FDA needs to step it up

FDA needs to step it up

Milwaukee Journal Sentinel: Two statistics should concern you about the U.S. Food and Drug Administration: 80 percent and 11 percent.

The first is the percentage of active drug ingredients that are produced abroad. The second is the percentage of foreign drug plants that the FDA actually inspects in any given year. At the present rate, the FDA can afford to inspect foreign plants only once every 13 years.

As the drug scare over a tainted blood thinner called heparin shows, that’s not enough. Congress should authorize new funding for the agency that will enable it to increase its inspection regime and make other changes to ensure safety. And the multinational pharmaceutical companies should take more responsibility to ensure that credible safety standards are met.

The FDA says 81 deaths can be blamed on heparin that it believes was tainted in China. The agency last week sent a warning letter to Changzhou SPL, a Chinese facility that is part of a joint venture operated by Scientific Protein Laboratories of Waunakee, Wis., saying that an inspection in late February revealed “significant deviations” from good manufacturing practices.

A Government Accountability Office report showed the FDA would need at least $67 million more next year to begin full inspections of foreign plants. FDA Commissioner Andrew von Eschenbach said increasing inspections isn’t enough; the FDA wants to upgrade computer systems and work with authorities in other countries.

That’s fine, but it’s feet on the ground that are needed. The FDA is proposing to spend a scant $11 million on foreign inspections this year.

American consumers must be assured that the drugs they use are safe. And the best way to ensure that is through stepped-up inspections in foreign plants. Drug safety shouldn’t be done on the cheap.