On February 4, the House Energy and Commerce Health Subcommittee held a hearing to discuss implementation of the Biologics Price Competition and Innovation Act (BPCIA).
Sean Cavanaugh, Deputy Administrator and Director of the Center for Medicare at the Centers for Medicare and Medicaid Services (CMS), and Janet Woodcock, the Director of the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA), offered testimony at this hearing.
Members of the committee expressed frustration over the FDA’s delay in releasing guidances on interchangeability, naming, labeling, and extrapolation. Dr. Woodcock said that the FDA should be issuing draft guidances on interchangeability, naming, and labeling this year. She noted that the agency will continue to review and approve biosimilar applications regardless of whether or not the guidances have been issued.
Committee members were concerned that CMS’ biosimilar reimbursement policy would stifle innovation. ASBM has previously expressed concern with this rule; read ASBM’s comment letter here.