The Food and Drug Administration

The federal Food and Drug Administration--the FDA--is the principal federal agency charged with overseeing the safety of our food supply and effectiveness of pharmaceuticals (drugs) and medical devices and procedures. Many people assume that this oversight is complete--that whatever the FDA says has been well-investigated and is true. That one can have 100 percent confidence in FDA's pronouncements. But is that true? Does the label 'approved by the FDA' literally mean there is no room for error--innocent or other? To understand how FDA's pronouncements can affect the health and safety of each one of us, it is perhaps best to first review the history of this federal agency.

Prior to 1962 the FDA was a pussycat. Its role, according to the Food and Drug Act of 1906 and the Food, Drug and Cosmetic Act of 1938, was to assure the purity of foods and safety of drugs. Although the 1938 Act required drug companies to submit safety data to the FDA prior to drug clearance and licensing, the potential for FDA conflicts of interest, chicanery and other devious practices was low, since certain safety tests were put in place for drugs as were standards for purity of foods: a drug either passed the safety tests or didn't; a food either met the purity standards or didn't. There was very little room for 'politics' and therefore reason for widespread oversight and/or enforcement powers by the FDA. But all that was to change abruptly.

In 1962 an antihistamine-type sedative, thalidomide, used by pregnant women particularly in Great Britain and Germany but throughout Europe, caused congenital deformities of all types in considerable numbers of babies--infants who were born without hands, arms, legs, feet, digits, and other very significant malformations. This did not happen in the United States, because thalidomide had not yet cleared the--largely administrative--safety hurdles of the FDA. This serendipitous 'escape' by the United States forever changed the course of the FDA and, with it, all aspects of modern medicine.

In 1962, recognizing it was only the 'safety' oversight exercised by the FDA which prevented a similar situation happening in America as happened in Europe, Congress passed the Kefauver-Harris Amendment to the 1938 Food, Drug and Cosmetic Act, granting enormously increased powers to the FDA, not only in terms of assuring drug safety, but more importantly in granting FDA efficacy oversight over drugs, as well as safety. It was now only FDA who could decide whether a drug was effective, whereas previously FDA would only decide whether a drug was safe and individual physicians would decide efficacy. With this new jurisdiction over efficacy, FDA became a powerhouse: it could make new rules, enforce them, even send armed personnel against any entity or individual it wished, by virtue of the extensive police power granted to it by the Amendment. With this Amendment the FDA became the most powerful government agency in the face of the medical establishment, making virtually every decision as to what drug--or device--or procedure could or couldn't be used in the treatment of human, even veterinary, patients, thereby dominating clinical practice and research of all kinds. With such power, however, also comes abuse of power. FDA has been accused of intimidating drug companies, individuals, even employee scientists and physicians who came to disagree with official FDA policies and practices, as well as those who sought to reform its approaches to alternative medicine and new research.

Perhaps most important, with the requirement of efficacy oversight thrust upon it by Congress, FDA was suddenly understaffed and overburdened. One of the ways FDA solved this problem was to create 'advisory committees.' These committees were composed of experts in their respective fields--who were not FDA employees, but were nevertheless frequently well known to the FDA to be sympathetic to FDA concerns. These advisory committees would meet to discuss--and recommend--whether any drug or device or procedure should be approved or disapproved. For example, the Oncology Drug Advisory Committee (ODAC) would meet to discuss cancer drugs and recommend to FDA what action should be taken. Almost without exception the FDA would adopt its advisory committee recommendations.

The only trouble was that after a period of time certain 'excesses' were being taken at the meetings of the advisory committees, some of which began resembling 'kangaroo courts.' Such meetings would frequently not present balanced viewpoints but only those sanctioned by the FDA. As a result Congress passed the Federal Advisory Committee Act of 1998, which specifically prohibited 'undue influence' from operating in the advisory committee meetings. This legislation, however, was not enough to halt the approval of drugs which later were shown to be dangerous, causing them to be "black-boxed" or pulled off the market entirely. Drugs such as Zelnorm, Baycol, Permex, Mellaril, Vioxx, Celebrex, Ketek and a host of others prescribed in good faith by doctors and taken in good faith and in high expectations by patients, were shown, after FDA approval, to produce heart attacks and heart damage, stroke, dissolution of muscles, liver toxicity, kidney damage, severe metabolic abnormalities, suicide and death.

These problems besetting FDA--approval of drugs which upon post-marketing experience are found to be dangerous, even lethal, essentially a failure of FDA's 'safety' oversight--follow in the wake of the 1962 Kefauver-Harris Amendment which conferred upon FDA efficacy oversight of drugs. As indicated previously, with the efficacy requirement thrust upon it by Congress, FDA was suddenly understaffed and overburdened.

