SWHR is committed to advancing the health of women through the discovery of new and useful scientific knowledge.
The FDA is tasked with guarding the safety, efficacy, and security of human drugs, biological products, and medical devices. We strongly believe that appropriate funding of the FDA by Congress is critical for the Agency to function and to assure the American public of the safety of its food and drugs.
SWHR is an active member of the Alliance for a Stronger FDA, a coalition composed of a broad group of patient groups, consumer advocates, biomedical research advocates health professionals and industry which have come together to work to increase FDA‘s appropriations in order that the Agency can adequately address the many challenges it faces in addition to its purely regulatory functions. The Alliance is supported by leading public health advocates, including three former HHS Secretaries and seven FDA Commissioners.
Since the founding of the Alliance for a Stronger FDA, the FDA has been provided significant increases to its budget every year to meet the needs of scientific growth, innovation and development, and adequate food and drug protection. In addition, through the efforts of SWHR to protect the budget of the FDA Office of Women’s Health (OWH), the Office has received an increase of $1 million dollars.
Information Technology (IT)
The antiquated nature of the IT systems at FDA make the agency unable to conduct safety analyses for product marketing applications, track the natural history and disease models for rare disorders, and access huge amounts of clinical data. The creation of a central database must happen to provide for a system query to a centralized repository for all relevant facts about a certain product including where, when and how the product was made. Such a uniform centralized database will be relevant for all information stored across agencies, so as to maximize functionality not only of FDA’s data but of expected research and analysis needed by the American public.
Currently, the FDA receives large volumes of information in applications from drug manufacturers for review and evaluation, many still in paper form. FDA reviewers must manually comb through the submitted drug trial reports and digital data in as many as twelve formats to evaluate a new drug’s safety and effectiveness. Frequently reviewers must handpick data manually from stacks of paper reports and craft their own data comparisons. This process is time consuming, makes the review process less efficient, and is error-prone and delays access to important information. Scientific and medical advances are occurring rapidly and the public needs and deserves access to the most recent and accurate information regarding their health. It is time Congress recognize that the Agency must utilize up-to-date information technology and that it sorely needs the resources to maintain them.
Office of Women’s Health
OWH at the FDA, established in 1994, plays a critical role in women’s health, both within and outside the Agency, supporting sex- and gender-based research, areas in which SWHR has long been a proponent. OWH provides scientific and policy expertise on sex and gender sensitive regulatory and oversight issues; endeavors to correct sex and gender disparities in the areas for which the FDA is responsible drugs, devices, and biologics; and monitors women’s health priorities, providing both leadership and an integrated approach across the FDA. OWH provides all women with invaluable tools for their health, both by the development and distribution of pamphlets on women’s health and via their website.