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Mylan Pushes Deal to Ensure Safety of Generic Drugs

Mylan Pushes Deal to Ensure Safety of Generic Drugs [the Pittsburgh Tribune-Review]

From Pittsburgh Tribune-Review (PA) (August 17, 2011)

Aug. 17--Generic drug makers and the federal government have a tentative deal that would provide $299 million in new funding a year to the Food and Drug Administration to speed approval of generics and provide for inspections of foreign drug manufacturing plants.

The deal, which could be finalized in coming months, was pushed by Mylan Inc. to ensure the safety of generic drugs made overseas for the U.S. market and to eliminate an incentive to ship American jobs to foreign countries.

"The rigor is just not there (at foreign manufacturing plants) as it is here in the United States," said Heather Bresch, president of Canonsburg-based Mylan, in an interview.

Plants in foreign countries that produce active pharmaceutical ingredients and finished drugs for sale in the United States are rarely inspected by the FDA, Bresch said. That can lead to safety problems in generic drugs and makes it less profitable to produce those drugs in the U.S., she said.

In 2009, the FDA inspected only 11 percent of the more than 3,700 foreign facilities where finished drugs and active ingredients are made for the U.S. market, according to a 2010 report to Congress from the Government Accountability Office. By comparison, U.S. plants are inspected every two years.

That difference means it's more expensive to produce generic drugs in America. About 40 percent of the drugs Americans take are made overseas and about 80 percent of the active ingredients in those drugs come from foreign plants, according to Mylan.

Mylan employs about 2,900 people at a large manufacturing plant in Morgantown, W.Va. Bresch said it costs 25 percent more to manufacture generics in the United States than overseas because foreign plants don't have to meet the same quality standards.

"I'm not asking to have an incentive to be in the U.S.," she said. "But there should be parity and a level playing field."

Mylan has produced active ingredients and finished products overseas since it acquired two foreign companies in 2007.

Generic industry representatives have been negotiating with FDA officials over a first-ever fee to boost government reviewers and inspectors since February, said David Belian, a spokesman for the Generic Pharmaceutical Association, a Washington-based advocacy organization.

Because negotiations are ongoing, Belian declined to comment on specifics. But, he said, "a tentative deal is in place" and he expects a "final deal very soon."

"The intent of a generic drug user fee program would be to provide additional revenues so that FDA can hire more staff and improve systems to support the generic drug review process," FDA spokeswoman Sandy Walsh said in a statement. She said the agency hopes to be able to take a proposal for a package of new fees, including $299 million from generic drug makers, to Congress by January.

Bresch, who is the daughter of U.S. Sen. Joe Manchin III, D-W.Va., said she also expects to see a bill introduced in Congress this fall to update the law that outlines the FDA's regulatory authority to give it a legal framework for inspecting foreign facilities.

That law, the Federal Food, Drug and Cosmetic Act, "was passed in 1938 and effectively hasn't changed," Bresch said.

Adding the fee and updating the law, Bresch said, "need to happen to get the FDA on the footing that they need to ensure safety in the global world we live in today."


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Posted: August 2011