Senators Joe Donnelly (D-IN) and Cory Gardner (R-CO) have re-introduced the bipartisan FDA Regulatory Efficiency Act, which would allow the Food and Drug Administration (FDA) to bring innovative medical devices to market more quickly.
Donnelly stated, “As scientists and innovators across Indiana and our country work to find new cures and therapies, we should be making it easier for them to bring these products safely to those who need them. I’m proud to work with Sen. Gardner on this bipartisan legislation to cut through the red tape at the FDA and safely speed up the approval process.”
The FDA Regulatory Efficiency Act would help the FDA concentrate on high-priority activities by authorizing third parties to approve quality systems of device companies. Authorized third parties could only approve changes that do not involve major technology changes or changes in the use of the product. The legislation would still hold companies accountable for their quality systems, while also helping to alleviate the overwhelmed FDA. Donnelly and Gardner first introduced the legislation in October 2015.
Health Care Reform Notes
Freshman Sen. Todd Young has reached across the aisle in an attempt to find common ground on health care. He recently sent a letter to all Democratic senators urging them to share their views on what’s working and what’s not with the Affordable Care Act. Young is a member of the Senate Health, Education, Labor and Pensions Committee, which will have a key role in shaping the Senate’s version of health care reform.
Congresswoman Jackie Walorski (IN-02) is touting the American Health Care Act (AHCA), as passed in the U.S. House of Representatives, and how it “brings us closer to a better health care system that puts patients first.” Her editorial appeared Sunday in the South Bend Tribune.
Congressman Larry Bucshon, M.D. (IN-08), who sits on the House Committee on Energy and Commerce where he is a member of the Subcommittees on Health, is using his web site to promote the Washington Post’s fact-checking of several recent claims about the AHCA. One is on coverage for those with pre-existing conditions and the other on classification of assault as a pre-existing condition; both claims were deemed untrue.