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  • Prescription Drugs and Biologics

    • CBER’s Learnings on Regenerative Medicine Development Reflected in Guidance UpdatesFebruary 19th, 2019

      With a little over a year under FDA’s belt implementing its Comprehensive Regenerative Medicine Policy Framework (which we blogged about here), CBER has updated its current thinking with the issuance of final versions of the two Regenerative Medicine Advanced Therapy (“RMAT”)-related guidance documents: Expedited Programs for …

    • You Down With CGT?February 18th, 2019

      Yeah, you know me. Given Commissioner Gottlieb’s clear proclivity for blog posts with song titles rather than Orange Book puns, we’ll stick with those for a while. We just hope the Commissioner likes early 1990s rap as much as he likes rock from the 1970s …

    • FDA’s Tenth Annual Report to Congress on 505(q) Citizen Petitions: New Numbers and the Same MessageFebruary 12th, 2019

      FDA released its annual Report to Congress on 505(q) Citizen Petitions last week – the Tenth Annual Report to Congress on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2017.  The Report, which is …

    • Orange You Glad We Didn’t Make an Orange Book Pun?February 4th, 2019

      In yet another step to address drug pricing, Commissioner Gottlieb announced last week several new initiatives, including an update to the revered Orange Book.  Cue the crazy Muppet arms!  Proclaiming the Orange Book update a “transparency initiative,” FDA expects that this undertaking will “provide greater …

    • This Cannot Stand, Man! The BLOCKING Act of 2019 Would Unnecessarily Reform 180-Day Generic Drug ExclusivityFebruary 1st, 2019

      Over the 12 years that we’ve been doing this blogging gig, we’ve never before drawn inspiration for a post from Lebowski Pony – a.k.a. “the Dude” – that iconic character from the 1998 film The Big Lebowski, written and directed by Joel and Ethan Coen. …

    • HP&M’s Anne Walsh to Present on Pharmacovigilance & Drug Safety IssuesJanuary 31st, 2019

      Hyman, Phelps & McNamara, P.C. is pleased to announce that Anne Walsh will present at this year’s Pharmacovigilance & Drug Safety: Risk Management & Regulatory Compliance Conference, to be held in Arlington, VA on March 12-13, 2019.   The focus of her presentation is on post-market …

    • Commissioner Gottlieb and CBER Director Marks Deliver “State of Cell and Gene Therapy” Joint StatementJanuary 30th, 2019

      As we await our nation’s State of the Union address, FDA’s own Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks issued a joint statement providing a state of union of sorts on the development and regulation of cell and …

    • Case Dismissed: Strike Two for PMRSJanuary 28th, 2019

      In one of the multiple lawsuits that Pharmaceutical Manufacturing Research Services (PMRS) has filed against the FDA related to the approval of abuse-deterrent opioids in the last few years, the Eastern District of Pennsylvania summarily rejected PMRS’s bid to keep abuse-deterrent opioid, RoxyBond, off the …

    • CBI’s 4th Edition Drug Pricing Transparency CongressJanuary 23rd, 2019

      CBI is holding its Fourth Edition Drug Pricing Transparency Congress on March 25-26, 2019 in Philadelphia, Pennsylvania.  This program convenes stakeholders to discuss how the future of drug pricing transparency regulations will impact commercialization, reimbursement, pricing, and compliance practices.  Given the novelty and complexity of …

    • What Will FDA Do With All Those “Violative” Stem Cell Clinics Once Enforcement Discretion Tolls in November 2020?January 21st, 2019

      Enforcement discretion for stem cell facilities (and certain other HCT/P manufacturers) ends in November of 2020, and as FDA indicated in a recent press release, the agency is “discouraged” by the dearth of manufacturers wanting to interact with them during the enforcement discretion period. Back in …

    • M.C. Escher By Way of Generic Drug PricingJanuary 18th, 2019

      Though FDA does not have the legal authority to control or even directly address drug prices, Commissioner Gottlieb has certainly not shied away from the issue.  In fact, drug (and biologic) competition and accessibility is one of Dr. Gottlieb’s main efforts at the Agency (see …

    • FDA is “Discouraged” by Dearth of HCT/P Manufacturers that have Reached Out to Agency During Enforcement Discretion PeriodJanuary 16th, 2019

      In November of 2017, FDA published its enforcement discretion policy regarding HCT/Ps that don’t meet all four criteria under 21 CFR 1271.10(a): To give manufacturers time to determine if they need to submit an IND or marketing application in light of this guidance and, if such …

    • Vermont Report Finds that the Costs of Prescription Drug Importation May Outweigh SavingsJanuary 15th, 2019

      As we previously reported, Vermont Governor Phil Scott signed a new law in May 2018 allowing for the wholesale importation of prescription drugs from Canada into Vermont.  Vermont’s Agency of Human Services (VAHS) recently issued a report containing the Agency’s preliminary design for a “Canadian …

    • A Pair of FDC Act-Related Convictions Upheld on Appeal in the Eighth and Eleventh CircuitsJanuary 10th, 2019

      In two unrelated cases, two U.S. Courts of Appeal affirmed FDC Act-related convictions earlier this week.  In United States v. Patino, the Eighth Circuit held that it was not an abuse of discretion to allow the government to introduce, in connection with a 2016 prosecution …

    • HP&M Releases 2018 Litigation BriefingJanuary 9th, 2019

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to present its annual report highlighting the leading cases and settlements from 2018 that affect the FDA- and DEA-regulated industries. Each page provides a concise summary of the relevant facts and key takeaways for our clients. We …