China's drug safety worries FDA

US regulator seeking to increase staff to carry out more inspections of mainland drug firms

PUBLISHED : Saturday, 05 April, 2014, 1:07am
UPDATED : Saturday, 05 April, 2014, 1:07am

Improvements are needed in the production of drug ingredients in China to erase the safety risks faced by American consumers, a US regulator said.

While the Food and Drug Administration attempts to ensure medicines imported from China are safe, regulators are pressing the country's drug industry to raise quality, Christopher Hickey, director of the FDA's China office, said at a hearing in Washington on Thursday.

"Clearly there have been a number of high-profile cases that have questioned the safety of products," Hickey said. "There clearly are challenges. We place primary responsibility on industry. We're seeking to get more information from Chinese authorities. We have tools in place to safeguard products into the US."

As a researcher in this area, we’re really frustrated by how hard it is to get evidence

Overseas drugmakers produce about 80 per cent of the active ingredients for medicines sold in the US, the FDA has said. While Hickey did not provide country-specific numbers, almost half of active pharmaceutical ingredients used in the US are expected to come from China and India, said Allan Coukell, a director at Pew Charitable Trusts.

Hickey's office opened in China in 2008 after safety problems arose with Chinese products, including a counterfeit active ingredient for Baxter International's blood thinner heparin that was linked to dozens of deaths and contaminated dog food that killed pets.

Since the crises, not enough data has been collected to define the issue, Ginger Zhe Jin, a professor of economics at the University of Maryland, said at the hearing.

"As a researcher in this area, we're really frustrated by how hard it is to get evidence," she said. "It's lack of attention from public policymakers, and lack of resources is in my view the first obstacle."

Jin conducted a study with two economists at the American Enterprise Institute of the active ingredient in more than 1,400 samples of the antibiotic ciprofloxacin from 18 low to medium income countries. The analysis found 59 of the samples had been falsified and 83 were substandard, meaning about 10 per cent contained zero or less-than-allowed amounts of active ingredient, she told the commission.

The study is likely to underestimate the safety risk, she said, because resources constrained researchers from also examining impurities, degradation or problems with inactive ingredients.

The FDA has tried to increase inspections of finished drug and pharmaceutical ingredient manufacturers overseas, particularly in India and China where companies are gaining market share. In India, the FDA recently banned products from plants operated by several major generic-drug companies including Sun Pharmaceutical Industries and Ranbaxy Laboratories.

China's active pharmaceutical ingredient manufacturers are less well known and drugmakers that buy from them must confirm the products' quality.

The FDA conducted 78 drug-related inspections in China last year, an increase from 19 in 2007, according to the agency. The FDA has two drug inspectors in China, Hickey said.

The agency has tried to increase its 13-person staff in China for more than two years after President Barack Obama recommended a US$10 million increase for the office to add employees, Hickey said, but Chinese officials have stymied the process.

He added that senior government intervention has helped and the FDA is in the process of submitting visa applications.