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TOPIC: US Importation .. Legal or Not ? How to Proceed.

US Importation .... Legal or Not 5 years 8 months ago #8967

  • mgalbrai
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An update on U.S. importation:

The packages seem to be arriving with few issues. If you do experience a problem with Customs, the FDA, the supplier or shipper, please email.
Also, everyone's success story needs to be told. Each one helps dispel peoples' "conditioned" mistrust of imported medications.
These are real.
They work.
They are affordable.

Mike
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forums.delphiforums.com/generichcvtx

G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
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US Importation .... Legal or Not 5 years 8 months ago #8980

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From HepMag Forums!!


REDEMPTION Clinical Trial Registered

Here is the link to the clinical trial listing:

www.clinicaltrials.gov/ct2/show/NCT02657...rm=redemption&rank=1

REDEMPTION (Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods) is observing and collating the treatment course, safety profile, and outcomes of patients around the world who are choosing to self import generic versions of the Direct Acting Antivirals Sofosbuvir, Ledipasvir and Daclatasvir from countries like China, India and Bangladesh.

Information on participation can be found at fixhepc.com

Coach Mike
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G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
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US Importation .... Legal or Not 5 years 8 months ago #9144

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Below is the actual story of a case in which a generics package was detained and eventually released by the FDA. I am aware of only two incidents where detention was an issue. Both packages were from India. Both were released.


This is Mrsklg's story from post #9105:

I am in Michigan, I was suppose to get delivery 2 weeks ago yesterday, 1/8/16 , this was one response I got ...

Thank you for the information. I fully understand your situation, a serious medical condition and expensive treatment options. But, I must address your case in accordance to applicable U.S. laws and regulations.

First, the imported medication is an unapproved foreign version of an U.S. approved medication. This foreign medication does not have an U.S. approved drug application and a valid drug listing.

Secondly, there are no availability issues with the U.S. approved medication, other than its high cost.

Lastly, the purported clinical trial, REDEMPTION-3, does not appear to be a viable clinical trial in the U.S., Europe, or Australia/New Zealand, according to the clinical trial registries.


I sent that response to Andrew@fix hep c and he wrote them stating the Redemption trials was registered and sent them the link, within hours my FedEx package was released, and no response from them stating my package was released .. lol.. so it took exactly 2 weeks..

Mike
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G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
Last Edit: 5 years 8 months ago by mgalbrai.
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US Importation .... Legal or Not 5 years 8 months ago #10827

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Februrary 13 Update:

It appears that shipments of HCV medications are not being allowed to leave India as of yesterday.

This is a very serious development. Access to generic HCV medications had been easing until this unfortunate event.

The loss of access to imported Indian medications limits the ultimate source for quality generic HCV DAA tx to exactly one.

There are three ways to import those life-saving medications:

1. Dr. Freeman's clinical trial

2. Bangladesh

3. Direct importation of APIs

The "how to" information can be found here and at fixhepc.com

This is a very troubling development. Gilead has a new CEO now. This could signal a more aggressive approach by Gilead concerning the importation of generics. The door is open now. However, it could slam shut. Don't be left out in the cold if that happens.

REDEMPTION shipments will be delivered. That is a given.

Mike
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G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
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US Importation .... Legal or Not 5 years 8 months ago #10829

  • Geno1b4
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Damn, hope it is only temporary ban. I dont think India want cash to divert on Bangladesh
There is also option 4. that I went, travel directly to India.
Genotype 1b & 4, F0/A1, failed Peg&Riba TX 2015,
22 Jan. 2016 - Back from Delhi with 12 week Ledifos supply :) Thx to Parag
Started TX on 27.Jan.2016 - AST 41, ALT 59, GGT 39, ALP 74, VL 500.000, Fibroscan 6.8
19. Feb 2016 - ALT 14, AST 14, GGT 19, ALP 107
19. Apr 2016 EOT - Undetected :)
26. Apr 2016 (1 week after EOT) - ALT 14, AST 17, GGT 12, ALP 77
28. Aug 2016 (17 weeks after EOT) - UND, ALT 15, AST 12, GGT 5, ALP 39 :)
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US Importation .... Legal or Not 5 years 8 months ago #10830

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Yes G1,
That is a very good point and going to the medicine is far less expensive than retail. It is just far more trouble than importation. Let's hope the remaining options continue to be viable and the "India" situation resolves itself in a positive manner.
M
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G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
Last Edit: 5 years 8 months ago by mgalbrai.
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US Importation .... Legal or Not 5 years 8 months ago #10834

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Geno1b4 wrote:
Damn, hope it is only temporary ban. I dont think India want cash to divert on Bangladesh
There is also option 4. that I went, travel directly to India.

