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Opinion: FDAs Plan to Diversify Trial Participation Criticized
In response to a law passed two years ago, the FDA was directed to assess the extent to which women and minorities are represented in clinical trials and also devise a plan to bolster their participation. The requirement was made in response to concerns that drugs and devices may often be used by subsets of the population on whom the products were not actually tested.
Well, the FDA released its plan the other day and it was met with what could best be described as faint praise. In particular, a pair of consumer advocacy groups says the biggest issue is that the so-called Action Plan lacks the sort of teeth needed to generate real change. They also complain the plan fails to require drug and device makers to contain specific demographic information in product labeling.
They acknowledged the plan does contain several constructive steps, such as working with drug and device makers to revise product applications with enhanced information on “demographic subgroups;” strengthening FDA reviewer training so the need for demographic data is communicated; improving FDA systems for collecting and analyzing such data; and updating or finalizing guidance for industry.
Read the article here: http://on.wsj.com/1qDQ2SK
Source: The Wall Street Journal
New Research Links Gender, Racial Microaggressions to Higher Postpartum Blood Pressure
January 9th 2025Acts of discrimination, including subtle microaggressions, during pregnancy and childbirth contribute to higher maternal mortality rates, especially among Black women, and are linked to increased postpartum blood pressure, highlighting the need for improved health care interventions and racial equity in maternity care.
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Advancing Women's Health: CVS Health Leader on Access, Technology, and Breaking Stigmas
December 5th 2024On this episode of Managed Care Cast, we speak with CVS Health's vice president and chief medical officer for women's health and genomics about advancements and challenges in women's health, focusing on care access, technology, and maternal outcomes.
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Infant Mortality Increases Across US Following Dobbs Decision
October 25th 2024The Dobbs decision was associated with a 7% absolute increase in overall infant mortality—equivalent to 247 excess deaths—and a 10% increase among infants with congenital anomalies, corresponding to 204 additional deaths.
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Cost Barriers Continue to Limit Access to Fertility Care
October 24th 2024Of the 10% of women contacted for this survey who said that they or their partner had ever sought fertility assistance, only 7% were able to get the necessary care; cost was cited as the top reason for not being able to access fertility services.
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