The US Congress will likely approve a new deal for the inspection of overseas drug manufacturing plants, many of which are not routinely FDA inspected. The generic drug industry’s reluctance to pay inspection fees has changed, partly due to the Heparin scandal and the hesitancy of Congress to designate money for inspections. Mylan President Heather Bresch was also instrumental; much of her proposal has been included in the deal. Under the deal, generic drug firms, which manufacture 75% of prescriptions sold in the US, will pay $299 million annually to aid biennial inspections of foreign plants, the same standard as domestic plants. The funds would employ more reviewers to accelerate approval times for selling generics from a median of 31 months to 10 months. The deal should reach Congress in January 2012 and will not include over-the-counter medications, vitamins or name-brand prescription drugs.

Source: The New York Times