FDA Lacks Examples of Canadian Drugs Harming Americans
by Tony Pugh
WASHINGTON - Although they've been warning Americans about the dangers of
prescription drugs from Canada for nearly a year, U.S. Food and Drug
Administration officials can't name a single American who's been injured or
killed by drugs bought from licensed Canadian pharmacies.
"We don't have that," said Tom McGinnis, the FDA's director of pharmacy affairs.
"I can't think of one thing off the top of my head where somebody died or
somebody got put in the hospital because of these medications. I just don't know
if there's anything like that."
Neither does Canada.
Health Canada, which regulates Canada's prescription industry, "does not have
any information that would indicate that any Americans have become ill or have
died as a result of taking prescription medications purchased from Canada," said
Jirina Vlk, a spokeswoman for Health Canada.
That doesn't mean there are no such cases, nor does it mean that all drugs from
Canada are safe. But the absence of documented harm strongly suggests that
medications obtained from licensed Canadian pharmacies are safe, and raises
questions about whether the FDA may be overstating the risk of buying less
expensive Canadian drugs.
FDA Commissioner Mark McClellan, in a speech last week in Canada before a group
of drug information experts, said the agency had found "thousands of examples of
unapproved and potentially unsafe medicines" coming into the United States from
"many countries, including from Canada."
In a subsequent news conference in Ottawa, McClellan was more specific,
according to news reports, saying there were "lots of examples of unsafe drugs
coming into the United States from Canada."
A recent report by the Congressional Research Service - the Library of Congress
expert that Congress turns to for objective information - supports the safety of
drugs from Canada. It found that medications manufactured and distributed in
Canada meet or surpass quality control guidelines set by the FDA.
Concern that the FDA may be misleading consumers has hurt its credibility among
some Capitol Hill lawmakers, who say the agency is carrying water for the
powerful drug industry.
"There's no question in my mind that the (FDA) is too dependent on the
pharmaceutical industry for their attitudes and decision-making," said Rep. Dan
Burton, R-Ind., who chairs a House subcommittee that's studied the Canadian drug
issue. "I had four hearings and I asked (FDA Associate Commissioner William
Hubbard) to give me examples where people have been damaged by Canadian
pharmaceuticals and re-importation, and he couldn't even give me one, not one."
In response to Burton, Hubbard cited examples of people who got the wrong drugs
from Canadian pharmacies. While that's a danger, U.S. pharmacists make similar
errors. Hubbard also told Burton that the FDA thinks many people don't report
adverse incidents that result from Canadian drugs.
That's because they fear being prosecuted for violating federal laws against
foreign drug imports, said Carmen Catizone, the executive director of the
National Association of Boards of Pharmacy, a Park Ridge, Ill., group that
represents state boards appointed by U.S. and Canadian governors.
In testimony before the Senate Commerce Committee, Catizone said injuries from
bad drugs might not surface for years, and then might not be linked to Canadian
drugs.
McGinnis said FDA warnings about bad drugs from Canada were valid and reflected
the "buyer beware" caution that's justified when people buy drugs via the
Internet. "A lot of Internet pharmacies that claim to be Canadian aren't even
based in Canada," McGinnis said.
? Knight-Ridder 2003
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