/ en Sun, 29 Jun 2025 13:43:42 -0500 Mon, 05 May 25 08:06:32 -0500 /executive-orders-and-federal-actions/2025-05-29-regulatory-relief-promote-domestic-production-critical-medicines <div class="container"><div class="row"><div class="col-md-8"><p>Directs the Commissioner of the Food and Drug Administration to review and eliminate any duplicative or unnecessary requirements in regulations and guidance pertaining to the development of domestic pharmaceutical manufacturing within 180 days. Further directs the commissioner to streamline and accelerate the development of domestic pharmaceutical manufacturing, and requires the commissioner to review regulations and guidance regarding the inspection and approval of manufacturing capabilities and emerging technologies that enable the manufacturing of pharmaceutical products and ingredients. Directs the commissioner to review the current risk-based approach to prior approval of licensure inspections and further directs the commissioner to undertake measures to improve enforcement of data reporting and to issue guidance on production, compliance, and related issues. Requires the commissioner to develop and advance improvements to the inspection regime within 90 days and make public disclosures regarding the annual number of inspections conducted by the FDA on foreign facilities.</p><p>Directs the Administrator of the Environmental Protection Agency to update regulations and guidance with respect to the inspection and approval of pharmaceutical manufacturing capacity and eliminate duplicative or unnecessary requirements within 180 days. Establishes the EPA as the lead agency for the permitting of pharmaceutical manufacturing facilities that require preparation of an Environmental Impact Statement and directs the EPA to work with the Office of Management and Budget and other agencies to expedite the review and approval of relevant permits. Further directs the Secretary of the Army, within 180 days, to review permits issued pursuant to certain environmental laws and determine whether additional permits are necessary to facilitate the efficient permitting of pharmaceutical manufacturing facilities.</p></div></div></div> Mon, 05 May 2025 08:06:32 -0500 Executive Orders and Federal Actions /executive-orders-and-federal-actions/2025-05-29-unleashing-prosperity-through-deregulation-10-1-order-caps-agency-costs <div class="container"><div class="row"><div class="col-md-8"><p>Requires agencies to identify at least 10 regulations to be repealed for each new regulation proposed or promulgated. Directs agencies to ensure total incremental cost of all new regulations for FY 2025, including repealed regulations, is less than $0. Requires any new incremental costs associated with new regulations be offset by eliminating costs associated with at least 10 regulations. Beginning with FY 2026, requires each agency to identify regulations that increase incremental cost, regulations to offset those costs, and provide an estimate of total costs or savings associated with each new or repealed regulation. Requires OMB approval before adding or removing regulations from the Unified Regulatory Agenda (URA) and prohibits agencies from issuing new regulations not included in the most recent URA, unless OMB provides advance written approval or as required by law. Directs OMB to establish a cap for total incremental costs allowed for new and repealed regulations for each agency for a fiscal year, beginning FY 2026. Directs OMB to revoke OMB Circular No. A-4 (Regulatory Analysis) of <a href="https://www.reginfo.gov/public/jsp/EO/fedRegReview/CircularA4Appendix.pdf" target="_blank" title="OMB Circular No. A-4: DEFAULT SOCIAL RATE OF TIME PREFERENCE ESTIMATES">2023</a> and reinstate <a href="https://obamawhitehouse.archives.gov/omb/circulars_a004_a-4" target="_blank" title="Office of Management and Budget: Circular A-4">2003</a> version. Reinstates <a href="https://home.treasury.gov/sites/default/files/2018-04/04-11%20Signed%20Treasury%20OIRA%20MOA.pdf" target="_blank" title="Memorandum of Agreement: The Department of the Treasury and the Office of Management and Budget Review of Tax Regulations under Executive Order 12866">Memorandum of Agreement between the Department of the Treasury and the Office of Management and Budget of April 11, 2018</a> (tax regulations).</p><h2>Related Content</h2><ul><li><a href="https://www.federalregister.gov/documents/2025/04/11/2025-06316/request-for-information-deregulation" target="_blnak">Request for Information</a>: Deregulation (OMB RFI)<ul><li>AHA <a href="/system/files/media/file/2025/04/Member-Advisory-Trump-Administration-Issues-Additional-Deregulation-Orders-and-Notices.pdf">Member Advisory</a></li><li>AHA <a href="/">Model Comment Letter</a></li><li><a href="/system/files/media/file/2025/05/aha-response-to-omb-deregulation-rfi-letter-5-12-2025.pdf">AHA response</a> to OMB Deregulation RFI</li></ul></li><li><a href="https://www.federalregister.gov/documents/2025/05/14/2025-08384/request-for-information-rfi-ensuring-lawful-regulation-and-unleashing-innovation-to-make-american" target="_blank">Request for Information</a>: Ensuring Lawful Regulation and Unleashing Innovation to Make America Healthy Again (HHS RFI)</li><li><a href="https://www.federalregister.gov/documents/2025/05/14/2025-08393/notification-of-hhs-documents-identified-for-rescission" target="_blank">HHS Rescissions</a></li></ul></div><div class="col-md-4"><h2>Other Government Reform E.O.s</h2><p><div class="views-element-container"><div class="js-view-dom-id-2e3a520bfe04a980a714676325e51c56969cae1d0d719ace20e61056ae7269ee"> </div> </div> </p></div></div></div> h3.field-content { font-size: 20px; } .views-field-body { font-size:16x; } Fri, 31 Jan 2025 08:10:46 -0600 Executive Orders and Federal Actions /executive-orders-and-federal-actions-tracker <div class="container"><div class="row"><div class="col-md-8"><p>In its first week, the Trump administration issued an unprecedented series of executive orders (EOs) and administrative actions that reinforce their administration priorities. EOs are directives issued by the president to federal agencies, guiding how the federal government should be managed. The federal agencies then set the rules moving forward. When a new administration takes office, it is common practice to review and overturn EOs and administrative actions from the previous administration to align with its own policies and priorities. The AHA has assembled a tracker of the actions that may be of interest to hospitals and health systems.</p><p>The AHA continues to review these administrative actions, as well as new actions that are being taken. We will provide additional updates to the field.</p><hr> <p id="pagetop"> <a href="#prescriptiondrugs">Prescription Drugs</a> | <a href="#healthtechnology">Health Technology</a> | <a href="#governmentreform">Government Reform</a> | <a href="#equalemploymentopportunity">Equal Employment Opportunity</a> | <a href="#immigration">Immigration</a> | <a href="#medicaleducation">Medical Education and Research</a> | <a href="#maha">Make America Health Again</a> | <a href="#emergencypreparedness">Emergency Preparedness</a> | <a href="#tariffs">Tariffs</a> | <a href="#litigationtracker">Litigation Tracker</a> </p> <hr> --></div></div></div> Wed, 01 Jan 2025 06:00:00 -0600 Executive Orders and Federal Actions