Blue states call on FDA to expand abortion pill access
The joint petition, filed Thursday, comes days after FDA Commissioner Marty Makary committed to reviewing the abortion drug amid pressure from Department of Health and Human Services Secretary Robert F. Kennedy Jr. and some Republican lawmakers.
The FDA first approved of the use of mifepristone and misoprostol for an abortion in 2000.
Unlike surgical abortions, medication abortions do not need to take place in a clinical setting, and patients are able to take the pills at home.
Most abortions in the U.S. are now medication abortions, according to data from the reproductive health and rights group Guttmacher Institute. In 2023, 63 percent of all abortions in the U.S. were medication abortions.
The safety of mifepristone has come under increased scrutiny by some Republican lawmakers, citing a flawed study claiming the rate of adverse health events that occur among patients is far higher than previously reported.
More than 100 scientific studies have been conducted looking at the safety and efficacy of mifepristone and misoprostol; all of them have found that the drugs are a safe way to terminate a pregnancy.
'Given Mifepristone's 25-year safety record, there is simply no scientific or medical reason to subject it to such extraordinary restrictions,' New York Attorney General Letitia James said. 'The FDA must follow the science and lift these unnecessary barriers that put patients at risk and push providers out of care.'
Mifepristone's use is subject to a Risk Evaluation and Mitigation Strategy (REMS) program under the FDA. The attorneys general argue three requirements under the REMS program for the drug should be removed since they pose a burden to patients and health care systems.
The first is related to prescriber certification. As part of the REMS program, health care providers who prescribe mifepristone are required to add their names to national and abortion provider lists, which the attorneys general say raise 'serious safety and legal concerns.'
The second has to do with patient agreement forms. All patients who want mifepristone — even those using the drug to treat a miscarriage — are required to sign a document stating they are using the drug to end a pregnancy.
The third requirement mentioned in the petition is connected to pharmacy certification. As part of mifepristone's REMS program, pharmacies that carry the drug are subject to tracking, shipping and reporting requirements, which the attorneys general argue may 'dissuade' some from carrying the drug.
The FDA has yet to reply to a request for comment from The Hill about the petition.
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The Hill
9 minutes ago
- The Hill
The FDA must be modernized for the era of personalized medicine
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Globally, more than 50 million children suffer from rare genetic diseases — and nearly one in five will die before the age of five. Even children with the same diagnosis can carry different genetic mutations, meaning a one-size-fits-all drug may be ineffective or impossible to make. The problem is our healthcare system isn't designed or incentivized to develop drugs for individual patients. The good news is that science and technology have caught up. We can now sequence a genome for under $100. Artificial intelligence models can design mutation-specific therapies in days and RNA-based treatments can be manufactured in weeks. Operation Warp Speed showed our ability to distribute advanced therapies at scale. And with wearables and digital health tools, we can monitor children's physiological response in real-time, both before and after treatment. The FDA's current approval framework is nearly a century old. It was originally designed to regulate mass-produced drugs for large populations. While there have been reforms since then, most have been incremental and tailored to conventional pharmaceutical development. The current process treats personalized medicines — especially 'N-of-1' therapies — as individual research trials. This approach is time-consuming, expensive and not scalable for the millions of patients who could benefit. Rare disease doesn't just affect patients, it drains families and their communities. Parents leave the workforce to become full-time caregivers. Families travel across the country for access to specialists. Experimental treatments, hospital stays, lost wages and uncovered expenses can bankrupt a family before a diagnosis is even confirmed. In many cases, the child's condition continues to deteriorate while waiting for a diagnosis or cure. The cumulative damage is incalculable. 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Without it, researchers and companies will hesitate to invest time and resources into what feels like regulatory guesswork. As the FDA and the Department of Health and Human Services undergo what appear to be structural changes, this is a rare window to modernize regulation and secure America's position at the forefront of next-generation medicine. To turn personalized therapies into a new standard of care, the FDA can take a number of key steps. The agency should create a new regulatory pathway for bespoke therapeutics. N-of-1 drugs can't be evaluated using the traditional Phase 1-2-3 frameworks. We need an entirely new process-oriented framework that considers families, physicians, payers, regulators and industry alike. The FDA should establish a dedicated oversight body. A centralized group within the agency should review personalized therapeutics, set transparent safety and ethics standards and ensure rigorous tracking of outcomes. This will build consistency, speed and public trust. The agency should enable sustainable funding and reimbursement. Cost no longer needs to be the barrier. Clear regulatory rules will unlock investment, while reimbursement frameworks will ensure payers can cover these treatments responsibly. Absent this, safe and effective therapies may never reach patients. Every week matters for a child with a rare, degenerative condition. Acting now can turn scientific breakthroughs into a public health reality. If we wait, we risk letting outdated regulation stall progress — and watching the rest of the world move forward without us. The tools are here. The science is ready. All that's missing is a regulatory system built for the future of medicine that doesn't treat individualized care as an exception, but as the new standard. Nessan Bermingham is an operating partner at Khosla Ventures, where he invests in genetic medicines and AI drug discovery and development. 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Forbes
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- Forbes
InnovationRx: Sarepta Blinks In Showdown With FDA
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Yahoo
an hour ago
- Yahoo
Talc Is Suddenly in the Spotlight. Is it Bad for You?
