Deadline Looms for Pharmaceutical Manufacturers and Distributors to Comply with New Expanded Access Program Reporting Requirements

Certain pharmaceutical manufacturers and distributors of an investigational drug under an investigational new drug (IND) application must make their policies for evaluating and responding to requests under an expanded access program “public and readily available” by the end of this week pursuant to section 3032 of the 21st Century Cures Act (Cures). Cures, which became effective on December 13, 2016, provided a deadline for making the policies available on the later of: (i) 60 days after the enactment of Cures, or (ii) the first initiation of a phase 2 or phase 3 study with respect to the investigational drug. Therefore, the 60-day deadline expires on Saturday, February 11, 2017, for those manufacturers and distributors who are already conducting a phase 2 or 3 study under an IND.

Expanded access, also known as “compassionate use”, refers to the use of an investigational drug outside of the context of a clinical trial with the primary intent to diagnose, monitor, or treat patients. To comply with Cures’ new “public and readily available” requirement, a manufacturer or distributor may post a policy on the internet that contains the following information: (i) contact information for the manufacturer or distributor to facilitate communication about requests under the expanded access program; (ii) procedures for making a request; (iii) the general criteria the manufacturer or distributor will use to evaluate and respond to the request; (iv) the length of time the manufacturer or distributor anticipates it will need to acknowledge the receipt of the request; and (v) a hyperlink or other reference to the clinical trial record containing information about the expanded access for such drug.

Cures does not obligate a manufacturer or distributor to establish a patient access program, nor does it create a guarantee of treatment under an existing program. Additionally, manufacturers and distributors who make their policies public are not required to provide a specific investigational drug to any individual patient.

Manufacturers and distributors conducting research under an IND who have an expanded access program must be aware of the Cures policy requirements and comply accordingly. We will continue to monitor and provide updates related to the implementation of Cures.

 

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Filed under Clinical Trials, Compliance, FDA

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