March 17, 2022

Reps. Mike Levin and John Joyce Introduce Bipartisan Bill to Foster Innovation in Drug Manufacturing

Washington, D.C. – U.S. Representatives Mike Levin (D-CA) and John Joyce (R-PA) introduced the bipartisan Drug Manufacturing Innovation Act to foster innovation in drug manufacturing by building on the Food and Drug Administration’s (FDA) Emerging Technology Program (ETP). The program plays a critical role in supporting drug manufacturers’ efforts to develop new technologies and navigate the regulatory process, which can ultimately help address supply chain challenges and lower prices for consumers. The Subcommittee on Health of the Committee on Energy and Commerce is holding a hearing on the legislation and other related bills today.

The bill directs the Secretary of Health and Human Services (HHS) to build on the ETP by facilitating stronger public-private partnerships in pharmaceutical manufacturing, conducting research and testing on innovative manufacturing technologies, supporting education and training for regulatory staff, advancing regulatory science related to development and review, and awarding grants or contracts to advance research and development or adoption of innovative approaches. The bill authorizes $20 million per year from FY2023-2027 to carry out this effort.

“As families face high drug costs and shortages of the medications they need, it’s critical that we invest in new manufacturing technologies that can help address supply chain challenges and bring down prices,” said Rep. Levin. “I’m proud to introduce the Drug Manufacturing Innovation Act with Rep. Joyce to ensure HHS is fostering the next generation of manufacturing technologies and improving the regulatory process so these innovations can come to fruition. Today’s Energy and Commerce hearing on our bipartisan bill is a positive step, and I’m hopeful we can advance the bill soon.”

Supporting innovation in drug manufacturing is critical in addressing the supply chain challenges that have become more acute in recent years. When drug manufacturing slowed in some countries during the pandemic, hospitals faced shortages of antibiotics, antivirals, and other drugs. Many Americans who rely on chloroquine and hydroxychloroquine for conditions like lupus and rheumatoid arthritis could not receive their usual supply of medication due to shortages. There are currently 120 drugs in shortages according to the FDA; the American Medical Association (AMA) has labeled drug shortages as an urgent public health crisis. The Drug Manufacturing Innovation Act would help prevent similar shortages in the future by supporting the development of more efficient drug manufacturing technologies.