Rep. McCaul outlines compassionate access bill

Rep. Michael McCaul (R-Texas) plans to introduce compassionate access legislation that would impose new requirements on drug developers and establish rights for patients. McCaul summarized the legislation and his reasons for introducing it in a white paper submitted to the House Energy & Commerce Committee's 21st Century Cures initiative.

McCaul's bill would require companies applying for accelerated approval, breakthrough, Fast Track or Priority Review designations to "develop and make publicly available their expanded access policy for such treatments." The white paper suggests that companies post information about access to investigational therapies on their websites, including a single point of contact for requests, a description of the application procedure, minimum eligibility requirements, and an expected response time. ...