For Immediate Release
Contact: Shaniqua Seth at sseth@nwhn.org or 202.682-2640, ext. 225

WASHINGTON, DC — Last week, the U.S. Food and Drug Administration released a 63-page memo regarding the dissemination of information about off-label use of medical products. The memo explains that drug makers need to provide evidence of the safety and effectiveness of the medical products they are marketing to the public.

Last November, during the FDA meeting on the Marketing of Off-Label Use of Medical Products, we testified that the FDA needs to ensure that patient and consumer safety be placed in the highest regard. Also, that women benefit from having the scientific evidence about safety and efficacy gained through clinical trials, which are circumvented when a manufacturer can turn to off-label communications.

We are pleased that the FDA is taking our concerns into consideration. We are particularly pleased that the FDA has pulled together two appendices with examples of where patients were hurt. In 2015, we submitted comments to the FDA regarding our concerns about vaginal estrogen products. Our concerns included issues of dosage, lack of studies about long-term risks, and lack of information on non-hormonal preparations that are equally effective in treating vulvovaginal symptoms.

The NWHN believes the FDA should continue to strengthen the drug and device regulatory process to protect the American public. Consumers must have access to adequate information in order to make the best medical decisions that are right for them. The NWHN is supported by members, not industry profits, and we feel the FDA should continue to stand up for women’s health and consumer safety by refusing to give in to industry demands that would make medical products less regulated.

The National Women’s Health Network is supported by our members and by choice, we do not accept financial support from drug companies or medical device manufacturers. We bring the voices, concerns and needs of women consumers to policy and regulatory tables.