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Faster, But…

While patients and their advocates hope that the new 21st Century Cures Act, which was passed by Congress last month, will get treatments approved faster, others worry that changes to how the US Food and Drug Administration regulates drugs and medical devices could make patients vulnerable, NPR reports.

Harvard Medical School's Jerry Avorn tells NPR's Weekend Edition Sunday that the bill was pushed through "with the idea that, somehow, Americans are being denied needed drugs because FDA is so slow and has these impossibly high standards."

The bill includes a provision that encourages FDA to use 'real-world evidence' like that from observational studies performed by drug companies or surrogate markers, which are less rigorous than randomized trials, as Vox has noted.

Avorn notes a surrogate marker was used to initially approve the drug Avastin for metastatic breast cancer, but a full study later showed it didn't help patients with advanced disease. As people tend to want the latest drug, that meant patients weren't taking older drugs that were more likely to be helpful in that time frame, he adds.

Instead, Avorn argues that the way to "fix" FDA would be to better fund it so it is no longer short-staffed.