Expanded Access Policy
SMPA may provide access to its investigational products outside of enrollment in clinical trials.
SMPA is committed to the development of therapies to benefit patients living with serious diseases or conditions who have not had success with existing, available therapies. Our aim is to provide these therapies to the broadest number of patients possible, through performance of clinical research with the goal of obtaining regulatory approval. Approval by regulatory authorities is the only way to make medicines broadly available to patients by prescription from a qualified Healthcare Professional. Clinical research allows SMPA to properly evaluate our investigational products and generate the safety and efficacy data required to secure regulatory approvals.
We recognize that some patients with serious or life-threatening diseases or conditions may not be eligible for any clinical trial and may not have other comparable or reasonable alternative options.Therefore, SMPA may, in limited instances, consider providing access to investigational products for patients who may benefit from SMPA investigational products.
This Policy describes the principles and general procedures that SMPA will follow when considering a request for Expanded Access to a SMPA investigational product.
Expanded Access Criteria:
Each request will be evaluated by SMPA in accordance with this Policy and will be required to meet all of the following criteria:
- The patient has a serious disease or condition, has no comparable or satisfactory alternative treatment options and is not eligible to participate in any appropriate clinical trial.
- The investigational product must be in active clinical development by SMPA and being studied in a similar disease state to that for which the Expanded Access is requested.
- There must be adequate supply of the investigational product to accommodate the needs of the Expanded Access request without interfering with SMPA's commercial or clinical supply needs.
- Expanded Access will not delay, interfere with or compromise ongoing clinical trials or the potential approval of the product.
- There is sufficient evidence, as determined by SMPA medical professionals who are involved in the development program, that the potential benefits to the patient would likely outweigh the potential risks to the patient.
- The Expanded Access request must be made by a physician who is qualified and licensed in the United States and who is knowledgeable in the treatment of the disease or condition.
- All applicable laws and regulations must be followed.
- If the request is granted, the requester must sign a written agreement setting forth the rights and obligations of the parties.
Process for making an Expanded Access request:
Requests for access to investigational products must be made by a qualified and licensed physician by contacting SMPA at 800.739.0565 or firstname.lastname@example.org. The physician requesting Expanded Access must provide specific case information, including:
- Copy of the physician's curriculum vitae (CV), signed and dated and a copy of the physician's current medical license.
- Pertinent patient history. The physician will be requested not to provide the patient's individually identifiable health information or protected health information.
- Scientific rationale for the potential benefits the investigational product may provide based on the available nonclinical and clinical data.
- A statement that the patient has exhausted reasonable approved therapy options, or the patient is no longer responsive to, or able to tolerate these therapies.
- A statement that there are no reasonable and viable alternative therapy options.
- A statement as to whether the physician intends to seek cost-recovery from an insurer, patient, or other third-party and the process for complying with applicable regulatory and insurer requirements.
Evaluation of Request(s):
Acceptance of a request is not a guarantee that investigational product will be provided. Requests will be evaluated on an individual basis by SMPA medical, clinical, and regulatory experts. Those professionals will evaluate the request based on the scientific evidence available to SMPA at the time of the request and may review other information relevant to patient safety. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals, as applicable, and to abide by all regulations and laws concerning patient safety.
SMPA will make every effort to acknowledge requests that have been submitted in accordance with the above requirements within five (5) business days of receipt.
Once the investigational product is commercially available, Expanded Access will be discontinued as soon as feasible, subject to any legal or regulatory requirements.
Information regarding SMPA's clinical studies may be found at www.clinicaltrials.gov.
If a program is designed to provide access to a number of patients, SMPA plans to abide by applicable regulations and laws to include information related to our Expanded Access activities on clinicaltrials.gov or other applicable registries.
SMPA reserves the following rights, which may be exercised at any time without prior notice:
- The right to discontinue the provision of investigational product to a physician and patient.
- The right to discontinue the Expanded Access program for any SMPA investigational product.
- The right to revise, modify or retire this Policy.
- The right to submit information received about use of an investigational product to regulatory authorities, as required to comply with applicable laws.