Mylan Pushes Deal to Ensure Safety of Generic Drugs
Nixon, Alex, Tribune-Review/Pittsburgh Tribune-Review
Generic drugmakers 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. …