Brands Push Back Against REMS Reform, Call Problem Small With Burdensome Fixes
BIO cautioned that its members may have difficulties meeting the purchase orders of product for generic sponsors, while PhRMA contended legislation is not necessary.
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Updated numbers from the US FDA's REMS abuse website show that Celgene has received two additional safety determination letters, raising question's about whether the public list has changed the practices of brand companies hindering generic company access to samples.
In addition to fielding tough questions about pricing practices at the session, executives may announce new voluntary efforts to lower drug costs and will offer their own ideas for legislation.
Legislation that would prevent REMS from blocking generics appears to be gaining momentum.