FDA package negotiated by Senator Murray, colleagues will finally empower FDA to regulate cosmetics, address the infant formula shortage, modernize accelerated approval, and more
Senator Murray: “I’ve been pushing hard to make progress on so many key reforms to ensure the FDA is living up to its mission and putting patients and families first—and that’s what this package delivers.”
(Washington, D.C.) – Today, U.S. Senator Patty Murray (D-WA), Chair of the Senate Committee on Health, Education, Labor, and Pensions (HELP), issued the following statement on the Senate’s passage of key Food and Drug Administration (FDA) reforms she negotiated this year and pushed to pass as part of the Fiscal Year 2023 Omnibus Appropriations bill.
“Every day, families and patients across the country count on the FDA to protect their health. I’ve been pushing hard to make progress on so many key reforms to ensure the FDA is living up to its mission and putting patients and families first—and that’s what this package delivers.
“Over the years, I have heard from people worried about whether the cosmetic products they use every day like nail polish, deodorant, hair dyes and straightener, shampoo, makeup, and baby powder are safe—especially after alarming reports of carcinogens found in some of these products. But since the FDA was first created almost a century ago, the agency has lacked the authority it needs to ensure the cosmetics and personal care products people use are safe. I’ve been pushing for years to empower the FDA to conduct oversight of cosmetics, and I am so glad this legislation finally does just that. This is a huge, hard-fought win that will mean people across our country can have more confidence that the cosmetics they count on every day are safe to use.
“This legislation takes critical steps to make the FDA work better for patients. It takes action to address the infant formula shortage and ensure that the failures that contributed to the infant formula crisis earlier this year never happen again. It strengthens the FDA’s accelerated approval pathway for drugs to put patients over pharmaceutical companies’ bottom lines. It addresses the lack of diversity in clinical trials to ensure that drugs work for everyone and no one is left behind in critical medical research. This legislation takes steps to keep counterfeit medical devices off the shelves, and it increases access to safe disposal of opioids and other drugs as communities across the country work to tackle the substance use disorder crisis head-on—and so much else.
“This is a strong, bipartisan package of reforms, and I look forward to getting it to President Biden’s desk and continuing to push to make the FDA work better for patients and families.”
Among other things, the FDA package included in the omnibus:
- Empowers FDA with authority to conduct oversight of cosmetic products for the first time since the agency’s creation;
- Modernizes and strengthens FDA’s accelerated approval pathway to work better for patients;
- Takes key steps to address the infant formula shortage and ensure the failures that contributed to the infant formula crisis never happen again;
- Modernizes and improves clinical trials by increasing diversity in trials to ensure drugs work for everyone;
- Works to keep counterfeit medical devices off the shelves;
- Increases safe disposal of opioids and other drugs with serious risks;
- Updates the process for determining therapeutic equivalence of certain drugs;
- Modernizes the data that can be used to support medical product development, including alternatives to animal studies;
- Supports the review and development of drugs for rare diseases.
A section-by-section of the health policies Senator Murray worked to pass in the omnibus, including the FDA package, is available HERE.
Full text of the FY23 Omnibus Appropriations bill is available HERE.
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