The pharmaceutical industry may want to forget the past couple of weeks, a time when a rash of stories detailing poor quality control practices set the buying public on edge.
On Feb. 5, the Associated Press reported on its own study of the industry's manufacturing operations in Puerto Rico, where it found "dozens of examples over four years of lapses in quality control in the Puerto Rican pharmaceutical industry, which churns out $35 billion of drugs each year, most of it for sale as part of the $300 billion market in the U.S."
Meanwhile, this week the federal Food and Drug Administration revealed that it had warned drugmaker Novartis on quality control failures in one of its German manufacturing plants that makes a human rabies vaccine and other drugs. The FDA's warning letter cited three problem areas, according to the report: production and process controls, failure investigations, and equipment cleaning and maintenance.
The bad news continued with a New York Times story on leukemia patients in China who have reportedly been paralyzed by tainted cancer drugs. A subsequent Times editorial on the situation opened with an ominous message:
"The F.D.A. — and American consumers — got another warning last week about the need for vigilant monitoring of imported drugs from the developing world, especially from China."
In more upbeat news, Pharmaline, a supplier of ingredients for dietary supplements, said it would resume manufacturing operations in Shanghai, China, in April, following an overhaul of its quality control procedures there.
In a news report last week, the company said the restructuring would give it traceability to raw materials to the pallet or drum level and help ensure safe products.