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Are Canadian drugs unsafe?
The senators who voted against the Canadian drug bill said they acted out of concern for safety. If the drugs were being imported from the Sudan or Burma then I might agree. But Canada? Does anyone believe that a pharmacy in Vancouver is less safe than a pharmacy in Seattle? There are Walmart stores with pharmacies in Canada, just like in the U.S.. And they are selling the same drugs from the same factories. Perhaps Canada's version of the F.D.A is completely corrupt and/or incompetent, but I doubt it. I have no qualms about assuming that Canada's standards are just as good as ours.
70 replies
= new reply since forum marked as read
= new reply since forum marked as read
from a FB post from a lawyer who has taken courses in FDA law:
Yesterday, Cory Booker and 12 other Democrats voted against an amendment offered by Bernie Sanders and Amy Kloubuchar that sought to create a deficit-neutral fund that would allow for the importation of Canadian drugs, and all day long, progressives have been excoriating Booker, in particular, for his vote.
They've suggested that Booker is simply doing the bidding of the pharmaceutical industry, pointing to the campaign donations he's received from the industry.
They've argued that Canadian drugs are just as safe as American drugs, and that, in many cases, we'd actually just be re-importing drugs that are already manufactured here.
They've pointed out that even Ted Cruz supported the Sanders-Klobuchar amendment (hey, if Ted Cruz likes it, it must be great, right?).
Today, on Twitter, Booker responded and explained his decision. The amendment, he said, did not guarantee that imported drugs would comply with basic FDA standards. He's right. It doesn't.
And people pushed right back at him. That's specious, they said, because in many cases we are talking about American drugs being re-imported, and besides, Canadian standards may even be stricter than America's. They've pointed out that the FDA already has guidelines that require foreign manufacturers to register with the FDA and comply with Current Good Manufacturing Practices.
And all of that is true (though I am not sure Canada's standards are stricter).
But Cory Booker and the other 12 Democrats were right to reject this amendment. It was fundamentally flawed.
Bernie Sanders's original amendment was not simply about Canadian drugs or the re-importation of American-manufactured drugs from Canada. The title was "DEFICIT-NEUTRAL RESERVE FUND RELATING TO LOWERING PRESCRIPTION DRUG PRICES FOR AMERICANS BY IMPORTING DRUGS FROM CANADA AND OTHER COUNTRIES."
So, let's disabuse the notion that Bernie Sanders had only wanted to open up the market to Canada, and perhaps that was smart of him. Perhaps that is the right solution. Why shouldn't we be able to import prescription drugs from other countries as well?
Amy Klobuchar subsequently amended Sanders's legislation and removed "other countries" from the title. That should settle it, right?
No, not really.
Because in both iterations, the amendments failed to include language that would allocate funding to the FDA to ensure consultative services to Canadian manufacturers, which we provide for American manufacturers.
Yes, Canada already has high standards, and yes, many of these drugs would simply be re-imported.
But Canada's standards aren't exactly the same as ours, and not all of these drugs are re-imported. Some would be manufactured in Canadian compounding pharmacies, for example.
Why does this matter?
Because although foreign manufacturers are required to register with the FDA and follow Current Good Manufacturing Practices, we essentially have to take them at their word. Scout's honor, you know?
And it is pretty easy to see how this is bad law and why any funding to import foreign drugs- even from our neighbors in Canada- should be tied to funding for the FDA to ensure compliance.
This doesn't just protect American consumers; it protects Canadian manufacturers as well.
This is the final paragraph of the FDA's guidelines for foreign drug imports:
"Due to the agency's limited resources, we are unable to provide extensive consultative services. It is the responsibility of each person marketing drug products to comply with all of the requirements of the Act and regulations. Should you have further questions concerning the manufacturing, labeling, approval requirements, etc. of any drug products you are interested in importing into the US, we recommend that you retain the services of an attorney or consultant with expertise regarding the Act and its implementing regulations, especially those affecting OTC drugs."
FDA compliance is not a simple process, which is why there are entire courses in law school that are about the FDA. And there aren't many attorneys- probably fewer than 300- who really understand this.
