US FDA Head Says China Improving Drug Safety

PharmaManufacturing.com
08/17/2010

The head of the U.S. Food and Drug Administration says China is improving its oversight of its exporters following a slew of scandals over bogus or substandard drugs and foods ranging from vaccines and infant formula to dog chow.

FDA Commissioner Margaret Hamburg said Friday that Chinese officials she spoke with during her first visit to China since she was appointed were pursuing a "common agenda" to improve manufacturing practices and regulation of complex supply chains for the food and drug industries.

"I leave feeling very encouraged by the partnership we've developed here," Hamburg said.

"This is a priority for China as it is for the United States," she said.

Since President Barack Obama appointed Hamburg last year, the FDA has taken swift action against companies selling bogus or dangerous products, seeking to restore its credibility. FDA officials say a skimpy budget and weak regulations keep them from going after companies that break the rules.

Hamburg, who has spent her career working in public health, said the agency is focusing on prevention, given the complexity and enormity of the global supply chains for both food and drug products.

The FDA has set up offices in three Chinese cities, including Shanghai, and is cooperating in training and joint inspections, among other areas.

More than 20 million imports of FDA-regulated products are expected this year, but typically less than 1 percent are inspected. Earlier this year, the FDA began using an automated system to sort through millions of foreign shipments and identify food and drugs that are most likely to be contaminated.

Still, relying on inspections is not enough in a 21st century of manufacturing by hundreds of thousands of factories around the world, Hamburg said.

"We will never have the resources physically and financially to inspect all those facilities," she said.

Instead, the agency is working with other governments and international organizations to develop common standards, improve accountability and identify areas of vulnerability that should be targeted before problems arise, she said.

The need to cooperate with other governments to counter risks from shoddy manufacturing practices was driven home in 2008, when hundreds of people in the U.S. reported severe allergic reactions to heparin, a medicine to prevent blood clots, exported from China.

Investigations found a contaminant — over-sulfated chondroitin sulfate — tainting raw heparin coming from China that was linked to the deaths of at least 81 people.

Earlier this week, China's health ministry said it was looking into claims by parents that a brand of milk powder caused a small number of babies to grow breasts.

China's handling of problems such as contamination of dairy products with the industrial chemical melamine — killing at least six children and sickening 300,000 — shows it takes such issues seriously, Hamburg said.

As recently as July, Chinese authorities reported finding caches of melamine-laced dairy products in two provinces, saying they were trying to determine if they were newly tainted batches or those stockpiled before the discovery in 2008 that milk suppliers were watering down milk and then adding melamine to make its protein content appear higher.

"It is not a simple problem to eliminate in terms of the practice of bad actors who are willing to put human health at risk to make more money," Hamburg said. "It is an area we are continuing to monitor very carefully."

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