House Republicans' demands for faster regulatory review of medical devices were met by Democratic warnings that the process would slow further with the lower regulatory funding expected from the Republican-controlled chamber.
Lawmakers debate cuts' effects on FDA
“Is it a culture that is slowing things down or do they not have enough resources?” Henry Waxman (D-Calif.), said during a hearing on the issue by the House Energy and Commerce Health Subcommittee.
As part of Republican efforts to obtain $100 billion in cuts government-wide, their funding measure for the remainder of the fiscal year would reduce Food and Drug Administration funding by $74 million from the previous year, or $220 million less than the Obama administration requested for the agency.
New initiatives proposed by the FDA—including the recently announced Innovation Pathway program for certain breakthrough technologies—will not occur if the funding cuts are approved, according to Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.
But no amount of additional funding for the FDA, according to Republicans, will overcome the systemic problems at the agency, including the tendency of its officials to regularly change their approval requirements for medical device developers in the middle of the application process.
“Why would you give more [money] for what you're getting?” Rep. Michael Burgess (R-Texas), said about the lengthy FDA reviews. “Do we want more of this?”
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