Tainted Drugs A Threat to US ConsumersFeb 6, 2008 | Parker Waichman LLP
Tainted drugs coming from Puerto Rico may be endangering consumers in the US mainland. Thirteen of the 20 best-selling drugs in the United States come from plants on Puerto Rico and, now, there is evidence that many other tainted drugs made on the island have been distributed to the U.S. An investigation by The Associated Press (AP) revealed dozens of examples over four years of lapses in quality control in the Puerto Rican pharmaceutical industry, which produces $35 billion of drugs yearly, most for sale in the U.S. An AP review of 100 pages of Food and Drug Administration (FDA) reports reveals even modern drug plants under U.S. regulatory purview failed to maintain sterility and have exported tainted pills.
According to the AP report, there is a good chance that tainted medications made by Biovail Corp. at a plant in Puerto Rico made it to the mainland. A worker in a Puerto Rican plant noticed blue flecks matching paint on the factory’s doors on the blood pressure medicine Diltiazem. When the flecks were again noticed, covers were placed over the drugs in manufacturing areas. U.S. regulators say factory owner, Canadian drug maker Biovail Corp., never investigated if past drug shipments were contaminated or did anything to prevent future contamination. Unfortunately, tainted drugs from Puerto Rico have been an ongoing problem for several years.
"People would be shocked to find this whole variety of contamination," said Dr. Sidney Wolfe of the Washington watchdog group Public Citizen. FDA officials argue that Puerto Rico’s problems are proportionate with the large number of pharmaceutical plants—they have one of the world’s highest concentrations of drug makers—and, generally, no worse than those on the mainland. Consumer advocates say the FDA does not sufficiently monitor the industry.
The FDA issued a warning letter to Wyeth in May 2006 after machinery pins were found inside bottles of the depression drug Effexor and the heartburn drug Protonix. The FDA was concerned the plant was unable “to detect that the affected equipment was missing some of its parts."
In a June 2006 FDA inspection report, a plant owned by Israeli drug maker Teva Pharmaceutical Industries exported drugs—including the diabetes drug, Metformin—despite the well-known fact that they contained small amounts of metal particles. Teva argued that some metallic material was to be expected because manufacturing equipment is made of metal; however, Teva ultimately recalled 21 different drugs and announced it was closing the plant, citing a restructuring. Spokeswoman Denise Bradley insisted the medicine was safe and effective.
GlaxoSmithKline PLC, produced tablets of the popular antidepressant Paxil CR that split apart, potentially causing patients to take incorrect dosages. When the company would not recall all the affected pills, U.S. marshals raided the plant in March 2005 in the largest drug seizure in FDA history and also collected tablets of the diabetes treatment Avandamet after some were found not to have accurate doses of the active ingredient.
Reports obtained by the AP were produced by FDA inspections from 2003 to 2007 of 13 pharmaceutical plants, roughly half Puerto Rico’s total. Several are closing or downsizing as the expense of updating decades-old plants to meet regulation, coupled with rising energy costs and tightening tax breaks is making it difficult to continue operating. Still, Puerto Rico produces a number of top-selling drugs on the U.S. market, including cholesterol drugs Lipitor and Zocor, the blood-thinner Plavix, anemia drugs Aranesp and Epogen, and the antidepressant Zoloft.