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Focus on Regulation

Short-Fuse Compliance Deadline for Expanded Access Provision in 21st Century Cures Act

Under Section 3032 of the 21st Century Cures Act, manufacturers and distributors of investigational drugs for serious diseases or conditions have 60 calendar days after the date of enactment to publicly post their expanded access (EA) policies for individual patient access. This deadline falls on February 11, 2017. For new investigational drugs, this provision applies upon initiation of a Phase II or Phase III study for that drug.

Companies have the option of either posting an EA policy for each of their investigational drugs, or a single policy that is generally applicable to all of its drugs. In either case, the Cures Act requires the following elements for each company’s publicly posted EA policies:

  1. Contact information for the company to facilitate communication regarding EA requests;
  2. Procedures for making EA requests;
  3. The company’s general criteria for evaluating EA requests for individual patients, and for responding to those requests;
  4. The length of time the company anticipates will be necessary to acknowledge receipt of EA requests; and
  5. A link or other reference to the clinical trial record information about expanded access to the drug that must be submitted to clinicaltrials.gov.

Importantly, the Cures Act does not require drug companies to make their products available on an expanded access basis. Additionally, the statute permits companies to revise their policies at any time.

If you have any questions about the 21st Century Cures Act and how it may affect your business or organization, please contact one of the authors of this alert or the Hogan Lovells attorney with whom you regularly work.