Editorial: We can't afford FDA bungling on pharmaceuticals

-Mercury News

04/03/2008 -  The Food and Drug Administration should be embarrassed by its lack of attention to the ingredients in prescription drugs.

The latest evidence is the 19 deaths and hundreds of allergic reactions reported by Americans using a bad batch of the drug thinner heparin. Some ingredients were contaminated, and the FDA admitted violating its own rules by not inspecting the Chinese factory where they were made.

This at the same time the FDA stubbornly refuses to allow cheaper prescription drugs to be imported. What hypocrisy.

The heparin disaster screams out for truth in labeling on the origin of ingredients in prescription drugs.

Americans may think most of their prescription drugs are manufactured here, but they are not. The latest estimates are that 80 percent of active ingredients in drugs sold here are imported. China and India combine to make just under half of them.

China's recent track record on safety should be a major concern for the FDA and for American drug companies, which ultimately are responsible for the safety of their products.

The FDA generally makes its factory inspections before a drug is approved. After that, the foreign manufacturer is rarely inspected. But in the case involving heparin, the FDA inspected the wrong facility with a similar name. The FDA still does not have an office in China to conduct inspections.

The blame for this shoddy work is shared by Congress, which has not given the agency enough money to do the job properly. It should authorize an additional $400 million every year for inspections.

Lawmakers also should require full disclosure of the origin of ingredients for prescription drugs sold in the United States. Then buyers can beware, and pharmaceutical companies will have a greater incentive to ensure quality.

California employers and individuals spend nearly $25 billion a year on prescription drugs, about $700 per person. The FDA should be ensuring safety - but at a minimum, we have a right to know where those drugs are made and what ingredients they contain.

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