The AAMC submitted a letter on Sept. 8 to the Food and Drug Administration (FDA) in response to a request for comments informing the strategic priorities for the Office of Women’s Health (OWH). The request for comment was published in the June 10 Federal Register.
In the letter, the AAMC recognized the OWH’s efforts to improve the health of women and agreed that the FDA can play a unique role in protecting and promoting women’s health by identifying research priorities and opportunities for interagency and external collaboration.
The AAMC affirmed the OWH’s reference to diversity throughout its strategic priorities. It recommended the OWH take note that intersectionality is a key tenet to ensuring the inclusion of women who hold multiple identities (e.g., racial, ethnic, sexual, and gender minorities).
Among other recommendations, the AAMC encouraged the FDA to increase partnerships with diverse groups of women and recommended that the OWH take the following steps to enhance its engagement activities:
- Collaborate with key stakeholders to help build public trust and strengthen the FDA’s relationship with researchers, patients, and caregivers in ways that shift the conversation from “outreach” to “partnership.”
- Work with the FDA’s Office of Patient Affairs to further agency efforts to develop guidance and educational resources on the use of patient experience data for medical product development and regulatory decision-making.
- Receive guidance from the FDA regarding how to incorporate relevant training or appropriate methods to facilitate successful implementation.
- Collaborate with the Office of Minority Health and Health Equity and other agencies within the Department of Health and Human Services, including the Indian Health Service and the Office for Human Research Protections’ Secretary’s Advisory Committee on Human Subject Protections.
- Include a clear process with defined metrics for the evaluation and assessment of the office’s current and new activities.