As a massive healthcare bill draws closer to the House floor, defenders are pushing back against attacks that it would lead to unsafe medical products.
During a press conference Tuesday, members of the House Energy and Commerce Committee said the 21st Century Cures Act would not roll back safety regulations. The bill attempts to streamline the clinical trial process, create a new pathway to accelerate approval of new devices, and give drug companies more exclusivity for developing needed products.
Recently two medical experts questioned whether the bill’s goal of speeding up the approval of cures could come at the expense of thorough reviews for safety and effectiveness.
Supporters of the bill took aim at the criticisms on Tuesday.
“I would like the people that raise the issues to just take a look at the legislation,” said Rep. Frank Pallone, D-N.J., ranking member of the committee. “We know that the status quo needs some changes.”
Rep. Diana DeGette, D-Colo., said the U.S. has a high safety standard for drugs and devices.
“We are the world standard for drugs and devices and we intend to meet or exceed that,” said DeGette, a member of the committee who was an instrumental part of the legislation.
DeGette said the bill also provides $550 million in additional funding for the Food and Drug Administration over the next five years to help ensure the agency does not take any shortcuts.
Committee members have been pushing to get the bill to the House floor, a goal that Chairman Rep. Fred Upton, R-Mich., said is just within reach.
“We want as strong a vote as we can,” Upton said, hoping that the bill will get to President Obama by the end of the year.
