Expanded Access Programs

Boehringer Ingelheim supports Expanded Access Programs (EAPs) as an important way of allowing patients access to investigational medicines prior to FDA approval.

All requests for access to a Boehringer Ingelheim investigational drug, including those under the Right-to-Try Act as described in the US Federal Food, Drug & Cosmetic Act (FFDCA) section 561B “Investigational Drugs for Use by Eligible Patients”, need to be sponsored by a health-care professional. In general, this will be during phase II clinical trials or later during the development and only for therapies with an active Investigational New Drug (IND) application. A healthcare professional submitting a request for the Compassionate Use of a Boehringer Ingelheim investigational drug on behalf of a patient or the patient’s caregiver, may do so by calling 1-800-542-6257.

An EAP is intended to allow patient access to an investigational medicine for a serious or immediately life-threatening disease or condition where no comparable or satisfactory alternative therapy exists and when the potential benefit of the medicine justifies the potential risks and those risks are not unreasonable in the context of the disease or condition being treated.

Boehringer Ingelheim follows FDA regulations and guidance that describe criteria that must be met to authorize expanded access and lists requirements for expanded access submissions. One type of EAP is an Expanded Access Treatment Protocol, which provides access to an investigational medicine to a larger population.

In some cases, patients and/or caregivers may inquire about Compassionate or Emergency use of an investigational medicine for an individual patient. These types of Expanded Access would apply if a patient does not meet the Expanded Access Treatment Protocol qualification criteria but requests the medicine due to a serious or immediately life-threatening disease or condition where no comparable or satisfactory alternative therapy exists. If potential patient benefit justifies the potential risks of the medicine and those risks are not unreasonable in the context of the disease or condition being treated, Boehringer Ingelheim will communicate with the patient’s individual healthcare provider regarding potential use of the investigational medicine(s).

• A Boehringer Ingelheim team of medical and scientific experts familiar with the investigational product in question will evaluate all Compassionate Use requests based on the medical/scientific assessment of the risks and benefits of the requested use of the investigational product.
• The Boehringer Ingelheim team may also elect to consult with external experts for the purposes of further review.
• Availability of the investigational product will also be considered.
• Not all Compassionate Use requests may be granted.

Boehringer Ingelheim will strive to respond to requests for Compassionate Use of an investigational drug within five business days of receiving a complete request that includes all necessary documentation.

If Boehringer Ingelheim agrees to the Compassionate Use request, required approval from the applicable health authority will take additional time.

Once approved, Boehringer Ingelheim will work to expedite shipment of the drug to the health-care provider who initiated the request and will be administering the drug. Because many investigational drugs produced by Boehringer Ingelheim are manufactured outside of the US, the importation process may add some additional time to the shipping process for US requests.

For additional information about Boehringer Ingelheim’s clinical trials and Expanded Access Programs (EAPs), including Expanded Access Treatment Protocols and Compassionate or Emergency use of Boehringer Ingelheim investigational medicines, please contact us at 1-800-542-6257.  Additional information about our global positioning on Compassionate Use can be found here.