WASHINGTON, D.C. [1/13/23] — More than half a dozen health care bills by U.S. Senator Tina Smith (D-Minn.) were signed into law by President Biden two weeks ago. The measures will take important steps to lower the cost of prescription drugs, address public health workforce shortages, and shore up supply chains while creating good-paying American jobs. Most of the provisions were bipartisan.
“Since my first day in office, I’ve promised Minnesotans that I would work to reduce the cost of prescription drugs and expand access to health care,” said Sen. Smith. “These measures provide the tools to make significant progress on lowering health care costs, boosting our public health workforce, and more.”
These new laws will:
- Require the Department of Health and Human Services (HHS) to establish a program to improve health outcomes and reduce health inequities.
- Help speed up the development of and improve access to lower-cost generic drugs by requiring the Food and Drug Administration (FDA) to make timely therapeutic equivalence evaluations for drugs approved through the complex generic pathway. This provision is based on Smith’s Modernizing Therapeutic Equivalence Rating Determination Act.
- Clarify the FDA’s ability to regulate combination products—products that meet both the definition of drugs and devices—as drugs rather than as devices. The provision is based on Smith’s Consistent Legal Evaluation and Regulation of Medical Products (CLEAR) Act and will eliminate unnecessary confusion and turmoil in the industry. This clarification will allow the FDA to spend more time and resources on bringing low-cost products to market to ultimately lower out-of-pocket costs.
- Enable the FDA to develop a clear protocol for the use of real-world evidence during the approval process for drugs, biologics, and medical devices. The provision is based on Smith’s Real-World Evidence legislation, which will help reduce the cost for medical innovators to bring a product to market.
- Reauthorize a public health workforce loan repayment program based on Smith’s Strengthening the Public Health Workforce Act to incentive health care workers to take jobs in underserved communities, including rural areas.
- Direct the CDC to develop a One Health Framework, based on Smith’s Advancing Preparedness Through One Health Act, to better address the link between animal and human health.
- Allow HHS, in consultation with the Administration for Strategic Preparedness and Response and FDA, to award contracts to increase domestic production of essential, generic antibiotics. This provision stems from Smith’s Onshoring Essential Antibiotics Act and will improve the United States’ supply chain for critical antibiotics.
- Incentivize domestic manufacturing of generics and biosimilars through provisions based on Senator Smith’s American Made Pharmaceuticals Act.
The bills were included in the year-end government funding package that was recently signed into law. In addition to Smith’s health care bills, the law includes many other important provisions supported by Sen. Smith such as the Electoral Count Reform Act, support for the people of Ukraine, fully funding provisions of the PACT Act, permanently extending postpartum coverage for mothers on Medicaid and CHIP, increasing child care and housing access, and more.