FDA Seeks Members for New Patient Engagement Panel
The FDA is seeking members for a new Patient Engagement Advisory Committee to provide input on issues related to the development of new treatment modalities.
The nine-member panel, announced Sept. 21, will advise the agency on guidance and policies, clinical trial and registry design, patient preference studies, device labeling and unmet clinical needs.
Potential topics include:
- Where can patients provide input across the medical device total product lifecycle?
- How can the agency engage patients for input related to medical device premarket considerations?
- How should the FDA seek input from patients related to device performance once a product is on the market?
- When should labeling include information about patient preference studies or patient-reported outcomes?
- How should sponsors present patient preference information or PROs in labeling?
- How should labeling indicate that only a portion of patients in a patient preference study are willing to accept certain risks to achieve probable benefits?
- How should sponsors and the FDA ensure patients receive and understand PPI?
- How can patient preferences be obtained in an unbiased manner if the study has been enrolled or published? and
- How do patients view clinical study informed consent forms?
The Center for Devices and Radiological Health is seeking experts from patient and health professional organizations, as well as those familiar with communicating risks and benefits to patients, to join the committee. It will also include a technically qualified consumer representative.
“Although it may seem odd in retrospect, the development of new technologies intended to improve patients’ lives has largely relied upon expert opinions rather than asking patients and families directly what they consider most important,” say FDA Deputy Commissioner for Medical Products and Tobacco Robert Califf and CDRH regulatory scientist Nina Hunter in a blog post accompanying the Federal Register notice. Califf was recently nominated to take over as FDA commissioner (IDDM, Sept. 20).
The committee is part of the FDA’s Patient Preference Initiative, which kicked off a little over two years ago. In May, the agency issued draft guidance describing factors sponsors should consider when collecting patient preference information for use in premarket approval and humanitarian device exemption applications and de novo requests ().
Patricia McGaffigan, chief operating officer and senior vice president of program strategy and management at the National Patient Safety Foundation, sees the committee as a win for patients and their families.
She’s also pleased that the committee will include a consumer representative, but says the FDA needs to clarify what “technically qualified” means.
But other groups, like the National Center for Health Research, worry that creating a distinct panel for patients will segregate them from other panels, on which they should play a greater role.