As we have mentioned in a previous article, the 21st Century Cures Act (enacted December 13, 2016) gave companies 60 calendar days to make their expanded access policies for certain investigational drugs publicly available. That deadline—Saturday, February 11, 2017—arrives in a matter of days.
Section 3032 of the Cures Act sets out criteria for determining whether a company must publicly post an expanded access policy and lists five required elements of each policy, including procedures for the public to make expanded access requests to the company and the company’s general criteria for evaluating and responding to such requests.
If you have any questions about the 21st Century Cures Act requirements or need assistance with drafting a compliant expanded access policy, please contact one of the authors of this alert or the Hogan Lovells attorney with whom you regularly work.