Aa
Just Spoke To Vertex
I have a contact at Vertex. We spoke at length about Telepravir and the "compassionate" use. That means use now (without placebo) for Cirrhotic victims. While he couldn't give me a definite time line for the compassionate release, he did say that telepravir being in Phase III, they are seeking approval by the FDA in the second half of 2010, and making it available through prescription instead of the current clinical trials.
Interestingly, he added a comment that we could hopefully expedite the "compassionate" use approval by the FDA if we write them an email stating the urgency for those who need this NOW.
Here is a direct link, with phone number to the FDA: http://www.fda.gov/comments.html
Write to them and continue to bombard them with emails until they give in. This is a battle to be sure, but if the government sees that we are desperately seeking a compassionate release of Telepravir, they could rethink this whole matter. Write an email now...
Magnum
Interestingly, he added a comment that we could hopefully expedite the "compassionate" use approval by the FDA if we write them an email stating the urgency for those who need this NOW.
Here is a direct link, with phone number to the FDA: http://www.fda.gov/comments.html
Write to them and continue to bombard them with emails until they give in. This is a battle to be sure, but if the government sees that we are desperately seeking a compassionate release of Telepravir, they could rethink this whole matter. Write an email now...
Magnum
Another point i want to bring up...the daily injections of inerfergen is punishmet, brutal in my opinion....the PI drugs are not even close to it in terms of SX....so why is ok to almost kill your self with interfergen,but its not ok to save yourself with the unapprovved PI`s....
Monday morning I'm going in for banding of some Esophageal Verices by my Gastro, who is also a surgeon. I'm going to run this by him and see how easy or difficult it will for him be to ask permission for a "compassionate" release of the drug by Vertex, for me, to be picked up by prescription. Should be interesting. I will report...
Magnum
Magnum
There has to be something we don't know about. This is by far the slowest FAST TRACK drug ever developed. I have heard of several drugs approved long before Phase 3 is completed. If and when this is approved will it give them more slack on their other pi's and the combo they are working on? In other words will they be able to forgo the rigorus phase one and two data requirments for next generation pi's.?
Ron
Ron
"It seems the best docs would have the confidence and expertise to proceed but others would hesitate".
Unfortunately due to the stigma that surrounds HepC I have to agree that alot of doctors would hesitate and even shy away from getting involved. Also unfortunate is that we don't have truckloads of supporters like the HIV movement did back when they forced the fda's hand. latr
Unfortunately due to the stigma that surrounds HepC I have to agree that alot of doctors would hesitate and even shy away from getting involved. Also unfortunate is that we don't have truckloads of supporters like the HIV movement did back when they forced the fda's hand. latr
"Emergency Use of an Investigation Drug or Biologic" For more info go to
http://www.fda.gov/oc/ohrt/irbs/drugsbiologics.html#emergency
UNITED STATES
Prepared by the Food and Drug Administration, Office of Special Health Issues
Introduction The acronym "IND" refers to an Investigational New Drug application, which is an application to the Food and Drug Administration (FDA) to administer an investigational new drug or biologic product to humans. Since a biologic is also considered a drug, the term "drug" as used in this document refers to either a drug or a biologic product.
Most human use of investigational drugs takes place in clinical trials conducted to assess safety and efficacy of those drugs. Consequently, FDA's IND processes are designed primarily for drug companies and medical researchers engaged in clinical development of new drugs. However, some patients not eligible to participate in a clinical trial may benefit from treatment with an investigational drug under study. For such cases, FDA has developed numerous regulatory mechanisms to make investigational drugs available outside of clinical trials. These mechanisms include single-patient INDS, emergency INDS, and treatment INDs/protocols.
Single-Patient INDs and Emergency INDs
In many cases, the investigational drug will not be available through an expanded access program from the manufacturer. For such cases, the discussion below addresses how a physician can file a single-patient IND or an emergency IND for treatment of a patient with an investigational drug. In the case of a single-patient IND or an emergency IND, all of the following conditions must be met before FDA can allow a physician to administer an investigational drug under a single-patient or emergency IND:
* a) The patient must be informed about the drug and consent to be treated with it.
* b) The physician must be properly licensed and must agree to administer the product and be responsible for monitoring and reporting to FDA on the patient's use of the product (See forms 1571 and 1572.)
* c) The local Institutional Review Board (IRB) must approve the proposed use of the investigational drug (please note that in emergency situations it may be possible for the physician to notify the IRB promptly after treating the patient),
* d) The manufacturer must be willing to provide the product without charge (unless the sponsor has applied for and FDA has allowed charges for cost recovery as provided for under Federal Regulations), and
* e) FDA has allowed the transfer of the product from the manufacturer to the physician.
