CHICAGO – Bipartisan legislation designed to streamline the US Food and Drug Administration review process is scheduled to be introduced in Congress this week, the measure’s chief author said here.
“Medical innovation has come under attack,” Representative Erik Paulsen (R-3, Minn.) said during a news conference at the American Society of Cataract and Refractive Surgery annual meeting.
“Truthfully, this American success story is now under threat within our own borders by our own government,” Rep. Paulsen said.
H.R. 3205, the FDA Renewing Efficiency from Outside Reviewer Management (REFORM) Act, includes enhancements to the third-party review process and reaffirms the FDA’s mission to review products in the “least burdensome” manner without compromising safety. It also calls for expediting approval of devices for humanitarian use.
Many companies cannot afford the high cost of FDA clinical trials, and as a result, the number of pre-market applications has diminished significantly in the last decade, Rep. Paulsen said.
However, medical products remain one of the leading exports in the US, he said.
The FDA can streamline and expedite the review process without compromising safety standards, Rep. Paulsen said.
“This is not going to reduce safety standards in any way whatsoever,” he said. “This is making sure that we’ve got the gold standard and the Good Housekeeping seal of approval for a safe device. It’s also making sure that the process is not only rigorous but it’s relevant.”
In addition, industry and the FDA should work as partners, not antagonists, he said.
“I think this is the way it used to be,” Rep. Paulsen said. “There used to be a partnership wanting to see the project through.”
Reviews for CE Mark designation in Europe are completed in about half the time, at about half the cost, compared with reviews at the FDA, Rep. Paulsen said.
Also being added to the bill is a provision that would significantly reduce a 2.3% excise tax on medical devices, Rep. Paulsen said. The tax places an undue burden on device companies and should be trimmed, he said.
Rep. Paulsen is co-chairman of the House Medical Technology Caucus, a bipartisan coalition of 70 House members. He also serves on the House Ways and Means Committee.