A bill approved by a Senate committee will speed up medical device approvals by the US Food and Drug Administration (FDA) and increase funding for medical research
According to Fortune the measures were approved Wednesday with bipartisan support across most of the issues. Democrats got on board after heavy negotiations that led to a budgetary boost for medical research at the National Institutes of health, as well as a simplified approval process for ‘breakthrough’ products.
The new ‘breakthrough’ designation stipulations will reduce the amount of time it takes for medical devices to gain FDA approval as clinical trials for these products will be allowed to have less participants or take a shorter amount of time than current conditions require.
Whilst the speed of devices that are passed through ‘breakthrough’ designation will be increased, the amount of devices that are approved under the ‘breakthrough’ designation will be narrowed.
However, Fortune reported that patient safety advocates worry that a faster approval process could leave patients at risk if the FDA doesn’t have the time to ensure each medical device’s safety
Diana Zuckerman, president of the National Center for Health Research in Washington, wrote a letter to senators, in it she said: “We are concerned that the focus of these bills is on getting medical products to market more quickly, instead of making sure they are safe and effective.
“Whether creating a new breakthrough pathway for devices (which already are approved based on much lower standards than drugs) or deregulating health IT software, for example, patients will be at risk.”
Yet AdvaMed, the medical-device industry association approved of the bill and said in a statement it, “will help ensure more timely patient access to the latest medical innovations and improve the efficiency of FDA’s device review process.”