The FDA Follies. - book reviews

Reason, Oct, 1994 by Robert Higgs

WHY WAS THE U.S. FOOD AND Drug Administration so fouled up during the 1980s? Herbert Burkholz in his book falls back on the familiar left-liberal litany: It was Reagan's fault. In doing so, he ignores the long-standing problems inherent in bureaucratic attempts to achieve "safety" at any cost.

Burkholz views the FDA fiascoes of the 1980s as anomalous because he has a starry-eyed view of the agency in earlier days. He says nothing about the tens of thousands who died prematurely in the '50s, '60s, and '70s because the FDA would not permit sellers to tell consumers about the health benefits of lowering dietary fat; nor does he mention that the agency dallied for nearly a decade before approving new beta blocker drugs being used to treat heart disease with great success in other countries. In Burkholz's eyes, before the Reagan administration arrived to ruin everything with its "cold-blooded business-as-usual attitude," the agency epitomized "the best that there was in public service: high, but attainable, scientific goals...sought by dedicated professionals." It enjoyed "worldwide respect" and was "a proud place" animated by a "laudatory purpose." In those days, heroic bureaucrats busied themselves holding in check "avaricious" capitalists who strained to peddle poisonous products to an unwitting public.

Then, with the arrival of the Reaganauts, who held the budget in check and insisted that the FDA go easy on business, the agency hit the skids. In a succession of incidents ranging from the farcical Chilean grape scare to the exposed bribery of FDA examiners, the bureaucrats dropped the ball or ran the wrong way with it. But can the "Reagan did it" explanation really account for this sorry succession of screw-ups? Evidently even Burkholz has doubts, as he opines that "the workings of the FDA during the 1980s seem to defy understanding."

For those aware of public-choice theory, the events of the 1980s present no mystery. The FDA's follies are precisely the sort of actions that one expects a powerful government bureaucracy to take--self-serving, irresponsible, heedless of the injuries it causes so long as they are ignored by the news media, and vindictive against whistle-blowers. Burkholz's ideology prevents him from presenting a coherent interpretation, but the facts he relates tell a sufficiently woeful tale in spite of the author's obtuseness.

Consider the generic drug scandal that climaxed in 1989. Under legislation enacted in 1984 to expedite the availability of generic drugs, producers are required only to establish bioequivalency between their product and the brand-name product; they need not repeat all the tests originally required. Some applications to market generic drugs did receive quick approval, but others languished in the bowels of the FDA. Stymied in their attempts to break through the official barrier, executives of three companies--Mylar, Barre-National, and Barr Laboratories--undertook investigations and then testified before Congress about the corruption they had discovered. Several FDA reviewers were accepting bribes to hasten the approval of certain companies' applications and derail those submitted by competing companies. Eventually 42 persons and 10 companies were found guilty of criminal acts.

How did the FDA respond? Of course the agency made the usual gestures to demonstrate that it had thoroughly cleansed itself--most regrettably, Dr. David Kessler was appointed to lead the agency out of the bog--but beyond the range of the TV lights the bureaucrats set about getting revenge against those who had exposed the FDA's malfeasance. Barr Laboratories, in particular, bore the brunt of the agency's wrath. As Burkholz says,"For the next three years the FDA never stopped trying to put the company out of business" by repeatedly inspecting its facilities and delaying approvals of its products.

Naturally the agency got away with this vengeful conduct; it virtually always does. Few people outside the industries subject to its regulation appreciate the extent to which the FDA acts as lawmaker, police officer, judge, jury, and executioner. Companies that want to remain in business have no effective recourse. Even if one were to win a case in court, one would certainly be crushed by the regulators somewhere down the line. As Mylar's CEO Roy McKnight testified before Congress, "It was well known throughout the industry that so-called complainers could expect to receive the harshest of treatment, including direct retaliation." Indeed, even companies that do not make waves may be attacked, because from time to time the FDA bludgeons a business merely to set an example and terrify others.

WITH REGARD TO THE FDA'S REGULAtion of medical devices, Burkholz considers three important episodes, each with significant consequences. The first involves the Dalkon Shield manufactured in the early '70s by the A.H. Robins Company and used by some 3.6 million women worldwide. It turned out that the device raised the risk of pelvic inflammatory disease and spontaneous septic abortion. When Robins stopped selling the product in 1975, users had reported 260 septic abortions, 15 of them fatal. Bad publicity about the device led Congress to pass the Medical Device Amendments in 1976, granting the FDA authority to require that manufacturers get permission from the FDA before marketing any new or substantially altered medical device.