At AbbVie, we are passionate about developing advanced therapies to
help address the world’s greatest health challenges. We also are
committed to providing access to therapies that are not yet approved
for use to people who are suffering from a serious or life-threatening
illness or condition and might potentially benefit from these medicines.
To do that, AbbVie has developed a Pre-Approval Access to
Investigational Drugs Policy. It outlines important considerations we
take into account when evaluating a doctor’s request to use
investigational drugs in a patient with a serious or life-threatening
illness or condition.
We created this policy so we can make an appropriate medical decision
about access to investigational drugs as quickly and as fairly as
possible. We also want patients and doctors to better understand what
guides our decisions.
Our policy applies to requests on behalf of individual patients
(Single-Patient Access) and to certain groups of patients with similar
characteristics (Multi-Patient Protocol Access). The Pre-Approval
Access program may also be referred to as Expanded Access,
Compassionate Use or Named Patient Basis programs, as defined by local
regulations. While our policy outlines the general criteria for
consideration, each case is unique and will be considered on an
The primary option for patients to get access to investigational
drugs is to participate in a clinical trial. Patients and physicians
can learn more by reviewing information on current or planned clinical
trials that is maintained by the U.S. National Institutes of Health.
We recognize, though, that there are extraordinary circumstances
where access to these investigational drugs outside of a clinical
trial is appropriate. Under our Access to Investigational Drugs
Policy, a patient’s doctor can request consideration for access if
three basic criteria are met:
- The patient suffers from
a serious or life-threatening illness or condition
are no other suitable treatment options
- The patient does
not qualify for ongoing clinical trials
Two other important factors play a role in our consideration of each
The first is to ensure that the potential benefits of the drug
outweigh the risks to the individual patient. Physicians consider this
before they prescribe any therapy for a patient; it’s absolutely vital
in these serious cases that an investigational drug doesn’t add new or
unreasonable risks for a patient.
The second is to ensure that providing access under this policy
doesn’t have a negative impact on clinical trials. Such an impact
would potentially put the patients in those trials at risk, or delay
approval and broad access to a new drug maybe offered to as many
patients as possible.
Requests for access to investigational drugs under development and
prior to approval under this policy must be made by Treating
Physicians. Treating Physicians should contact us via this link. complete the necessary fields
and submit. following submission, you can expect to receive the
necessary forms to begin the request process.
Because we are committed to addressing the world’s greatest health
challenges, AbbVie takes requests for access under this policy very
seriously. We will treat every request with respect, dignity and in a
way that protects the privacy of the patient. We will consider each
request carefully, individually and fairly. And once we have all the
necessary information, we will strive to provide a decision as soon as
If you have questions about our policy, please consult the below FAQ.