If they're selling it, it must be safe. Right? Wrong! The FDA needs to hear YOUR voice. Drug companies must routinely include women in health research!
For decades, health research was done on men and the results were assumed to apply to women. Women were treated as if we were just smaller versions of a male body. Ridiculous! Serving a woman's real health needs should always be first on the list of reasons why a new drug might be available on the market.
Even today, women's aren't required to be included in all clinical trials. That means women may still take drugs or use devices that have never been tested on women.
The National Women's Health Network drew attention to this problem more than 20 years ago. While things started to change in the research world, many clinical trials still fail to include enough women to provide ample information so women can make informed decisions. How can you know whether a drug will improve your health if there weren't enough women in the trial to evaluate its safety and effectiveness?
Now, as directed by the law we helped put in place, in August the FDA has to release an Action Plan to improve the data it gets about medical products for women. And we need your help.
Please write today to FDA Commissioner Margaret Hamburg and urge her to develop a strong Action Plan that will improve women's health by requiring companies to include women in clinical trials, evaluate the evidence based on sex, and make that information available to women!
Dear Commissioner Hamburg,
Women and their healthcare providers need complete and accurate information about the medical products available to them – particularly the specific benefits a drug or device might offer and risks it might pose to a woman because she is a woman.
I am writing to urge the FDA to address the lack of evidence on sex-specific effects of drugs and medical devices by ensuring that the Action Plan called for in Section 907 of the Food and Drug Administration Safety and Innovation Act includes the following requirements:
• The FDA should require that companies submitting trial data to the agency not only include women in clinical trials but ensure enough women are in the trial to analyze a drug or device's safety and effectiveness data based on sex.
• The FDA should require companies to evaluate the safety and effectiveness of drugs and devices based on sex and reject applications that do not include the required information.
• The FDA should require that companies include sex-specific safety and effectiveness information on the labels of drugs and devices so that it is publicly available to women and their healthcare providers.
• The FDA should establish procedures to track and publicly report compliance with these requirements on a regular basis and should take enforcement action against companies that do not comply.
[Your comments here]
You have an important opportunity to improve women's health by requiring companies to include women in clinical trials, evaluate the evidence based on sex, and make that information available to women. Please take it!
[Your name here]
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