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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
The Pivotal Role of Payers in Improving Health Equity, Maternal Health Care in the US
March 26th 2024A presentation at the Greater Philadelphia Business Coalition on Health's 2024 Women’s Health Summit discussed how payers, including employers and public entities, can strategically influence health care purchasing to prioritize maternal health and equity.
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Addressing Maternal Mortality in Medicaid by Focusing on Mental Health
February 15th 2023On this episode of Managed Care Cast, we speak with Inland Empire Health Plan, a managed care plan serving more than 1.4 million residents on Medi-Cal in California, about a new maternal mental health program aimed at supporting new mothers, both before they give birth and afterward.
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For National Women’s Health Week, One Company Emphasizes Cardiovascular Risk Management
May 10th 2022On this episode of Managed Care Cast, we speak with Joanne Armstrong, MD, MPH, vice president and chief medical officer for Women’s Health and Genomics at CVS Health, on the distinct pathophysiology of cardiovascular disease in women and how her own health experiences have influenced her perspective on cardiovascular disease management.
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What We’re Reading: Historic Low of Uninsured; Youth Gender Treatments; Birth Control Recall
August 4th 2023A record low of 7.7% of Americans had no health insurance at the start of 2023; the American Academy of Pediatrics renewed its backing of gender care for children while requesting a research review; 2 lots of an oral contraceptive were recalled for possible reduction in effectiveness.
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Lawyers were questioned in a federal lawsuit intending to overturn approval of a drug used for medication abortion; during the COVID-19 pandemic in 2021, US maternal mortality increased for the third year in a row; the Alzheimer’s Association is lobbying Congress to push for Medicare coverage of new Alzheimer drugs under early access.
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