Office of Women’s Health Strategic Priorities; Establishment of a Public Docket; Request for Comments


The National Health Council (NHC) appreciates the opportunity to provide comments as the Food and Drug Administration’s (FDA’s) establishes its Office of Women’s Health (OWH) Strategic Priorities public docket. The OWH mission is critical to reducing health disparities that disproportionately affect women. We agree that the FDA has unique role in protecting and promoting women’s health.

Created by and for patient organizations 100 years ago, the NHC brings diverse organizations together to forge consensus and drive patient-centered health policy. We promote increased access to affordable, high-value, sustainable health care. Made up of more than 140 national health- related organizations and businesses, the NHC’s core membership includes the nation’s leading patient organizations. Other members include health-related associations and nonprofit organizations including the provider, research, and family caregiver communities; and businesses representing biopharmaceutical, device, diagnostic, generic drug, and payer organizations.

Overarching Comments

FDA should work across the agency to address disparities affecting women.

While we wholeheartedly support the OWH’s focus on addressing gender disparities, we believe that the FDA should also work throughout the agency to identify the unique needs of and address disparities faced by women. While the OWH can serve an important role, it is important that its focus be incorporated throughout the culture and operations of the agency. An emphasis on bringing issues affecting women to the forefront of the FDA and ensuring that there is sufficient expertise on the topic, should exist in all aspects of the FDA, ranging from the Commissioner’s office to each review division. This could be a comparable process to the FDA’s current approach to rare disease, where Rare Disease Program staff are embedded in each review division.

The NHC particularly asks the FDA to include women with complex chronic diseases and disabilities in its emphasis on improving women’s health. As FDA noted in its draft guidance on Enhancing the Diversity of Clinical Trial Populations, “failure to include complex participants in a development program may lead to a failure to discover important safety information about use of the investigational drug in patients who will take the drug after approval.” For many individuals, the ability to take part in the drug-development process is an empowering step that aligns with their health care goals and could allow earlier access to treatments to significantly improve health outcomes. A focus on this population, not only in clinical trials, can help ensure that the FDA considers how medical products work in a real-world setting.

Many of the comments we are providing, particularly relating to representativeness, are similar to those we submitted to the Office of Minority Health and Health Equity (OMHHE) and other previous communications with the agency. We encourage the OWH and the OMHHE to work together closely to address issues of representativeness and other intersectional issues identified in these comments.

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