SWHR Recommendations to FDA OWH on Strategic Priorities

SWHR submitted comments on the U.S. Food and Drug Administration (FDA) Office of Women’s Health’s strategic priorities. SWHR celebrates the achievements of the Office of Women’s Health (OWH) over the past 26 years in advising the FDA Commissioner and other agency officials regarding scientific, ethical, and policy issues relating to women’s health.

SWHR’s comments encouraged the FDA OWH to:

  • Lead inter- and intra-agency conversations on how best to advance SABV and the inclusion of women within clinical trials.
  • Lead agency efforts to improve the inclusion of pregnant and lactating women within clinical trials for vaccines, therapeutics, and devices and to encourage further research on already-approved products that have yet to be studied within the pregnant and lactating population.
  • Utilize real-world evidence and real-world data to supplement traditional data collection methods in order to gain a full picture of the experiences of women and minority populations both during clinical trials and post-trials follow-up.
  • Apply lessons learned from the COVID-19 pandemic to make research participation more available to an increasingly diverse range of patients, which may include specific efforts to decentralize clinical trials.
  • Continue efforts to gather patient input within the research, development, and approval processes and to prioritize diverse patient voices to the greatest extent possible.
  • Partner with relevant stakeholders to raise awareness and support women’s health programming.
  • Explore how the regulation of digital health technologies can best prioritize the specific needs of women and minority populations, and how these technologies may be appropriately applied to support the decentralization of clinical trials and to increase participation of diverse patient groups within research.
  • Identify areas where there is a clear need for innovation with regard to diagnosis and/or treatment of women’s health-specific conditions as well as conditions that predominantly affect women.

Read the Comments

SWHR submitted comments on the U.S. Food and Drug Administration (FDA) Office of Women’s Health’s strategic priorities. SWHR celebrates the achievements of the Office of Women’s Health (OWH) over the past 26 years in advising the FDA Commissioner and other agency officials regarding scientific, ethical, and policy issues relating to women’s health.

SWHR’s comments encouraged the FDA OWH to:

  • Lead inter- and intra-agency conversations on how best to advance SABV and the inclusion of women within clinical trials.
  • Lead agency efforts to improve the inclusion of pregnant and lactating women within clinical trials for vaccines, therapeutics, and devices and to encourage further research on already-approved products that have yet to be studied within the pregnant and lactating population.
  • Utilize real-world evidence and real-world data to supplement traditional data collection methods in order to gain a full picture of the experiences of women and minority populations both during clinical trials and post-trials follow-up.
  • Apply lessons learned from the COVID-19 pandemic to make research participation more available to an increasingly diverse range of patients, which may include specific efforts to decentralize clinical trials.
  • Continue efforts to gather patient input within the research, development, and approval processes and to prioritize diverse patient voices to the greatest extent possible.
  • Partner with relevant stakeholders to raise awareness and support women’s health programming.
  • Explore how the regulation of digital health technologies can best prioritize the specific needs of women and minority populations, and how these technologies may be appropriately applied to support the decentralization of clinical trials and to increase participation of diverse patient groups within research.
  • Identify areas where there is a clear need for innovation with regard to diagnosis and/or treatment of women’s health-specific conditions as well as conditions that predominantly affect women.

Read the Comments