Wednesday, April 22, 2015

Why did the FDA make a statement about Health Canada that gives False Impression of Safety, Efficacy

The publisher of a leading informational website on the high cost of prescription medicines in the U.S. says Congressional supporters of personal importation of safe, affordable prescription medicines should demand that the U.S. Food and Drug Administration explain why it says that it is ‘unable’ to ‘ensure’ the safety and efficacy of prescription medicines approved by Health Canada for sale in Canada, if those medicines are purchased by U.S. citizens.

Daniel Hines, publisher of RxforAmericanHealth and TodaysSeniorsNetwork says that on its website, the FDA notes:  “... if a drug is approved by Health Canada (FDA’s counterpart in Canada) but has not been approved by FDA, it is an unapproved drug in the United States and, therefore, illegal to import. FDA cannot ensure the safety and effectiveness of drugs that it has not approved.”

“This statement is a reflection of the flawed reasoning and overreach of the FDA,” says. Hines.  He points out that Health Canada is internationally recognized for its proven record of professionalism and safety in its oversight of the Canadian health system.

“As a matter of fact, Health Canada and the FDA have indeed independently reviewed and approved many of the same brands of medicines. The only distinction is that the labeling of the Canadian medicine is different from that of the same medicine sold in the U.S,” Hines explains.

Hines points out that by suggesting that Health Canada does not have the expertise to determine the safety and efficacy of a medicine, the FDA has moved from being a regulatory agency to taking an advocacy stance that flies in the face of the facts, and undertaken a stance that is directly contrary to legislation introduced in the U.S.Congress.

 He points to S. 122, a bi-partisan bill introduced by Senators Amy Klobuchar (D-MN) and John McCain (R-AZ) calling specifically for facilitating personal importation of medicines from Canada that are approved by Canadian Provincial authorities, which are subject to the oversight of Health Canada.

“This is a recognition of the safety of medicines approved by Health Canada, and by extension, the regulatory agencies of other Tier One countries whose standards of safety and efficacy meet or exceed those of the U.S.,” Hines says.

“One can only hope that Senators Klobuchar and McCain demand that the FDA retract this disingenuous statement about Health Canada, an agency of the highest repute, and ensure that the FDA not make such statements about legislation awaiting consideration of the United States Congress in the future ,” he says.

He concludes that the stance of the FDA should also be questioned as to its relationship with Pharma since the FDA stance reflects the claims of Pharma.

He also urges that Congress be alert to what supporters of personal importation fear will be a misguided application of Section 708 of the Food and Drug Administration Safety and Innovation Act that runs contrary to Congressional intent.

“The soon-to-be-announced rules for administration of Section 708 which authorizes the seizure and destruction of imported prescription medicines deemed to be counterfeit, unsafe, or ‘misbranded’, takes on special importance since if medicines approved by such an internationally respected authority as Health Canada are deemed to be ‘illegal’ or ‘unsafe’, the FDA will, almost certainly rule the same is true of other countries.

“This will lead to the spectacle of the FDA-- an agency ostensibly designed to protect and promote the health and well-being of Americans --doing just the opposite by destroying valid personally imported vital medications which, at prices of as much as 60 percent more in the U.S., are unavailable because they are unaffordable.

“The only beneficiary of such action will be Pharma, as the FDA endangers one of the few avenues of relief for Americans from the industry’s predatory pricing practices.”


Monday, April 20, 2015

‘Curiouser and Curiouser!’ The Alice in Wonderland World of the FDA



Alice in Wonderland, recognized as a‘Children’s Classic, also is a reflection of our own Wonderland populated by strange creatures whom, as one sees and hears more of them, we discover that, as Alice said, things get ‘Curiouser and Curiouser.’

 It’s called The Beltway, a reference to the seat of our Federal government (although several agencies have headquarters outside the ‘physical boundaries’ of The Beltway, it is the ‘Source’ or Mother head from which all our laws and regulations flow).

It is comprised of both elected and unelected persons who make decisions that affect our everyday lives, our health and well-being, and our prosperity...and not always for the best. 

That’s because, unfortunately, the things that they do too often reflect special interests, are based on self-contradictory stances, and exhibit complete disregard for facts that disrupt their Wonderland.

The most notable example of this denial of facts is evidenced by the Food and Drug Administration (FDA) decisions affecting the right—and the need—of Americans to make personal, responsible decisions to determine that safe and affordable brand-name medicines are indeed available from licensed, registered pharmacies in Tier One Countries whose standards of safety and efficacy meet or exceed those of the FDA, and are therefore safe sources for them to use to purchase their medications.

The FDA reflects Alice’s thoughts even before she descends into Wonderland.  Consider this telling quote she makes:  “If I had a world of my own, everything would be nonsense. Nothing would be what it is, because everything would be what it isn't. And contrary wise, what is, it wouldn't be. And what it wouldn't be, it would. You see?”

Yes, Alice and FDA we see.  Both of you believe you have a world of your own and it is subject to the bending of your will, even though the FDA was ostensibly designed to protect the health and well-being of American citizens, ensuring among other things that the prescription medicines made available to Americans are indeed safe and effective.

