Dive Brief:
- The GAO released two reports this week that suggest the FDA is failing to keep pace with medical science.
- Tennessee Senator Lamar Alexander (R), Senate health committee chairman, is attempting to seize the findings to ignite Senate progress on biomedical reform, STAT reported.
- The reports come just as the Senate is working to pass a version of the 21st Century Cures Act (already passed by the House) which would push for drugs and medical devices to get faster approval.
Dive Insight:
The GAO's first report concluded the FDA is not measuring its progress -- or lack thereof -- in keeping up with the science behind the drugs and devices it regulates, and that it is not accounting for its spending on these efforts.
The second report found fault with the FDA’s strategic plan, intended to help bring life-saving drugs and devices to patients more quickly. It said the FDA lacked plans for actually implementing processes to achieve its stated goals and performance measures for oversight of medical products, including combination medical products like heart stents also purposed with delivering blood thinners to reduce the risk of clots.
“These reports demonstrate the need for Congress to pass smart laws and then conduct rigorous oversight to ensure that an agency tasked with safeguarding the health of Americans isn’t falling behind,” Alexander stated.
It’s unclear whether the issues outlined by the GAO would be resolved by either the 21st Century Cures bill or other Senate biomedical bills, STAT added.
Some opponents to the Cures bill argue it would excessively diminish the FDA's standards for drug and device approval.