UPDATED Oct. 22, 2015, with details on additional legislation.
Indiana’s junior senator, Sen. Joe Donnelly (D-Ind.), yesterday launched a “medical innovation agenda” by co-sponsoring a pair of bills and signing on to 3 others that aim to streamline the FDA’s approval process.
Donnelly and Sen. Cory Gardner (R-Colo.) co-sponsored a pair of new bills, the Rare Device Innovation Act and the FDA Regulatory Efficiency Act.
The rare device measure aims to expand the FDA’s Humanitarian Device Exemption program by doubling the number of U.S. cases required to qualify, from 4,000 annually to 8,000. The regulatory efficiency measure would allow the FDA to use outside contractors to review 510(k) clearance applications.
“As a global leader in the device and pharmaceutical industries, Indiana is at the forefront of life-saving research. We must continue to close the gap between the development of new drugs and devices and bringing safe and effective products to the public. Our policies should ensure safety and encourage innovation in order to make life-saving technologies and medicines available to the people who need them the most,” Donnelly said in prepared remarks.
“Streamlining the medical device approval process will enhance the quality of healthcare for those living in Colorado and across America. While the Rare Device Innovation Act incentivizes the development of life-saving medical devices for those with rare diseases, the FDA Regulatory Efficiency Act allows the FDA to prioritize innovative medical devices that have the potential to revolutionize the health care industry. It is commonsense policy, and I look forward working with Senator Donnelly and my colleagues to support patient-centered solutions that improve quality of care while bringing down costs,” Gardner added.
J.C. Scott, senior executive vice president for government affairs at AdvaMed, said the rare device act “would allow more patients to be treated under the HDE program and remove a significant disincentive which is hampering the development of devices for small pediatric populations and for rare diseases and conditions.”
“We look forward to working with members of Congress, FDA and other key stakeholders to move this important legislation forward,” Scott said.
Donnelly also signed on to several other measures aimed at improving the FDA, including 1 that would create a fast-track program at the FDA for breakthrough medical devices. That bill, S. 1077 or ” A bill to provide for expedited development of and priority review for breakthrough devices,” was introduced in April by Sen. Richard Burr (R-N.C.) and co-sponsored by Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.). Yesterday signed on to the measure, which has been assigned to the Senate Health, Education, Labor & Pensions Committee.
The S. 1077 bill would create a priority review program at the FDA’s Center for Devices & Radiological Health for devices “representing breakthrough technologies,” “for which no approved alternatives exist” or which offer significant advantages over existing treatments. The designation would also be available to devices “the availability of which is in the best interest of patients,” according to the bill.
Donnelly also backed S. 1767, the Combination Product Regulatory Fairness Act introduced by Sens. Johnny Isakson (R-Ga.) and Bob Casey (D-Pa.) and S. 1597, the Patient-Focused Impact Assessment Act introduced by Sens. Roger Wicker (R-Miss.) and Amy Klobuchar (D-Minn.).
The combination product legislation aims to improve how the federal safety watchdog evaluates combination products that incorporate medical devices, drugs and/or biologics; the impact assessment bill would create a “patient engagement assessment tool” for the drug approval process.