ROCKVILLE, MD: The FDA has launched a national education campaign to help reduce confusion about the risks and benefits of menopausal hormone replacement therapy (commonly known as HRT).
Commissioner Mark McClellan announced the initiative at a press conference on Tuesday.
Although Congress mandated the directive last year, when a landmark HRT study was halted for concerns about increased risk of heart disease, stroke, and breast cancer, legislators have not yet provided funding for the programs. Nor has Wyeth, the largest maker of hormone products.
The budget, which is "still under discussion," according to Peter Pitts, head of external
relations at the FDA, is being funded by the FDA and several healthcare organizations involved in the cause.
Along with some Health and Human Services departments, such as the National Institutes of Health and the National Women's Health Information Center, as well as other women's and community groups, the FDA has created materials based on the latest science involving HRT.
The FDA's internal communications team will handle information dissemination and media relations with the aid of partner organizations. The agency is also developing its own ads, and working with publications to run them pro bono. No external PR or ad agencies have been retained for the effort.
Pitts called the effort "an integral part" of the FDA's push to better inform consumers, which is one of five focus areas from the FDA's strategic action plan, which was released last month.
Natalie deVane, spokesperson for Wyeth, which markets the HRT therapy, said, "We are not formally involved, but clearly the initiative is important. Hopefully this information will empower women to go out and have discussions with their doctors so they can make informed decisions about HRT."