The federal government is preparing for the first time to charge makers of generic drugs a fee for federal approval, which manufacturers of name-brand medicines have already been paying.

 

The change was incorporated into legislation that gained bipartisan approval in Congress, seemingly a rarity these days.

 

Under the bill, the Food and Drug Administration (FDA) expects to collect more than $1 billion a year in fees from pharmaceutical companies. About $300 million will come from generic-drug manufacturers, with another $693 million from name-brand drug companies.

 

Medical-device manufacturers also will contribute $595 million in fees paid to the FDA over the next five years.

 

In exchange for imposing the fees, the FDA has promised to speed approval of generic drugs and more closely scrutinize imported generics. The number of pending generic applications has more than doubled in the last five years, and the review period for the average application has slowed from 17 months to 30 months.

 

The bill also allows the FDA to increase scrutiny of foreign drug manufacturers since 80% of the active ingredients used in U.S. drugs are made in other countries.

-Noel Brinkerhoff, David Wallechinsky

 

Measure To Increase FDA Funds Through New Company Fees Goes To Obama (by Dina ElBoghdady, Washington Post)

US To Charge Fee on Generic Drug Sale Application (by Sushmi Dey, Business Standard-Mumbai)