Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023
Impact
If enacted, HB3532 would allow the Secretary of Health and Human Services to grant reciprocal marketing approval for covered products under specified criteria. This includes products that are already authorized for marketing in other countries listed by the FDA or in the United Kingdom. The legislation is designed to ensure that products meeting safety and effectiveness standards abroad can also be made available domestically, which could significantly reduce the time and resources needed for traditional FDA approval processes.
Summary
House Bill 3532, titled the 'Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023,' seeks to amend the Federal Food, Drug, and Cosmetic Act to establish a framework for reciprocal marketing approval of drugs, biological products, and medical devices that have been authorized for sale in other countries. The bill aims to simplify and expedite the process for bringing certain foreign-approved medical products to the U.S. market, thereby addressing public health needs and potentially offering faster access to lifesaving treatments for American patients.
Contention
While the bill is intended to facilitate access to essential medical products, it raises concerns regarding the safety and efficacy assessment of these products. Critics argue that adaptive approval methods could undermine rigorous testing standards established by the FDA. Moreover, there are fears about the regulatory implications, as allowing products approved abroad without comprehensive domestic evaluation may lead to public health risks if those products do not meet U.S. safety standards. Ongoing discussions will likely focus on balancing expedited access to treatments with the need for robust safety regulations.
Authorizes statewide municipal reciprocal program agreements and the issuance of program bonds; authorizes proceeds to be made available to a statewide municipal reciprocal program.
In fishing licenses, providing for active duty military fishing reciprocity and for disabled veteran annual fishing license reciprocity; and, in hunting and furtaking licenses, providing for active duty military hunting reciprocity and for disabled veteran annual hunting license reciprocity.
In fishing licenses, providing for active duty military fishing reciprocity and for disabled veteran annual fishing license reciprocity; and, in hunting and furtaking licenses, providing for active duty military hunting reciprocity and for disabled veteran annual hunting license reciprocity.