PUERTO RICO'S DRUG FACTORIES STUMBLE ON QUALITY
February 11, 2008
Puerto Rico, long a manufacturing center for the drug industry, is home to dozens of examples over four years of lapses in quality control, the Associated Press (AP) reports, citing a review of Food and Drug Administration (FDA) records from 2003 to 2007.
Thirteen of the 20 best selling drugs in the United States are manufactured on the island, according to the story, which argues that "even modern drug plants here under the watch of U.S. regulators have failed to keep laboratories sterile and have exported tainted pills."
According to one report:
- Plant workers started covering drugs sitting in carts after an employee noticed that blue flecks on the capsules matched the paint on the factory walls.
- But the company never tried to figure out whether past shipments of the drug, a blood pressure medicine called diltiazem, were contaminated, the AP reports.
In another incident:
- The FDA issued a warning letter to Wyeth after consumers found machinery pins inside bottles of the anti-depressant Effexor and the heartburn drug Protonix.
- The agency was concerned that the plant was not "able to detect that the affected equipment was missing some of its parts," according to the AP.
- Wyeth suggested workers who packaged the drugs had made mistakes.
FDA officials say manufacturing problems in Puerto Rico are no more prevalent than in the United States. In any case, as the drug industry moves some of its manufacturing to Asia and outsources some of it outright, the Puerto Rican drug industry is waning. Companies have shed more than 3,000 jobs in Puerto Rico over the last 18 months.
Source: Jacob Goldstein, "Puerto Rico's Drug Factories Stumble on Quality," Wall Street Journal, February 6, 2008.
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