WASHINGTON—Having secured a funding boost for the National Institutes of Health in the 21st Century Cures legislation, House Democrats now say the Food and Drug Administration would be ill-equipped to handle the new burdens under the bill without more resources.
Rep. Frank Pallone (D-N.J.), the ranking member of the House Energy and Commerce Committee, raised the matter during a hearing Wednesday on the latest iteration of the legislative package, which is intended to accelerate the pace of innovation in medical drug and device development.
The bill would create significant new regulatory leeway for manufacturers and in the process would put new demands on the FDA.
Pallone, noting that the draft bill calls for the FDA to develop 15 new guidances, asked whether the FDA would have the resources to meet those requirements.
“There's a trade-off between creating new guidance and programs and … reviewing products in a timely manner,” answered Dr. Janet Woodcock, the head of FDA's Center for Drug Evaluation and Research. Previous congressional decrees have caused the agency's performance to suffer, she said. “We're making all our deadlines, and we'd like to keep it that way.”
Dr. Jeff Shuren, Woodcock's counterpart in the FDA's device division, said the agency's budget is roughly the same now as it was a decade ago when adjusted for inflation. “Our purchasing power today is the same as 10 years ago, but our responsibilities are greater,” Shuren said. That increased burden, he said, contributes to high turnover in the agency.
Pallone's fellow Democrats, including Reps. Diana DeGette of Colorado and John Sarbanes of Maryland, also raised concerns about whether the agency could carry out the new responsibilities in a timely manner.
“We are asking the FDA to make many changes to their current operation,” DeGette said. “We should make sure the agency has the resources to carry out these duties.”
Democrats may be running out of time to influence the shape of the legislation. DeGette said that legislative markup of the package would be “soon,” though she did not provide a specific timeline.
However, DeGette also noted that the bill has not been scored by the Congressional Budget Office, and that the drafters have not yet found money to pay for the bill's various provisions.
