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Drug bill receives hearing

FDA official calls Gutknecht proposal dangerous

By Angela Greiling Keane

agreiling@postbulletin.com

WASHINGTON -- A senior Food and Drug Administration official on Thursday said a prescription drug bill sponsored by U.S. Rep. Gil Gutknecht could endanger U.S. consumers.

Gutknecht, a Rochester Republican, countered that the measure that would allow U.S. consumers and pharmacists to buy prescription drugs from abroad would be safe and allow cash-strapped senior citizens access to medications they might not otherwise be able to afford.

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"From a public health standpoint, importing prescription drugs for personal use is a potentially dangerous practice," William Hubbard said at a House Health Subcommittee hearing. Hubbard is the FDA senior associate commissioner for policy, planning and legislation. "FDA and the public have no assurance that unapproved products are effective or safe or have been produced under U.S. good manufacturing practices."

Gutknecht and Rep. Jack Kingston, a Republican from Georgia, the bill's other lead sponsor, challenged Hubbard's arguments. They especially questioned claims that the number of counterfeit drugs in the United States would greatly increase if people were allowed to buy drugs from other countries.

During his testimony, Hubbard hauled out examples of counterfeit drugs that patients, pharmacists and physicians would not be able to detect just by looking at them.

"Most of the counterfeit drugs you showed us here today originated in the United States, didn't they?" Gutknecht asked, seeking to show that the problem should not be blamed on other countries.

Hubbard acknowledged that was true but said authorities expect to see an increase in counterfeit drugs if Congress makes it legal to buy medication abroad.

While it is illegal for pharmacists and consumers and anyone else to order prescription drugs from other countries, many individuals, particularly senior citizens, do it.

Hubbard said the FDA does little to stop them. He said the agency focuses on wholesale importers and ignores people importing personal prescriptions.

At the hearing, Gutknecht and Kingston were the only Republicans speaking strongly in favor of changing the law. Most of the other supporters were Democrats, while most of the lawmakers' Republican colleagues spoke about safety concerns.

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Gutknecht and Kingston introduced their legislation on Tuesday. Democratic supporters credited the pair for Thursday's hearing. But Rep. Frank Pallone, a Democrat from New Jersey, lashed out at subcommittee chairman Rep. Michael Bilirakis, a Republican from Florida, calling the hearing "a sham."

"The fact is that Republicans don't want to address the issue of re-importation," Pallone said.

Gutknecht said committee leaders had to be goaded into conducting the hearing. But he said shining a spotlight on the issue is good, regardless of the motives behind the hearing.

He said he was heartened by the testimony of Elizabeth Wennar, president and chief executive officer of United Health Alliance, a Vermont non-profit health system.

Wennar said it is possible to design U.S. laws to allow for prescription drug importation while ensuring safety. She said buying drugs from Canada can be assuredly safe and that technology is available to track drugs from their time of manufacturing until they are sold to consumers.

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