WASHINGTON — The U.S. Senate approved a Food and Drug Administration bill on Thursday containing measures to reform the medical device approval process. The bill, which passed 96-1, includes half a dozen provisions from Minnesota Sens. Amy Klobuchar and Al Franken.
The crux of the bill relates to the fees medical device companies pay to the FDA, which Congress needs to reauthorize by the end of September. The bill includes a litany of measures meant to speeding up the FDA’s approval of medical devices, an industry with a major Minnesota presence and one of the main focuses for some members of the state’s congressional delegation.
Both Minnesotans in the Senate are taking credit for three sections of the FDA bill. Klobuchar provisions include those instituting a quicker, more seamless medical device approval process, a section meant to curb medication shortages and one solidifying the federal ban on synthetic drugs.
“It’s a triple-whammy for Minnesota,” Klobuchar said after the vote.
Franken included language meant to streamline the FDA device approval process by reforming conflict of interest rules, encouraging companies to manufacture devices for rare diseases and cutting down on paperwork companies have to file with the FDA. Franken is a member of the Senate Health, Education, Labor and Pensions committee, the panel tasked with assembling the bulk of the bill.
The House must pass an FDA bill before the fall, and it’s expected to do so relatively soon and with similar bipartisan support as the Senate.
Devin Henry can be reached at firstname.lastname@example.org. Follow him on Twitter: @dhenry