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Post by Allen on Oct 9, 2014 11:22:28 GMT -8
The FDA has released the details of a process that a doctor can use to obtain permission to treat a patient with an investigational new drug (IND). This would be outside of a clinical trial and on a one-off basis. First the doctor has to obtain agreement from the pharmaceutical manufacturer to supply the drug. There are special provisions for expedited approval in emergency cases, and it can be done with a phone call. This may enable a patient to get a life-extending/saving drug without the uncertainty of a random placebo in a clinical trial. Here's the process: Physician Request for an Individual Patient IND under Expanded Access for Non-emergency or Emergency Use |
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Post by Tony Crispino on Oct 11, 2014 7:00:17 GMT -8
Allen,
Many folks believe that getting investigational drugs to patients in compassionate cases is blocked mostly by the FDA. That is totally false. The #1 rejection of the use of these drugs is typically the Pharma that makes the drug. The process linked above is only part of the process. The drug maker has to agree as well to provide the drug and they typically do not do so unless the drug is in a Phase III trial and evidence is present that the drug is safe and effective. There are still many reasons why a Pharma will reject an application for compassionate use of their products.
Reasons for rejection:
1. Legal. They don't want to be sued for use of drugs that yet to clear FDA approval.
2. Informed Consent is still being defined.
3. Drug may not be available as production is limited to the trials they are still in. This can make compassionate use a virtual impossibility.
4. Cost. Compassionate use will likely not be covered by insurance. And many companies have yet to establish drug costs.
More reasons for rejection exists but these are the primary reasons compassionate use is not available or rejected.
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Post by KC on Oct 14, 2014 5:40:57 GMT -8
It seems intuitive that physicians (and patients) would ONLY consider making a request for an investigational drug while it is in Phase III, which comes AFTER Phase I ("is it safe?") and Phase II ("does it work?").
In addition to the potential reasons a sponsor (drug manufacturer) WOULD NOT want to fulfill an IND listed above by Tony, there are other reasons why they WOULD, including...
* experimental drugs have shown promise in early clinical testing for serious or immediately life-threatening conditions
* final clinical work is and/or the FDA review procedure is underway
* physician may submit research IND to propose studying an unapproved drug (or an approved product for a new indication)
* physician may submit IND for patients who do not meet strict existing study protocols, or in an approved study protocol does not exist
* FDA approved marketing applications not yet developed by the sponsor
During the period of my wife's cancer battle, she and her physician experimented with an investigation new drug. Unfortunately, in her already weakened state, she could not tolerate it for very long. We were at the phase of treatment in which Allen's posting was (I believe) directed, and many people with advanced disease do get to this same phase...we were willing to throw everything including the kitchen sink at the problem, and see if anything helped. In her case, it didn't...but she tried.
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