Hepatitis C Support Group
Hepatitis C is a blood-borne viral disease which can cause liver inflammation, fibrosis, cirrhosis and liver cancer. The hepatitis C virus (HCV) is spread by blood-to-blood contact with an infected person's blood. Many people with HCV infection have no symptoms and are unaware of the need to seek treatment. Hepatitis C infects an estimated 150-200 million people worldwide.
Presidio Pharmaceuticals Announces Collaboration with Boehringer Ingelheim
http://www.heraldonline.com/2013/03/13/4688490/presidio-pharmaceuticals-announces.html
http://www.heraldonline.com/2013/03/13/4688490/presidio-pharmaceuticals-announces.html
Now I don't know if you have read everything yet but, you do not have to get into a trial for the expanded access or compassionate use programs, and I think it's important that you read the entire processes involved and go over them with your Doctor...
The main thing is that you must convince one of the companies who make the specific drug or drugs to use it for compassionate use and since it's already been done previously, the process and the steps to take are clearly defined in one of the FDA links I provided in my previous posts.
Respectfully,
Henry
To permit treatment of a patient with an investigational drug under an expanded access program, FDA generally must be satisfied that
The patients disease or condition has no satisfactory approved therapy. An example of this is a rare type of cancer that has no known or approved treatment. Or, it may be the case that the available treatments did not work for the patient.
The potential benefit for the patient justifies the potential risks. An example of this is the potential for longer survival with a disease or condition.
The expanded availability of the untested drug will not interfere with that products development. For example, access to an investigational drug shouldnt interfere with enrollment in clinical trials needed to demonstrate the drug's safety and effectiveness.
Among other things, the expanded access rule will explain the several different kinds of access that are possible, including access for individual patients, for small numbers of patients, and for large numbers of patients in what are called treatment protocols ensure safeguards to protect patients preserve the ability to develop meaningful data on the drugs available under expanded access
Charging Rule
The charging rule permits drug manufacturers to charge patients for an investigational drug in clinical trials or that's being made available for expanded access. Charging in clinical trials will be allowed under very limited circumstances, but will be permitted for most expanded access uses.
In some cases, a company could not develop a drug unless it is able to charge for the drug in clinical trials. Allowing charging for expanded access helps provide access to investigational drugs that manufacturers may not be able to offer without being able to charge.
FDA revised this rule to provide more explicit criteria for when charging should be permitted in clinical trials and for drugs available for expanded access.
Among other considerations, the revisions are meant to make the process of obtaining authorization to charge more transparent
specify what costs can be recovered by drug manufacturers:
-only the direct costs of the drug when charging for a drug in a clinical trial
-the direct costs of the drug plus the costs of administering the expanded access program when charging for a drug for an expanded access use
FDA has launched a new Web site where patients can learn about options for investigational drugs. The site explains the various options that patients may use to explore the possible use of investigational drugs with their health care professional.
Topics addressed on this site include information on deciding whether to seek access to an investigational drug clinical trials and investigational drugs access to investigational drugs outside of a clinical trial (expanded access)
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Date Posted: August 12, 2009
Here are the final rules for the expanded access program as of 8/01/2009:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm172492.htm
In the link above, there are .pdf's that have all the details.
In this link below, the applications for your Doctor are listed in .pdf. form:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm090039.htm
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm163982.htm
Go over these applications and rules with your Doctor and then you'll find out if you're eligible for any of these programs.
Respectfully,
Henry