• 12
  • July
    2011

Awhile back, we wrote a couple posts on this blog in which we mentioned a recent decision by the U.S. Supreme Court which now prevents plaintiffs from bringing state law product liability claims against generic drug manufacturers for inadequacy of warning labels. As we said in those posts, the rationale behind that decision was that federal law required manufacturers of generics to abide by FDA approved standards.

The decision to hold generic drug manufacturers to a lower standard of liability than brand name pharmaceuticals has some consumer advocates concerned that generics will fail to ensure the quality of the products they place on the market. This, in turn, may place some consumers at risk.

According to consumer advocates, there is a growing problem with poorly made, substandard drugs imported from other countries making their way into the U.S. market. More countries, often with the support of charitable agencies, are beginning to develop pharmaceutical manufacturing capabilities. But the manufacturing processes employed by such companies are not necessarily up to U.S. standards.

According to sources, around 80 percent of active pharmaceutical ingredients originate outside the United States, mostly from China. This has, in recent years, created a growing problem of tainted products from China, which is now the largest supplier of pharmaceutical chemicals to the world.

Unfortunately, the FDA isn't much help in this area. In a recently released document entitled, "Pathway to Global Product Safety and Quality," the FDA explained that it is not capable of overseeing the safety of chemicals manufactured in other countries and imported to the United States.

Pharmaceutical companies that manufacture generics do test the ingredients they source, but such tests are not always able to detect every contaminant. Consumers also need to be aware that not all generic drugs are the exact same thing as the brand name products they emulate. While such products do work for most patients, not every patient will have the same reaction. Tragic events are very rare, but they can occur unexpectedly.

Source: American Enterprise Institute, "Dangerous Substandard Medicines," Roger Bate, 1 July 2011.