Clinical Trials

Beating the FDA in Court

Alexander Volokh from the May 1995 issue

(Page 2 of 5)

When a device or drug fails, an FDA regulator can count on hostile headlines, angry congressional hearings, and the threat of new legislation. But suppose a regulator is super-cautious and doesn't approve a life-saving device. What happens? Nothing. The heart-attack victims don't know that they could have been saved by streptokinase, and so the 22,000 deaths are invisible and safe. Sam Kazman, a public-interest attorney with the Competitive Enterprise Institute in Washington, dubs the problem "deadly overcaution" and calls the system "consistent with neither good government nor good science nor respect for individual liberty and dignity."

All this is, of course, disputed by FDA partisans. Fans of the FDA use two main arguments. The first goes something like this: "Those who claim that the FDA is doing a bad job take money from drug companies. Therefore, the FDA must be doing a good job." The second argument, recently made by Sidney Wolfe of Public Citizen Health Research Group, is that "the evidence for a lag in important drugs getting marketed here later than in other countries is extremely weak."

The first argument is stupid; the second is just wrong, and everyone in the drug and device industry knows it. Thankfully, these issues are now being discussed, after years of having been swept under the rug.

The second struggle for the soul of the FDA is waged in courtrooms by food and drug lawyers. Its goal is not to change the law, but to stop the FDA from breaking it. And by making the agency's decision-making processes public, these lawsuits can expose the FDA's vindictive, sloppy, and overreaching procedures.

Since 1990, when David Kessler took over as FDA commissioner, enforcement has been one of the FDA's top priorities. In his first two months, Kessler added 100 new criminal investigators to his enforcement staff, many of them formerly with the Secret Service and the Drug Enforcement Administration. Armed raids on alternative health clinics and dietary supplement dealers followed, as well as increased warning letters, product seizures, and criminal prosecutions in the drug and device industries.

"We're getting new regulations out faster than ever before," Kessler boasted immediately after the 1992 elections. "We rely much less on voluntary agreements, and much more on court-enforceable consent decrees."

Unfortunately, the FDA isn't virtuously ensuring public safety in accordance with the law. "As with most administrative agencies," says Glenn Lammi of the Washington Legal Foundation, a D.C.-based public-interest litigation group, "the agency constantly attempts to expand its jurisdiction and power, straining against the limits the law places upon its actions."

In his 1994 book, The FDA Follies, Herbert Burkholz tells the story of what happened to Barr Laboratories during the generic drug scandal of the 1980s. Edwin Cohen, the president of Barr, testified before a congressional subcommittee in 1989 about the arbitrary and unfair treatment he had received at the hands of the FDA--"retroactive decision making, shifting standards, procedural and substantive leaks, favoritism by a reviewer, and high-handed and arrogant treatment by FDA officials." Within hours, FDA inspectors were swarming over Barr's facilities. Barr repeatedly sued the FDA for relief from harassment. The FDA said it wanted to close Barr down and assiduously tried to for the next three years. The company was deluged with minor inspection violations and delays in drug approval. Its share price fell from $37.50 to $6.00. It had to stop production on several product lines and lay off 25 percent of its employees. And in 1993, Edwin Cohen was replaced by someone whose mission was to make peace with the FDA.

The lesson of Barr Laboratories is simple. Says Burkholz: "In matters of compliance, the FDA is supreme. If the agency says that the floor of your plant is dirty, then you'd better grab a mop and a broom, even if you know that it's pristine clean, because no court in the country will take your side." Or, as Joel Nobel says, "You are not paranoid. They are really out to get you."

The generic drug scandal is over, but the FDA is still around. And, according to Glenn Lammi, so are reasons to sue.

* Under the Food, Drug, and Cosmetic Act, new drugs have to be approved or rejected within 180 days. So do "Class III" medical devices--the most heavily regulated devices, including pacemakers. But we should be so lucky. Pre-market approval requests for Class III devices take an average of 840 days (up from 337 in 1988), and new drug applications are running at two and a half years. One hundred eighty days used to be a mandatory deadline. Now, it's a discretionary "goal"--no thanks to Congress, which has never even commented on the change, much less authorized it.

* Since 1991, medical-device distributors have been required to register with the FDA. Before then, only those who "manufactured, prepared, propagated, compounded, or processed" drugs and devices had to register and were subject to "Good Manufacturing Practices" requirements and mandatory inspections. But in 1991, the FDA decided that even though distributors aren't listed, they propagate devices and so they should register too. According to Lammi, to "propagate," in this context, probably means to create drugs or devices for sale. If Congress had meant to "distribute" it they would have said so; it did after all, refer to distributors elsewhere in the act.

* In 1990, the FDA decided to regulate liquid chemical germicides that are used to clean medical devices and health care products. Not only did the FDA do this without public comment, but a lot of those germicides were already being regulated by the EPA as pesticides.

Then there are those FDA procedures that aren't illegal but really ought to be. If you make medical devices, the FDA can fine you $15,000 per violation of the law, up to a total of $1 million. "Per violation" means that if you made a mistake on your label and you shipped 70 devices with that label on it, you've violated the law 70 times, which means that you have to pay the full $1 million.

Another quirk of this rule is that the judge who figures out how much you owe works for the FDA. Whoops! There goes independent, objective adjudication. The judge's ruling can only be appealed to a federal court if the judge acted "arbitrarily and capriciously," which is a tough standard to meet; it goes without saying that rules like these give the FDA a lot of clout.