TOPIC:

Hello Grass, I can only add this to what Mike said, it worked for me. I like many on this site live in the US and couldn't afford the branded form of meds and insurance denied helping out. I took a slightly different tack regarding getting a script so I didn't end up relying solely on the Redemption package. While at a scheduled visit with my doctor, I showed him an article that'd recently been posted on EASL's website about the results Dr. Freeman is having with the e-trials, I then, mustered up the courage to ask my doctor if he'd be willing to provide me with a prescription for Harvoni, (branded treatment of sofosbuvir and ledipsavir) and to my delight and somewhat of a surprise he agreed. And not reluctantly, but readily.
I'm posting the link to that EASL report in case you think it'll help.
ilc-congress.eu/low-cost-generic-direct-...randed-formulations/
Hoping you get started on treatment ASAP,

MK

Genotype 1a,
Diagnosed 2007
Joined trial 3 in Sep. 2017 and received meds 2 weeks ago. So far, all is well with no side effects. I am 62 and very active in work and have been a runner for over 40 years. No fatigue detected at this time. Do have an FDA issue that i am actively trying to find answers for, so if anyone has received an FDA action letter PLEASE share your knowledge. Thanks.

Hi Are125,

Welcome, I'm glad you have been able to start treatment.

For assistance with answers to your current issue I suggest you email Fixhepc at This email address is being protected from spambots. You need JavaScript enabled to view it. or phone them on +61 3 8672 7825

I'm sure they will be able to help with the answers required, although it is Sunday morning in Australia at the moment so the main office may not be fully manned but will be within 22 hours of my post.

Forum members
May I ask what the FDA is doing with the 3 month out of country personal prescriptions? In my investigation, this is legal, up to 3 months personal use age.
Any responses are very welcomed.

I agree this is very troubling that FDA is questioning people about imports to the USA.

In all the hundreds, more, people who have shipped into the US there hasn't been a problem- it is probably statistically inevitable that the import process will eventually float past some genius' desk who get excited because they don't understand it yet. I think when they are upskilled, it will be fine.

The rules of personal importation from the FDA start with a statement that it's not allowed, and then follow on with the exception cases:

www.fda.gov/ForIndustry/ImportProgram/Im...Basics/ucm432661.htm

In most circumstances, it is illegal for individuals to import drugs or devices into the U.S. for personal use because...

It then goes on to say:

Are there any circumstances when I could purchase or bring an unapproved drug or device into the U.S.?

FDA has guidance for personal importation of drug or device products. Below provides information regarding situations for which this might be allowed:

• Product is not for treatment of a serious condition and there is no known significant health risk (Over the Counter, OTC); and
• Product is for the treatment of a serious condition ( Prescription Drug Products):
• The product is for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means.
• There is no known commercialization or promotion of the product to persons residing in the U.S.
• The product does not represent an unreasonable risk.
• The consumer affirms in writing that the product is for personal use.
• The quantity is generally not more than a three month supply and either:
• Provide the name and address of the doctor licensed in the U.S. responsible for your treatment with the product, or
• Provide evidence that the product is for the continuation of a treatment begun in a foreign country.

This is the grey area in which we operate. There has definitely been a recent tightening of these rules and the assumption that the status quo will prevail indefinitely has ALWAYS been wrong. The going is still good but like the financial people say "past performance is no guarantee of future performance". We offer a money back delivery guarantee to help de-risk it for patients.

It has been said often but bears repeating.

There is currently a window of opportunity to access these medications.

That opportunity may well not exist indefinitely.

In all the hundreds, more, people who have shipped into the US there hasn't been a problem

Ah, actually there are regular problems. We do what's required to make sure patients get their medication, but it is not always smooth sailing.

There are 2 people working full time on a task that could be broadly defined as "get stuff cleared through customs".