Busting 5 Common Myths About the FDA and Women’s Health
Dr. Marjorie Jenkins, Director of Medical Initiatives and Stakeholder Engagement, Office of Women’s Health, U.S. Food and Drug Administration
As a doctor and medical school professor, I have seen firsthand that men and women experience the same health problems in different ways. Physical factors like body size or hormones can influence how diseases affect women and how treatments work for them. My experiences motivated me to work toward more personalized care by focusing on sex and gender differences in my research, teaching, and clinical care. They also led me to the FDA Office of Women’s Health, where I work to educate health professionals and the public about women’s health.
Sometimes, I act as a myth-buster, meaning I share how FDA uses information about sex differences in our work and counter common myths about FDA that can mislead people about their treatments. I wanted to do some myth-busting for you with the hope that these facts and resources will help you make informed decisions about the use of FDA-regulated medical products.
FACT: FDA examines medical products to see if they work differently for women as compared to men.
FDA looks for sex differences when reviewing products. Since 1998, FDA has required companies to present data showing the effectiveness and safety of drugs for women and men. Information about known sex differences is included in the labeling for your medicine and drug trials snapshots. Because some problems don’t become apparent until after the product is approved, FDA also monitors and alerts the public about sex differences in side effects after the product is in widespread use.
FACT: FDA does not pay for and conduct the clinical trials that test new drugs or medical devices.
It is a common misconception that FDA runs clinical trials on new medical products. We do not. However, we do provide guidance to companies on how to report clinical trials data when they submit product applications for FDA review.
FACT: Women are generally in clinical trials.
Today, women are not excluded. We have made progress in many areas. FDA continues to monitor women’s participation and raise awareness about the importance of diverse women joining clinical trials.
FACT: Since 1987, FDA has required that animal drug studies be performed in both male and female animals.
Before products meant for both men and women are tested in people, they are first tested in male and female animals.
FACT: FDA can’t tell a drug company how to price their product.
FDA reviews and approves products but has no authority over the price of the product. Price is determined by the company.
Now that I have busted these common myths, I encourage you to learn more about your medicines and medical devices. FDA has resources to help you talk to your health care provider about your medicines. You can also visit FDA.gov for more information on other products.
Originally posted on: www.womenshealth.gov
JR:
Agreed. The docs in practice have to pick and choose what they have time to read. And they are held to very high standards in what they can prescribe. Even though things that don’t have rigorous approval may seem good, docs can get sued if they prescribe something “off label” (not FDA approved), and some harm is done.
That said, the whole reason for the existence of the Sex and Gender Women’s Health Collaborative is to have a site where research and articles about differences in men’s and women’s diseases and reactions to treatments are different. We hope to provide a place for quick, easy reference for clinicians.
The problem is the medical practitioners are not reading the studies that include women - and you know it. They also do not believe that if a woman does her own research on some meshuganah drug she has been prescribed, or “feigned” condition, that she hasn’t gone through National Institute of Health research, and FDA research, but must have gotten some kinda wild information from television.