NYT op-eds: 21st Century Cures strengthens FDA

The New York Times published 2 letters-to-the-editor supporting the 21st Century Cures act after releasing 2 op-eds slamming the act over the past week.

The letters came from Marc Boutin, chief exec of the National Health Council and Stephen Ubl, the chief exec of medical device trade association Advamed. Both responses outlined what the authors believe to be benefits for patients in the bill.

Boutin responded by stating that the bill would improve oversight by allowing the FDA to use data from patients currently using drugs and devices. This data, he said, would only be used to supplement clinical trial data, not supplant the “rigorous agency standards already in place.”

Boutin said that more than 250 organizations representing individuals with chronic conditions had signed a letter supporting the bill and its strengthening of the FDA’s oversight.

In his letter to the editor, Ubl said that the FDA’s oversight was far from “flimsy”, a line used to describe the federal watchdog’s regulation of medical devices in an earlier Times article.

“The agency can require any data it deems necessary to determine a product’s safety and effectiveness, and it has ample authority to remove any device from the market that fails to meet specifications,” Ubl wrote.

Ubl states that the act will not change the agency’s regulatory requirements, but build onto an existing program to expedite breakthrough technologies for serious conditions and diseases.

By allowing the FDA to focus its resources on critical review activities and providing the agency with more data, Ubl argues, the bill will give the federal watchdog more data to take into consideration, not less.

“This bipartisan legislation will encourage development of safe and effective treatments and make them available to patients more quickly. No wonder it has strong support from the agency and patient and physician groups,” Ubl concluded.

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