The Pharma & Biopharma Outsourcing Association (PBOA), a trade group that represents Contract Manufacturing Organizations (CMOs) and other service providers in the bio/pharmaceutical sector, is pleased that Senate and House Committee leaders have released a Discussion Draft of the FDA Reauthorization Act, legislation which would reauthorize the Generic Drug User Fee Amendments (GDUFA II), among other things.
 
The PBOA agrees with statements from the chairs and ranking members of the Senate Health, Education, Labor and Pensions (HELP) and House Energy & Commerce Committees that reauthorization must occur in a timely manner in order to insure continuity at FDA and to advance our common goal of providing access to safe and effective medicines to the American public.
 
“Our members are happy to see that the program enhancements and fee model revisions that we helped negotiate for GDUFA II are reflected in the Discussion Draft and moving through the legislative process,” said PBOA president Gil Roth. “We worked extensively with FDA and other stakeholders to improve GDUFA II and look forward to seeing it enacted in a timely manner as part of the FDA Reauthorization Act of 2017.”