FDA Goes Up Against a Newly Revived GOP : Regulation: Lawmakers assail rules as hostile toward business. Agency says it must strike a proper balance.

It has become the symbol of overzealous government regulation: a small plunger-like device to resuscitate heart attack victims. House Speaker-designate 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 a 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 troubling 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, which 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 in 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, Dr. David A. Kessler, have been under fire from the new Republican-controlled Congress for the latter. The current 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 EPA “a close second.”

In a recent speech before a biotechnology industry conference, Gingrich threatened to dismantle the agency, saying that 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 agency--riddled by a generic-drug bribery scandal, low morale among career employees and charges that it was too friendly with industry--was under siege for being too lax. When Kessler arrived, he promised to restore the agency’s original mission.

Under Kessler, a Republican appointed by former President George Bush and reappointed by President Clinton, the agency initiated a series of often-controversial actions that put it in the forefront of federal enforcement.

The agency took on major food companies for making false claims; it overhauled food-package labels; it substantially decreased the availability of silicone gel breast implants, and it launched an investigation into the possible regulation of tobacco, a probe that is still under way.

While many lawmakers and industry officials have complained that the agency has gone too far, the FDA insists that it has found a good balance. Agency officials point out that Congress legislated almost all of its responsibilities as a response to tragedies in which a drug or a device resulted in injury or death.

Congress gave the agency jurisdiction over medical devices in 1976 after thousands of women were hurt by the Dalkon Shield, an intrauterine device for birth control. Many suffered permanent infertility and other problems.

“People always complain (about regulation) until a drug or device hurts or kills somebody,” said a senior agency official. “Then they want to know where the cop on the block was.”

Republicans on Capitol Hill, including Gingrich, and, on the Senate side, Sens. Nancy Landon Kassebaum (R-Kan.), who will chair the Labor and Human Resources Committee, and Orrin G. Hatch (R-Utah), a past chairman of the committee, say they are concerned that the FDA has become excessive, making decisions that informed consumers should be allowed to make for themselves.

Also, they say they fear that many companies will move their businesses overseas, where licensing can be quicker.

The device Gingrich has often displayed, the Cardiopump, developed by a Danish company, is designed to aid in the decompression of the chest cavity during cardiopulmonary resuscitation. Initially, the company asked for rapid approval, saying the pump was similar to other devices already on the market. The FDA disagreed and told the company to submit a broader application accompanied by data showing that the device works.

Supporters of the Cardiopump say the agency is being overly demanding and depriving heart attack victims of something that might help them. The FDA says the research is insufficient, and others have questioned whether the device is truly saving lives. The company has not yet filed another application, and the agency cannot act until it does.

Another experimental device that has raised ire recently is the Sensor Pad, designed to help women detect breast lumps during self-examination. It is composed of two latex-like sheets with a liquid silicone lubricant in between and is supposed to enhance the tactile surface of the breast.

It is available in Europe and Asia, but the FDA has thus far refused to approve the product until the manufacturer submits evidence that it is effective. Agency officials are concerned that the pad could mask abnormalities, cause women to feel something that is not there--resulting in undue anxiety or unnecessary medical procedures--or cause women who use it to possibly forgo conventional detection methods.

The manufacturer has argued that it should not be subject to the same kind of regulatory scrutiny as heart valves or IUDs.

“We have people dying because they can’t get the devices they need,” Hatch said. “Of course, they should make sure the devices are safe--that’s their job. But they are paralyzed with fear at the FDA that they will be criticized by liberal groups if an accident happens and a device doesn’t work properly.

” . . . We want negligible risk to be the standard, not zero risk,” Hatch said. “There’s nothing that’s a zero risk. If consumers want to take a certain risk, they ought to be able to do it.”

An aide to Kassebaum said the committee intends to study the agency’s performance to review “things they are doing well and might be doing differently,” particularly in device review. She said they may look at licensing systems in other countries.

“We’d like to look at the European model, where they do more post-market surveillance, or using private-sector firms which are contracted to do preliminary review work, where the industry pays,” she said.

Hatch said he plans to introduce legislation that would decentralize the medical-device review process, farming it out to FDA regional offices closest to where manufacturers are located. Hatch said he believes that this will encourage the regional offices to compete among themselves.

“Let’s get it out of the Washington, D.C., mind-set of bureaucratic arthritis,” Hatch said.

But FDA officials said Hatch’s proposal would be difficult to implement.

“All the medical-device expertise is in Washington, where the specialists are, and there are individual specialists for each area, such as cardiopulmonary,” said a high-ranking FDA official. “Instead of one expert here, there would have to be experts in all of the regional offices. How would you maintain quality control?”

Agency officials have acknowledged, though, that the pace of device approval is too slow.

They have asked Congress to approve legislation that would impose “user fees” on the device industry, which would pay for hiring additional reviewers. A similar system for the pharmaceutical industry has worked well, the FDA said. Such legislation was introduced during the last Congress, but time ran out and it died.

In the meantime, FDA officials said they do not intend to change their regulatory approach, and they are girding for a tough debate in the new year.