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No need for an apology, it's clearly an important issue. And i'd love to answer what i can. it's an unapproved new drug. Even if it's the patent is nearly identical. The exception does not apply as the treatment is available in the US. There could be a legal argument made that it's excessive cost which creates a climate where it's practically impossible. But you'd need to wait for the legal precedent. (there is a suit against Gilead for excessive cost, but it's unclear how that will end up without the FDA trial info)
Sorry to continue with the issue, but as you know its so important and delicate, which it can turn to be the life saving alternative for many Hep C patients. As per FDAs importation of drugs states, " Unapproved new drugs, including foreign-made versions of U.S. approved drugs that have not been manufactured in accordance with and pursuant to an FDA approval". How will Sofosbuvir manufactured by an Indian Laboratory under a License from Gilead Science Ireland UC be considered? Such product has been manufactured by Gilead Technology transfer to the laboratory, it will be of no health risk to patient or anyone else. Also FDA General Guidance Sections states That the FDA should consider not taking enforcemnet actions against importation: "when 1). the intended use[of the drug] is unapproved and for serious condition for which efective treatment may not be available domestically either through commercial or clinical means; my interpretation as per above is, if Sovaldi is so expensive and economically out of reach of the majority Hep C patients either with or without insurance, then its not available to Hep C patients. will such argument be legally viable? Thanks
I want to preface: i am not a lawyer. I read law. I understand law. That does not mean I've passed a bar exam. Legal advice, like medical advice is not something to be treated so flippantly. I advise caution, and to seek legal counsel for your scenario if you (or anyone reading this) so chose to do something of this nature. So to be very specific absolutely NO. http://www.fda.gov/ForIndustry/ImportProgram/ucm173751.htm The FDA is SPECIFIC on this issue. Hell, if they even THINK it might not be okay it can be confiscated/barred from import. Thank you for your specificity on the question, i hope this helps resolve any confusion.
Rick Does it states importing for personal use for 3 months supply is punishable too? I might interpret is punishable for selling, trading, etc. not for life saving. Other alternative is do what Greg Jefferys from Australia did, he went to India to get his treatment.US people can travel to Honduras, its just 3 hours plane ride from Houston, Atlanta, 2 hours from Miami, and bring treatment.
While i appreciate the notion, Importation of pharmaceutical drugs is punishable by up to 10 years and $250,000. In the United States. US Code: Title 21, §333.Penalties: (b) Prescription drug marketing violations "(1) Notwithstanding subsection (a) of this section, any person who violates section 331(t) of this title by- (A) knowingly importing a drug in violation of section 381(d)(1) of this title, (B) knowingly selling, purchasing, or trading a drug or drug sample or knowingly offering to sell, purchase, or trade a drug or drug sample, in violation of section 353(c)(1) of this title, .... shall be imprisoned for not more than 10 years or fined not more than $250,000, or both." Canada's healthcare system is very different than the United States'. While there are Canadian import exceptions, they are for Canadian licensed pharmacies. And this is all going to get even weirder if the Trans-Pacific Partnership passes. If we skirt around the laws, we cannot expect to improve them. Should we suffer the slings and arrows of outrageous fortune as the events conspire against us? The fear of legal persecution simply so that we may survive, so we may...live?
I've oreads on Greg Jeffery's blog 2 important issues for US citizens can do about HCV: 1. Generic Sofosbuvir and ribavirinn can be imported for 3 months supply for personal use into US 2. A pharmaceutical distributor in Honduras, Central America can shipped such medicines by courier, they sell generic Sofosbuvir from one Gileads licensed Reputed Indian Labs. Company email is : info@drogueriahumana.com We better start to have initiative or wait and die.
Mark Baroni
Sad to wait more, so many lives are at stake. Will be in touch Thanks
July 22, 2015