That is why the ‘Long Title’ of The Prescription and Drug Marketing Act of 1987 is: An Act to amend the Federal Food, Drug, and Cosmetic Act to ban the reimportation of drugs produced in the United States, to place restrictions on the distribution of drug samples, to ban certain resales of drugs by hospitals and other health care facilities, and for other purposes.

Although, the ‘reimportation’ mention is specific to restrictions upon reimporting medicines produced in the US, marketed outside the Country and then brought back into the US, i.e., ‘reimportation’, the FDA, in collusion with the special interests of Pharma  shapes its and our world with that ‘reimportation’ of prescription medicines somehow doesn’t mean what it means.

To come to such a conclusion, the FDA and Pharma say that the law doesn’t mean what it means.


Significantly, all the Lipitor produced by Pfizer for sale in the US is manufactured in Ireland for sale in the US and elsewhere.  That means it is imported into this country, whether by Pfizer or by individuals. 

Pfizer, as the manufacturer of Lipitor has the right, of course, to sell the medicines it produces, but in the absence of any restriction upon the right of individuals to personally import their medicines, then it is self-evident that Americans do indeed have the right to personally import their Lipitor and other prescription medicines.

In yet another example of Wonderland-speak, the FDA refers to seized personally imported Lipitor prescriptions as a ‘new drug’ or a drug not approved by the FDA, although it clearly is a valid medicine ordered by an individual with a doctor’s prescription.  So, says the FDA,  it is not what it is.

A further reading of The Prescription and Drug Marketing Act of 1987 makes it abundantly clear that the law’s intent is to ban ‘certain’ resales of reimported medicines “by hospitals and other health care facilities...” and there is no intent to restrict Americans from purchasing their medicines via personal importation, except for the FDA creating its own world where nothing is what it seems.

But perhaps the best example of this bizarre world is on the FDA’s own web page as it answers the question: Is it legal to import prescription medicines?

The FDA response:  “In most circumstances, it is illegal for individuals to import drugs into the United States for personal use. This is because drugs from other countries that are available for purchase by individuals often have not been approved by FDA for use and sale in the United States. For example, if a drug is approved by Health Canada (FDA’s counterpart in Canada) but has not been approved by FDA, it is an unapproved drug in the United States and, therefore, illegal to import. FDA cannot ensure the safety and effectiveness of drugs that it has not approved.”

Let’s take this point-by-point:

FDA Statement: In most circumstances, it is illegal for individuals to import drugs into the United States for personal use. This is because drugs from other countries that are available for purchase by individuals often have not been approved by FDA for use and sale in the United States.

Common Sense Response:  The FDA says drugs sold in other countries to their citizens ‘often’ have not been approved by the FDA.  The use of the term ‘often’ indicates that there are some drugs that the FDA has approved.  The FDA should let us know which of those medicines have been approved...or should the ‘often’ term be ‘never’?  (The answer is ‘never’.)

FDA Statement: “For example, if a drug is approved by Health Canada (FDA’s counterpart in Canada) but has not been approved by FDA, it is an unapproved drug in the United States and, therefore, illegal to import. FDA cannot ensure the safety and effectiveness of drugs that it has not approved.”

Common Sense Response:  This is the winner of the Wonderland double-talk award.  Senator Bernie Sanders (I-VT) has asked opponents of personal importation: “Where are all the Dead Canadians”.  It is ludicrous of the FDA to say that a medicine approved by Health Canada is inferior to that of the FDA.  Also, the FDA talks about  challenges in ‘ensuring’ the safety of the drug, even though it is the same medicine as sold in the US. 

This statement is also a reflection of the abuse and overreach of the FDA.  Congress has repeatedly supported personal importation in favorable votes only to be stymied by unprecedented ‘certification’ requirements by the Secretary of Health and Human Services.  Now, S. 122, a bi-partisan bill introduced by Senators Amy Klobuchar (D-MN) and John McCain (R-AZ) calls specifically for facilitating personal importation of medicines from Canada that are approved by Health Canada.

By suggesting that Health Canada dos not have the expertise to determine the safety and efficacy of a medicine, the FDA has moved from being a regulatory agency to an advocacy stance that flies in the face of the facts, and undertaken a legislative initiative that is outside its legal boundaries as a department of the executive branch.

One can only hope that Senators Klobuchar and McCain will demand that the FDA remove this incorrect statement about Health Canada, an agency of the highest repute.


At least for Canadians?  Really, is there a genetic distinction between Americans and Canadians that makes a prescription safe for Canadians, but somehow unsafe for Americans?  Not hardly. But then, in this world of outlandish claims, everything is nonsense. Nothing is what it is, because everything would be what it isn't. And contrary wise, what is, it wouldn't be. And what it wouldn't be, it would.

“You see?”

It is time for Congress to step up and end this Alice in Wonderland scenario and to direct the FDA to cease attempts to increase its intended limited authority, and to work on behalf of the millions of Americans who are being denied their access to safe, affordable medicines because of illogical and contradictory actions that usurp legislative oversight and direction of the agency. Otherwise, things will get ‘Curiouser and Curiouser’!

Friday, April 10, 2015

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