Buy Zoë Christopher, Resource Liaison & Office Manager
We Can’t Be Pink’d week TWO is here and we’re calling on the Food and Drug Administration (FDA) to do better to protect patients and consumers! Last week you joined us in our first week of Think Before You Pink® action and told the Environmental Protection Agency (EPA) to stop rollbacks and protect our health. This week we are calling on the FDA to uphold strong standards and improve transparency to ensure drugs and medical devices are safe and effective.
Here’s the problem:
Breast cancer patients need to depend on the FDA to ensure that medical drugs and devices are safe and effective. However, there has been a decline in standards at the FDA.
The FDA is under extreme pressure from the administration and industry to rush approvals to market. This new and flawed approach to approvals could be precedent setting, further lowering the already low standards used to assess safety and efficacy of future breast cancer drugs, treatments, and devices.
In addition to the implications of accelerated approvals, the FDA lacks transparency regarding potential harms and risks. This lack of transparency in the approval and regulatory process leaves patients and consumers misinformed, putting them at risk for other health complications that can be debilitating, costly to treat, or even life threatening.
Breast implants have been on the market for more than fifty years, yet there is still a lack of adequate safety data. Earlier this month, the agency updated their labeling recommendations for breast implants, and added new informed consent procedures. However, the guidance is not mandatory for manufacturers or plastic surgeons and there is weak language that minimizes risk and disregards the thousands of women who have reported health harms.
We expect the FDA to say no to pink policies and fulfill its mission to protect the public’s health with strong regulations and transparency.