While the recent chemotherapy drug shortages have abated, the Society of Gynecologic Oncology (SGO) continues to advocate for policy changes to prevent future shortages that will impact the health of patients and limit their access to standard of care cancer therapies. To this end, SGO proudly endorsed two bipartisan, bicameral pieces of legislation aimed at reinforcing the U.S. drug supply chain to prevent and mitigate drug shortages. Both bills—the Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act (H.R.3955/S.2062) and the Mapping Americas Pharmaceutical Supply (MAPS) Act (S.1784/H.R.___)—were reintroduced earlier this summer in the House and Senate.
The RAPID Reserve Act, reintroduced on June 12 by a bipartisan group of lawmakers in the House and Senate, would direct the Department of Health and Human Services (HHS) to award contracts to quality manufacturers of critical generic drug products based in the United States or in a country that is a member of the Organization for Economic Cooperation and Development (OECD) in order to maintain reserves of critical medications and their active pharmaceutical ingredients (APIs). HHS would also be directed to publish a list of critical drugs and issue guidance on the criteria for determining inclusion on the list and awarding contracts, with preference being given to domestic manufacturers. Through these contracts, the bill aims to strengthen vulnerable supply chains by ensuring that when there is a disruption in supply, manufacturers can draw on reserves and surge production to meet demand. Thus, the legislation aligns closely with SGO’s policy priorities by advancing efforts to build resilient supply chains – particularly through the promotion of domestic manufacturing – to prevent future shortages and protect patient access to care.
The MAPS Act, reintroduced with bipartisan support on May 15 in the Senate and June 26 in the House, tasks HHS—in partnership with relevant agencies and the private sector—to address drug shortages by maintaining a list of essential medicines and APIs, directing the Secretary to conduct a risk assessment of the supply chains of those essential medicines. It would also require the mapping of the entire supply chain—from key ingredients to distribution in hospitals and pharmacies—using data analytics to proactively identify vulnerabilities, overreliance on foreign sources, and cybersecurity threats. SGO endorses the MAPS Act as it is consistent with our efforts to combat chemotherapy drug shortages by increasing transparency, identifying supply chain bottlenecks early, and ensuring gynecologic cancer patients have continuous access to essential treatments.
SGO applauds both measures for their complementary approaches to address drug shortages—while the RAPID Reserve Act builds reserves and surge capacity, the MAPS Act enhances early warning systems and end-to-end supply chain transparency. Together, these bipartisan, bicameral bills seek to protect patients and providers by addressing both chronic and emerging threats to the drug supply chain. We hope to see these pieces of legislation enacted into law during the 119th Congress!