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Health policy roundup: Trump establishes women's health division at NIH


President Donald Trump on Monday signed an executive order alongside First Lady Melania Trump creating a task force and a division of NIH that will focus on women's health, in today's roundup of the news in healthcare politics.

Trump signs order creating task force and NIH division focused on women's health

President Donald Trump on Monday signed an executive order alongside First Lady Melania Trump creating a task force and a division of NIH that will focus on women's health.

The task force will be led by Chief of Staff Susie Wiles, according to HHS Secretary Robert F. Kennedy Jr. Meanwhile, the Women's Health Division at NIH is aimed at streamlining research into understudied diseases in women, advancing innovation in diagnostics, improving treatment, and establishing "a new standard for women's health," according to First Lady Melania Trump. The Women's Health Division will not replace the current Office of Research on Women's Health at NIH.

Trump credited the first lady with proposing the idea for a women's health division at NIH. "Think of it, a women's health division," Trump said. "Who the hell wouldn't have a women's health division? Melania said, 'They don't have it.'"

The first lady added her signature to the executive order after President Trump signed it, though her signature does not carry any legal weight.

"This is a transformative moment for women in America," the first lady said. "Beginning today, we will change the reality of women's health. Previous generations fought for women's rights. Our generation will fight to discover the cures that will ensure a woman can live her life in health and to the fullest."

In an interview with CBS on Tuesday, NIH Director Jay Bhattacharya said the amount of funding for the new project was yet to be determined.

"The first lady made it very clear that she wants to focus on topics in women's health that have been just neglected, you know, endometriosis, menopause, a whole host of topics that, you know, frankly, we've underinvested in, learned less about than we should have over the years," he said. "And so it's very, very exciting, and, yes, some new money will very likely be devoted to this, although that's still to be determined exactly how much."

(Cooney, STAT, 10/19; Hunnicutt/Aboulenein, Reuters, 10/19; Watson, CBS News, 10/20)

FDA pushes forward with peptides

FDA last week submitted a peptide "interim access policy" to the White House for review, which would allow compounding pharmacies to temporarily produce and sell peptides that were previously restricted.

Peptides are short chains of amino acids that play a role in regulating hormones, releasing neurotransmitters, and repairing tissue. Over 100 drugs approved by FDA are peptide-based, including insulin and some GLP-1 medications like Ozempic.

Synthetic peptides have gained popularity among wellness influencers and biohackers, who often take them via injection, hoping to enhance their athletic performance and optimize their health. Different peptides have different claims associated with them, but some of the most popular purport to enhance muscle growth, improve immune function, and slow aging.

FDA warns that synthetic peptides not approved by the agency pose "serious safety risks," including allergic reactions. FDA has banned their production by compounding pharmacies in the United States; however, personal use is legal.

HHS Secretary Robert F. Kennedy Jr. has previously said that U.S. compounding pharmacies must be allowed to sell peptides because Americans are increasingly turning to "gray market" peptides that are made in China and elsewhere.

While the White House filing from FDA doesn't give specifics of the new policy, two people familiar with the plan who spoke to the Associated Press said it's intended to allow pharmacies to temporarily compound some of the most popular peptides.

(Perrone, Associated Press, 10/15; Weixel/Choi, The Hill, 10/15)

CDC sends disease expert to assist with measles outbreak in PA

CDC last week said that it sent a "disease detective" within the agency's Epidemic Intelligence Service to Pennsylvania to assist with the state's growing measles outbreak, marking the first in-person assistance to the state after HHS Secretary Robert F. Kennedy Jr. disputed the measles deaths recorded in the state.

Since August, six people diagnosed with measles have died in Pennsylvania, according to health officials and county coroners. So far, CDC has acknowledged three of the deaths on its measles outbreak website and noted the other deaths are "under review."

"CDC will continue working closely with Pennsylvania health officials to provide the expertise and support needed to respond to the outbreak and protect public health," a spokesperson for CDC said, adding that CDC Director Erica Schwartz recommends the measles, mumps, and rubella vaccine "as the most effective way to prevent measles and protect against infection."

In addition to deploying the disease expert, CDC is also releasing almost $4 million to aid the measles response in Pennsylvania.

(Edwards, NBC News, 10/15; McCracken, The Hill, 10/17; Chakraborty, The Hill, 10/20)

Trump administration reinstates ACA coverage for some whose plans shouldn't have been canceled

CMS has reinstated a small number of people whose health insurance coverage under the Affordable Care Act (ACA) had been erroneously canceled and classified as fraud, according to industry sources who spoke to KFF Health News.

Last month, the Trump administration announced it had cut 760,000 people from the ACA rolls, claiming fraud and improper enrollments. However, sources told KFF Health News that not all of the people who were kicked off the ACA were fraudulently enrolled, and CMS has reinstated their coverage. More reinstatements could come in the following weeks.

Overall, the administration has provided few details about the cancellations, including how robust the outreach was to the people it targeted, how long it takes for people to get reinstated after they discover their coverage was incorrectly canceled, and how many cancellations have been reversed.

"It may be true that some of those enrollments were not authorized, but it can be equally true that people got lost in the shuffle and have a valid enrollment. Without more information, it’s almost impossible to tell," said Katie Keith, a director of the Center for Health Policy and the Law at Georgetown Law. "That [the Trump administration is] not being very transparent is telling too," she added.

(Appleby, KFF Health News, 10/16)


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