Federal policy relating to providing incentives and federal funding to strengthen capabilities for domestic manufacturing of generic drugs; and Federal policy relating to amending the Hatch-Waxman Act to provide incentives for manufacturing generic pharmaceuticals and their ingredients in the United States and allied nations.
Federal policy relating to addressing drug shortages and strengthening pharmaceutical supply chains through partnerships with North American and other allied countries; Federal policy relating to providing preferential federal direct and indirect purchasing treatment for domestic and North American manufactured pharmaceuticals; S. 43, Skinny Labels Big Savings Act, provisions relating to providing a safe harbor from infringement for a method of use patent relating to drugs or biological products; and HR 1483/S. 1302, The Increasing Transparency in Generic Drug Applications Act, provisions relating to the Food and Drug Administrations authority to share information about ingredients and deviations in inactive ingredient concentration with generic pharmaceutical product applicants.
Executive Order 14231 and 14325, Amendment to Duties To Address the Flow of Illicit Drugs Across our Northern Border, provisions relating to the imposition of tariffs on products from Canada and the exemption of pharmaceuticals compliant with the United States-Mexico-Canada trade agreements from such tariffs; Executive Order 14257, Regulating Imports With A Reciprocal Tariff To Rectify Practices That Contribute To Large And Persistent Annual United States Goods Trade Deficits, provisions relating to the exemption of pharmaceuticals from reciprocal tariffs; and Federal policy relating to the Department of Commerce's Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients [Docket No. 250414-006] and the exemption of pharmaceuticals compliant with the United States-Mexico-Canada trade agreement from any tariffs implemented following the completion of the Section 232 investigation.