Lawmakers Urge FDA To Rewrite 'Deemed To Be A License' Biosimilar Guide

September 20, 2017 at 5:04 PM
Congressional Diabetes Caucus Co-chairs Diana DeGette (D-CO) and Tom Reed (R-NY) wrote to FDA Commissioner Scott Gottlieb Wednesday (Sept. 20) urging the agency to revise guidance on the Biologics Price Competition Innovation and Act (BPCIA)'s “deemed to be a license” provisions, arguing FDA's existing policy discourages market entry for lower price insulin products. The Association for Accessible Medicines made a similar plea earlier this year to the Commerce Department, saying the policy stems the availability of biosimilars. FDA laid out...


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