Rx DRUG IMPORTS: FDA Beefing Up Overseas Drug Probe
Responding to "congressional criticism" on a lack of effort to prevent counterfeit drug imports, the FDA has launched a probe reviewing thousands of drug shipments, the Wall Street Journal reports. Members of Congress, particularly House Commerce Committee Chair Thomas Bliley (R-Va.), have voiced concerns that substandard ingredients may be making their way into U.S. drugs via imports that frequently are not inspected by U.S. officials. Bliley has called the FDA's efforts "ineffective" and "limited," saying that Americans are "at serious risk of being harmed." However, the agency has already reviewed several hundred of an estimated 4,600 foreign drug manufacturers, finding "no evidence of a substantial problem of counterfeit drug ingredients entering the U.S." The agency also does not feel the public is at risk of harm from substandard substances. On the other hand, the review found 46 manufacturers from China and Hong Kong and 11 in India that apparently exported "misbranded drug ingredients" to the United States. The FDA has also alerted importers that "they must be more thorough in helping regulators keep track of shipments" and has met with officials of U.S. pharmaceutical companies to discuss the issue (Adams, 9/12).
Kidney Cancer Association Chimes In
Adding fuel to the drug import debate, the Kidney Cancer Association posted a full-page ad in the Washington Times today, warning that "Congress is now only a few steps away from allowing drugs from Mexico and Canada to become commonplace in American medicine." The ad continues: "But something else could also become commonplace in American medicine -- Americans made sick or sicker by counterfeit, contaminated, diluted, adulterated or bogus drugs that enter America from outside of our borders. Before these dangerous imports become as commonplace as the common cold, Congress should pause and consider the medical legacy of what it is about to do" (9/12).