Re: FDA Considers Expanded Use of HCV Drugs part 2

[Guest guest]

, I forgot to mention something important about compassionate access. Last year the FDA announced new relaxed rules about access that apply to HCV drugs and many others. The problem is that the manufacturers (1) can charge whatever they want, and (2) they do NOT want to make these meds available until they get FDA approval. Why? Attorneys, I suspect. If someone being treated with Pegylated interferon, Ribavirin, AND a new non-approved drug such as VX-950, and should happen to die, this event could delay approval and cost the drug company millions in lost revenue. This, even if the death were from some totally unrelated cause! So, early access is already in place, but just try to get the drugs! And, of course, Medicare won't pay and neither will most health insurance programs.

Those who say money can't buy happiness are wrong, when money can pay for drugs that can prolong our lives and help improve our quality of life.

I will prepare a letter to the FDA, have it reviewed by some leaders in the HCV field, and send the revised version to FDA and copy to this board.

FDA HCV Hearing on Early Access to New Drugs: report from Jules Levin - (05/04/10)

From Mark Antell, a Hep C/hemophilia activist:

Hi All,'People with Bleeding Disorders and Hepatitis C' did attend and speak out at the FDA hearing on compassionate access to promising drugs for Chronic Hepatitis C. Below you’ll find an article from MedPageToday.com reporting on the hearing. A few additional thoughts:1. The initial speaker, Dr. Lurie representing the FDA Commissioner, stated that our petition was a major factor in initiating the hearing. Every speaker at least mentioned that we, people with bleeding disorders and chronic hepatitis C, are among those who are not served well by current medication or testing procedures. We signers should be proud. 2. Another speaker, Dr. Sylvestre, noted that the only speakers calling for “go slow, stay on the existing track,†were manufacturers of SOC therapy. Hers was a courageous statement ... and true.3. Several panel members told us that FDA must rethink the current requirement for liver biopsy before acceptance into clinical drug trials. It may be that the health and dollar cost of biopsy for people with bleeding disorders is not worth the benefit.4. FDA welcomes additional written comments on compassionate access till June 25. The hearing should result in guidance on compassionate access to promising drugs for Chronic Hepatitis C, probably in about six months. Mark and