Credit - Photo-Illustration by TIME (Source Images: Liudmila Chernetska—Getty Images, LanaSweet/Getty Images) Federal health officials are scrutinizing a mineral—added to some makeup, medications, and foods—that many people have never thought twice about: talc. In a recent viewpoint article called 'Priorities for a New FDA,' published in the medical journal JAMA, Dr. Martin Makary, commissioner of the U.S. Food and Drug Administration (FDA), and Dr. Vinay Prasad, the FDA's Chief Medical and Scientific Officer, wrote that the FDA conducted an expert panel on talc in May. They also noted that some companies have removed talc from baby powder because it's a carcinogen. Johnson & Johnson, for example, stopped using talc in 2023 following more than 60,000 legal claims from ovarian cancer patients. The JAMA article added that talc remains common, since people still 'ingest it regularly' as an ingredient in various medications and foods. Despite the lawsuits, though, research hasn't confirmed whether talc causes cancer, especially when consumed through food. Meanwhile, companies continue to use talc in powders and cosmetics. Here's how people get exposed to talc, the potential health risks, and what to do about them. Talc and asbestos A naturally occurring mineral, talc consists of several elements like magnesium and silicon. When ground into fine particles, talc becomes talcum powder, which works to absorb moisture and soothe the skin. People have used cosmetics and powders with talc for more than a century. Before talc is mined by companies from deep within the earth, it mixes with another mineral, asbestos. This often results in talc's contamination with asbestos, which is proven to cause cancer. Talc, when laced with asbestos, is a carcinogen, especially when it's inhaled. Less clear is the cancer-causing potential of talc when it's not contaminated. In theory, talc on its own could drive cancer because its particles create inflammation when inhaled or migrating into the body after talc is applied to skin, according to Joellen Schildkraut, professor of epidemiology at Emory University. 'Inflammation can promote cancer,' Schildkraut says. 'Many studies have shown an association.' Some research shows that asbestos-free talc leads to tumors in animals, but animals reveal little about ovarian cancer in humans, Schildkraut says. Read More: The Race to Explain Why More Young Adults Are Getting Cancer Regardless, it's impossible for consumers to learn if products with talc are contaminated. Since the 1970s, companies have tested talc voluntarily, but the methods aren't sensitive enough to detect asbestos in their products—and the FDA doesn't require proof that they're asbestos-free. 'This means a lot of contaminated talc likely went through without anybody detecting the asbestos,' Schildkraut says. Using better tests, researchers have spot-checked whether cosmetics are asbestos-laced. From 1948 to 2017, two-thirds of these tests (conducted as part of litigation) came up positive for asbestos, typically in trace amounts. In 2020, the nonprofit Environmental Working Group found asbestos contaminated 15% of makeup samples with talc. In 2023, the FDA detected no asbestos in 50 talc-containing cosmetics. (The agency didn't reply to TIME's request for comment.) However, conclusions can't be drawn about the entire market from these checks because they involved small sample sizes, says Kaley Beins, a senior scientist at the Environmental Working Group. Later this year, the FDA is expected to finalize a new rule aimed at improving companies' testing methods. Ovarian cancer risk Some data show links between cancer of the ovaries and a specific type of talc exposure: the use of baby powder in intimate areas for personal hygiene. But the findings have been mixed. In a June letter to Makary, several talc researchers—some with ties to companies that make products with talc—criticized the recent FDA roundtable on talc's health impacts. The roundtable discussions, the authors wrote, were skewed because they 'included several paid plaintiff-side experts in talc-related litigation' without any defense-side experts. The letter says that studies involving several different groups of women have found only very weak associations with ovarian cancer. Schildkraut—an expert participant in the May roundtable without any ties to the lawsuits—notes that some of these studies involved relatively few women diagnosed with ovarian cancer. It's possible there simply wasn't enough data to yield stronger evidence. However, in 2020, scientists pooled together data from groups studied previously and still found no significant link. Read More: Scientists Are Finding Out Just How Toxic Your Stuff Is An important factor is that 'people may not be good at reporting their personal talc use,' says Katie O'Brien, a staff scientist at the National Institute of Environmental Health Studies and lead author of the 2020 research. In another study last year, she tried to correct for reporting errors while reanalyzing data from over 50,000 women and found that frequent users of talcum powder did have higher risk of ovarian cancer. 'This type of research doesn't determine causation,' says Schildkraut, who emphasized the same point during the public roundtable. 'But we do see a consistent relationship.' The self-report issue noted by O'Brien could extend to powder use for babies. 