FDA Drug Center Chief: Legislation Not Needed For Patient-Reported Outcomes Collection

FDA drug center chief Janet Woodcock told the House Energy and Commerce health panel Friday (July 11) that legislation is not needed to help the agency better incorporate patient-reported outcomes in the drug development process. Instead, she said, FDA could engage patients and industry to develop standards for soliciting patient perspectives, and to develop validated tools to measure patients' risk tolerance. Democrats also raised concerns with Congress playing a role in ensuring FDA includes patient-reported outcomes in the approval process,...