U.S. Senator Mitt Romney (R-UT) today offered several amendments to the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act—legislation to be considered by the HELP Committee tomorrow—which will prevent a future infant formula crisis, support the dietary supplements industry in Utah, and advance more options to lower drug prices. One of Romney’s amendments to lower drug prices has already been included in the legislation, and he will push for inclusion of other measures during tomorrow’s markup.
“Utahns and Americans across the country are strapped with skyrocketing prescription drug costs, and it is increasingly difficult for them to receive the medicine they need,” Senator Romney said. “We must explore ways to lower costs for medication and spur the research and development of new drugs, including finding ways for nonprofit generic drug companies like Utah’s Civica Rx to lower drug costs, address shortages, and accelerate the development of new drugs.
“Every member here understands the effects that the recent Abbott infant formula recall has had on infants and families across the country,” Romney continued. “The stories of parents who worried about whether they were going to be able to safely feed their child are absolutely heartbreaking. The FDA has a responsibility to protect infant health by ensuring they have access to safe formula, and when crises arise, to initiate contingency plans to mitigate shortages that risk the lives of infants across the nation.
“The dietary supplements industry is a more than $7 billion dollar industry in my state, having flourished under policies championed by the late Senator Hatch. This is a vital economic driver and source of good jobs in the state that helps sustain our Utah-based suppliers and manufacturers in raw materials, technology, logistics, and service jobs that support the dietary supplements industry. Like any new regulatory policy, we must ensure a balance between government oversight and burdensome, unnecessary requirements,” Romney concluded.
Romney measures being offered to the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act:
To Prevent a Future Infant Formula Crisis: An amendment aimed at preventing a future formula crisis by requiring that HHS provide Congress notification within 24 hours of initiating a voluntary or mandatory recall, including an initial estimate of the disruption in the domestic production that could result from their actions, information on the risk to human health, and when the FDA was first made aware of the problem (Cosponsored by Senator Roger Marshall (R-KS)). Additionally, an amendment that would require HHS to give manufacturers concrete steps to address deficiencies in their facilities if they are impacted by a recall (Cosponsored by Senators Roger Marshall (R-KS) and Bill Cassidy, M.D. (R-LA)).
To Support Utah’s Dietary Supplements Industry: Seven amendments to ensure dietary supplements companies, an industry vital to the state’s economy and health, can continue to thrive even as Congress looks to increase transparency.
To Advance Options to Lower Drug Prices: Two bipartisan amendments with Senator Jacky Rosen (D-NV) to research and hold public meetings to better understand the impact that nonprofit generic drug companies have on lowering drug costs, addressing drug shortages, and accelerating the development of new drugs.
To Eliminate Supply Chain Delays: An amendment to address the backlog of delayed FDA postmarket inspections exacerbated by the COVID-19 pandemic. This amendment requires FDA to recognize routine postmarket inspections from trusted partners like the European Union, the United Kingdom, Australia, Canada, Israel, Japan, New Zealand, Switzerland, and South Africa for five years. The amendment frees up FDA resources to focus on high risk facilities in China.
Romney measure included in the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act:
To Advance Options to Lower Drug Prices: S. 4351, Enhanced Access to Affordable Medicines Act of 2022, eliminates tactic for delaying generic competition by increasing the temporary label change differences from 60 days to 90 days, and creates parity in generic approvals between when a brand is off-patent and when its patent is expiring.