Newspaper article St Louis Post-Dispatch (MO)

FDA Facing New Anti-Regulatory Mood Republican Leaders Say Agency Is Too Zealous

Newspaper article St Louis Post-Dispatch (MO)

FDA Facing New Anti-Regulatory Mood Republican Leaders Say Agency Is Too Zealous

Article excerpt

A SMALL PLUNGER-LIKE device to resuscitate heart-attack victims has become the symbol of overzealous government regulation.

Incoming House Speaker Newt Gingrich, R-Ga., has displayed it on several occasions, insisting that it could save countless lives if only the slow-moving Food and Drug Administration would approve it.

But those who have blasted the FDA in the past for not being zealous enough have their own symbols: among them, a defective heart valve that was blamed for at least 360 deaths before it was taken off the market.

The two extremes dramatize the dilemma that has plagued government agencies that deal with issues of health and safety: How do you find the proper balance between protecting and overburdening the American public?

Many agencies have tried over the years to juggle this equation - the Environmental Protection Agency, the Occupational Health and Safety Administration, the Federal Aviation Administration, among others - but nowhere is the conflict more visible today than at the FDA. It oversees food, drugs, cosmetics and medical devices - products that account for 25 cents of every consumer dollar spent.

When people talk about the FDA, they often use the image of a pendulum. Either it swings too far into relaxing its standards, potentially exposing the public to products that could prove harmful. Or it swings too far in the other direction by being too tough, potentially hurting business, stifling enterprise and preventing consumers from getting goods they might need.

These days, the agency and its commissioner, David A. Kessler, have been under fire from the incoming Republican-controlled Congress for being too tough. The hot-button topics fueling the GOP attack are medical-device approval, which they say is moving too slowly, and the impending regulation of tobacco, which they say is moving too fast.

Gingrich, describing Kessler as "a thug and a bully," has called the FDA "the leading job killer in America," with the Environmental Protection Agency "a close second."

In a recent speech before a biotechnology industry conference, Gingrich threatened to dismantle the FDA, saying he has been working with an outside, nonprofit group, the Progress for Freedom Foundation, to design a replacement organization staffed by biomedical "entrepreneurs" who themselves would test and certify products.

It is questionable whether such a plan has a realistic chance of approval, particularly because a full agenda of more pressing issues awaits Congress during its first 100 days. But the agency will almost certainly face some intensive scrutiny at some point from lawmakers on Capitol Hill who are in a distinctly anti-regulatory mood.

Paradoxically, before Kessler took over, the FDA was under siege for being too lax. It had been hurt by a generic-drug bribery scandal, low morale among career employees and charges that it was too friendly with industry. …

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