FDA lags on inspections of foreign drug plants

While some members of Congress are pushing to allow U.S. residents to buy prescription drugs from other countries, including Canada, the Food and Drug Administration is unable to keep up with biennial inspections of foreign manufacturers that already sell drugs here, officials said.

"We are supposed to inspect each foreign drug manufacturer at least every other year, but do not achieve that goal, due to limited resources," the agency said in a statement issued in response to questions from CongressDaily. "We have only about $50 [million] to do all drug inspections each year, both domestic and foreign, so we do not get to every firm every other year, although we do inspect every firm before a new drug is allowed on the market."

The disclosure that the FDA cannot keep up with inspections is sure to factor into the debate on both sides of the contentious reimportation issue, which lawmakers vow to continue when the 109th Congress convenes. The FDA statement -- which comes as the department prepares to release a congressionally mandated report on prescription drug imports -- also noted that it would "be very costly for the agency to inspect foreign pharmacies in the way contemplated" by legislation that would allow prescription drugs to be purchased in Canada.

The debate over reimportation masks that about four in 10 prescription drugs now sold in this country are manufactured elsewhere. That includes one of the most widely prescribed drugs, Pfizer's Lipitor -- in fact, much of the cholesterol-lowering medication sold in the United States is manufactured in Ireland. The FDA inspects only the part of the Irish plant that makes the pills sold here, not the part of the facility that makes Lipitor bound for Canada or elsewhere, said William Hubbard, associate FDA commissioner.

"We can't be sure any drug we don't examine and check is safe and good," Hubbard said in an interview. "The problem with the Canadian stuff is that it hasn't gone through FDA reviews and supervision." The existing law requires that any drug sold in this country be approved in advance, regardless of where it was made.

While safety is often mentioned as a reason for opposing reimportation, some supporters of the effort say raising those concerns is merely a smokescreen from drugmakers who fear their profits will be undercut by lower prices from Canada. Other critics of the current system, including a Pfizer official whose statements have been disavowed by the company, say the FDA is already failing to ensure safety.

"The FDA has failed to keep our drug supply safe from criminals and corporate profiteers," said the Pfizer official, Peter Rost. "The FDA has failed to protect the American consumer."