I had a conversation with Gabriel Levitt from PharmacyChecker.com the other day, as I was in search of a Canadian Pharmacy that I could travel to and obtain affordable, needed, drugs. The reason for this “travel” was the recognition of the newest law (the new FDA bill) on the books in the U.S. that any drug under the value of $2,500.00 would (or could) be seized and destroyed by border security agents.
My particular situation is this: I am on blood thinner (anti-coagulate) medicine. I must continue on this medicine for the remainder of my life. A few years ago I had open heart surgery to repair a defective Mitral valve inside my heart. I elected to have an artificial valve installed instead of a “bio” valve (Porcine or bovine). After weighing the options it was pointed out to me that “bio” replacements would not last as long as artificial valves have proved to be. If any of you have had open heart surgery in the past you will share my desire to not do that again. Very painful recovery and many weeks of gaining strength back.
This brings up the only downside of the artificial, compared to “bio”, replacement. My blood has to be thinned and monitored to prevent clots from forming around the replacement valve. This requires the drug Coumadin to be taken daily. All is fine so far.
Here’s the real kick – If I have to have any procedures that might involve bleeding, be it surgery or even as insignificant as tooth extraction, I must wean myself off Coumadin and bridge this time period with one of the heparin derivative drugs. One of the least expensive of these is Lovenox.
The cost of this drug in the US is approximately $1,200.00 per box of ten Syringes. I must self-administer twice a day so this is only a five day supply. My experience with this medicine is that I must refill and administer more before my Coumadin goes takes effect. Ok, so that is another $1,200.00 out of pocket. Even when I was on Medicare part D my out of pocket was still about $420.00 per purchase.
I was in contact with one of the pharmacies in Canada that your organization verifies. The cost at the Canadian pharmacy was about $140.00 per box of ten syringes. Same manufacturer, same dosage, and same freshness.
I ask you, what is the $1,060.00 extra for? I know that the Canadian pharmacies are not selling me this drug at their cost, so they are making a profit, but why the huge difference?
It makes me think that the drug companies here, in the states, are being allowed to make OBSCENE profits by a significant number of members of congress. What else would explain the very large difference in pricing?
This brings us back to the enactment, with lightning speed, this new law provides for the destruction of mail order drugs from “over the border “pharmacies. The law makers established a price of $2,500.00 as a criteria to destroy (or not) these drugs. Interesting!
Well, that is my story. I know I am not the only US citizen that is being held hostage by those that have a vested interest in keeping US drug prices at an apparent, artificial, level. I think the word extortion is repugnant but does it apply is this discussion? Unfortunately, I think so.
To Mr. Gabriel Levitt and the good folks at Pharmacy Checker please feel free to use this letter in any effort to help bring down the cost of drugs in this country. In the short run, to rescind any attempt by lawmakers to prevent my obtaining affordable drugs from Canadian Pharmacies.
Thank you for reading my story. I am not alone.
Mike M
Syracuse, NY
Date: Mon, Aug 13, 2012 at 10:43 AM
Subject: RE: Is There a New Law That Prohibits Importation of RX for Personal Use?
The law, often called PDUFA V, did pass. But from my quick read, some provisions, such as Section 708 and 713 will not become active until final implementing regulations are issued by HHS.
Overall, section 708 of PDUFA V is intended to prevent manufacturers from importing drugs that lack proof of authenticity. The allowance for HHS to sieze and possibly destroy non-compliant drug products is meant to prevent manufacturers, and their agents from simply taking those refused drugs back out to sea and then attempt to ship them into the US via another port.
Ultimately, the law is intended to be the ‘teeth’ that will allow FDA’s overseas quality inspectors to have access to foreign manufacturing plants. Thus if a plant refuses to allow an inspection, then no products from that plant may enter the US.
The law is not intended to target small amounts of drugs that are sent into the US by Canadian pharmacies. (That being said, the language of the law is somewhat broad, and, possibly could be argued to allow an unfriendly administration to use the new law to prevent reimportation.)
