FDA Contests Court Intervention On Plan B As Teva Argues For Exclusivity
This article was originally published in The Tan Sheet
Executive Summary
In CRR’s lawsuit, FDA and Teva argue that the firm’s potential for OTC market exclusivity for Plan B One-Step should be protected. But while Teva is open to judicial intervention on whether to allow universal OTC sales, FDA says precedent supports judicial deference to agency scientific decisions.