That's why- for American manufacturers- the FDA often holds your hand through the process (that's what they mean when they say, "extensive consultative services"
.
Look, we definitely need to open up drug importation from Canada. That's something with which we should all agree.
But we need to get the law right, because if we don't, we risk putting people's lives in even greater danger.
Of course, a single law school class in the subject doesn't make me an expert, but I'd humbly suggest that it did give me an education in the FDA that 99% of Americans do not have and would never even want.
Yesterday, Cory Booker and 12 other Democrats voted against an amendment offered by Bernie Sanders and Amy Kloubuchar that sought to create a deficit-neutral fund that would allow for the importation of Canadian drugs, and all day long, progressives have been excoriating Booker, in particular, for his vote.
They've suggested that Booker is simply doing the bidding of the pharmaceutical industry, pointing to the campaign donations he's received from the industry.
They've argued that Canadian drugs are just as safe as American drugs, and that, in many cases, we'd actually just be re-importing drugs that are already manufactured here.
They've pointed out that even Ted Cruz supported the Sanders-Klobuchar amendment (hey, if Ted Cruz likes it, it must be great, right?).
Today, on Twitter, Booker responded and explained his decision. The amendment, he said, did not guarantee that imported drugs would comply with basic FDA standards. He's right. It doesn't.
And people pushed right back at him. That's specious, they said, because in many cases we are talking about American drugs being re-imported, and besides, Canadian standards may even be stricter than America's. They've pointed out that the FDA already has guidelines that require foreign manufacturers to register with the FDA and comply with Current Good Manufacturing Practices.
And all of that is true (though I am not sure Canada's standards are stricter).
But Cory Booker and the other 12 Democrats were right to reject this amendment. It was fundamentally flawed.
Bernie Sanders's original amendment was not simply about Canadian drugs or the re-importation of American-manufactured drugs from Canada. The title was "DEFICIT-NEUTRAL RESERVE FUND RELATING TO LOWERING PRESCRIPTION DRUG PRICES FOR AMERICANS BY IMPORTING DRUGS FROM CANADA AND OTHER COUNTRIES."
So, let's disabuse the notion that Bernie Sanders had only wanted to open up the market to Canada, and perhaps that was smart of him. Perhaps that is the right solution. Why shouldn't we be able to import prescription drugs from other countries as well?
Amy Klobuchar subsequently amended Sanders's legislation and removed "other countries" from the title. That should settle it, right?
No, not really.
Because in both iterations, the amendments failed to include language that would allocate funding to the FDA to ensure consultative services to Canadian manufacturers, which we provide for American manufacturers.
Yes, Canada already has high standards, and yes, many of these drugs would simply be re-imported.
But Canada's standards aren't exactly the same as ours, and not all of these drugs are re-imported. Some would be manufactured in Canadian compounding pharmacies, for example.
Why does this matter?
Because although foreign manufacturers are required to register with the FDA and follow Current Good Manufacturing Practices, we essentially have to take them at their word. Scout's honor, you know?
And it is pretty easy to see how this is bad law and why any funding to import foreign drugs- even from our neighbors in Canada- should be tied to funding for the FDA to ensure compliance.
This doesn't just protect American consumers; it protects Canadian manufacturers as well.
This is the final paragraph of the FDA's guidelines for foreign drug imports:
"Due to the agency's limited resources, we are unable to provide extensive consultative services. It is the responsibility of each person marketing drug products to comply with all of the requirements of the Act and regulations. Should you have further questions concerning the manufacturing, labeling, approval requirements, etc. of any drug products you are interested in importing into the US, we recommend that you retain the services of an attorney or consultant with expertise regarding the Act and its implementing regulations, especially those affecting OTC drugs."
FDA compliance is not a simple process, which is why there are entire courses in law school that are about the FDA. And there aren't many attorneys- probably fewer than 300- who really understand this.
That's why- for American manufacturers- the FDA often holds your hand through the process (that's what they mean when they say, "extensive consultative services" .
Look, we definitely need to open up drug importation from Canada. That's something with which we should all agree.
But we need to get the law right, because if we don't, we risk putting people's lives in even greater danger.
