Generic Drug Makers May Soon Pay for Inspection of Overseas Plants


"There's no doubt it should be done, but it should be done through the congressional appropriations process," said Dr. Sidney Wolfe, director of Public Citizen, the nonprofit consumer advocacy group.

The generic drug industry, he said, should not be funding these inspections.

Wolfe is critical of PDUFA and the concept that fees are being used to pay for the drug-approval process. He also expressed concern that GDUFA will give the drug industry more power over the FDA.

"It also isn't clear who is going to do the inspections," he added. "My guess is it will be some jumble of U.S. and foreign inspectors."

Bresch of Mylan Pharmaceuticals said that under the proposed plan, inspections will fall under control of the FDA.

Other experts believe the inspection plan is promising, even though there are still unanswered questions.

"Costs will be passed along to the consumer, but if that means it eliminates another source of concern, then it sounds like a great idea," said Paul Doering, distinguished service professor of pharmacy practice at the University of Florida in Gainesville.

"If there's a concern that the standards overseas are different, then let's make the standards the same," he added. "I can't see what harm there is in that."

The FDA has not yet responded to questions from ABC News about the plan, but commissioner Dr. Margaret Hamburg told the New York Times that she welcomes the proposed assistance.

"If a program along the lines of what the parties are working on is enacted by Congress, it would represent a real breakthrough," she said. "FDA's entire generic drug program would be placed on a much more stable footing."

Bresch has high hopes Congress will pass the measure next year. "This is a very important consumer issue," she said.

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