Follow-On Biologic Pathway Legislation Could Endanger Patients, PhRMA Says

PhRMA voiced opposition to proposed legislation that would create a pathway for the FDA to approve follow-on biologics because it will not ensure patient safety and will hinder innovation, the group said. While PhRMA does support a regulatory pathway for the products, the proposed bill does not ensure the best process for the FDA or consumers, the group added.

The "Access to Life-Saving Medicine Act," (S.623 and H.R.1038) does not require clinical trials to prove the safety and efficacy of follow-on biologics, PhRMA Senior Vice President Caroline Loew said. The trials are necessary because even minor differences between follow-on biologics and the brand versions would affect patients, she added.

The proposed bill would deny the FDA the authority to determine how to monitor an approved follow-on biologic, Loew said.

It would also allow for the replacement of a follow-on biologic with a similar product that could have a different make-up, Loew said. Physicians would not know if the drug they prescribed was that specific product or a similar one that could have different effects, putting patients in danger, according to Loew.

Loew called Express Scripts' claim that the regulatory pathway will save money "completely wrong." It is based on "unrealistic assumptions, outdated patient information, basic arithmetic errors and a failure to account for existing competition," she said. She refuted the main assumption that the market for the follow-on biologics will match the market for small-molecule generic drugs. ( http://www.fdanews.com/did/6_70/ )