Yes Geno1b4, in the current scenario that option looks the best, that is what even i did. Though slightly expensive, but makes the whole episode completely safe. Quite disturbing news that Gilead wants to ban the generics while they were the ones who licensed their sale.
Geno 1a since 2003,
Generic Harvoni purchased from Mumbai Ledifos
started treatment on 1st january 2016,
VL after 4 weeks of treatment - ONLY 508 :)
Hopefully UND within one week.
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US Importation .... Legal or Not 5 years 8 months ago #10837

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People wanting treatment simply need to join REDEMPTION. Delivery is guaranteed. Costs less than airfare and lodging, not to mention the time, effort and cost of the medicine when you get there.
M
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G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
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US Importation .... Legal or Not 5 years 7 months ago #11663

  • mgalbrai
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Wednesday, February 24, 2016

Mike,

I bank wired money to Mesochem on Friday (time stamped at 11:10 A.M. Rachel emailed me on Monday,
and said she had shipped Sof / Led. I received it today at 9:00 A.M. no problems whatsoever.I'm waiting
on my capsuling supplies now. I'll let you know when I start treatment. I joined the delphi forum.Name on
there is freepat. that's what I will feel like if TX works, and I'm very confident that it will. You are my main
mentor on this. You've been patient and answered all my questions as well as countless others. I hope I
can help others also. I Thank God that I came across your story on fixhepc website. I hope we can talk
on phone sometime. if not in person.

Until Later,
XXXXXX

Why I do what I do....
Mike
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G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
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US Importation .... Legal or Not 5 years 7 months ago #11686

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It looks like Rachel is not being as "picky" as she has been in the past. Now, it appears to be a simple order, pay and deliver process.
and the price is right...$860.00 for 12 weeks of sof & led APIs.
M
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forums.delphiforums.com/generichcvtx

G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
Last Edit: 5 years 7 months ago by mgalbrai.
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US Importation .... Legal or Not 5 years 7 months ago #11806

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This email address is being protected from spambots. You need JavaScript enabled to view it.
forums.delphiforums.com/generichcvtx

G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
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US Importation .... Legal or Not 5 years 7 months ago #12332

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The situation appears to be good right now as far as the importation of generic HCV medicines into the U.S. is concerned. The biggest obstacle, in my view, is convincing people the medicines are genuine copies and the suppliers are not going to take their money and run. Some just don't believe, not matter how much evidence you present, that the medicines won't be seized by Customs.
M
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forums.delphiforums.com/generichcvtx

G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
The administrator has disabled public write access.

US Importation .... Legal or Not 5 years 7 months ago #12335

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Haven't been here in a long time and I find this thread which relates to the thread started when I was here last. I did spend a lot of time being cautious about shipping from China to US and Mr. M here has most of the answers I came up with.
I am in a situation without insurance or ample funds hence comes importation. Of course there is need to find a Dr. willing to help. Then there are the tests and in my case CAT scan and MRI's knowing that I've been infected for 40yrs+. These additional expenses add up although I was able to negotiate very good prices for the imaging scans.
To the point, I went to an HIV/AIDS foundation and asked if they would consider HCV. They were happy to consider it and have since begun to integrate such into their regiment!! All are very excited about this, especially myself. They supplied me with a Dr. willing to more than just work with me. They take care of my blood tests and the Dr. is meeting monthly with a hepatologist who directs us.
Thought I'd throw this out here if it helps anybody even if just to find a Dr. to work with you. It was as good a move as I have ever made.
So much for self medication. :)
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US Importation .... Legal or Not 5 years 7 months ago #12336

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Hi and welcome back.
So, you are treating now?
M
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G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
The administrator has disabled public write access.

US Importation .... Legal or Not 5 years 7 months ago #12337

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Yes indeed I am! Reading through posts truly you are an ambassador to the cause. Hopefully one finds my 2 cents worthwhile.
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