Yesterday, Cory Booker and 12 other Democrats voted against an amendment offered by Bernie Sanders and Amy Kloubuchar that sought to create a deficit-neutral fund that would allow for the importation of Canadian drugs, and all day long, progressives have been excoriating Booker, in particular, for his vote.
They've suggested that Booker is simply doing the bidding of the pharmaceutical industry, pointing to the campaign donations he's received from the industry.
They've argued that Canadian drugs are just as safe as American drugs, and that, in many cases, we'd actually just be re-importing drugs that are already manufactured here.
They've pointed out that even Ted Cruz supported the Sanders-Klobuchar amendment (hey, if Ted Cruz likes it, it must be great, right?).
Today, on Twitter, Booker responded and explained his decision. The amendment, he said, did not guarantee that imported drugs would comply with basic FDA standards. He's right. It doesn't.
And people pushed right back at him. That's specious, they said, because in many cases we are talking about American drugs being re-imported, and besides, Canadian standards may even be stricter than America's. They've pointed out that the FDA already has guidelines that require foreign manufacturers to register with the FDA and comply with Current Good Manufacturing Practices.
And all of that is true (though I am not sure Canada's standards are stricter).
But Cory Booker and the other 12 Democrats were right to reject this amendment. It was fundamentally flawed.
Bernie Sanders's original amendment was not simply about Canadian drugs or the re-importation of American-manufactured drugs from Canada. The title was "DEFICIT-NEUTRAL RESERVE FUND RELATING TO LOWERING PRESCRIPTION DRUG PRICES FOR AMERICANS BY IMPORTING DRUGS FROM CANADA AND OTHER COUNTRIES."
So, let's disabuse the notion that Bernie Sanders had only wanted to open up the market to Canada, and perhaps that was smart of him. Perhaps that is the right solution. Why shouldn't we be able to import prescription drugs from other countries as well?
Amy Klobuchar subsequently amended Sanders's legislation and removed "other countries" from the title. That should settle it, right?
No, not really.
Because in both iterations, the amendments failed to include language that would allocate funding to the FDA to ensure consultative services to Canadian manufacturers, which we provide for American manufacturers.
Yes, Canada already has high standards, and yes, many of these drugs would simply be re-imported.
But Canada's standards aren't exactly the same as ours, and not all of these drugs are re-imported. Some would be manufactured in Canadian compounding pharmacies, for example.
Why does this matter?
Because although foreign manufacturers are required to register with the FDA and follow Current Good Manufacturing Practices, we essentially have to take them at their word. Scout's honor, you know?
And it is pretty easy to see how this is bad law and why any funding to import foreign drugs- even from our neighbors in Canada- should be tied to funding for the FDA to ensure compliance.
This doesn't just protect American consumers; it protects Canadian manufacturers as well.
This is the final paragraph of the FDA's guidelines for foreign drug imports:
"Due to the agency's limited resources, we are unable to provide extensive consultative services. It is the responsibility of each person marketing drug products to comply with all of the requirements of the Act and regulations. Should you have further questions concerning the manufacturing, labeling, approval requirements, etc. of any drug products you are interested in importing into the US, we recommend that you retain the services of an attorney or consultant with expertise regarding the Act and its implementing regulations, especially those affecting OTC drugs."
FDA compliance is not a simple process, which is why there are entire courses in law school that are about the FDA. And there aren't many attorneys- probably fewer than 300- who really understand this.
That's why- for American manufacturers- the FDA often holds your hand through the process (that's what they mean when they say, "extensive consultative services"
.
Look, we definitely need to open up drug importation from Canada. That's something with which we should all agree.
But we need to get the law right, because if we don't, we risk putting people's lives in even greater danger.
our Canadian snowbirds fill our community in the winter here in AZ..they laugh -
Consider too, Arizonans go to Mexico not just for prescriptions but for drastically reduced cost for dental work...YES< ARIZONANS..let's not forget our close proximity to Rocky Point...awesome vaca spot - actually can drive there in 3-4 hours....gorgeous beaches..and friendly people...Music and food - authentic - just be sure to bring your own water..
