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McCain, Obama Back Prescription Drug Importation But Acknowledge Safety Concerns, Advisers Say

By Meghan McCarthy, CQ Staff

October 27, 2008 -- Presidential candidates Barack Obama, D-Ill., and John McCain, R-Ariz., have reaffirmed their support for allowing Americans to import cheaper prescription drugs from abroad, but both campaigns note that concerns over international drug safety will take precedence in determining this policy, commonly known as drug reimportation.

At a generic pharmaceuticals conference in September, senior advisers to the Obama and McCain campaigns acknowledged that recent incidents with tainted heparin, a blood thinner, and infant formula that were imported into the United States from China illustrate the policy challenges to ensuring drug safety abroad.

"We have not changed our position on this issue, but obviously there have been concerns in countries like China," Obama campaign adviser Neera Tanden said in an interview. "Our plan does not envision importing drugs from China . . . but from countries with strong records of safety, like Canada and Europe."

The McCain campaign also confirmed continued support for drug reimportation. Campaign spokesman Brian Rogers said in an e-mail McCain understands the need to have a "properly documented" drug supply chain, and he would insist that all imported drugs "meet state and federal standards for safety." Rogers also noted that additional Food and Drug Administration funding would be needed to secure imported drugs.

But Rep. Jack Kingston, R-Ga., an outspoken proponent of drug reimportation measures on Capitol Hill, said talk of unsafe drugs is nothing more than a stall tactic.

"Safety is the politically acceptable red herring here . . . most people will tell you that the safety issue has been a convenient way to fight [reimportation]," Kingston said.

He said large increases in FDA funds for foreign inspection are not necessary.

"As the ranking member on the Appropriations Agriculture subcommittee which has jurisdiction over the FDA, they don't know what they are talking about–they just want to grow," Kingston said, referring to FDA Center for Drug Evaluation and Research Director Woodcock's statement that inspection of foreign drugs would require an additional $225 million increase.

"The reality is that 10 years ago they wanted $25 million to do this . . . maybe they need $250 million if they want to make sure they can reimport drugs from Nairobi," Kingston said.

Kingston would prefer to focus on importing cheaper drugs from Canada first.

"This is no strange, third world country, it's our number one trade partner . . . really and truly, if we could get Canada, it would be a good day's work," Kingston said.

Sen. Byron L. Dorgan, D-N.D., another champion of drug reimportation efforts, sponsored legislation that he said includes stringent safety measures that will protect Americans from tainted drugs (S 242).

"Our legislation has a greater measure of safety than current law, it requires much greater resources and tracking devices that don't exist currently," Dorgan explained. "Our legislation does not include China, only countries that have similar chains of custody and regulations of the type that exist in the U.S."

Dorgan's legislation explicitly allows for reimportation from Australia, Canada, the European Union, Japan, New Zealand, and Switzerland.

Dorgan also noted that importing drugs across country borders is a common and safe practice in Europe.

"The EU has been doing something called parallel trading . . . for two decades, with no safety issues at all, allowing prescription drugs to go from Spain, to Italy, to France. If they can do it for two decades, it seems our country can do this as well," Dorgan said.

Despite bipartisan support for drug reimportation, serious challenges to the practice exist. Rep. John D. Dingell, D-Mich., the powerful chairman of Energy and Commerce committee, remains a staunch opponent of drug reimportation efforts, advocating instead for domestic health care reform to address the high cost of prescription drugs.

"GAO reported last week that FDA inspections of foreign drug facilities are alarmingly low–once every 13 years, despite the fact that serious violations are often found in foreign plants," Dingell said.

"That report, and the heparin crisis, call into serious question claims that reimportation is the answer to high drug prices. An unsafe, cheap drug is still an unsafe drug. A national health care program would guarantee every American the safe and effective drugs they need."

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