New report stresses safety risks to Americans from Chinese-made pharmaceutical ingredients
A new report (pdf) by the U.S. China Economic and Security Review Commission stresses the safety risks to Americans posed by pharmaceutical ingredients made in China.
According to the report, issued by a group that advises Congress on the economic and trade implications of U.S.-China relations, found that the U.S. is the number one destination for Chinese pharmaceutical raw material exports – a $2.2 billion business each year. The U.S. relies heavily on Chinese products not only for over-the-counter drugs but for active pharmaceutical ingredients (API) found in prescription drugs. For instance, 94 percent of all tetracycline antibiotics imported into the U.S. come from China, as do three-quarters of the ingredients used to make another important class of antibiotics, the aminoglycosides, which are administered intravenously and in eye drops.
And the report makes clear that China has neither the will nor the systems in place to monitor its exports. Though domestic regulation in China has improved, the SFDA, China’s main regulatory agency for drugs, provides limited oversight of exported pharmaceutical products. For example, Chinese regulation assigns total responsibility for product quality to oversight responsibilities on the importing party. And as the proportion of U.S .drugs made overseas has exploded in recent years, the FDA has been unable to keep up. We saw the risks most dramatically when heparin, a common blood thinner, was contaminated during its manufacture in China, causing a number of U.S. deaths. From the report:
Many reports, publications, and public testimonies assert that China’s health and safety regime for export products is fragmented and ineffective. The impediments are many: poorly enforced regulations, lack of inspections and ineffective penalties for code violators, underfunded and understaffed regulatory agencies and suspect interagency cooperation, the proliferation of fake goods and ingredients, the existence of numerous unlicensed producers, falsified export documents, intense business competition that often induces firms to cut corners, failure by Chinese companies to closely monitor the quality of their suppliers’ products, government corruption and lack of accountability, especially at the local level.The report includes a series of recommendations, including more and better-targeted FDA inspections of Chinese plants, and ensuring FDA databases contain accurate and integrated registration and inspection information.
Indeed, the report is an alarming but needed reminder that we need to take steps to shore up the inspectorate, resources and systems to ensure foreign drugs are safe before they reach American medicine cabinets. At a recent hearing on drug safety, a spirited dialogue between Rep. John Dingell (D-MI) and FDA Deputy Commissioner Joshua Sharfstein made clear that a system-wide remedy for imported drug safety is sorely needed.
–Kate Petersen, PostScript blogger