Policy on Investigational or Unlicensed Product Use Outside of a Clinical Trial
Effective October 1, 2015
The purpose of this policy is to describe the requirements for compassionate access to Pfizer investigational or unlicensed products to patients outside of a clinical study.
Pfizer development resources are focused on conducting clinical studies required by regulatory authorities to fully answer important scientific questions about the potential risks and benefits of our investigational products, and to obtain regulatory approval.
Pfizer is committed to making investigational or unlicensed products available to seriously ill patients who have exhausted other treatment options. A treating physician, who is able to comply with the requirements that are stated in this document, may request information about how to apply for access to Pfizer’s investigational products by contacting Medical Information at www.pfizermedicalinformation.com .
This policy applies to:
- Compassionate access to a Pfizer investigational product that is not approved for any purpose in the country from which the request is intended to be used. This also includes the time period between regulatory approval of an investigational product and its commercial availability in a country.
- The use of a Pfizer unlicensed product which is not approved for the indication requested in the country where the product is intended to be used.
This policy generally does not apply to requests for unapproved new dosage form versions of an approved product (e.g., a request for a liquid formulation of a product that is already approved in a solid oral dosage form). However, decisions relating to such requests are governed by the same considerations as those presented in this policy in accordance with applicable legal/regulatory requirements and are evaluated on a case-by-case basis.
1. POLICY STATEMENTS
- Any use of a Pfizer investigational product outside a clinical study or unlicensed Pfizer product in a country must be in accordance with local laws and regulations governing such programs, including Pfizer policies and procedures.
- In general, where permitted by local regulation, the investigational product supplied via compassionate access may no longer be provided by Pfizer when it becomes available via the local healthcare system.
1.1. Patient Eligibility Criteria
To be eligible for access to an investigational or unlicensed product, patients must meet the following criteria:
- Suffer from a serious or immediately life-threatening disease or condition;
- Have undergone appropriate standard treatments without success and no comparable or satisfactory alternative treatment/prophylaxis vaccine is available or exists to diagnose, monitor or treat the disease or condition;
- Are ineligible for participation in any ongoing clinical study of the investigational product, which includes lack of access due to geographic limitations;
- Meet any other pertinent medical criteria for access to the investigational or unlicensed product, as established by the Pfizer clinical or medically responsible individual.
1.2. Investigational Product Criteria
In addition to the patient eligibility requirements, the investigational product must meet the following criteria:
- The product is under investigation in one or more clinical studies.
- There is sufficient evidence to expect that the investigational product will have an acceptable safety profile for the intended patient population.
- Alternatively, for molecularly targeted agents, there must be compelling biological rationale for that disease coupled with adequate human clinical data to support an assessment that the potential patient benefit justifies the potential risks of the treatment use, and those potential risks are not unreasonable in the context of the disease or condition to be treated.
- The provision of the investigational product will not interfere with or compromise the clinical development of the product.
- Adequate supply of the investigational product exists to perform necessary clinical studies in addition to provide access to patients who do not have alternative treatment options.
1.3. Treating Physician Criteria and Responsibilities
The physician(s) attending to the patient(s) who is/are receiving an investigational or unlicensed product through compassionate use access is (are) properly licensed and fully qualified to administer the product.
The physician must agree in writing to comply with:
Any applicable country-specific legal and regulatory requirements related to providing an investigational or unlicensed product under compassionate access; and
Any Pfizer requirements in terms of medical criteria, safety reporting, drug supply/use, and protection of intellectual property.