Patient Involvement Emphasized by Health Council in Advice to Next President
The FDA should promote greater patient involvement in development of drugs and other treatments for diseases, the National Health Council said in a set of priority considerations for the next presidential administration.
The council was among more than 100 thought leaders recruited by the National Academy of Medicine to write expert papers to address “the unprecedented challenges — and extraordinary opportunities — the incoming presidential administration must weigh as it charts the next steps for health reform in the United States.”
The NHC said efforts to increase patient and family engagement should include:
- Strengthening and expanding initiatives for patient engagement, such as those under way at the FDA Center for Drug Evaluation and Research and the Center for Devices and Radiological Health.
- Continuously evolving the FDA’s Patient-Focused Drug Development program to create opportunities for patients and patient organizations to provide their perspectives to FDA.
- Convening the FDA and stakeholders, including the patient community, to establish methods for gathering and using patient input in drug development.
- Clarifying how the FDA will evaluate and measure patient preferences and incorporate them into regulatory assessment.
- Helping to educate the patient community about drug development, regulation, and insurance coverage and about mechanisms for participating in patient-engagement efforts.
- Convening the Centers for Medicare & Medicaid Services and stakeholders, including the patient community, to gather input for assessing the value of new medications and the implications for drug coverage and reimbursement.