Generic Drug Makers Could Face Fees For Overseas Inspections

Generic drug makers might have to pay for inspections of their overseas facilities and, now, one of the largest generic drug makers is asking fellow drug makers to help pay to ensure the industry’s regulator inspects foreign facilities.

Mylan Pharmaceuticals is working on negotiations with the U.S. Food and Drug Administration (FDA) and other generic drug manufacturers to pay $299 million annually for inspections, said ABC News.

The issue surrounds the large amount of drugs used in the United States that come from overseas. As a matter-of-fact, said ABC News, some 40 percent of drugs used in the U.S. are imported and about 80 percent of active drug ingredients come from overseas, Only about 11 percent of the over 3,700 foreign drug plants were inspected by the FDA in 2009, said ABC News, citing the U.S. Government Accountability Office (GAO). U.S. manufacturing facilities in the U.S. must be inspected once every two years.

Regardless, according to the GAO, the FDA does not maintain accurate records on overseas facilities and, because of this, likely cannot track where inspections are necessary, noted ABC News. And, in the U.S., pharmaceutical plants only receive a federal inspection, on average, once every 2.7 years.

Heather Bresch, president of Mylan, came up with the emerging plan to increase foreign inspections over concerns that foreign plants are not subject to the same standards as U.S.-based plants. “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 told ABC News.

We previously wrote that a prior GAO report concluded that it would take approximately 13 years to inspect the 3,249 foreign manufacturing plants that make medications for the U.S. The report stated that, at the time, the FDA was nowhere near being close to resolving “a huge oversight gap” that would allow foreign facilities to receive the same scrutiny as domestic plants.

The FDA has been broadly criticized for the way in which it handled a 2008 investigation into tainted heparin, an active drug ingredient manufactured in China that was linked to 80 deaths and hundreds of illnesses. Recalls were implemented by Baxter International, with similar recalls issued by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France, Germany, and Japan. In total, the FDA said tainted heparin was identified in 12 countries. In the US, the FDA ultimately initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.

In March 2008, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. Changzhou used two consolidators to supply it with a raw ingredient made from pig intestines, as is chondroitin sulfate. Those consolidators obtained the ingredient from unregulated workshops. Chondroitin sulfate costs a fraction of the ingredient usually used in heparin, and producers may have used it to cut costs. The FDA investigation never identified the culprits, saying that there were too many sources to trace. ABC News pointed out that the agency never inspected the plants that made the key ingredient.