 …