Friday, June 1, 2007

Bill Hubbard's FDA Letter-Wrongly Blaming The FDA

If you want to know how contaminated pet food threatened livestock and the food supply in the US, read this. (The links are mine.)

The current FDA, suffering from a decade without a strong leader and another emerging scandal, needs tools to keep consumer safe, and it's not getting them. The administration's current plans, to close laboratories and facilities in N.J. and Puerto Rico, home to the country's major drug manufacturing operations, could cripple its enforcement ability.

This photograph is an FDA staffer with a typical drug application for the time, about 1965.

By William Hubbard, Monday, WaPo, May 8, 2006; Page A19

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.

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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.

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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...

[There are] developments and innovations [that] 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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