Spencer Fane attorneys Brian Malkin and Sadaf Deedar’s article, Congress Extends Rare Pediatric Disease Priority Review Voucher Program Through 2029, was recently published by Drug Discovery World.
In the article, which was originally a firm blog post, the team examines federal legislation affecting the pharmaceutical and biotechnology industries, with a focus on incentives supporting the development of treatments for rare pediatric diseases. The article outlines key updates to the Rare Pediatric Disease Priority Review Voucher program, including its extension and the potential implications for drug developers, investors, and long-term regulatory planning.
“While the CAA’s extension restores predictability for companies developing therapies for rare pediatric diseases, sponsors can also incorporate the potential value of a priority review voucher into portfolio planning, licensing negotiations, and financing strategies. For companies currently in development, the 2029 sunset provides a clear window for evaluating whether their programs may qualify,” the team wrote.
At the firm, Brian streamlines processes for clients navigating the complex intersection of patent law and food and drug law, leveraging unique public and private sector experience, in-depth creative and strategic analysis, and advanced negotiation tactics to meet and exceed stakeholder expectations.
Sadaf’s legal and professional experience informs her approach to handling patent prosecution and litigation, trademark prosecution and litigation, internet law, and trade secrets. Prior to entering private practice, Sadaf served as a patent administrator for a technology company specializing in low-cost point-of-care diagnostics and health information.
Read the team’s full article here.