Improving Generic Drug Market, Supply Chain Emphasized in ASCO Response to Drug Shortages Request for Information

July 18, 2023

The Association for Clinical Oncology (ASCO) responded to a bicameral Request for Information (RFI) on the underlying factors driving drug shortages. The Association’s comments highlighted the impact of the shortages on patient care and pointed to economic failures and supply chain vulnerabilities that have led to shortages of critical oncology drugs for more than a decade.

“The generic market must be stabilized so that manufacturers do not continue to exit due to the unfavorable market conditions…,” said ASCO Board Chair Everett E. Vokes, MD, FASCO, in the response. “…We urge consideration of a reserve or buffer of critical drugs outside of the Strategic National Stockpile (SNS) that would focus on drugs at risk of shortage; creating tax incentives or restructuring the reimbursement system for generics; encouraging the federal government to participate in long-term contracts with a variety of generic manufacturers for the programs it oversees directly; waiving or decreasing the generic drug user fee in specific situations; and making more supply chain information available to the Food and Drug Administration (FDA) and the public.”

The RFI was released by House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Senate Finance Committee Ranking Member Mike Crapo (R-ID). Chair Rodgers and Energy and Commerce Health Subcommittee Chair Brett Guthrie (R-KY) also announced their intent to release a discussion draft of legislation aimed at preventing future drug shortages as part of their ongoing work to address this crisis. ASCO continues to engage with lawmakers to draft and advance legislative solutions on this issue. 

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