Brand/Generic Battles Over REMS Raise Constitutional Questions For FDA
ANDA sponsors may increasingly face a new roadblock to FDA approval: a Risk Evaluation and Mitigation Strategy (REMS) that restricts access to samples of the brand name product.
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Generic companies say innovators are using voluntary restricted distribution programs to prevent them from obtaining reference drugs for bioequivalence testing; a July hearing is set in a dispute involving Actelion’s Gaucher disease drug Zavesca, which is not subject to a Risk Evaluation and Mitigation Strategy.
The Federal Trade Commission is looking into whether companies are using their Risk Evaluation and Mitigation Strategies to thwart generic competition.
FDA should create a system to allow generic firms that want to develop ANDAs for products in closed distribution systems to obtain samples from the brand sponsors, the Generic Pharmaceutical Association says