While many in the FDA labor ceaselessly in good faith, this agency cannot hope to keep up with the burdensome requirements imposed upon it. In particular the requirement of efficacy oversight has necessarily shifted FDA resources away from its other responsibilities, depriving the FDA of adquate personnel and means to guarantee the integrity of its 'safety' operations--with the result that many dangerous drugs are needlessly being presented to the American people.

FDA's efficacy oversight also operates in other ways to impede its safety functions. FDA-approved pharmaceuticals have become a big business. Much money is made by drug companies by the sale of these pharmaceuticals. Thus, much attention is occupied by FDA in overseeing its efficacy function. Unfortunately, politics, moral decay, instances of criminal behavior have infiltrated FDA's efficacy deliberations--have entered into its equations of drug approval--with the result that drugs with 'marginal' or insufficient safety records being accorded 'approval.' (In October 2006 FDA Commissioner Lester Crawford was charged by the Justice Department with failing to disclose his income from exercise of stock options in the very companies he [FDA] regulated.)

Efficacy oversight corrupts safety standards in still another way. Many high officials in the FDA, upon leaving FDA, go on to become high officials in pharmaceutical companies, their efficacy experience in the FDA often being utilized in their new employ to guide new pharmaceutical products into quick and economical approval. For example, Michael A. Friedman, M.D., a former high NCI (National Cancer Institute) official, became acting commissioner of the FDA upon the resignation of Dr. David A. Kessler, assuming full control of FDA's operations. Dr. Friedman left the FDA to become Senior Vice-President for Clinical Affairs at G. D. Searle & Company, a division of the giant Monsanto Chemicals. In that capacity Dr. Friedman was responsible for the implementation and development of new drugs and products by Monsanto's Life Sciences Program and their successful navigation through FDA's regulatory processes, which as acting FDA commissioner he oversaw for one and a half years. Dr. Friedman's example is legion. Many former commissioners and deputy-commissioners of FDA become important pharmaceutical executives because of their ability to 'traverse' the often-difficult efficacy requirements imposed by the FDA on new drug products. Out of necessity the successful conclusion of their efforts--especially as concerns the efficacy of new drug products--is at the expense of safety concerns.

Thus the efficacy requirements imposed upon FDA by the Kefauver-Harris Amendment has come in time to undermine FDA's safety operations--by virtue of displacing limited FDA resources and personnel away from its safety oversight, by virtue of engaging FDA and pharmaceutical company officials in illegal collusion, by virtue of former FDA officials using their expertise and experience, as high pharmaceutical company neo-executives, in guiding new drugs to approval. In fact it is this efficacy aspect of FDA operations which has most occupied FDA procedures and consciousness since the Kefauver-Harris Amendment.

Some years ago I was on the telephone with a deputy commissioner of the FDA, discussing various aspects of FDA oversight of drug efficacy. We discussed FDA's issuance of INDs (Investigational New Drug Exemptions), its requirements for pharmaceutical drug development, its evaluation of clinical trials, its constant reminders to the medical profession concerning drug use. I happened to innocently remark that a certain drug had been 'proven' by large-scale controlled clinical trials. He disputed me, saying: "No drug is proven until we say it's proven."

What can be done to restore safety to FDA operations, so that drug products which are dangerous, even deadly, have the least likely chance to enter the marketplace?

The most immediate measure is to return FDA to its original, pre-Kefauver Amendment function to assure the safety and purity of foods and drugs--and rescind the efficacy oversight requirement. Relinquishment of FDA's virtual stranglehold on drug efficacy could have multiple--and far-reaching--benefits on the public health: Judgment of the effectiveness of drugs would be returned to individual practitioners; doctors would be free to choose drugs based on their medical expertise, experience, interpretations of studies in the medical literature, attendance at scientific conferences, interaction with colleagues, etc., knowing full well FDA has certified these drugs as safe. Smaller pharmaceutical companies would be free to engage in true competition with larger companies--it now costs $300 million for any drug to undergo FDA-mandated testing and evaluation, largely to satisfy efficacy requirements, assuring that only large companies 'need apply'--ushering in an era in which the pent-up pressures of innovation and new ideas in smaller companies would be free to emerge in the form of new products. Most importantly, FDA would now be free to concentrate its entire resources on drug and food safety, a not inconsiderable function in view of the many drugs approved by the FDA which have been shown in Phase IV--post-marketing--experience to be dangerous, even fatal, and have been recalled. With exclusive concentration on food and drug safety, FDA could play a more crucial and enhanced role in the nation's effort to exclude harmful substances from our drug supply--to provide increasingly safe, decreasingly toxic and progressively more effective agents in the conquest of disease.