Wrongly Blaming The FDA

By William Hubbard
Monday, May 8, 2006

Last month the Government Accountability Office released another report criticizing the Food and Drug Administration's efforts to ensure the safety of prescription drugs. It seems to have become great sport for public officials to revel in FDA shortcomings. Time after time in recent years, FDA scientists have warned of threats to the safety of the nation's food and drugs, sought new resources and tools to deal with those threats, and been duly dismissed. Yet when their predictions have come true, decision makers of all political stripes rush to bemoan the agency's failures.

Take drug safety. When the public clamored a decade ago for faster access to new drugs, the FDA developed procedures to get lifesaving drugs on the market in less time -- for instance, by allowing much data about a drug's safety to be gathered after the drug was approved. But there was a trade-off: FDA scientists would accept greater risk that safety problems could slip through, while drug companies would continue to study the drugs for such problems (and Congress would give the FDA authority to compel such study if needed).

FDA scientists have done as they promised -- new drugs have been sped to market, and the FDA leads the world in approval times. But the companies often fail to do the needed safety studies, and Congress has taken no steps to allow the agency to compel them. FDA scientists also recognized that rapid drug approvals can miss important safety indicators and requested funding to create state-of-the-art systems to monitor drug safety. The new dollars that the White House proposed and Congress provided for this come to a nice round number: zero.

These are not isolated examples. They are part of a pattern of neglect by officials of both parties in the White House and Congress. FDA scientists warned almost a decade ago that mad cow disease would inevitably strike in the United States, and they sought help to prevent it. No help came, but the disease did. The FDA was raising alarms about the dangers of bioterrorism as far back as the Reagan administration. Again, no money, no attention. Also at that time, FDA officials began pleading for resources -- mostly to no avail -- to inspect the ever-increasing flood of foods imported from 130 countries, including Sudan, Iran, Iraq and Colombia, to name a few examples. The list of problems identified by the FDA, then ignored, goes on and on.

For most of the FDA's 100-year history, presidents and congresses have recognized its importance to public health by giving it the resources and authority to respond to the rapid evolution in risks from the thousands of products it regulates. But for some years now, the agency's budget has remained essentially flat while major new responsibilities have been piled on. The results of this weakening of the agency are easy to document: Food inspections have dropped from a robust 50,000 in 1972 to about 5,000 today, meaning that U.S. food processors are inspected on average about every 10 years. The chance of a food product from overseas being inspected is infinitesimal. Most raw materials for our drugs come from foreign producers that are rarely inspected. The rate of quality-control failures found in manufacturing facilities by FDA inspectors has soared. Think your pacemaker, heart valve, microwave oven or morning vitamin was inspected? Dream on.

How much does Congress appropriate for the agency that has responsibility for the safety of the whole country's supply of food, drugs, vaccines, medical devices, cosmetics, animal foods and drugs, dietary supplements, and more? The same amount as Fairfax County, Va., provides for its schools.

The future could get worse. On the horizon are somatic cell and gene therapies that might perform miracles for dying patients or might create tragedies of a kind never seen before. There are medical devices that make today's "high tech" seem primitive and vaccines that could well be needed to save much of our civil society. Soon to appear in your supermarket are foods from genetically modified and cloned animals. A majority of our fruits and vegetables will be foreign-grown in the near future.

These developments and innovations hold the promise of transforming the terrain of modern medicine and food production. FDA officials have been trying mightily to get the attention of decision makers who can give them the ability to adequately oversee these things. And, in a post-Sept. 11 world, there are new challenges to the food and drug supply that I cannot even hint at publicly.

Sens. Orrin Hatch and Edward Kennedy and a few other political leaders have expressed concern about the effects of starving what has been the world's foremost consumer protection agency. But most legislators are content to await the emergence of problems rather than head them off.

Maybe the FDA's scientists can keep their finger in the dike. Maybe we'll be lucky and avoid a major crisis. But maybe the great Dodger baseball executive Branch Rickey got it right: When asked how much luck played into his teams' success, he scoffed that luck was a residue of design. If we keep failing the FDA, and the FDA in turn fails, it's inevitable that our luck will run out.

The writer retired last year after more than 25 years at the Food and Drug Administration, the last 14 as associate commissioner.

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