FDA Approval: Who’s Being Harmed and Who’s Being Helped?

March 2014

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How the heck does the Food and Drug Administration (FDA) decide whether a new breast cancer treatment or diagnostic tool is safe and effective? Why are new drugs and devices not necessarily better than old ones? What does it mean for a drug to get “accelerated approval,” and is this a good thing? And if a new medical product has benefits that outweigh the risks, does that mean the product is a good idea for you?

The FDA approves a few dozen new drugs every year, but approximately 5,000 new medical devices, such as breast and other implants, mammography and MRI machines, radiation therapies, and infusion devices. Prescription drugs are tested in clinical trials, but almost all devices are approved through a “quick and easy” process that usually doesn’t require any testing to prove that these medical devices are safe or effective. As a result, some of these devices are neither safe nor effective!

Sahru Keiser, MPH Education and Mobilization Coordinator and Dr. Diana Zuckerman, President of the Cancer Prevention and Treatment Fund of the National Research Center for Women & Families, discussed the FDA drug and medical devices approval process and ways you can get involved to ensure that patient interests come first at the FDA.

 

 FDA Approval webinar slides

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