Committee approves bipartisan Wicker bill to add transparency to FDA approval process

A Senate committee approved bipartisan legislation cosponsored by U.S. Sen. Roger Wicker (R-MS) on Wednesday to make FDA product approval more transparent.

The Senate Health, Education, Labor and Pensions (HELP) Committee approved the Patient Focused Impact Assessment (PFIA) Act, S. 1597, that was cosponsored by Wicker and U.S. Sen. Amy Klobuchar (D-MN).

Under the bill, the FDA would be required to establish a patient engagement assessment tool and establish new guidance on how patients can submit data to the agency for review.

“This legislation would help ensure patients’ voices are heard throughout the development of new treatments,” Wicker said. “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.”

The bill’s assessment process entails a review survey that would look at how patient-focused tools and authorities shaped the FDA’s decision on a particular drug application.

“Patients deserve a strong voice in the drug development process,” Klobuchar said. “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 Food and Drug Administration Safety and Innovation Act of 2012 authorized patient involvement in the FDA approval process. The PFIA Act would require the FDA to provide guidance on how feedback can be submitted and to report on how that information was used in the approval process.

U.S. Sens. Susan Collins (R-ME), Johnny Isakson (R-GA), Al Franken (D-MN), Michael Bennet (D-CO), Tom Cotton (R-AR), Joe Donnelly (D-IN) and Lisa Murkowski (R-AK) cosponsored the bill.