Patients facing serious illnesses who have exhausted all available treatment options often want to know if and how they can receive early access to investigational drugs that haven’t yet been approved by government regulatory agencies. The information below explains options that may be available to patients in these circumstances.
1. Clinical Trials
For new medicines and vaccines to be legally approved for use, companies like Pfizer are required to evaluate their safety and effectiveness in clinical trials and submit trial results to regulatory agencies. To participate in a trial, you must meet certain criteria. For those who meet the criteria to join a clinical trial, participation offers the chance to contribute to medical research that may benefit many others. Participation in a clinical trial comes with certain risks; that is why patient “informed consent” is a required step in the process of enrolling.
2. Expanded Access or Compassionate Use
In cases where a clinical trial isn’t an option, and the patient has exhausted all available treatment options, regulators/health authorities may grant permission for us to provide a treating physician with an investigational drug pre-approval. Such individual use of an investigational drug pre-approval is often called "expanded access" or “compassionate use” but may go by other names. Pfizer refers to these requests as expanded access.
Inquire about expanded access of a Pfizer investigational or pre-approval drug
For expanded access requests related to fosmanogepix, click here
For expanded access (compassionate use) requests related to PAXLOVID, click here
It’s important to remember that investigational drugs have not yet received regulatory approval; therefore, their potential risks and benefits are not yet established. Doctors and patients should consider all possible benefits and risks when seeking expanded access to an investigational drug.
Please feel free to contact us with any questions.