'People may not know whether baby powder was used on them,' O'Brien explains. Meanwhile, some laboratory research shows that human ovarian cancer cells, when exposed to talc, have more inflammation and cellular growth, mechanisms that can fuel cancer. Read More: Inflammation May Be the Culprit Behind Our Deadliest Diseases But Jennifer Permuth, an epidemiologist at the Moffitt Cancer Center who has served as an expert witness for J&J and signed the letter to Makary, questions how talc would migrate from where it's applied to cause cancer in the ovaries—without causing cancer in other organs along the way, such as the cervix. 'We would expect cancer to also develop in those other organs,' but studies find only weak links to these cancers, says Permuth. In a 2024 review, the World Health Organization found that, overall, evidence doesn't prove talc causes cancer, but it's 'probably carcinogenic.' The review focused on ovarian cancer 'because that's where the most evidence was' compared to other cancers, says Schildkraut, who served on the review committee. Meanwhile, the American Cancer Society states that, if there's an increased cancer risk, it's 'likely to be very small.' The E.U. has designated talc as a carcinogen, and it's expected to ban talc from cosmetics in 2027. Other potential health issues There's less research on other health issues related to talc. Some studies suggest that when miners repeatedly inhale talc, even if it's asbestos-free, their risk of lung cancer increases—but evidence on inhaling baby powder is more limited. In addition, a deadly cancer called mesothelioma is closely linked to asbestos exposure, though links to talc are less clear (partly because mesothelioma is extremely rare). Read More: What to Expect at a Mammogram Karen Selby, a patient advocate for the Mesothelioma Center at team of advocates, doctors, and attorneys supporting people with mesothelioma—works with patients who developed the disease decades after early-life exposure to cosmetics, she says. Every Christmas as a kid, Selby got a new box of cosmetic powder to play with. She'd cover herself and act like Casper the Friendly Ghost. She doesn't have mesothelioma, but recalling the haze of talc dust, she sometimes thinks, 'Holy cow, what was I doing to myself?' These makeup kits often have cheaper ingredients like asbestos-contaminated talc, despite that 'children are a susceptible group in environmental health,' says Beins, the Environmental Working Group scientist. 'I would try to keep talc away from them.' Safety precautions As researchers continue to study talc, Beins recommends using products with talc substitutes like cornstarch. (That's what J&J now uses instead of talc.) 'We can acknowledge the uncertainty and use safer alternatives,' Beins says. The Environmental Working Group has a database called Skin Deep that tracks which cosmetics contain ingredients like talc. Currently, the database lists about 150,000 products, and 8,000 have talc, Beins estimates. 'I wouldn't use talc personally,' Schildkraut says. 'It's not worth the risk because you don't need much exposure to asbestos to develop cancer.' Read More: 6 Things to Eat to Reduce Your Cancer Risk If possible, try passing on baby powders in general. Even if they lack talc, 'there may be other chemicals of concern,' such as ones added for fragrance or texture, O'Brien notes. If you've been exposed to talc for decades—whether through personal product use or occupations that often involve talc, like those in hair care—share this information with your doctors. They may recommend screening for ovarian cancer and other conditions, O'Brien says. What about food and medicine? Talc is commonly added to several foods like chewing gum and candy to keep them from sticking to wrappers and caking together. However, relatively few foods have talc. 'It's there and present sometimes, but it's not in a ton of food,' Beins says. To find which foods contain talc, you can search EWG's Food Scores, which tracks ingredients. Out of 80,000 products in the database, only 39 are currently listed to contain talc. In addition, the Environmental Working Group's Verified program certifies brands that meet its strictest health standards. To be certified, brands must disclose their ingredients, provide testing data, and avoid ingredients of concern. Products with talc can't be certified. Read More: Why Food Chemicals Are a Problem—And How to Reduce Your Exposure Talc is also added to some pill coatings because it helps pills travel smoothly through manufacturing equipment during production. But very little is known about cancer risk from talc in either food or pills. 'There's some thought that gastrointestinal issues might happen due to food exposure, because it's pro-inflammatory,' Beins says. However, this effect is mostly theoretical at this point. 'For the sake of public health, we shouldn't raise false alarms and make people scared of their food and medications,' says Permuth, who researches gastrointestinal cancer. 'Frequent users of talc-based personal care products or cosmetics are at the highest risk,' O'Brien says, adding that there's no medical reason for using these products. Whereas other established environmental risks like air pollution may be hard to avoid, O'Brien notes that for the most part, the 'use of talc products is something that individuals can control.' Contact us at letters@ Solve the daily Crossword
