"Compassionate Drug Use
What is compassionate drug use?
Medical professionals use the term “compassionate use” to refer to the treatment of a seriously ill patient using a new, unapproved drug when no other treatments are available. Drugs that are being scientifically tested but have not yet been approved by the United States Food and Drug Administration are called investigational drugs. Access to one of these drugs when you are not in a clinical trial has many names, but is most commonly referred to as compassionate use.
Is compassionate drug use legal?
Compassionate drug use is legal, but it is tightly restricted to people who meet certain conditions. The FDA first approved investigational drugs to be used in this way for critically ill patients in 1987. There are 2 ways a drug company commonly gives access to their unapproved drug to a person who is not in a clinical trial:
expanded access program (EAP)
single patient access
A company sponsoring a drug in the late stages of drug development, including Phase III clinical trials, can offer expanded access programs for patients who are not able to enroll in a clinical trial. The FDA generally approves these programs if the drug has shown some effectiveness against a specific cancer in the clinical trials that are being done.
Patients who are not eligible for either clinical trials or an expanded access program (if one exists) may be able to get the unapproved new drug by applying for single patient access. In this case, the patient's doctor must first request permission for access to the drug from the drug company. If the company agrees, the patient's doctor works with the drug company to ask the FDA to approve the drug for use by this one patient. The length of time it takes to get single patient access varies. But if it is an emergency, the FDA can complete the paperwork in 24 hours.
Why are compassionate drugs used?
Compassionate drug use is mostly obtained for patients with advanced disease who have tried all of the available treatment options and whose disease has not responded, or for patients with diseases that have no approved treatment options and no clinical trials that meet the patients' needs. There must also be reason to expect some benefit from the investigational drug. In cases such as these, the doctor may consider trying to get a new, unapproved drug for a patient who is not in a clinical trial.
What problems are associated with compassionate drug use?
Perhaps the biggest problem with compassionate drug use is that it is hard to get. The simplest way to get access to an unapproved drug is through a clinical trial. But many people with life-threatening diseases either cannot find suitable clinical trials, or they live far from cancer research centers, or they are not eligible for any studies being done.
Expanded access programs (if offered by the drug company) or access through single-patient compassionate use is possible for some. But working out single-patient compassionate use of an unapproved drug is often time-consuming and frustrating. For instance, there is no single policy or process followed by the FDA and drug companies. As of 2007, no one publishes a list of all the drugs that are available through compassionate use in the United States. There is no way to require the drug company to supply the drug. Producing extra medicine for people who are not in clinical trials can be expensive for the drug company, especially since there is a chance the drug will not be approved.
Compassionate drug use can also be very confusing. There are several programs that regulate it. There are many terms and definitions that are used to describe how a patient may get access to an unapproved, new drug outside of a clinical trial. Drug companies, patient advocacy groups, and the FDA all may use different terms for the same things. For example, the terms used by the FDA are defined in their regulations, while most drug companies refer to their compassionate access programs with terms that are unique to their specific programs and not in line with the FDA language"
Source:http://www.cancer.org/docroot/ETO/content/ETO_1_2x_Compassionate_Drug_Use.asp
Compassionate Drug Use
Take Care
Jimmy B
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