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Daily Briefing

Around the nation: FDA to rule if 'abortion drug' mifepristone can be used to manage miscarriages


Danco Laboratories plans to seek FDA approval of its abortion drug Mifeprix, also known generically as mifepristone, to be used to manage miscarriages, in today's bite-sized hospital and health industry news from Maryland, Minnesota, and New York. 

  • Maryland: Earlier this month, CMS issued a request for information on a proposed model that would lower prices for certain generic drugs purchased through Medicare Part D plans to $2 per month. According to the agency, the model is designed to provide individuals with more certainty about out-of-pocket costs for some generic drugs for common conditions like high blood pressure and high cholesterol. In the sample list, there were 271 medications, which include several dosages and formulations of different drugs. "We want generic drugs for common chronic conditions to be affordable for people on Medicare," said HHS Secretary Xavier Becerra. "Reliably low copayments for essential generic drugs make it more likely that seniors and people with disabilities can afford the drugs they need to stay healthy." However, some industry experts were skeptical about the value of the proposed model and doubted that many plans would participate. The list "has the possibility to lower out-of-pocket drug costs for some Medicare beneficiaries, but it is unlikely to have a broad impact," said Margaret Scott, a principal at the healthcare consulting firm Avalere. "The generic products on the list are generally low-cost to plans and have wide coverage at low copays," she added. (Frieden, MedPage Today, 10/9)
  • Minnesota: According to a new study published in Neurology, some cancers occur more frequently in patients with multiple sclerosis (MS) than others. For the study, researchers reviewed data from a French national healthcare organization between 2012 and 2021. Overall, they identified 140,649 people with MS and matched them on age, sex, residence, insurance plan, and cohort entry date with 562,596 controls. Overall, the cancer risk among MS patients was higher than their matched controls. Specifically, the risks were higher for bladder cancer, brain cancer, and cervical cancer. In comparison, the risks for prostate cancer, breast cancer, and colorectal cancer in MS patients was lower. After stratification by sex, the researchers discovered that the overall higher risk of cancer was only found in women. According to Emmanuelle Leray, one of the study's authors from Rennes University, some of the higher risks of certain cancers among MS patients may be due to earlier detection or the use of immunosuppressant drugs. "More research is needed, including studies that look more closely at how cancer screenings may play a role," Leray said. (George, MedPage Today, 10/9)
  • New York: Danco Laboratories, which manufactures the abortion medication Mifeprix, is preparing scientific data and other information to request FDA approval for the drug for the management of miscarriages. Mifeprix, which is also known generically as mifepristone, was originally approved for terminating pregnancies in 2000. Currently, mifepristone is used in almost two-thirds of abortions as part of a two-pill regimen, with the other being misoprostol. Although misoprostol is used by doctors to treat miscarriages with medications, few use mifepristone as well, largely due to restrictions on the drug. In a study of 300 women, researchers found that 9% of those who received both misoprostol and mifepristone for their miscarriages required a follow-up surgical procedure compared to 24% of those who received misoprostol alone. According to abortion rights activists, a new approval could encourage more doctors to get certified to prescribe mifepristone and lessen stigma around the drug. So far, it's not clear when Danco will formally submit its application, but an FDA decision on the drug will likely take months and occur under a new presidential administration. (Whyte, Wall Street Journal, 10/8)

Top drivers of change in the maternal and reproductive health market

Maternal and reproductive healthcare is rapidly changing. Health leaders must grapple with worsening maternal health disparities, the nationwide maternal mental health crisis, lasting impacts of the Dobbs v. Jackson  ruling, and the rise of femtech disruptors.  Download our report to learn about how these  key drivers reshaping maternal and reproductive healthcare delivery.


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