Aa
WIll you get involved politically to speed up new treatment access?
The FDA is accepting comments regarding expanded access to the Direct acting anti-virals for Hep C at http://www.regulations.gov/search/Regs/home.html#submitComment?R=0900006480ab98ce. Will those of us who cannot or will not take interferon post comments demanding greatly expanded trials with combinations of the best STAT-C drugs, in the public health interest? Highly safe and effective treatments for hepatitis C are already developed, they just need to be combined correctly to prevent resistance from developing. Lets tell the FDA remove all obstacles from the speedy delivary of these treatments to patients.
Heck no, Politics has NO place in medicine nor war. Getting paper pushers involved only mucks everything up as they often are clueless on the details of these matters.
The FDA on the other-hand is a bit different in that they appear to stradle the fence between politics and being knowledgeable of the subject area.
The FDA on the other-hand is a bit different in that they appear to stradle the fence between politics and being knowledgeable of the subject area.
You do not have to post a long document or PowerPoint presentation. Two sentences will do it. Here is a sample comment.
FDA Question 3) Under what circumstances and in which populations would early access to multiple DAAs be appropriate?
Early access to multiple DAAs would be appropriate for HCV infected patients with cirrhosis. Patients with cirrhosis who failed to respond to interferon and ribavirin therapy should be strongly considered along with patients who are intolerant to interferon or ribavirin.
What will happen to your comment? FDA will write new guidelines for HCV. In a typical FDA report, they would say something like "83 comments requested that patients with cirrhosis who failed interferon and ribavirin should be eligible for expanded access. Based on our analysis, FDA's position is ....."
FDA reads and considers all comments. They respond with guidelines based on all available evidence. If you write a comment on http://www.regulations.gov you may be helping yourself and thousands of others in a similar situation. At the website, search on FDA-2010-N-0107.
FDA Question 3) Under what circumstances and in which populations would early access to multiple DAAs be appropriate?
Early access to multiple DAAs would be appropriate for HCV infected patients with cirrhosis. Patients with cirrhosis who failed to respond to interferon and ribavirin therapy should be strongly considered along with patients who are intolerant to interferon or ribavirin.
What will happen to your comment? FDA will write new guidelines for HCV. In a typical FDA report, they would say something like "83 comments requested that patients with cirrhosis who failed interferon and ribavirin should be eligible for expanded access. Based on our analysis, FDA's position is ....."
FDA reads and considers all comments. They respond with guidelines based on all available evidence. If you write a comment on http://www.regulations.gov you may be helping yourself and thousands of others in a similar situation. At the website, search on FDA-2010-N-0107.
While i understand where you are coming from, if the FDA speeds things up and it back fires people would be lining up to sue who ever they could....... Best to you
Have an Answer?
You are reading content posted in the Hepatitis C Community
Learn about this treatable virus.
Getting tested for this viral infection.
3 key steps to getting on treatment.
4 steps to getting on therapy.
What you need to know about Hep C drugs.
How the drugs might affect you.
These tips may up your chances of a cure.
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.
