Overseas Facility Inspections May Cost Generic Drug Makers Millions Annually
It may well be that generic drug makers will have to pay millions of dollars annually to have their overseas manufacturing plants inspected. In fact, one of the largest drug makers in the United States is trying to get other manufacturers to help them pay for the annual inspections.
Mylan Pharmaceuticals, the makers of the controversial antidepressant Paxil, is trying to negotiate with the FDA as well as other generic drug manufacturers to pay an astonishing $299 million every year for the inspections of their foreign facilities — this according to reports by ABC News. Mylan would understand how important it is to have foreign plants inspected ever since the company’s plant in Puerto Rico was shut down after a whistleblower talked of adulterated drugs like Paxil being made there. The whistleblower accounts also spoke of Paxil and Avandia being packaged together. The case was even profiled on the TV show 60 Minutes.
There is currently a gigantic amount of drugs that are used in the United States today that come from someplace overseas. In fact, ABC News reports that as much as 40 percent of the drugs that are taken in the United States come from other countries, and an estimated 80 percent of the active ingredients that are in the drugs come from overseas. The report also states that “only about 11 percent of the over 3,700 foreign drug plants were inspected by the FDA in 2009 ... citing the U.S. Government Accountability Office (GAO). U.S. manufacturing facilities in the U.S. must be inspected once every two years.”
The GAO says that the FDA doesn’t keep proper records on any of the overseas facilities. That is why it can’t properly track which facilities need inspections. ABC News also states that American plants only get inspected an average of once every 2.7 years.
Heather Bresch, president of Mylan, wants to increase the inspections in the foreign plants because the foreign standards are different than American standards.
“Every American has the right to know that whenever they go to have a prescription filled, it’s held to the same standard of quality, whether it’s made in the U.S. or overseas," Bresch says.
