U.S. regulators can't go solo on securing the U.S. drug supply. Nor can the FDA afford to count on agencies in developing nations, where counterfeiting abounds and unscrupulous manufacturers cut corners to lower costs. What the FDA can do, the Institute of Medicine says, is work with its more reliable counterparts to help build up regulatory resources in those increasingly important emerging markets.
In a new report, the influential government watchdog recommends 13 steps the FDA, other U.S. agencies, industry groups and fellow regulators can take to improve drug safety in the developing world. And improving safety is key: These days, emerging markets have become the world's medicine chest, with more and more manufacturing moving to low-cost sites. More than 80% of active drug ingredients and 40% of finished products now originate abroad.
With fake Avastin popping up in the U.S., public attention on the drug supply is high, just as it was several years ago when tainted, Chinese-made heparin sickened and killed U.S. patients. Back then, the FDA was urged to increase its oversight of foreign facilities, but the agency's resources can't stretch worldwide. IOM now says the FDA needs to avoid wasting time in countries with "technologically advanced counterparts," i.e., EU-member nations, Canada, Japan, Switzerland and a few others. These groups ought to come up with a mutual-recognition system, so they're not dispatching inspectors to the same facilities.
Meanwhile, the IOM says, the FDA and a few other U.S. agencies should help build up oversight in developing countries, either by offering technical expertise and training directly, or by working through international groups such as the WHO. The agencies could also offer financial incentives for companies and academia to develop low-cost technology for tracking and verifying products along the supply chain. More recommendations follow; check out the report for details.
- read the IOM release
- get the report