• where experts go to learn about FDA
  • Year: 2019

    • A Round Up of New State Laws to Control Drug PricesJuly 8th, 2019

      While the federal government continues to debate the hot topic of drug prices, states continue to pass new laws designed to tackle drug pricing, price reporting, and discounting.  We’ve previously reported on the laws passed in California, Connecticut, Louisiana, Maryland, Nevada, New York, Oregon, Vermont …

    • Cybersecurity Fears Lead to Insulin Pump RecallJuly 3rd, 2019

      On June 27, Medtronic announced that it was recalling certain MiniMed insulin pumps due to “potential security vulnerabilities.”  On the same day, FDA issued a Safety Communication and the Department of Homeland Security issued a Cybersecurity Infrastructure Security Advisory about the same issue. FDA’s Safety Communication …

    • Device Manufacturer’s Criminal and Civil Penalties Deserve Closer AttentionJuly 2nd, 2019

      Today’s blog post illustrates how a company’s problems can escalate rapidly from an administrative warning letter to the full weight of the criminal system.  The unfortunate subject is ACell, a manufacturer of medical devices derived from porcine urinary bladder material.  ACell received a Warning Letter …

    • HP&M’s James Valentine Named a 2019 RARE Champion of Hope; Moderates Global Rare Disease Town Hall with FDA and EMAJuly 1st, 2019

      Last week, Global Genes, a global rare disease patient advocacy organization, announced the 2019 RARE Champion of Hope Awardees, which included Hyman, Phelps & McNamara, P.C.’s very own, James Valentine.  This is a great honor, bestowed upon “true champions for rare disease”, “people who inspire …

    • FDA Issues Final Guidance on Declaration of Added Sugars for Single Ingredient Products and Certain Cranberry ProductsJune 28th, 2019

      As we discussed previously, FDA’s 2016 final regulation updating nutrition labeling requirements included a requirement to declare added sugars.  This requirement created quite a stir among several segments of the industry.  Among others, the honey and maple syrup manufacturers pushed back on the requirement to …

    • Not Dead Yet – Far from It: OTC Monograph Reform Back on Congress’ RadarJune 27th, 2019

      We knew it would be back. It was never dead, though perhaps forgotten by some (never us), but OTC Monograph Reform is back in the public eye again.  Lawmakers appear to be taking to heart CDER Director Janet Woodcock’s remarks last week in which she urged …

    • SCOTUS Makes it Easier for Government to Withhold Commercial or Financial InformationJune 26th, 2019

      In a 6-3 decision, the U.S. Supreme Court reversed and remanded the lower courts’ decision to publicly disclose commercial information that previously had been submitted to the government.  Given that FDA-regulated entities often submit to FDA commercial or financial information that those entities regard as …

    • FDA Updates MDR Program in an Effort to Increase TransparencyJune 25th, 2019

      FDA recently announced new changes it is making to the Medical Device Reporting (MDR) program as part of its ongoing efforts to increase transparency on device performance, and detection of device-related safety concerns. FDA is formally discontinuing the Alternative Summary Reporting (ASR) Program, which permitted certain …

    • Hyman, Phelps & McNamara, P.C. is Hiring!June 24th, 2019

      The authors of this blog are busy, and we are actively seeking attorneys interested in working at the nation’s largest boutique food and drug regulatory law firm (and ideally writing for the FDA Law Blog).  We have at least two openings: The first position is for …

    • Consumers Encouraged to “Make Smart Choices” About CBD ProductsJune 24th, 2019

      FDA published a Consumer Update acknowledging the ubiquitous presence of CBD products in the marketplace, and providing the agency’s current perspective on questions regarding the regulatory status, safety, and quality of such products.  The Consumer Update follows closely on the heels of a recent statement issued jointly …

    • Pharmaceutical Manufacturers Argue Price Disclosure Rule Will Mislead ConsumersJune 21st, 2019

      The pharmaceutical industry has filed a lawsuit challenging a recently finalized rule from the Centers for Medicare & Medicaid Services (CMS) which requires drug pricing disclosures in television advertisements for certain prescription drugs and biological products (the Final Rule).  In an effort to block the …

    • Criminal Convictions for Compounding Activities Overturned for “Legal Impossibility”June 20th, 2019

      The government lost a significant battle in its aggressive prosecutions of individuals involved in the New England Compounding Center (NECC) disaster, in which the vilified, and now-defunct, NECC “compounded” contaminated batches of drugs that led to a multitude of deaths and injuries.  Gregory Conigliaro, a …

    • Go for It! (Connect) Paragraph IV! FDA Revamps ANDA Paragraph IV Certifications ListJune 19th, 2019

      The Paragraph IV certification list on FDA’s website is a very useful tool for generic drug manufacturers in evaluating the potential for 180 day exclusivity for any given product. The list generally describes drug products for which one or more substantially complete ANDA containing a paragraph …

    • APHIS Proposes a More Hands-off Approach for Genetically Engineered PlantsJune 13th, 2019

      On June 5, 2019, the Animal Plant Health Inspection Service of the USDA (APHIS) announced the availability of a proposed rule titled “Movement of Certain Genetically Engineered Organisms.”  The proposed rule was published on June 6, 2019.  On June 7, the 449 pages long draft environmental …

    • NOP Clarifies Requirement for Land Underlying Organic Crop Container SystemsJune 10th, 2019

      On June 3, 2019, the Agricultural Marketing Service (AMS) announcedthat the National Organic Program (NOP) published a letter to certifiers titled, “Certification of Organic Crop Container Systems.” Over the last decade, there has been a disagreement within the organic industry about use of container systems in …