Over the last decade or so there have been growing concerns about the quality of generic drugs. That is because 40 percent of the finished products and 80 percent of the raw ingredients are manufactured abroad in countries like India, China, Thailand and Brazil. The majority of the foreign plants have not been inspected by the U.S. Food and Drug administration. That is largely because the FDA does not have the resources or personnel to inspect all the facilities where generic drugs are manufactured.
That may soon change. Generic drug manufacturers and the FDA have reached an agreement whereby the industry will pay about $300 million to the Food and Drug Administration in user fees. This would allow the feds to hire more staffers. The generic industry wants faster approval of its products and part of this contribution would be devoted to speeding up the generic drug review process. There would also be funds devoted to improved inspections of both U.S. and foreign manufacturing plants. Before this initiative can be implemented, however, Congress will have to vote on the proposal.
