We're not shy, so we asked the FDA
"If a drug (Sofosbuvir) is approved in the USA, however, too expensive for consumers and not covered by insurance, can the patient import the drug from another country? Would affordability qualify as a reason to address availability in the USA?"
Their answer....
"Unfortunately, you cannot obtain Sofosbuvir through personal importation because the drug is approved and available in the U.S. Although I understand how the price of the drug can be an access barrier for you, affordability is not considered when the Food and Drug Administration (FDA) is determining if a medical product can be personally imported into the United States.
I hope this information is helpful. Contact me if you have any questions or concerns.
Take care,
Deb
Deborah J. Miller, Ph.D., M.P.H., M.S.N., R.N.
Health Programs Coordinator
Office of Health & Constituent Affairs
Office of External Affairs
U.S. Food and Drug Administration"
I say what are they going to do? Throw everybody who buys generics in jail? Because we have 233,000 veterans with Hepatitis C (180,000 diagnosed the rest undiagnosed) under the care of the Veterans Administration and as of June they had only treated 39,000 (only 8.000 with the new meds) and they say there's no more money to pay for treatment.
In the 1980's people with HIV started Buyers Clubs to sell supplements unapproved by the FDA in an effort to improve their conditions. The FDA finally allowed it when HIVrs held protests and had one where they laid on the floor with tombstones above their heads that said "Killed by the FDA", etc.and it made the national news.
Unfortunately, people with HCV are not as organized.
Anyway, I see why I was invited to this site. I'm known for attempting the impossible, out in the forums where my shield of "good nurse" doesn't protect me.
Mesochem is selling both sofosbuvir and Daclatasvir (both powder form) without a prescription. $1800 American dollars for both. Lots of people in the forums are using them without a doctor. That worries me. Nobody should treat on their own. Plus they're doing very creative things when they can't find a compounding pharmacy to make the capsules for them. One woman said she puts the powder in a tablespoon and adds a little water then drinks a glass of juice to get rid of the taste. Others are getting different size capsules, some add fillers, most don't.
Re side effects:
We lost one on Sovaldi+Olysio, liver and kidney failure and a post transplant patient ended up on permanent dialysis (had a GFR of 23 at baseline) and tests showed he had a heart attack during treatment with Harvoni. One forum had a heart attack (Sovaldi=Riba) and another had a man who had chest pain for the last 3 weeks of treatment and refused to stop (his doctor gave him Tramadol). He was having cardiac symptoms a few days after finishing treatment. I sent him to the cardiologist.
Plus I'm seeing quite a bit of retinal damage. Well recorded because some of the people had eye exams before and after treatment and their vision got worse (studies did eye exams and they did them for a reason). One of ours had a detached retina a few days after finishing treatment with Harvoni. So far people taking generics are complaining of only minor side effects. Some are not talking, I guess they're taking the 5th.
Pee Pee Price