On Friday, August 21, the Alliance for Aging Research submitted feedback to the U.S. Food and Drug Administration (FDA) regarding the reauthorization of the Prescription Drug User Fee Act (PDUFA). PDUFA authorizes the FDA to collect fees from companies that produce specific drug and biological products to support the drug review process. PDUFA has decreased the times to review new drugs, improved engagement between the FDA and patient stakeholders, increased the patient-centricity of the agency, and has accelerated the pace at which new treatments are brought to market. It was first passed in 1992, and it is reauthorized every five years. PDUFA is up for renewal in 2022.
The Alliance put forward the following key recommendations:
- Increase the representation of older adults in clinical trials
- Test and research the use of virtual and decentralized clinical trials
- Clearly define the role of real-world evidence in regulatory decision making
- Collect data on drug efficacy for older adults in post-market setting
- Expand investment in core outcome sets that can be used for assessing multiple conditions.
You can read the comments here.
About the Alliance for Aging Research
The Alliance for Aging Research is the leading nonprofit organization dedicated to accelerating the pace of scientific discoveries and their application to vastly improve the universal human experience of aging and health. The Alliance believes advances in research help people live longer, happier, more productive lives and reduce healthcare costs over the long term. For more than 30 years, the Alliance has guided efforts to substantially increase funding and focus for aging at the National Institutes of Health and Food and Drug Administration; built influential coalitions to guide groundbreaking regulatory improvements for age-related diseases; and created award-winning, high-impact educational materials to improve the health and well-being of older adults and their family caregivers. For more information, visit www.agingresearch.org
Vice President of Communications