The Power Of The Public: Isotretinoin iPLEDGE Advisory Cmte. Is Case Study In An Effective OPH
Open public hearings can include both emotional patient testimony and angry, anti-industry proclamations. During the isotretinoin REMS panel, the OPH was particularly effective in making a case for easing patient access despite the risks. Will it get FDA on board?
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iPLEDGE REMS: US FDA Advisory Cmte. Supports Relaxing Restrictions But Wants More Data
Panel favors elimination of 19-day lockout after patients who can become pregnant miss the first prescription pickup and continuation of at-home pregnancy tests. Members call for more data from isotretinoin sponsors on why acne patients are not participating in pregnancy registry and on disparities by race and ethnicity.
REMS Need Metrics For Assessing Success, Burden On Health Care System
“We don’t really have clear methods for assessing burden and access,” CDER’s Mary Willy acknowledges. A lack of baseline information hinders the measurement of whether REMS and their components are working.
‘Anti-Aging’ R&D? One Drug To Prevent Many Diseases Is Possible, But Endpoints First Need Outside Work, FDA’s Califf Says
So-called ‘healthspan’ products would reduce the risk of multiple diseases; Califf seems open to the idea but said industry and outside groups must first find consensus on the science.