Improvements are needed in the production of drug ingredients in China to erase the safety risks faced by American consumers, the top U.S. pharmaceutical regulator for the Asian country 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 yesterday in Washington.
“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 U.S.”
Overseas drugmakers produce about 80 percent of the active ingredients for medicines sold in the U.S., the FDA has said. While Hickey didn’t provide country-specific numbers, almost half of active pharmaceutical ingredients used in the U.S. are expected to come from China and India, said Allan Coukell, senior director of drugs and medical devices at The 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 Inc.’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 policy makers, 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 percent 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. Jin said the study will soon be published in the Journal of Economics & Management Strategy.
The FDA disputed research presented to U.S. lawmakers in February by Preston Mason at Brigham & Women’s Hospital that generic versions of Pfizer Inc.’s Lipitor made by overseas companies contained impurities rendering them ineffective. The FDA took issue with Mason’s method for extracting the active ingredient and the agency said it found no impurities using a different method.
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 Ltd. and Ranbaxy Laboratories Ltd. 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, speaking at a hearing held by the U.S.-China Economic and Security Review Commission in Washington, D.C.
“It seems to me you’re woefully, inadequately staffed for this job,” Dennis Shea, commission chairman, said.
The FDA makes companies primarily responsible for ensuring their own products, Hickey said, though the agency is attempting to keep a closer eye and verify manufacturers are following manufacturing standards.
The FDA has tried to increase its 13-person staff in China for more than two years after President Barack Obama recommended in February 2012 a $10 million raise for the office to add employees, Hickey said. Chinese officials have stymied the process, though Hickey said senior government intervention is allowing for movement and the FDA is in the process of submitting visa applications.
“We were looking to more than triple our staff through this bump-up in funding and that’s a big request for any government,” he said.