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Challenging dangerous drugs & devices.

As we described in the March issue, the Food and Drug Administration (FDA) recently announced its decision on Essure, the controversial non-surgical, non-hormonal sterilization device. The FDA incorporated most, but not all, of the NWHN's recommendations. It will now require the manufacturer to add a warning label describing adverse events experienced by the Essure's users, provide a patient information checklist of risks, and conduct a follow-up study to determine the device's long-term effects. In the NWHN's comments to the FDA, we continued to push it to require the manufacturer to fund an independent registry to track Essure patients.

On the same day as the Essure announcement, NWHN Program Director Sarah Christopherson was at the FDA reiterating the need to include women, people of color, and the elderly in clinical trials for drugs and devices. There have been a number of highly-publicized failures in this area; in 2013, for example, the FDA was forced to cut its approved dose for women taking the sleeping aid Ambien in half, after belatedly learning that the drug affected men and women differently. So, you might think the FDA's learned its lesson by now. Instead, officials suggested that advocates needed to "rethink our approach," and move away from categories like gender and race. We testified that, "Unless industry is prepared to do genetic testing on all study participants, unless physicians can do so on patients, sex, race, ethnicity, and age are now--and will be for years to come--the best proxies we have for determining how widely-used drugs and medical devices are likely to affect certain individuals." We'll keep you posted on the discussion.

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Title Annotation:The Network In Action
Publication:Women's Health Activist
Article Type:Brief article
Geographic Code:1USA
Date:May 1, 2016
Words:268
Previous Article:Raising Women's Voices for the health care we need.
Next Article:Securing sexual & reproductive health and autonomy.
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