Lois Capps: “I thank my colleague for yielding. Mr. Speaker, I rise today in strong support of the FDA Safety and Innovation Act.…”

“I thank my colleague for yielding. Mr. Speaker, I rise today in strong support of the FDA Safety and Innovation Act. This bipartisan effort will improve the health and safety of the American people; and at the same time, it will support good jobs and innovation in the health care industry. I am especially pleased that this bill includes two provisions which I authored: The first is modeled on my SAFE Devices Act, which will improve the post-market surveillance of medical devices and the implementation of the unique device identifier program. This essential provision will allow us to identify potential device problems early, thereby protecting patients and identifying issues when they are easier and less costly to address; The second provision I authored comes from my bipartisan HEART for Women Act, which the House has passed two times. It requires the FDA to report on the availability of new drug and device safety and efficacy data by sex, age, and racial and ethnic subgroups. Drugs and devices can have dissimilar effects among various populations, and this provision will help reduce substantial disparities in health care, especially for women and minorities. So I thank the chairmen and ranking members for their leadership on the FDA Safety and Innovation Act and for their support of these two provisions. I urge my colleagues to support this bipartisan bill.”