Defective drugs and the FDA

The regulation of prescription drugs is an important issue confronting the Food and Drug Administration. The FDA is seeking greater authority to address the growing problem of dangerous or defective drugs coming from foreign sources. When the FDA was first tasked with regulating medication, drug production for American consumers occurred almost exclusively in the United States. As more U.S. drug distributors turned to international production companies, the threat of dangerous pharmaceuticals reaching our shores increased. The FDA is now calling for greater authority to manage the realities of today’s drug market.

The concerns over pharmaceutical security stem, in part, from the 2008 incident involving counterfeit Heparin. The drug, which was produced in China, was actually a substitute created from pig intestines. It was not safe for use and its subsequent use on numerous patients led to 81 deaths. Part of the FDA request for increased authority is the power to increase penalties for using counterfeit and diverted products.

The FDA cannot currently stop shipments of drugs they suspect are dangerous or counterfeit. They do not have the authority to require that drug makers and distributors recall drugs suspected of being counterfeit. With massive amounts of money at stake, the counterfeiting of pharmaceuticals is likely to increase, particularly among foreign producers who have less to fear from criminal prosecution.

As the infected Heparin case showed, Americans are at risk of exposure to dangerous and even deadly prescription drugs. The current system forces the FDA to respond after the damage has been done. The current law restricts the FDA from taking positive steps to protect patients from substandard medications. Congress will have to decide how the FDA can best fulfill its mission of regulating the drugs distributed in the United States going forward.

Source: The Daily Caller, “FDA calls for more congressional oversight on global drug economy,” Jacqueline Klimas, 13 July 2011.