Rosen-Led Amendments Included in Bipartisan FDA Reauthorization Package, Advances Out of Committee

Rosen Provisions in FDA Package Will Help Increase Prescription Drug Access  and Reduce Medication Costs Through Nonprofit Drug Manufacturing, Strengthen Medical Device Cybersecurity, Improve Health Research for Women

WASHINGTON, DC – Today, the U.S. Senate Committee on Health, Education, Labor and Pensions advanced the bipartisan Food and Drug Administration Safety and Landmark Advancements Act, which includes four amendments led by Senator Jacky Rosen (D-NV). 

Two of these amendments are based on legislation Senator Rosen introduced earlier this year – her bipartisan  Advancing Affordable Medicines for Families Act with Senator Mitt Romney (R-UT), which would require the Government Accountability Office to issue a report on the effects of nonprofit prescription drugs on bringing down costs; and her bipartisan Strengthening Cybersecurity for Medical Devices Act with Senator Todd Young (R-IN), which would require the Food and Drug Administration (FDA) to update its medical device cybersecurity guidance within two years and improve coordination of resources to address cyber threats. 

The other Rosen-led amendments included in this package would require the FDA to hold a public meeting on how nonprofit prescription drug manufacturers can address drug prices and shortages, and require the FDA to update its Women’s Health Research Roadmap, which was last updated in 2015.

“I’m proud that several of my bills and amendments are moving forward as part of the bipartisan FDA legislative package and are now one step closer to becoming law,” said Senator Rosen. “These commonsense provisions will increase access to affordable prescription drugs and bring down medication costs through nonprofit drug manufacturing, strengthen medical device cybersecurity, and improve health outcomes for women.”