While the Lower Health Care Costs Act is intended to increase competition and patient access to lower cost medicines, section 205 of the bill needs to address FDA concerns about the “parking” of generic applications. We believe generic manufacturers need to launch new medications into the market as soon as possible after approval. However, as written, Section 205 may undercut the goal of the 180-day exclusivity period. Any delays would result in fewer generic competitors coming to market, which will forestall lower competitive prices for patients. Congress needs to address this deficiency in the legislation.

You can read our coalition letter here.