Transform the FDA

Friday, Nov. 28, 2008 | 2:05 a.m.

Four years ago skeptical eyes were turned toward the Food and Drug Administration after the arthritis drug Vioxx was voluntarily recalled by its manufacturer, Merck & Co. Tests by Merck showed that people taking the drug were far more susceptible to having heart attacks than the general population.

The FDA was heavily criticized for not conducting follow-up research after approving drugs like Vioxx, which was linked to thousands of deaths during its five years on the market.

Criticism of this agency, which is vital to public health, has only risen since the Vioxx debacle. In a story Wednesday, The Washington Post reported that government studies, former officials of the FDA, members of Congress and watchdog groups have concluded the FDA needs new leadership, better technology, more professional staff and a bigger budget.

The newspaper quoted William K. Hubbard, who retired in 2005 after serving the previous 14 years as an FDA associate commissioner. “The FDA is hanging on by its fingertips in protecting us,” Hubbard said.

The FDA’s responsibility includes oversight over prescription drugs, medical devices, the nation’s blood supply and food. It has 11,000 employees and a $2.1 billion budget.

While that might sound sufficient, safeguarding food alone is almost overwhelming the agency. In today’s global economy, processed food contains ingredients produced in countries all over the world.

This includes China, where melamine, used to make plastics and fertilizer, has been intentionally introduced into the food chain. Producers there discovered that adding melamine masks the fact that food, whether for pets or for newborn children, has been watered down to increase profits.

Food tainted with high levels of melamine can cause kidney disease and has sickened and killed people and pets in many countries. Trace amounts of melamine have now turned up in baby formula sold in the U.S., although the FDA says the formula remains safe.

Nevertheless, much more vigilance than is now being seen from the FDA is required to keep Americans protected against tainted food and blood and unsafe medical devices.

We hope that Congress and President-elect Barack Obama transform the FDA so that it can again be trusted to fully accomplish its lifesaving mission.