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Crapo, Rodgers Issue Request for Information to Inform Policymaking on Drug Shortages

Washington, D.C.--U.S. Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) and U.S. House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Washington) announced a bicameral Request for Information (RFI) to subject matter experts and stakeholders regarding the increase in drug shortages. 

From the request:

For American families, these trends can pose dire consequences, from life-threatening delays in treatment to drug rationing and devastating financial strain.

While some shortages resolve relatively quickly, others can last for well over a decade, denying access to crucial therapies and forcing those living with even the most serious medical conditions to seek out alternatives or suffer from debilitating lapses in care.

As our committees work to examine the drivers of life-threatening medication shortages, as well as to pursue potential policy solutions to bolster patient access and shore up our critical drug supply chains, we request feedback on the inquiries outlined below.

Read the full request here or below:

  • How would you define the scope and impact of the recent and ongoing U.S. drug shortages? 
  • For drugs currently in shortage, what percentage of their market is reimbursed through public payers, such as Medicare and Medicaid?
  • What are the impacts of recent and recurring shortages of generics and other critical medicines on patient care? 
  • What market and economic conditions undermine pharmaceutical supply chains or the availability of drugs? Please discuss any specific barriers in public payment programs. 
  • What are the regulatory challenges to manufacturing drugs in the United States, as compared to other countries? Please specify which agency issued and enforced such regulations. 
  • How can federal agencies, such as the Centers of Medicare and Medicaid (CMS), better address the economic forces driving shortages? Are these agencies using their current authorities effectively?
  • How does the current generic drug reimbursement structure in federal programs, including those programs’ mandatory discounts and rebates, contribute to drug shortages, and what solutions exist?
  • Given that supply chain issues can trigger manufacturing delays and disruptions that result in shortages, are further incentives necessary to address manufacturing issues? 
  • What role, if any, has growth in the 340B program played in drug shortage trends?
  • Would innovative CMS reimbursement models for drugs at risk of shortage status better allow manufacturers of these drugs to meet production and patient demand? What factors should be incorporated into any model seeking to address shortages? 
  • How do existing inflation penalties in Medicaid and Medicare create additional barriers for generic manufacturers, leading to drug shortages? How does the discretion given to CMS to reduce or waive these penalties for drugs on the FDA’s Drug Shortage list, as well as certain drugs facing severe supply chain disruptions, introduce additional uncertainty into drug development, and what can be done to remedy that uncertainty?
  • How might uncertainty in the drug coverage process, particularly as it relates to National Coverage Determinations (NCD) and coverage paradigms like Coverage with Evidence Development (CED), affect competition and, ultimately, the supply of drugs? What can be done to promote greater certainty in that process for FDA-approved drugs? 
  • Are there any guardrails that Congress should to consider related to demonstration projects, including via the CMS’ Innovation Center, that would help protect against drug shortages? Are there any proactive demonstrations that would prevent drug shortages?
  • How has consolidation among Group Purchasing Organizations and Prescription Drug Wholesalers led to less redundancy in the drug supply chain? Has this consolidation contributed to drug shortages, especially among generic drugs? Have business practices, such as just-in-time deliveries and limited-source contracts contributed to the drug shortage issue we are seeing?
  • What factors would lead to a generic drug receiving approval but not coming to market?
  • Are there any other issues leading to drug shortages that we have not considered in this RFI?