iPLEDGE REMS: FDA Panel To Consider Changing Pregnancy Testing, Counseling Requirements
Advisory committee to discuss proposed changes to isotretinoin REMS to minimize burden and treatment delays while preventing risk of fetal exposure. Agency recommends against at-home pregnancy tests.
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US FDA makes five changes to ease burden of risk management program for acne drug – going further than the agency initially seemed comfortable with in March, though not always in line with what the generic sponsors were seeking.
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.
McKesson’s exit from the space forced sponsors to switch vendors managing their REMS programs, which in some instances affected patient access to drugs. Omnibus legislation requires GAO report and collection of public input on factors FDA should consider in reviewing vendor changes.