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Author Topic: prescription drugs
philnotfil
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This will probably get swallowed up by the elections, but I thought it was interesting.

NYTimes

quote:
To ensure the safety of imported drugs, the F.D.A. relies almost entirely on its own inspections of foreign plants. This was not much of a problem 30 years ago, when most medical products consumed in the United States were made here and F.D.A. inspectors could drive around to plants in their district. Most of those plants have since moved abroad, and now decades can pass between inspections. Testifying before Congress in April, Dr. Janet Woodcock, director of the F.D.A.’s drug center, spoke with rare frankness about the ability of the agency to do its job abroad. “The F.D.A. of the last century is not configured to regulate this century’s globalized pharmaceutical industry,” she testified.

Other current and former F.D.A. officials I talked to echoed Woodcock’s warning. Tim Wells, who was a field investigator and then a compliance officer for 24 years at the F.D.A., now does private audits of drug plants and sees the holes in the agency’s safety net. “A company I recently visited abroad hasn’t been inspected for 10 years,” he told me.

Besides being more frequent, domestic inspections are unannounced and more intense. And when inspectors find dangerous conditions at domestic plants, they generally return promptly to ensure that those conditions get fixed. Not so in foreign plants. In a report released Oct. 22, government auditors reported that between 2002 and 2007, F.D.A. inspectors found dangerous conditions in 15 foreign plants. Only one of those plants was reinspected within two years, the auditors found. In every other case, the agency took foreign managers at their word that promised changes were made.

The record is particularly bad in China. Over the past six years, the F.D.A. has managed to inspect annually an average of just 15 of the 714 Chinese drug plants that export to the United States. At its present pace, the F.D.A. would need more than 50 years to visit all of these Chinese plants. By contrast, the F.D.A. inspects domestic drug plants every 2.7 years.

There is more to the article, but I wanted to highlight this section.

The thing that jumped out at me was how it contrasted to what the FDA said about the safety of Canadian prescription drugs. From 2002-2004 the reimportation of prescription drugs from Canada was a big deal, and the FDA stepped up and said several times that they couldn't guarantee the safety of drugs coming into the US from Canada and that people shouldn't rely on Canadian pharmacies for their drugs, even if it was cheaper, because the FDA was watching out for us and making sure that only safe drugs came into the US.

What a bunch of liars.

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KnightEnder
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They should take the money and personnel from the old DEA, (since the "drug war" has failed), after they legalize drugs less harmful than beer and tobacco, and give it to the FDA so they can have the manpower and money to go overseas. And the Canadian thing is bs put out because Big Pharma puts pressure on the politicians they own who put pressure on the FDA. Our country is so ****ed up I wonder if it can be saved.

KE

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JoshCrow
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It's such a crock... my mother was a Canadian pharmacist technician, and so I hear an earful about it all the time, but the bottom line is that our cheaper medications up here are every bit as good and safe as those marked-up meds you've got in the States.

I know plenty of privately owned pharmacies here did incredible business with the elderly population of Florida [Wink] Everyone "in the know" was buying their medication through Canada. The FDA should be embarrassed.

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scifibum
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So is there no testing of drugs that have been imported? It seems a lot easier and cheaper to simply randomly take 1 in 100 pills and run some tests on it to make sure it doesn't have anything we don't want in it, and does have what it's supposed to have in it. What does inspection of plants really accomplish that we couldn't get with random testing of the product?
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Stevarooni
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quote:
Originally posted by JoshCrow:
I know plenty of privately owned pharmacies here did incredible business with the elderly population of Florida [Wink] Everyone "in the know" was buying their medication through Canada. The FDA should be embarrassed.

As far as I know, there is no legitimate safety concern that justifies blocking prescription drugs from Canada, just international treaties.
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Jesse
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From what I understand, a huge percentage of those "cheaper" meds in Canada were produced right here in the US of A.

The price difference is entirely a matter of mark-up, not production cost or quality.

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Stevarooni
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quote:
Originally posted by Jesse:
The price difference is entirely a matter of mark-up, not production cost or quality.

Doesn't Canada have price fixing, though? So that if American drug companies didn't want to sell at the mandated price, Canadian pharmaceuticals would simply ignore the patents and manufacture them, themselves?

[ November 03, 2008, 12:36 PM: Message edited by: Stevarooni ]

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Jesse
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And?

Price fixing or not, American Pharmaceuticals certianly seem to think the margin is worth selling in Canada.

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G2
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quote:
Originally posted by Stevarooni:
Doesn't Canada have price fixing, though? So that if American drug companies didn't want to sell at the mandated price, Canadian pharmaceuticals would simply ignore the patents and manufacture them, themselves?

They have subsidies, from the Canadian Institute for Health Information:
quote:
In 2001, 46.3% of prescribed drugs were paid for by the public sector, rising to an expected 47.2% in 2003. Provincially, in 2003, the share varied from a low of 29.8% in Prince Edward Island to a high of 53.0% in Manitoba. Despite the differences, each province and territory increased its share of public funding between 1985 and 2001, with the exception of Nova Scotia, New Brunswick and Saskatchewan.

<snip>

Internationally, among 11 industrialized countries ranked by the OECD (Organisation for Economic Co-operation and Development), Canada falls behind only Japan, France and Hungary in drug spending as a percentage of total health spending. The United States was ranked eighth, with drug expenditures accounting for 12.4% of its total health care expenditures.

Drugs in Canada only seem cheaper because of the subsidies. The drugs are about half price at retail because of the subsidy.
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Stevarooni
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quote:
Originally posted by Jesse:
Price fixing or not, American Pharmaceuticals certianly seem to think the margin is worth selling in Canada.

...and if they didn't sell in Canada, their I.P. would be violated, and they would be competing against other companies that don't have the R&D costs.

So in response to the "And?" I'm saying that this is why pharmaceutical companies continue to export to countries where they're forced to sell at lower prices (and possibly raise prices in countries where that's permitted). The alternative would be a bit more costly.

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Jesse
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And if they weren't making money selling in Canada at current controled prices, they would cease doing it, and they wouldn't be "competing" with anyone.
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Stevarooni
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quote:
Originally posted by Jesse:
And if they weren't making money selling in Canada at current controled prices, they would cease doing it, and they wouldn't be "competing" with anyone.

No, they'd be competing against drugs manufactured by Canadian companies, shipped to the U.S. because of their low costs instead of the current situation, in which they're competing against their own drugs (subsidized by the Canadian government).
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scifibum
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Stevarooni, you're saying that Canadian companies can ignore US based IP if the US companies won't play ball...but I highly doubt that translates to them being able to market US IP-protected products in the US too.
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Stevarooni
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quote:
Originally posted by scifibum:
...but I highly doubt that translates to them being able to market US IP-protected products in the US too.

Not directly, no. On the other hand, there seem to be some forms of such advertisement even now.
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