RELEASE:

Wicker, Klobuchar Earn Committee Support for FDA Bill

Senators Work to Increase Accountability Regarding Productive Use of Patient Data

WASHINGTON – U.S. Senators Roger Wicker, R-Miss., and Amy Klobuchar, D-Minn., today announced the approval of the “Patient-Focused Impact Assessment (PFIA) Act” by the Senate Health, Education, Labor, and Pensions (HELP) Committee. The bill – approved unanimously – urges greater transparency of product approval at the Food and Drug Administration (FDA) by requiring the development of a patient engagement assessment tool as well as new guidance on how patients may submit relevant data to the agency.

“This legislation would help ensure patients’ voices are heard throughout the development of new treatments,” said Wicker. “Additionally, the reports required by the agency would provide a better understanding of how FDA uses patient input in the drug approval process, encouraging accountability. Patients suffering from rare and fatal diseases should play a part in the process of creating safe, effective drugs, and this measure would make sure their valuable time and resources are spent wisely as potential new therapies are being approved.”

“Patients deserve a strong voice in the drug development process,” said Klobuchar. “Our bipartisan legislation will help advocates understand how the Food and Drug Administration engages patients, including those with rare diseases, as it reviews drugs and therapies. It will also increase transparency in how the FDA uses patient-focused drug development tools. With today’s committee action, our bill is now one step closer to law.”

The assessment process would include a review survey that examines how a number of existing, patient-focused tools and authorities informed the FDA’s decision on a newly approved drug application.

The proposed legislation builds on the “Food and Drug Administration Safety and Innovation Act” passed in 2012, which authorized patient involvement in the FDA process. With the new bill in place, the FDA would simply be required to provide guidance on how patients and advocates can submit data to the agency and later report on how the FDA did or did not use such information, increasing accountability and transparency.

The bill is cosponsored by Senators Johnny Isakson, R-Ga., Al Franken, D-Minn., Susan Collins, R-Maine, Michael Bennet, D-Colo., Tom Cotton, R-Ark., Joe Donnelly, D-Ind., and Lisa Murkowski, R-Alaska.

3/9/16