Kaine Welcomes Draft FDA Guidance to Improve Accelerated Approval Process for Lifesaving Drugs

WASHINGTON, D.C. –  Today, U.S. Senator Tim Kaine (D-VA), a member of the Help, Education, Labor, and Pensions Committee, released the following statement regarding the U.S. Food and Drug Administration’s (FDA) issuance of draft guidance, in accordance with bipartisan legislation Senator Kaine championed, to provide clarity regarding the FDA’s accelerated approval pathway, an important regulatory mechanism that speeds up development of treatments for patients with serious and life-threatening conditions:

“I applaud the Food and Drug Administration for taking this important step—following my urging and legislation—to provide the clarity needed to help critical medicines reach the market faster via the accelerated approval pathway, while also ensuring safety and transparency. This will play an essential role in ensuring individuals with serious and life-threatening conditions have access to care. I will continue to advocate for patients and keep pushing to ensure they can access the medicines and treatments they need.”

This guidance is subject to a 60 day public comment period before it can be finalized.

Kaine and U.S. Senator Susan Collins (R-ME) previously introduced the Modernizing Accelerated Approval Act, legislation that was passed by the HELP Committee to make significant improvements to the accelerated approval pathway. Similar language was included in the Consolidated Appropriations Act of 2023, signed into law in December 2022.

The accelerated approval pathway—which was established by the FDA in 1992—helps new treatments reach patients with serious illnesses more quickly. Under this regulatory process, manufacturers must meet the same “substantial evidence” standard as regular approval. Accelerated approval can be granted, however, if there is “substantial evidence” that a new drug can improve a marker—such as reducing tumor size for cancer patients or reducing viral loads for HIV patients—that can predict a drug’s effectiveness at treating the underlying condition. After the drug is made available to patients, the manufacturer is still required to complete studies confirming the drug’s benefits.

Kaine has long championed legislation to help Virginians access the medicines they need. Earlier this week, Kaine introduced the bipartisan Protecting Our Essential Medicines Act, which would help address drug shortages and vulnerabilities in the prescription drug supply chain by requiring the Secretary of Health and Human Services to maintain a list of the country of origin of certain critical drugs marketed in the United States. Last month, Kaine introduced the End Drug Shortages Act, bipartisan, bicameral legislation to help reduce the prevalence and severity of drug shortages. 

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