Theravance Biopharma, Inc. - Expanded Access Policy
Theravance Biopharma, Inc. and its Affiliates (collectively referred to as “Theravance Biopharma”) is a diversified biopharmaceutical company with the core purpose of creating medicines that help improve the lives of patients suffering from serious illness. Under the 21st Century Cures Act1, the manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make available its policy on how it evaluates and responds to requests submitted under section 561(b) of the Federal Food, Drug, and Cosmetic Act for provision of such a drug. “Affiliate” means any entity that controls, is controlled by or is under common control with Theravance Biopharma, Inc.
The following is Theravance Biopharma’s expanded access policy for investigational drugs:
(1) General Criteria. Theravance Biopharma is not currently making any of its investigational drugs available for use on an expanded access basis. In the event Theravance Biopharma decides to consider expanded access use for one or more of its investigational drugs, Theravance Biopharma will evaluate and respond to each expanded access request that it receives on a case-by-case basis. Theravance Biopharma anticipates that the factors considered in evaluating any such request may include, but will not necessarily be limited to, the following:
- Has the patient’s physician determined that treating the patient with the investigational drug is in the patient’s best interests?
- Is the investigational drug in active development for the indication requested?
- Is there sufficient clinical data to identify a safe and appropriate dose and dose duration for the patient?
- Does the potential benefit outweigh the collective potential risks to the patient?
- Is another comparable or satisfactory therapeutic alternative reasonably available?
- Is the patient eligible or able to participate in a clinical trial or similar sponsored access program?
- Is there a regulatory mechanism in the country / geographic location to support the request?
(2) Contact Information. Please submit any questions or requests regarding expanded access to Theravance Biopharma Medical Information at the following: email@example.com or 1.855.633.8479 (phone) or 1.844.633.8479 (fax).
(3) Request Procedures. Requests for expanded access need to be made by the physician responsible for treating the patient, and each request needs to relate to a single patient. Please submit sufficient supporting detail (including the indication) to enable Theravance Biopharma to evaluate the expanded access request. Please also include your contact information (including e-mail, phone number, practice address) so Theravance Biopharma may follow-up with you directly. Theravance Biopharma anticipates that it will acknowledge receipt of any expanded access questions or requests within five (5) business days of receipt.
(4) Clinicaltrials.gov. As stated above, Theravance Biopharma is not currently making its investigational drugs available for expanded access use. In the event Theravance Biopharma decides to make one or more of its investigational drugs available on an expanded access basis, this policy will be updated with a hyperlink to the expanded access field on clinicaltrials.gov after such record becomes active.
As authorized by the 21st Century Cures Act, Theravance Biopharma may revise this expanded access policy at any time. Additionally, the posting of this policy by Theravance Biopharma shall not serve as a guarantee of access to any specific investigational drug by any individual patient.
1The 21st Century Cures Act was enacted by the 2016 Congress and covers a number of topics related to health.