Safer drug supply requires update to our regulation

Americans might expect their prescription drugs to be “Made in the U.S.A.,” but just like clothing or electronics, their medicine is increasingly produced in developing nations. In fact, according to a U.S. Government Accountability Office (GAO) report, at least 80 percent of the ingredients in U.S. drugs now originate overseas. This could be real cause for concern.

The U.S. Food and Drug Administration (FDA) is less likely to inspect locations abroad than domestic plants. To make matters worse, not all Western companies oversee product safety by physically assessing their own suppliers. Even when companies conduct a careful review of their contractors, government inspections are still necessary. Supplier audits are generally brief, pre-announced and voluntary, and access to information is limited due to confidentiality concerns. In contrast, FDA has the authority (though not always the resources) to probe deeply into potentially useful sources of information such as records of customer complaints, and can arrive unannounced.

Although domestic pharmaceutical-makers can expect an FDA inspection every two to three years, their global counterparts might never be visited. Indeed, the GAO reported last year that at the agency’s current pace, it would take the agency about nine years to visit all foreign facilities just once. While not a guarantee of safety, the possibility of an unannounced FDA inspection is an additional incentive for a manufacturer to maintain consistently the “good manufacturing practices” required under law.

One particular tragedy provides useful lessons as we work to strengthen drug-supply policies. In late 2007, Illinois-based Baxter International began receiving reports of unusual allergic reactions to heparin, the company’s widely used blood thinner. The problem was eventually traced to a contaminant introduced during manufacture of the drug’s active ingredient in China. The FDA would eventually receive reports of 574 Americans who suffered symptoms associated with this tainted medicine, some of whom died, over a three-month period in early 2008 — a clear breach of the U.S. supply chain. 

The heparin incident provides insight into where a broken system must be repaired.

First, Baxter did not conduct its own audit of the Chinese supplier until three years after it began contracting with this firm. U.S. drugmakers must be held accountable for the contractors they choose. They must demand that their foreign suppliers meet the FDA’s rigorous standards — even if it means conducting a meaningful investigation before adding contractors’ goods to a pharmaceutical supply chain.

Second, the FDA approved the Chinese supplier of heparin without conducting a pre-approval inspection in part because the contractor had a name similar to another supplier in the agency’s database. This example, and others like it, indicate that to provide ongoing oversight of the industries and technologies it regulates, the FDA must modernize old and error-prone databases. In addition, the FDA needs to conduct more inspections of foreign plants that supply drugs and pharmaceutical ingredients for use in the United States. Unfortunately, the agency lacks the resources to visit overseas manufacturing sites with any meaningful regularity.

Members of the Bulk Pharmaceuticals Task Force, an industry trade organization of drug ingredients-makers, have called for more frequent foreign inspections — and are willing to pay fees to support them. In a marketplace with frequent, thorough and unannounced inspections, foreign suppliers could improve conditions at their facilities even before FDA officials visit them. However, this solution is not achievable without greater cooperation and collaboration between the FDA and foreign health agencies.

A Pew Health Group-commissioned poll of likely voters found that Americans are concerned about the safety of drugs imported from developing countries. Moreover, Americans across the political spectrum overwhelmingly support giving the FDA greater authority and resources to inspect foreign sources of pharmaceuticals and drug ingredients. For example, more than five out of six respondents wanted the FDA to inspect each foreign facility every two years.

Our modern, global drug supply can deliver many benefits to consumers in need of pharmaceutical care. But we need a contemporary regulatory system that will match today’s marketplace.

We cannot afford another heparin-like tragedy. Fortunately, we know what it will take to prevent one, and members of Congress on both sides of the aisle are interested in working to protect our nation’s supply of medicine. We urge them to act without delay.

Coukell is a pharmacist and director of medical programs at the Pew Health Group. Benson is chair of the Bulk Pharmaceuticals Task Force.