FDA’s Accelerated Approval Process Shouldn’t Compromise Safety for Patients

By Karuna Jaggar, Executive Director

As a public health watchdog, Breast Cancer Action works to bring a patient perspective to the Food and Drug Administration’s (FDA) evaluation of new breast cancer treatments and devices.

Patients and consumers depend on the FDA to ensure that medical drugs and devices are safe and effective. No one is more concerned than patients with bringing effective new drugs and devices to the market as quickly as possible. But any effort to streamline the FDA’s approval process must also uphold the strongest safety standards. Patients and their physicians need adequate data to make informed decisions. Unfortunately, current expedited approval processes fail to provide doctors and patients with sufficient evidence and have effectively lowered safety standards.

For years, BCAction has expressed concern about the use of surrogate endpoints, accelerated approvals based on limited data, failure to conduct post-market studies, and the 510(k) pathway for device approval, among other issues. We applaud Congresswoman DeLauro’s leadership in urging the FDA to strengthen safeguards for all medical products sold in the United States. Consumers and patients depend on the FDA to ensure timely approval of new drugs and devices, and they depend on the FDA to make such decisions without compromising strong standards of safety and efficacy.

This entry was posted in BCA News.