Just Spoke To Vertex

[Magnum]

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

[fretboard]

You should have your doctor involved in the issue of getting “compassionate use of telaprevir” b/c although it’s a good idea to send the fda emails, it’s time to focus and work on a sure thing.  Having worked for a regulatory agency you absolutely must follow all guidelines that are in place.  I pulled this information off of a cancer site, I left the link as well.  good luck

"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".

http://www.cancer.org/docroot/ETO/content/ETO_1_2x_Compassionate_Drug_Use.asp

[Magnum]

I received the same “ore-prepared form”statement form the FDA as Tippyclub. Doesn't matter to me, I will still bombard them. That's the whole point. Passing the buck to your doctor is a way of sometimes saying "don't bother us, talk to your doctor to do something about this".

We all know doctors are very busy with dozens of patients a day. Can we all count on them to write this necessity letter to Vertex? I say bombard the FDA into submission. No letup, no mercy, no giving in, no capitulating...no, no, no... You don’t win battles by quitting..........

Magnum

[Tippyclubb]

THIS IS THE RESPONSE I RECEIVED FROM FDA :

Thank you for writing to the Division of Drug Information in the Center
for Drug Evaluation and Research (CDER).  
  
Please note that under the Freedom of Information Act (FOIA), we cannot
comment on products that have not been approved.  However, we can
provide information on the drug review process.  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.  For more
information accessing unapproved products and single patient/emergency
IND, please visit the sites at http://www.fda.gov/cder/cancer/access.htm
and http://www.fda.gov/cder/cancer/singleIND.htm  

If you have further questions on this information, please contact our
Division of Drug Information at 1-888-463-6332 or our direct line is at
301-796-3400.

Sincerely,

Division of Drug Information LL
Center for Drug Evaluation and Research
Food and Drug Administration

This communication is consistent with 21 CFR 10.85 (k) and constitutes
an informal communication that represents our best judgment at this time
but does not constitute an advisory opinion, does not necessarily
represent the formal position of FDA, and does not bind or otherwise
obligate or commit the agency to the views expressed.

[Rockerforlife]

How bout im dying and i need help....no beating around the bush with me

[Emilio44]

Could I please start by thanking you for initiated this initiative you are indeed a champion. Today I intend to put a backgrounder and a link to this information on my home site of 'hep c australasia' .  I think it's important that we also get this information to all sites like Janis, Nomads and others. Great letters everyone I'm sure you will make the difference.  Lastly can I say to everyone who reads this thread is that your letter/email does not have to be extensive, spell checked or grammatically correct, just to the point.  It's okay to write something like 'Hi my name is Emi and I have hep c, I've been battling this disease for a long time, please please can you approve this drug now for special cases so I don't have to watch anymore friends die of end stage liver disease and to cure myself'.  So anything that is to the point will do. REgards Emi

[Rockerforlife]

http://www.fda.gov/comments/webform.html