Wednesday, February 16, 2011

Generic Drug Makers Ready Pay FDA User Fees.

Generic Drug industry is pushing forward an unified plan on proposal to pay user fees to the FDA. These user fees, like the branded drug manufactures pay, will speedup approval of drugs and plant inspections. Generic drugs now take an average of 2½ years to get approval.

In a conversation with WSJ Health Blog, Mylan President Heather Bresch has indicated that the Generic Drug Industry is willing to pay in order to get a level playing filed with brand name drugs.
Talking about the drugs that being imported in to USA (More than half of both generic and Brand Name Drugs are imported from various parts of the world);
“You’re giving those drugs to your children, Don’t you want to know that they were made in safe conditions?  We are ready to put our money where our mouth is,” says Bresch who presides over Mylan which has 18 processing facilities, 11 of them overseas.
Faster approval will help generic drug companies in producing and selling drugs like Pfizer’s Lipitor and Bristol-Myers Squibb and Sanofi-Aventis’s Plavix, whose patents are set to expire this year and next.

WSJ

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