Fewer than one in 10 U.S. voters is confident that drugs made in India and China are safe, even as exports from the two nations continue to grow, according to a survey released Tuesday by the Pew Charitable Trusts’ Prescription Project.
Consumers rarely know, however, if a medication was produced abroad because of a lack of country of origin labeling requirements, and the Food and Drug Administration lacks the staff and resources to adequately monitor foreign plants, USA Today reports.
“When you buy a shirt, it will say right on the label where it was made,” said Allan Coukell, a pharmacist who directs the medical safety portfolio for the Pew Health Group. “But when you get a pharmaceutical, you don’t know.”
India and China accounted for 68 percent of ingredients for drugs worldwide in 2007, up from 49 percent in 2004.
The FDA also lacks the power to recall contaminated drug batches, although it may take a drug off the market entirely by withdrawing approval. In addition, voluntary drug recalls shot up fivefold in 2009, to a record 1,742.
A drug safety bill being introduced by Sen. Michael Bennett (D-Colo.) would set new quality standards for drug companies, as well as their contractors, including those outside the United States. It also would give the FDA the power to order recalls.
Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, defended the performance of the industry and its regulators. “Brand-name pharmaceutical companies make tremendous investments in quality-control systems,” Johnson said in a statement. “The U.S. regulatory system for prescription drugs is the toughest and safest in the world.”
