Two Republican senators are calling for the reauthorization of the FDA user fee act as a catalyst for changes at the agency.
In a letter addressed to the various councils representing the life sciences industry, Sens. Richard Burr (R-NC) and Tom Coburn (R-OK) wrote that “reauthorization of the U.S. Food and Drug Administration user fee agreements provides an important opportunity to address the root causes of the threats to our nation’s leadership in medical innovation.”
“As you negotiate the next user fee agreement and prepare to submit the proposal to congress, we wish to underscore the necessity of restoring regulatory certainty and predicability,” they wrote.
Click here to download the letter from Sens. Coburn and Burr
The GOP senators said they would welcome proposals to streamline the FDA process to “ensure America’s patients have access to safe and effective life-saving drugs and devices in as timely a manor as possible.”
The letter comes as the medical device industry prepares to renegotiate the Medical Device User Fee and Modernization Act, which is set to expire in 2012. It also marks another level of escalation of the rhetoric on Capitol Hill that cumbersome regulation at the FDA is affecting innovation in medicine. The GOP has been particularly helpful in echoing the calls of industry and are calling for changes to be made at the watchdog agency.
In hearings on The Hill earlier in the month Rep. Erik Paulsen (R-Minn.) told the panel that America’s “supremacy [in the medical device world] is at stake by bureaucracy within our own borders,” pledging to introduce legislation that would “restore the balance, as well as modernize and streamline the FDA.”
