Per BioCentury, Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.) previewed on Tuesday the goals of legislation they plan to release this month as part of their 21st Century Cures initiative.
In commentary published by CNN, the legislators wrote that their bill will seek to “modernize clinical trials to streamline the approval of drugs and devices,” in part by reducing paperwork and promoting adaptive trials. It will also help FDA “better integrate the patient perspective into the regulatory process,” including using public-private partnerships to strengthen science around biomarkers and patient-reported outcomes.
The bill's sponsors also aim to promote “better access to and sharing of information such as genomic and other clinical data to foster more collaboration among researchers," and to invest in programs for young scientists. Upton -- the chair of the U.S. House's Energy & Commerce Committee -- and DeGette also plan to “incentivize new drugs and devices for unmet medical needs” by “streamlining the premarket process while establishing mechanisms to better capture real world evidence post-market." They also said they will examine incentives, including “exclusivity or simplifying the reimbursement process,” to stimulate the development of new drugs and devices for unmet medical needs.
More as more develops.