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.”