Generics REMS Hurdles Lowered Somewhat By FDA Protocol Letters
This article was originally published in PharmAsia News
But the U.S. FDA still cannot force brand firms to provide products for bioequivalence testing, which may limit the policy’s ability to remove a barrier that generic firms allege some NDA sponsors use to block competition.
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Advantages could be shorter review times and expanded labels, but there are concerns about no global regulator having access to full patient-level data.
GPhA says congressional action is only remedy after study estimates $5.4 billion in potential savings is lost annually because of brand manufacturers using REMS to prevent generic competition.
FDA’s use of REMS continues to fall to almost undetectable levels, with the agency using the safety tools just a handful of times in the sixth full year of the program. REMS are now very much the exception and not the rule for new products – but still a very important exception.