Inspections insufficient

Charlottesville Daily Progress
Published: April 23, 2008

“We have to find the right balance between regulation and market demands,” said Health and Human Services Secretary Mike Leavitt, recently returned from a visit to Asia amid controversy over defective products coming from China.
Events prove that balance remains elusive.
The problem of a contaminated blood thinner containing an ingredient made in China has expanded into a worldwide health risk. Ten other countries have now found contaminated heparin, U.S. officials said, and the suspected death toll has risen to 81.
China has expressed skepticism that the contaminant was introduced there. Chinese health officials urge a review at the U.S. facilities of the company that imported the blood thinner from China and distributed it here.
But the Food and Drug Administra-tion says the contamination occurred in China. About a dozen Chinese facilities were part of the heparin supply chain there. The FDA suspects that the contaminant came through a Chinese facility that was never inspected by U.S. authorities.
Overseas producers that market products to the United States are supposed to meet U.S. standards. U.S. inspections of overseas plants are supposed to help make that happen.
But the Government Accountability Office says the FDA would need far greater resources to inspect each of 3,249 foreign drug facilities every two years, as is the goal.
The FDA dedicated about $10 million to foreign inspections last fiscal year, and visited 30 plants. This year it plans to visit 50. At that rate, it would take decades to complete the task.
These “incremental increases … will have little impact in the near future to reduce the interval between inspections,” auditors said.
The FDA also plans to open offices in Beijing, Shanghai and Guangzhou, China, and later possibly in India, the Middle East, Latin America and Europe. The GAO said it is too soon to predict whether these changes will be effective, because the FDA has not presented any details or schedules for implementing the program.
The heparin scandal is only the latest in a long series of failures by Chinese plants to ensure product safety. Problems have ranged from contamination of pet food that killed an unknown number of dogs and cats, to lead contamination of toys that endangered children, to now the lethal contamination of medication.
U.S. business enterprises with developing nations such as China were supposed to provide advantages to both parties. U.S. consumers would gain products at lower prices; developing countries and their work forces would benefit from economic stimulation.
But basic safety was part of the agreement, both legally and morally.
Mr. Leavitt says he is committed to product safety but also notes that too much reliance on inspections could deter trade.
True enough.
But with new stories about dangerous products from China emerging almost every month, it’s clear that the balance hasn’t been achieved yet — and that more weight needs to be placed on product safety.