FDA Opposes Drug Reimportation

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FDA Commissioner Margaret Hamburg sent letters to two senators laying out the administration's view on the amendment. In short, the FDA now thinks that allowing consumers to buy drugs from foreign countries would compromise the safety of the U.S. prescription drug supply, which she called "the safest in the world."

"There are significant safety concerns relating to allowing the reimportation of nonbioequivalent products, and safety issues related to confusion in distribution and labeling of foreign products and the domestic product that remain to be fully addressed in the amendment," wrote Hamburg in letters sent to Sens. Sam Brownback (R-Kansas) and Tom Carper (D-Del.).

http://www.medpagetoday.com/PublicHealthPolicy/Washington-Watch/17430
 






Even Big Pharma's legendary political clout has proven no match for the anger of ordinary folk over escalating costs at the drugstore. The industry thought its heated lobbying, hefty campaign contributions, and White House backing could quash Capitol Hill's drive to allow Americans to import drugs from countries with far lower prices. But in an early morning vote on July 25, the House handed the industry a stunning rebuke -- a 243-to-186 vote on a bill that opens the door to widespread imports. "The will of the Congress spoke," says Representative Jo Ann Emerson (R-Mo.), who led the fight. "The American people want relief."

The vote shines a harsh light on the prices Americans pay for medicines -- often more than twice what Canadians or Europeans face. "American consumers are footing the bill for R&D while consumers in other countries get the benefit," says Senator Susan M. Collins (R-Me.), a key Senate supporter of drug imports. "I don't think that's fair."
SAVINGS AND PROFITS. The price disparity has already spawned scores of storefronts across the country and hundreds of Web sites offering U.S. residents cheaper drugs from Canada and elsewhere .

If Congress gives the green light to imports, the impact on Big Pharma's prices -- and profits -- could be huge. Even if imports were limited to products from Canada, Senator Byron L. Dorgan (D-N.D.) pegs the savings for consumers at up to $38 billion a year, most of which will come out of drugmakers' pockets.
 






FDA Commissioner Margaret Hamburg sent letters to two senators laying out the administration's view on the amendment. In short, the FDA now thinks that allowing consumers to buy drugs from foreign countries would compromise the safety of the U.S. prescription drug supply, which she called "the safest in the world."

She probably didn't know about the recent warning letter of Novartis http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm281843.htm or she would allow reimportation of Novartis drugs.

Bearing in mind for how long the issues in Novartis TRD have been going on and how long it took FDA to take action, the validity of her statement that US drugs are "the safest in the world" is at best questionable.
 






FROM 2003

THWARTING IMPORTATION. Drugmakers are also contemplating strategies to get around any importation bill. If the law required that all drugs imported from, say, Canada, be made in FDA-approved facilities, then drugs designated for sale in Canada could be made in plants purposely removed from FDA purview. "It's simple to defeat the intent of the bill," says Richard T. Evans, a pharmaceutical analyst at Sanford C. Bernstein & Co.
Maybe so. But clearly, the industry can't put this issue back in the bottle. Whatever Congress finally does, outrage over high drug costs has already led many Americans to buy their drugs from other countries. Hans W. Jenau, founder of a storefront in Oviedo, Fla., that helps seniors buy from Canadian pharmacies, reports that 10,000 people have used his service since he opened in June, 2002

That's why the House vote is just the latest indication that rising drug costs have put Big Pharma on the defensive. "This was a sign that drug prices are unconscionable -- and that the industry is not as powerful as it thought it was," says James Packard Love, director of the Consumer Project on Technology. No amount of drugmaker lobbying or campaign contributions will keep Americans from seeking cheaper drugs wherever they can find them.
 






YOU & OBAMA NEED TO STOP CUTTING DEALS

Soon we'll find out if the Senate is really going to buck President Obama on the deal he cut with Big Pharma. I wonder how serious this is:

North Dakota Sen. Byron Dorgan, a member of Democratic leadership, isn't a party to that bargain. "Senator Dorgan intends to offer an amendment to the health reform bill and his expectation is that it will be one of the first amendments considered," his spokesman Justin Kitsch told HuffPost in an e-mail. "Prescription drug importation is an immediate way to put downward pressure on health care costs. It has bipartisan support, and has been endorsed by groups such as the National Federation of Independent Businesses and AARP."

U.S. patients pay far more than the rest of the world for prescription drugs. The Canadian government keeps prices down by using its purchasing power to negotiate for lower rates. Dorgan wants American consumers in on the deal.

A bill to allow re-importation -- S. 1232 - has 30 cosponsors, several Republicans among them, including Olympia Snowe and Susan Collins of Maine, John Thune (S.D.) and David Vitter (La.).

The Congressional Budget Office estimates that the bill would result in $50 billion in direct savings over the next decade, with $10.6 billion of that being savings to the federal government.
 






YOU & OBAMA NEED TO STOP CUTTING DEALS

Soon we'll find out if the Senate is really going to buck President Obama on the deal he cut with Big Pharma. I wonder how serious this is:

North Dakota Sen. Byron Dorgan, a member of Democratic leadership, isn't a party to that bargain. "Senator Dorgan intends to offer an amendment to the health reform bill and his expectation is that it will be one of the first amendments considered," his spokesman Justin Kitsch told HuffPost in an e-mail. "Prescription drug importation is an immediate way to put downward pressure on health care costs. It has bipartisan support, and has been endorsed by groups such as the National Federation of Independent Businesses and AARP."

U.S. patients pay far more than the rest of the world for prescription drugs. The Canadian government keeps prices down by using its purchasing power to negotiate for lower rates. Dorgan wants American consumers in on the deal.

A bill to allow re-importation -- S. 1232 - has 30 cosponsors, several Republicans among them, including Olympia Snowe and Susan Collins of Maine, John Thune (S.D.) and David Vitter (La.).

The Congressional Budget Office estimates that the bill would result in $50 billion in direct savings over the next decade, with $10.6 billion of that being savings to the federal government.

Is this the same CBO that said ObamaCare was going to save us money?
What a fucking joke MORON you are..... importing drugs from Canada is NOT a VALID long-term solution for reducing drug costs.
 






Is this the same CBO that said ObamaCare was going to save us money?
What a fucking joke MORON you are..... importing drugs from Canada is NOT a VALID long-term solution for reducing drug costs.

Hey The Citizen's for fair drug pricing PAC is looking for
a few indoctrinated mindless lemmings. Why not ditch your low paid pharma
gig & get on board with a worthwhile cause ?

Since you obviously are not very effective at shilling FOR pharma
 






Hey The Citizen's for fair drug pricing PAC is looking for
a few indoctrinated mindless lemmings. Why not ditch your low paid pharma
gig & get on board with a worthwhile cause ?

Since you obviously are not very effective at shilling FOR pharma

Yes.... lets all give pretend Monopoly money to this delusional Drone and his fake PAC..... LOL