Pre-approval access to investigational medicines
At Bristol Myers Squibb, patients are at the center of everything we do. Every day, we come to work committed to our mission — to discover, develop and deliver transformational medicines that help patients fight serious disease.
Our employees are motivated by this single focus and work tirelessly with the hope that our scientific insights can be translated into new medicines that make a meaningful difference in the lives of patients. We work with urgency, knowing that many patients around the world are waiting for new therapeutic options.
We receive many inquiries about our investigational medicines, including requests outside of our clinical trials – a practice commonly referred to as “compassionate use” (which we call “Pre-Approval Access”). This is an important topic for our company, as we know that many of the patients seeking access to our investigational medicines are facing a serious or life-threatening illness and often have no further treatment options or a clinical trial available to them. We welcome requests for Pre-Approval Access from the physicians treating these patients and we take great care to have each individual patient case assessed by a physician on our staff. The goal of Pre-Approval Access is to ensure that eligible patients can obtain access to our investigational medicines.
Decisions about Pre-Approval Access to our investigational medicines are made after considerable thought. Our first concern is that of any doctor, namely the safety and well-being of the patient. This is especially important because these medicines have not completed the normal course of studies for the indications at issue. Then, consideration must be paid to the possibility of a benefit for the patient based on what we know about the investigational medicine at the time. In this regard, we work closely with the patient’s physician to determine whether access to the investigational medicine is best for the patient. We also make sure that medicines are provided in a fair and equitable manner, but there is no guarantee that every request will be fulfilled.
Lastly, we must ensure that, by providing an investigational medicine to an individual outside of a clinical trial, it in no way compromises the scientific validity of the broader development program or delay any regulatory filings, which are aimed at making the medicine available to help many more patients through regulatory review and approval.
If you are a patient with questions concerning access to an investigational medicine — either through a clinical trial or under compassionate use – please discuss your situation with your treating physician.
Pre-Approval Access requests must be made through your physician who can reach Bristol Myers Squibb by visiting Bristol Myers Squibb Pre-Approval Access. Bristol Myers Squibb strives to respond to the request as quickly as possible. You can also access more information on our clinical trial programs at Bristol Myers Squibb Study Connect.
Specific eligibility criteria must be met for access outside of a clinical trial. These criteria include:
- The illness must be serious, debilitating, or life threatening
- There are no other viable options (including approved products or active clinical trials)
- There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks based on what is known at the time
- There is a plan by Bristol Myers Squibb to make the medicine, once approved, available commercially in the country from which the request was received
- Whether or not sufficient quantities of the investigational medicine are available
- Additional criteria regarding the therapy, its development program, the patient, or other circumstances may impact eligibility
This is an unprecedented time for scientific innovation and the development of important new medicines. At Bristol Myers Squibb, we are doing everything we can to ensure that patients with serious disease get the benefit of these innovations as quickly as possible.
Where can I find more information on Bristol Myers Squibb PAA program?
A list of Bristol Myers Squibb PAA programs can be found at ClinicalTrials.gov. This information can also be accessed through the Reagan-Udall Foundation's Expanded Access Navigator.
For further information or to request access to a Bristol Myers Squibb investigational product, please discuss with your physician.
Right to Try Act
In May 2018, the President of the United States signed into law the Right to Try Act.
Bristol Myers Squibb supports efforts to improve the safe and timely access to investigational medicines for patients facing a serious or life-threating illness and who have no further treatment options or a clinical trial available to them. We believe our current approach to Pre-Approval Access, as outlined above, is consistent with the objectives of the Right to Try Act. Requests for Pre-Approval Access to Bristol Myers Squibb investigational medicines should continue to be made through the treating physician by visiting Bristol Myers Squibb Pre-Approval Access page.
At Bristol Myers Squibb, we are doing everything we can to ensure that patients with serious or life-threatening diseases receive the benefit of our innovative medicines as quickly as possible.
Submit a new patient request form
We welcome requests for Pre-Approval Access (PAA) from the physicians treating these patients. Request forms must be submitted by the healthcare professional. Patient eligibility will be determined by Bristol Myers Squibb in accordance with established policies and procedures. Bristol Myers Squibb’s acceptance and processing of this application does not guarantee that access to the investigational product will be provided.
