• where experts go to learn about FDA
  • Year: 2021

    • Most Favored Nation Drug Pricing Rule on Hold Awaiting ChangesJanuary 22nd, 2021

      As we previously reported (see here and here), in three separate cases, federal courts blocked the implementation of the Most Favored Nation (MFN) rule for Medicare Part B drug payment.  (Our summary of the MFN rule is available here.)  In December 2020, the District Court …

    • FDA Continues Discussion of AI/ML Software Medical DevicesJanuary 21st, 2021

      On January 12, 2021, FDA issued an Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (“AI/ML Action Plan”) and a discussion paper on their Proposed Regulatory Framework for Modification to Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical Device …

    • Proposed Changes to Short-Form Version of Safe Harbor Proposition 65 WarningJanuary 20th, 2021

      On January 8, 2021, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced proposed amendments to Proposition 65 warning regulations that would limit use of the short-form version of the safe harbor warning. Proposition 65, California’s Safe Drinking Water and Toxic Enforcement Act of 1986, mandates …

    • 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 …

    • Orange Book Modernization Act: Congress Largely Codifies FDA’s Existing Orange Book Practices, But Also Brings PTAB Decisions Into the FoldJanuary 14th, 2021

      Those of you keeping up with the Orange Book know that FDA has been considering changes to patent listing requirements, many of which industry has been requesting for decades.  Now, Congress is trying to facilitate effective administration of the Orange Book.  On January 5, 2021, …

    • OTC Monograph Drug User Fees FY2021 (Temporarily?) Off the TableJanuary 11th, 2021

      That did not take long.  As we reported at the end of 2020, FDA announced in a notice the User Fees for OTC Monograph Drug Manufacturers and other fees.  Then on Jan. 6, 2021, HHS announced that the fees are off the table. What happened?  Well, …

    • When Will the Emergency End?January 11th, 2021

      It’s a burning question: when will we return to normal?  And although the answer is hugely subjective, this post focuses on the date the official emergency declaration for COVID-19 will terminate.  Despite the general sentiment that we want to be back to normal sooner rather …

    • The Long and Winding Road: DEA Issues Final Marijuana Registration RuleJanuary 8th, 2021

      More than four years ago the Drug Enforcement Administration (“DEA”) started down a path by issuing a policy statement asserting that the agency “fully supports expanding research into the potential medical utility of marijuana and its chemical constituents.”  Applications to Become Registered Under the Controlled …

    • Strike Three. Southern District of New York Joins Other Federal Courts In Blocking Trump Administration’s Most Favored Nation Drug Pricing Rule on Procedural GroundsJanuary 7th, 2021

      On December 30, 2020, District Court Judge Kenneth M. Karas of the Southern District of New York issued a nationwide preliminary injunction preventing the Most Favored Nation (MFN) rule from applying to Regeneron’s drug EYLEA (aflibercept).  This is the third federal court ruling preventing implementation …

    • HP&M’s Food, Beverage & Supplement Wrap Up: December 2020January 6th, 2021

      Welcome to the final 2020 edition of Hyman, Phelps & McNamara, P.C.’s monthly wrap up of food, beverage and supplement news, including regulations, guidances, events, and whatever else is catching our eye.  Happy New Year, everyone. Food & Beverage Make Every Bite Count: USDA and HHS …

    • Final Medicaid Best Price Changes Encourage Value Based Purchasing but Discourage Copay AssistanceJanuary 5th, 2021

      In the New Year’s Eve edition of the Federal Register, CMS published a final rule to implement statutory amendments to the Medicaid Rebate Program statute, and to add CMS’s own policy proposals to encourage value based purchasing arrangements and discourage patient copay assistance.  The variety of …

    • 2020-2025 Dietary Guidelines for AmericansJanuary 4th, 2021

      At long last, and with just two days remaining in 2020, HHS and USDA released the 2020-2025 Dietary Guidelines for Americans (Guidelines).  For those who work in and around the food industry, the Guidelines are a big deal (I could quote Joe Biden here, but …