[10/3/2025] Today, the U.S. Food and Drug Administration (FDA) is announcing a new pilot prioritization program for the review of abbreviated new drug applications (ANDAs) (ANDAs) that aims to spur and reward investment in U.S. drug manufacturing and research and development and strengthen the domestic pharmaceutical supply chain by providing faster reviews for generic companies who test and manufacture their products in the U.S.Continue reading
Category Archives: Advocacy and Regulations
Administration Announces a 100 Percent Potential Tariff on Branded or Patented Pharmaceuticals
President Trump posted the following on Truth Social on Thursday, September 25, 2025: “Starting October 1st, 2025, we will be imposing a 100% Tariff on any branded or patented Pharmaceutical Product, unless a Company IS BUILDING their Pharmaceutical Manufacturing Plant in America. “IS BUILDING” will be defined as, “breaking ground” and/or “under construction.” There will, therefore, be no Tariff on these Pharmaceutical Products if construction has started. Thank you for your attention to this matter!” Source: https://truthsocial.com/@realDonaldTrump/115267512131958759Continue reading
Next up for Section 232 Investigations – Medtech
The US Commerce Department disclosed on September 24, 2025 that new “Section 232” investigations into the import of personal protective equipment, medical items, robotics and industrial machinery were opened on September 2, 2025 but not previously disclosed.Continue reading
AdvaMed, Patient Groups, State Medtech Associations Urge Medicare Coverage of Breakthrough Medtech
In a letter to CMS Administrator Dr. Mehmet Oz, the 67 organizations noted medtech enables remarkable patient outcomes, yet FDA-designated, authorized breakthrough medtech faces years of delays in Medicare coverage. Continue reading
Governor Katie Hobbs Takes Action to Lower Cost of Prescription Drugs for Arizonans
New initiative will help Arizonans save up to 80% on qualifying medications
Stanford faculty member George Tidmarsh, M.D., Ph.D. named Director of Center for Drug Evaluation and Research
The U.S. Food and Drug Administration today announced the appointment of George Francis Tidmarsh, M.D., Ph.D., as Director of the Center for Drug Evaluation and Research (CDER). In this role, Dr. Tidmarsh will lead the FDA’s efforts to ensure safe, effective, and high-quality drugs are available to the American people.Continue reading
The R & D Expensing Fix in the One Big Beautiful Bill
New tax law restores immediate R&D expensing in the US
As Congress Focuses on the Budget – Life Science Leaders Focus on an EPIC solution.
From full page ads in the Boston Globe to panels of thought leaders at BIO 2025,and podcasts, leaders are highlighting the problems being created by the Pill Penalty that is part of the Inflation Reduction Act. As Congress works through the Budget Reconciliation Process, the EPIC Act could be a solution.Continue reading
FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests
The U.S. Food and Drug Administration today announced its Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans. The new voucher may be redeemed by drug developers to participate in a novel priority program by the FDA that shortens its review time from approximately 10-12 months to 1-2 months following a sponsor’s final drug application submission.Continue reading
Health Innovation Leaders Respond to the Executive Order on Most Favored Nations Pricing
On May 12, 2025, President Donald J. Trump signed Executive Order DELIVERING MOST-FAVORED-NATION PRESCRIPTION DRUG
PRICING TO AMERICAN PATIENTS that establishes a requirement for Most Favored Nations Prescription Drug Pricing.
Section 5 of the EO states: “Within 30 days of the date of this order, the Secretary shall, in coordination with the Assistant to the President for Domestic Policy, the Administrator for the Centers for Medicare and Medicaid Services, and other relevant executive department and agency (agency) officials, communicate most-favored-nation price targets to pharmaceutical manufacturers to bring prices for American patients in line with comparably developed nations.”
The intent is to obtain the lowest prices offered by drug companies in other wealthy countries, known as “most-favored-nation” (MFN) pricing, and to take action if those prices aren’t extended to Americans. It also calls for direct-to-consumer programs, drug importation from countries with lower costs, and antitrust enforcement against companies that block price competition.Continue reading