On Tuesday, Senator Michael Bennet introduced legislation aimed at dramatically increasing the Food and Drug Administrationâ€™s ability to monitor and regulate foreign components of U.S. drugs. Over three-quarters of the active ingredients in U.S. drugs are produced overseas, some in countries with far less stringent safety regulations than the U.S. If passed, the law would allow the FDA to globally monitor all foreign producers who contribute to U.S. drugs, compel U.S. drug companies to keep track of every company from which they purchase drug ingredients, and provide the FDA with the authority to unilaterally issue drug recalls.
Not coincidentally, the bill was introduced on the same day that the Pew Proscription Project published the results of polls that show that American consumers are deeply distrustful of foreign drug suppliers. According to the polls, 89% of Americans favor toughening national drug safety laws.
The bill follows on the heels of several years of heightened incidences of drug mishaps. In 2009, drug recalls rose 400% compared to the previous year, with over 1700 drugs pulled off the shelves.
While many greeted the proposed law enthusiastically, some in the pharmaceutical industry were more reserved. Ken Johnson, a key member of the powerful lobbyist group the Pharmaceutical Research and Manufacturers of America, argued that the law would unnecessarily add to an area where regulation is already tight. Said Johnson, “the U.S. regulatory system for prescription drugs s the toughest and safest in the world.”