What's The Cure for Burnout?

By Dick Thompson

Deodorant soap, pacemakers, food-color additives, blood banks, coffee, tongue depressors, eyeglass screws, tampons and cancer drugs -- all come under the scrutiny of the Food and Drug Administration. The FDA certifies the purity and safety of one-quarter of all U.S. consumer products, in addition to regulating the $400 billion food, pharmaceutical and medical-devices industries. But throughout the 1980s the FDA has been traumatized by budget and staff reductions, fusses over testing of drugs to combat AIDS, second- guessing over poisoned Chilean grapes, corrupt employees and controversies over the nutritional claims adorning food packages.

As a result, the agency has a bad case of bureaucratic burnout. Approval of new drugs requires mountains of corporate filings, and delays in processing applications now run well over two years. That has led to more scandal: this summer investigators discovered that a few generic-drug developers had bribed underpaid FDA employees to speed up the agency's responses to the paperwork for their products. Three FDA reviewers have already pleaded guilty, and more prosecutions are expected. "This past year has been one of the most difficult in FDA's history," said Commissioner Frank Young last week.

Congress, industry and consumer groups agree that something needs to be done to resuscitate the ailing agency. Young is a victim of the urge for change: last month Health and Human Services Secretary Louis Sullivan said he was transferring Young to a new post -- Deputy Assistant Secretary of Health for Health Science and Environment -- effective this week. The position was created especially for Young, and is widely regarded as a demotion.

Last week Sullivan went further by announcing the creation of a blue-ribbon commission to get the FDA back on course. "The President and I are committed to strengthening the FDA," Sullivan declared. In the Senate, meantime, Massachusetts liberal Edward Kennedy has joined with Utah conservative Orrin Hatch in a bipartisan effort to beef up the FDA's anemic annual budget by setting a floor level of $500 million, vs. the current total of $492 million. Their proposal would also provide the FDA with a single facility -- currently, it is spread across 22 buildings in Washington, from converted chicken coops to renovated Army barracks. Even regulated industries, fearing a loss of consumer confidence, are demanding a stronger FDA. The agency, as former FDA official Peter Barton Hutt puts it, "is a precious national resource, and we shouldn't squander it."

With its meager funds, the FDA is responsible for monitoring 63,000 food firms, 14,000 drug companies, 13,000 medical-device manufacturers and 1,700 cosmetics houses. During the Reagan Administration, cutbacks at the FDA were seen by many probusiness advocates as one important means of unshackling industry. But now, with the number of staffers at the agency down to 7,500 from a 1980 high of 8,100, even business lobbyists are not so sure. "The problems at the FDA stem directly from the deregulatory process," says John Cady, president of the National Food Processors Association. "They just do not have the resources to do the job correctly."

The shortfall is worsening. Among other things, Congress reacted to the Reagan cutbacks by passing 23 public health bills during the '80s, many of them efforts to shore up the FDA's powers. The action significantly expanded the FDA's workload. Yet Congress never moved to restore a single lost staff position or add employees to meet the increased responsibilities. The advent of an entirely new industry, biotechnology, demanded an FDA response to more than 950 genetically engineered products during the 1980s.

Popular pressures have also played a role. As AIDS has spread, protesters have charged that the agency has been keeping lifesaving drugs out of the hands of victims. In fact, the FDA spent $5 million more than the $46 million Congress provided to seek a cure for the disease. With health-conscious Americans including less red meat in their diets, the FDA's thin line of inspectors has been forced to monitor increasing amounts of seafood, imported fruits and vegetables, and chicken and eggs. A number of spectacular food- tampering cases, like last March's poisoned Chilean grape case (only two tainted grapes were discovered), forced the agency to reassign up to one-third of all FDA inspectors for long periods of time. "When an emergency comes along," says one FDA official, "we stop doing things we were scheduled to do and divert people elsewhere."

Decaying labs and desperately low salaries have made hiring another FDA travail. Some important drug-review posts have an annual turnover rate of 20%. At least one former FDA official believes many new employees use their stint at the agency to bolster resumes that are then quickly circulated to industry.

Amid all the institutional turmoil, Secretary Sullivan's decision to push out Commissioner Young has been especially inept. Sullivan has no replacement waiting, and in fact has been unable to fill many important health jobs because White House conservatives filter out nominees with proabortion views. Pro-lifers are sure to scrutinize Young's successor closely since the agency is likely to decide on approving new abortion-inducing drugs like RU 486, the pill manufactured by a French subsidiary of Hoechst.

With so many intractable problems facing the FDA, Sullivan's blue-ribbon panel is unlikely to be enough to stop the agency's decay. Says Democratic Congressman John Dingell, chairman of the House Energy and Commerce Committee: "It was an attempt to look like they were doing something, but they aren't and they won't." In an effort to find some creative financing for the FDA, the White House has disclosed that it is considering charging user fees to companies that seek FDA approval for products. The size of the proposed service charges has ranged from an official White House suggestion of $1,500 to Young's own desire for as much as $150,000 for each product. Those funds would be welcome, but they would represent a tiny fraction of the cost of refinancing confidence and competence at the agency.