If enacted, HB1790 could lead to significant changes in how interchangeable biological products are regulated. By directing the Secretary of HHS to investigate and report on this matter, the bill seeks to enhance clarity in the marketplace, potentially leading to fewer barriers in substituting interchangeable products. This could have implications for both consumers and manufacturers in the pharmaceutical sector, promoting greater access to biologic therapies and reducing costs associated with these treatments.
Summary
House Bill 1790, titled the Biologics Competition Act of 2023, aims to address the complexities surrounding the substitution of interchangeable biological products. The bill mandates that the Secretary of Health and Human Services conducts a study to evaluate how differences between regulatory systems affect the substitution of these products. Specifically, it focuses on the criteria used to determine interchangeability for biological products compared to the therapeutic equivalence ratings assigned to conventional drugs.
Contention
However, the bill may encounter some contention related to the balance between regulatory oversight and market freedom. Some stakeholders may be concerned about the implications of harmonizing the systems for biologics and traditional drugs, fearing that it could either dilute the unique regulatory pathways for biologics or increase the risk of inappropriate substitutions. The necessity for a thorough study as stipulated in the bill underscores the complexity of this regulatory landscape and the potential for significant policy shifts in how biologics are made available to patients.
A bill to require the Secretary of Health and Human Services to conduct a study on the designation of biosimilar biological products as interchangeable.
Medical Manufacturing, Economic Development, and Sustainability Act of 2023 or the MMEDS Act of 2023 This bill provides incentives for relocating medical manufacturing facilities in the United States and for manufacturing medical products (i.e., drugs and devices) in economically distressed zones. Specifically, the bill allows a income tax credit for 40% of the sum of wages paid in a medical manufacturing economically distressed zone, employee fringe benefit expenses, and depreciation and amortization allowances with respect to qualified medical manufacturing facility property, and a credit for economically distressed zone products and services acquired by domestic medical manufacturers. The bill increases the credit rate for minority businesses.
A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products.