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Mylan CEO Urges Lawmakers to OK Oversight Bill, New Fee

From Pittsburgh Tribune-Review (PA) (February 10, 2012)

Feb. 09--Mylan Inc. CEO Heather Bresch urged Washington lawmakers today to approve a new $300 million a year fee on the generic drug industry and to update a law that will give federal regulators greater power to inspect foreign pharmaceutical facilities.

Bresch, the daughter of U.S. Sen. Joe Manchin, D-W.Va., testified this morning before the House Energy and Commerce Committee's Health Subcommittee, which held a hearing on the proposed fee. The fee and increased oversight are essential for keeping pharmaceutical manufacturing operations, like Mylan's plant in Morgantown, W.Va., in the United States, Bresch told the subcommittee.

"U.S.-based facilities participating in both the U.S. and global pharmaceutical market should not be competitively disadvantaged and effectively encouraged to move jobs outside the U.S. as a result of an antiquated law that is impeding FDA (Food and Drug Administration) from carrying out its oversight responsibilities over all players supplying the U.S. pharmaceutical market," she said.

Canonsburg-based Mylan, the world's third largest generic drug maker, promoted Bresch to CEO at the start of this year.

The new fee, a first for the generic drug industry, would generate $1.5 billion for the FDA over five years to help it eliminate a backlog of some 2,500 applications for new copies of branded drugs.

"This backlog is preventing important generics from getting to the market, putting additional financial strain on our nation's patients," said U.S. Rep. Fred Upton, R-Mich., chairman of the Energy and Commerce Committee.

Bresch also called for foreign plants where drugs or drug ingredients are produced to be subject to the same frequency of inspections as U.S. plants. While the number of foreign drug facilities supplying the U.S. market more than doubled between 2001 and 2008, FDA inspection rates during that time dropped by more than 50 percent, according to the FDA.

"By taking these steps, we can further reduce government and taxpayer health care spending through more timely access to affordable generic medicine (and) ensure American competitiveness by addressing the unlevel playing field currently faced by U.S. manufacturers," Bresch said.


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Posted: February 2012