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Faster approval for drugs and medical devices under the 21st Century Cures Act raises concerns for patient safety

President Obama signed a bill that will provide US$6 billion in federal funding for basic medical research on Dec. 13. Called the 21st Century Cures Act, it also introduces changes to how the Food and Drug Administration approves drugs and medical devices, creating two new mechanisms aimed to speed regulatory review to bring medicines and devices to market faster.

The first of these eases the process of review for certain medical devices deemed to be “breakthrough” technology. The second speeds up review of certain drugs by lowering the threshold on the types of data the FDA can use to make decisions.

These changes were longstanding demands of the pharmaceutical industry, which lobbied heavily in favor of the new law. Patient advocacy groups also supported the legislation.

As an FDA scholar at the Jaharis Health Law Institute at DePaul, I worry that faster regulatory review and approval might come at a cost. We may sacrifice safety and efficacy of drugs and devices approved under this new system.

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