RELEASE:

Wicker, Klobuchar Introduce Bill to Increase FDA Transparency

Senators Encourage Accountability Regarding Productive Use of Patient Data

WASHINGTON – U.S. Senators Roger Wicker, R-Miss., and Amy Klobuchar, D-Minn., today introduced the “Patient-Focused Impact Assessment (PFIA) Act,” which urges greater transparency of product approval at the Food and Drug Administration (FDA). The measure would require the development of a patient engagement assessment tool, the results of which would be included in the publicly disclosed safety and effectiveness data package of any approved drug.

“This legislation would allow advocates to see how FDA is incorporating the voice of the patient community during the drug approval process,” said Wicker. “Its potential impact on victims of rare and fatal diseases, such as Duchenne muscular dystrophy, is instrumental in facilitating the use of necessary – and often high-risk – medication.”

“We have successfully fought to give patients an increasingly strong voice throughout the drug development process,” said Klobuchar. “Our bipartisan legislation will build on this progress by helping advocates understand how the FDA uses patient-focused drug development tools and engages patients, including those with rare diseases, as it reviews drugs and therapies.”

The assessment process would include a review survey that examines how a number of existing, patient-focused tools and authorities informed their decision on a new drug application. Topics would include benefit/risk data for the indicated populations, draft or final guidance, patient-preference data, patient-reported outcomes data, and the views of patients and other external experts on the application. The FDA would also compile a report summarizing the agency’s use of the tools within applications reviewed during the preceding year.

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, FDA would simply be required to report on how they are using data provided to them by patients and advocates, increasing accountability and transparency.

The bill is cosponsored by Senators Johnny Isakson, R-Ga., Al Franken, D-Minn, Susan Collins, R-Maine, and Michael Bennet, D-Colo.

6/18/15