All Biological IND submissions must be made in triplicate and should be addressed as follows:
Center for Biologics Evaluation and Research
HFM-99, Room 200N
1401 Rockville Pike
Rockville, MD 20852-1448
Phone: 800-835-4709 or 301-827-1800
Additional information and and all forms may be obtained at the FDA's Center for Bioloics Evaluation and Research (CBER) web site
http://www.fda.gov/cber/ind/ind.htm
Additional FDA information about the IND program can be found at
Investigational New Drug Application process
Hectorsf
http://www.fda.gov/oc/ohrt/irbs/drugsbiologics.html#emergency
UNITED STATES
Prepared by the Food and Drug Administration, Office of Special Health Issues
Introduction The acronym "IND" refers to an Investigational New Drug application, which is an application to the Food and Drug Administration (FDA) to administer an investigational new drug or biologic product to humans. Since a biologic is also considered a drug, the term "drug" as used in this document refers to either a drug or a biologic product.
Most human use of investigational drugs takes place in clinical trials conducted to assess safety and efficacy of those drugs. Consequently, FDA's IND processes are designed primarily for drug companies and medical researchers engaged in clinical development of new drugs. However, some patients not eligible to participate in a clinical trial may benefit from treatment with an investigational drug under study. For such cases, FDA has developed numerous regulatory mechanisms to make investigational drugs available outside of clinical trials. These mechanisms include single-patient INDS, emergency INDS, and treatment INDs/protocols.
Single-Patient INDs and Emergency INDs
In many cases, the investigational drug will not be available through an expanded access program from the manufacturer. For such cases, the discussion below addresses how a physician can file a single-patient IND or an emergency IND for treatment of a patient with an investigational drug. In the case of a single-patient IND or an emergency IND, all of the following conditions must be met before FDA can allow a physician to administer an investigational drug under a single-patient or emergency IND:
* a) The patient must be informed about the drug and consent to be treated with it.
* b) The physician must be properly licensed and must agree to administer the product and be responsible for monitoring and reporting to FDA on the patient's use of the product (See forms 1571 and 1572.)
* c) The local Institutional Review Board (IRB) must approve the proposed use of the investigational drug (please note that in emergency situations it may be possible for the physician to notify the IRB promptly after treating the patient),
* d) The manufacturer must be willing to provide the product without charge (unless the sponsor has applied for and FDA has allowed charges for cost recovery as provided for under Federal Regulations), and
* e) FDA has allowed the transfer of the product from the manufacturer to the physician.
All Biological IND submissions must be made in triplicate and should be addressed as follows:
Center for Biologics Evaluation and Research
HFM-99, Room 200N
1401 Rockville Pike
Rockville, MD 20852-1448
Phone: 800-835-4709 or 301-827-1800
Additional information and and all forms may be obtained at the FDA's Center for Bioloics Evaluation and Research (CBER) web site
http://www.fda.gov/cber/ind/ind.htm
Additional FDA information about the IND program can be found at
Investigational New Drug Application process
Hectorsf
I didn't even know the FDA's position until this thread got started. I'm pretty happy to see it in black and white:
Just to cut and paste again from above posts:
------------------------------------------------------------------------------------------------------
FROM THE FDA
There is a mechanism to
access products that have not been approved. However, this would
involve a physician willing to file a single patient or emergency
Investigational New Drug (IND) application and this must be done with
the cooperation and permission of the drug supplier.
------------------------------------------------------------------------------------------------
So there's a policy in place to make it do-able NOW.
I wonder how many docs have enough experience with cirrhotics to sign off on this? It seems the best docs would have the confidence and expertise to proceed but others would hesitate. And the best docs would have the application process streamlined, perhaps able to make it happen within twenty-four hours.
Just to cut and paste again from above posts:
------------------------------------------------------------------------------------------------------
FROM THE FDA
There is a mechanism to
access products that have not been approved. However, this would
involve a physician willing to file a single patient or emergency
Investigational New Drug (IND) application and this must be done with
the cooperation and permission of the drug supplier.
------------------------------------------------------------------------------------------------
So there's a policy in place to make it do-able NOW.
I wonder how many docs have enough experience with cirrhotics to sign off on this? It seems the best docs would have the confidence and expertise to proceed but others would hesitate. And the best docs would have the application process streamlined, perhaps able to make it happen within twenty-four hours.
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