US and Chinese officials have signed 14 agreements designed to assure the safety of exported pharmaceuticals, medical devices, food and animal feeds. The deals “satisfy our firm principle that any country that desires to produce goods for American consumers must do so in accordance with American standards of quality and safety,” said US Health and Human Services Secretary Mike Leavitt, who was in Beijing for the US/China Joint Commission on Commerce and Trade, where the accords were signed.
Certain aspects of the agreements still have to be worked out but, as they stand, Chinese producers of goods covered by the deals will be required to register, submit to inspections and notify the authorities of any potential problems with their products. There will also be information-sharing between US HHS and Chinese State Food and Drug Administration (SFDA) officials, and China has agreed to adopt quality assurance product tracking measures which, said Sec Leavitt: “will help ensure that growers and manufacturers are building quality into their processes and that we can take action if they do not.”
Chinese exports of pharmaceuticals to the USA have doubled in the last five years and, with the recent scandals involving fake, substandard and dangerous products, many people have expressed unease at the lack of controls. The US Food and Drug Administration licenses 714 drug manufacturing plants in China but it has conducted only 13 inspections so far this year, Congressman John Dingell, Chairman of the US House Committee on Energy and Commerce, told a hearing last month. “At this rate, it would take the FDA 55 years just to clear this backlog,” he said.
But China has been taking major steps to repair the tarnished image of its manufacturers. Several days ago the SFDA reported that, by end-October, it had shut down 900 companies which were producing counterfeit drugs. Also, more than 7,300 drugmakers, or 24% of the total number investigated, had withdrawn marketing approval applications, said the SFDA, which was reporting on the campaign which it began in July to tackle counterfeit, substandard and dangerous medicines, foods, toys and other products. These withdrawals indicate that “pharmaceutical companies are examining themselves in this special campaign and their awareness for drug safety has been greatly enhanced,” said SFDA deputy commissioner Wu Zhen.
However, the agency also acknowledged that 1,100 drugs which had received approval were subsequently found to be counterfeit.
Death penalty sought for counterfeiters
The SFDA is also now seeking comments on its proposal to impose the death penalty on manufacturers and sellers of counterfeit drugs which cause serious injury or death. For less serious injuries, the penalties will be fines, confiscation of property and a maximum of life imprisonment, but these will be heavier if the injuries occur during public health emergencies. Hospitals which knowingly buy and use counterfeit or substandard drugs will also be subject to criminal prosecution.
In June, a former head of the SFDA, Zheng Xiaoyun, was executed for accepting bribes after counterfeit drugs which were approved led to a number of deaths. In the same month, the ex-director of the agency’s registration department, Cao Wenzhuang, was given a suspended death sentence for taking bribes.
