Stopping Counterfeit Drugs at the Source
Here at the Partnership for Safe Medicines, one of our core principles for drug safety is the need to unify in the fight against counterfeit drugs. This week, we saw progress.
Recently, U.S. Secretary of Health and Human Services Michael Leavitt said the agency will station as many as 15 inspectors in three Chinese cities to scrutinize exports to the United States. Unfortunately, it took more than 80 deaths from compromised heparin (the drug was produced with counterfeit drug ingredients from China) to get the FDA, Congress and Chinese authorities to take action.
Getting the inspectors in the country is an important first step. But it’s important that we don’t stop there. In order to stop counterfeit drugs and other unsafe products from pouring out of China and into the U.S., the FDA needs staff those foreign offices with inspectors and criminal investigators armed with the same authority as their State-side colleagues. Additionally, the FDA needs to be granted the authority to enter and inspect foreign manufacturing facilities without previous notice.
Finally, we need both a carrot and a stick. The carrot: cooperation with FDA activities by Chinese factories and authorities will allow these drug sources to be treated like US factories that have undergone inspection, and hence pass into our distribution system. The stick: lack of cooperation (such as limiting the ability of FDA authorities to make surprise inspections) will result in an FDA import alert to all such products at our borders and delay for detailed inspections before allowing such products to be distributed. This will cost time and money and even result in rejection of these imports. In this way, we can reward safety efforts while simultaneously deter suspect factories and their products from reaching us on our shores.