Who’s responsible for safety of outsourced drugs?

These are trying times at FDA. The agency has its hands full regulating pharmaceuticals produced in the United States: Now come the perils of globalization, which were dramatized by the recent heparin scandal. FDA contends that the adverse events and deaths associated with Baxter’s heparin products were caused by a contaminant deliberately introduced somewhere in China’s raw material supply. Chinese regulators quickly rebuffed FDA’s claim, asserting the problem was more likely caused by impurities introduced in the final US drug production process.

While US and Chinese regulators point fingers at one another, the big question remains: Is heparin the tip of the iceberg?

In fairness to FDA, due to a substantial shift in global business, the agency’s regulatory task is daunting. Seeking the lowest prices, Big Pharma outsources its products across the globe; approximately 80% of the active ingredients in US prescription drugs are currently manufactured overseas.

Even the most ardent critics of FDA concede that the agency is underfunded and understaffed. At a recent Senate hearing, Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, said that the extraordinary number of medication ingredients manufactured overseas limits the ability of the agency to ensure the safety of all the drugs sold in the United States.

She drove home the point by noting that inspection resources have dropped while responsibilities have soared: “FDA can’t be the quality control unit of the world. We’ll never have enough resources to do that.”

Dr. Woodcock told the Senate committee that FDA needs additional funds to conduct more inspections, update information technology systems, improve laboratory science, and begin education and outreach efforts that target foreign regulators and companies. In addition, she said that the pharmaceutical industry should take more responsibility for the safety of its products.

She’s absolutely correct, since it is nave to think that FDA alone can ensure drug safety in a market that is increasingly turning to overseas producers.

For example, within the next several years, AstraZeneca, Britain’s second largest pharmaceutical company, will outsource its entire drug manufacturing activities. In a press release, the company’s executive vice president, David Smith, said, “Manufacturing for AstraZeneca is not a core activity. We are about innovation and brand-building . . . there are lots of organizations that can manufacture better than we can.” And cheaper, he neglected to add.

But when manufacturers outsource to reduce production costs and increase profits, they should assume a greater responsibility for the safety of their products and be held accountable for mishaps that occur.

Meanwhile, as regulators and industry grapple with this difficult issue, the oncology community should be following along, asking hard questions about where and how our cancer drugs are produced. The FDA can’t do it alone.