Call it a PR problem. Puerto Rico is the birthing center for 13 of the 20 top-selling drugs in the U.S., but plants there have had repeated quality-control problems, according to an investigation by the Associated Press. From paint flecks on Biovail capsules to metal in Teva tablets to machine screws in Wyeth pill bottles, the problems are either a) normal, everyday lapses that aren't any worse than those on the U.S. mainland, as the FDA says, or b) more evidence that the agency is failing to monitor the industry sufficiently, as consumer advocates say.
The AP combed through FDA inspection reports from 2003 to 2007, covering 13 pharmaceutical plants, or half of those in the territory. Four of the plants have since closed or are slated for closing as part of company restructurings.
How did drug makers react when problems were found? In some cases, as in Teva's, recalls ensued. In others--such as when GlaxoSmithKline was found to be producing Paxil CR tablets that split into pieces--the company refused to recall the products. GSK's plant was later raided by the FDA and the meds seized, but the agency isn't always so quick to act because drug makers can chalk up problems to isolated mishaps, the AP said. Typically, though, said one FDA official, companies clean up the problems on their own and issue recalls as necessary.
- read the report for more