And section 713 of PDUFA V (pasted below) does allow for admission of imported drugs, so long as they meet the requirements of rules that will be drafted and issued by HHS. Such a criteria could, for instance, be some proof or certification from the Canadian pharmacy that the package/shipment meets the Canadian government’s requirements for such exports into the US. This may prompt the Canadian government to issue some regulations of some kind in this area. It could be good for US consumers to have Canada regulating the authenticity of drugs exported to the US.
SEC. 713. STANDARDS FOR ADMISSION OF IMPORTED DRUGS.
Section 801 (21 U.S.C. 381) is amended—
(1) in subsection (o), by striking ‘‘drug or’’; and
(2) by adding at the end the following:
‘‘(r)(1) The Secretary may require, pursuant to the regulations
promulgated under paragraph (4)(A), as a condition of granting
admission to a drug imported or offered for import into the United
States, that the importer electronically submit information demonstrating
that the drug complies with applicable requirements
of this Act.
‘‘(2) The information described under paragraph (1) may
include—
‘‘(A) information demonstrating the regulatory status of
the drug, such as the new drug application, abbreviated new
drug application, or investigational new drug or drug master
file number;
‘‘(B) facility information, such as proof of registration and
the unique facility identifier;
‘‘(C) indication of compliance with current good manufacturing
practice, testing results, certifications relating to satisfactory
inspections, and compliance with the country of export
regulations; and
‘‘(D) any other information deemed necessary and appropriate
by the Secretary to assess compliance of the article
being offered for import.
Additionally, these relevant sections of the law become active only after HHS issues regulations, after a notice and comment period of at least 60 days. So consumers who advocate for such reimportation from Canadian sources will have an opportunity to publicly comment on the necessity to exclude such legitimate transactions from the scope of this new law.
Wells Wilkinson, JD.
Director, Prescription Access Litigation Project
Staff Attorney │ Community Catalyst
30 Winter Street 10th Floor │Boston, MA 02108
617-275-2822 │ c:857-540-2333 │ wwilkinson@communitycatalyst.org
http://www.prescriptionaccess.org http://www.communitycatalyst.org
twitter.com/healthpolicyhub │ blog.communitycatalyst.org
twitter.com/saferxwatch
I sympathize with your terrible situation. I don't have to say that there are many million Americans who unjustly face dilemnas like yours. My situation is no where as serious as yours, but I had to write a letter to the Pledge Secretary of my church stating that I could no longer contribute to its financial support, the sole reason being the hundreds of dollars I will now have to spend every month because of the outrageous prices I will now have to pay for my meds. Just one example is that I now have to pay $500 each for two tubes of ointments that I need which are neither rare nor expensive to make. It's the U.S. patent laws that impose these cruel prices.
Be sure to read the Open Letter to PharmacyChecker. com below.
In reply to Mike M’s question about why the price difference between identical medications from Canada and the US, the answer is that Americans are SUBSIDIZING the lower drug prices that other countries who have national or single payer health systems negotiate with drug companies. For example, in the UK which is a single payer system, the UK government negotiates what prices it will pay for each and every drug that is imported to the UK. The drugstores there make a profit, the drug companies make a profit (not as big as in the US but still a profit) and costs are contained.
When we in America pay double or triple the price for the same drug that someone in Cuba, the UK or Canada does it allows the drug companies to recover their lost profits from the sale of products in those countries and effectively means that WE are paying for the prescription drugs for these other countries!
What exactly are lost profits? Profits the drug companies expected to earn but then didn’t? So, if I expect to earn $50,000 dollars this year but only earn $40,000, does that mean that I will be losing $10,000 dollars? I’d say I would be gaining $40,000, wouldn’t you? You can’t recover something you didn’t already have to begin with.
Be sure to read the Open Letter to PharmacyChecker.com ABOVE AND the very informative responses below if you care at all about this critical issue.
Thank you for the very interesting and informative comments above. I encourage everyone to read them closely.
To update my own comment of Sept. 5th: I was obviously in a panic about the legislation and feared being forced to pay U.S. prices of hundreds of dollars a month. Currently, my contacts in the two Canadian Pharmacies that I do business with routinely say there has been no change, and it’s still business as usual. Thank heaven!