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Living With Cancer

Advocacy

Once I know what drug I want, how do I get it?

You've found a drug; however, you are not eligible for the clinical trial. The next steps are:

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Find the drug company

Most companies have websites and can be located through standard internet searches. The following websites list pharmaceutical company information:

The Physician's Desk Reference (PDR) for prescription drugs can also be found at your local library.

Many companies have call lines (800#s) set up for their clinical trials, and these lines are a place to start. First you should ask if the company has an Expanded Access Program for the drug

Check for an Expanded Access Program (EAP)

If you learn that new drug you want is available in an Expanded Access Program (EAP) you must find out if you qualify to enter the EAP. Most drug companies sponsoring Expanded Access Programs also sponsor an 800-telephone service to assist patients in determining their eligibility for the EAP.

The 800 numbers can often be found on the drug company's web site or by calling FDA's Office of Special Health Issues - Cancer Liaison Program at 301-827-4460. If the patient meets the EAP entry criteria, the drug company will provide the information about the sites where the patient may get the drug.

Ask about Single Patient Access

If an Expanded Access Program doesn't exist or if you don't qualify for it, then you can ask the company to supply the drug on a Single Patient Access basis. If the drug company says they are restricting use of their new drug and not providing it to patients outside the clinical trials, it is important to understand the following:

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Talk to the right person about Single Patient Access

If a program or policy about compassionate use doesn't exist, you'll need to push. The person you'll want to reach is the Medical Director for Oncology Clinical Development for the specific drug you're interested in. Getting to him or her on the phone will probably take persistence and creativity. Getting what you want once you do so may be even harder.

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Meeting FDA requirements for Single Patient Access

Remember, you will either be given the new drug as an individual - Single Patient Access, or as part of a group - Expanded Access Program (EAP). In an EAP, the clinical researchers or their staff at the site running the EAP will walk you through the required process.

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What happens if demand for the drug is greater than the supply? How does a company decide which patients will receive the drug?

The fact is there are as many answers to this question as there are drug companies.

A drug company might allow the physician researchers (also known as investigators) at each clinical trial site to select a few promising patients to be given the new drug outside of the clinical trial. This is called a site-specific protocol exemption.

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Summary

The best way to get access to an unapproved drug is through a clinical trial. Expanded access programs, if offered by the drug company, offer another option. If neither of those two options exists, access through single-patient compassionate use may be possible.

Working out single-patient compassionate use of an unapproved drug will almost certainly be confusing, time-consuming and frustrating. There is no single policy or process adhered to by the FDA and drug companies. There is no single list of drugs currently available through compassionate use. There is no way to force the drug company or FDA to permit treatment through compassionate use.