House Subcommittee on Health Addresses BPCIA Implementation and FDA Biosimilars Guidance

The House Energy & Commerce Committee’s Subcommittee on Health met this morning to discuss implementation of the Biologics Price Competition and Innovation Act. Sean Cavanaugh, Deputy Administrator and Director of the Center for Medicare, and Janet Woodcock, Director of the Center for Drug Evaluation and Research, testified. The subcommittee’s questioning focused on the FDA’s lack of progress in key areas like interchangeability, naming, and labeling. The subcommittee also addressed CMS’s recent decision to place biosimilars under a single billing code for medicare reimbursement.

Dr. Woodcock noted early that progress has mostly been under the hood, stressing that significant technical and policy challenges remain. Nevertheless, FDA has issued guidance in important areas, and the FDA expects to issue guidance on interchangeability and labeling this year. Still, the FDA may approve an interchangeable product without issuing guidance. Also, the advisory committee will consider another biosimilar next week.

Dr. Woodcock suggested that the perceived lack of progress stems from a lack of funding. Congress did not appropriate any additional funding to implement the BPCIA. The more recent introduction of user fees has had a limited effect because the biosimilars industry is still in its infancy. Dr. Woodcock expressed concern that the number of biosimilar applications could “explode” and overwhelm the FDA’s staff.

Overall, subcommittee members and the FDA seem aligned on the importance of safety and efficacy for patients, and transparency and predictability for the fledgling biosimilars industry. Further guidance from the FDA appears to be a question of time or money—a choice that the FDA suggests is in Congress’s hands.