EDITORIAL

Why Not Abolish the FDA?

T he evolution of the FDA has continually involved indifference to the many deaths caused by its own stubbornness and intransigence. Yet when forced to defend its actions in court, the FDA’s imperious attitude has resulted in a system that withholds life-saving drugs from the market, approves dangerous drugs, and denies everyone freedom of choice.

Death By Regulation—The Price We Pay For The FDA

“[In the 1970s] [w]hile the British continued to enjoy many new drugs to treat their illnesses, only half of these were available to Americans, and only after many more years of waiting. One of these new drugs denied to Americans was propranolol, the first Beta-blocker to be used extensively to treat angina and hypertension. Approximately 10,000 Americans died needlessly every year because it was against the law for their doctors to treat them with propranolol.1

Propranolol was finally approved here for minor uses in 1968, but was only approved in 1973 and 1976 for angina and hypertension respectively. The regulatory delay of this single drug may have been responsible for the death of more Americans than all other deaths from drugs in this century. Even so, the FDA came under severe criticism by Congress for “premature” approval of this valuable drug!

Former FDA Commissioner Alexander Schmidt noted that “…rarely, if ever, has Congress held a hearing to look into the failure of FDA to approve a new entity; but it has held hundreds of hearings alleging that the FDA has done something wrong by approving a drug …” The drug lag, he claimed, could only “be remedied by Congressional and public recognition that the failure to approve an important new drug can be as detrimental to the public health as the approval of a potentially bad drug.”

The toll of such a bureaucracy is unburdenable. Now is the time to privatize the FDA or abolish it altogether.

If we truly knew that the FDA’s actions were clearly negative, would we hesitate in our advocacy? The relevant laws now on the books require drug and medical device manufacturers to prove their products to be safe and effective, and to make no unproven claims. The FDA’s role, in essence, is to be the arbiter of what constitutes proof. Questions to ask: “Does the FDA have a dog in the fight?” “Do they care which side wins?” “Do they benefit or profit from their actions?” “Proof” is not truth, especially when the FDA is both judge and jury.

Is the FDA Fit to Judge?

A recent issue of Forbes Magazine,2 finds that as recently as 2008, companies filing applications to sell never-before-marketed drugs, which are referred to by the FDA as “new molecular entities,” faced rejection 66% of the time. Yet so far in 2015 (when the article was written), the FDA rejected only three uses for new chemical entities, and approved 25, an approval rate of 89%. Given the scare stories about how the unrestricted market would poison everyone, there doesn’t seem to be too much to worry about, based on these figures, unless all companies live in fear. Fear is not a way to promote originality, inventiveness or even thoroughness.

Full-Service Bureaucracy

“The FDA is a full-service government bureaucracy. Within broad and often vague statutory limits, it makes the rules; monitors compliance without inconveniences such as search warrants; and, with wide discretion, punishes those it finds guilty. It is promulgator, police, judge, jury, and executioner all rolled into one.”3

While the FDA’s actions are subject to formal judicial review, but aggrieved parties go to court only as a last resort. Separately, from the likelihood that they will lose in a court of law—where judges usually tolerate a wide range of agency action—the suers will eventually lose. Why? Because as long as they remain in business they will be subject to the agency’s enormous and ill-defined regulatory powers, and the agency will take its revenge sooner or later.

Its vindictiveness is notorious. Kim Pearson, publisher of the Food & Drug Insider Report, “found that 84% of companies polled in 1991 reported declining to file a complaint against the FDA for fear of retaliation.” After drug company executives blew the whistle on corrupt FDA officials and precipitated the generic drug scandal in 1989, the FDA rewarded them by trying to drive them out of business with repeated inspections, in which “violations” of good manufacturing practices (GMP) regulations can always be found, and long delays in approving their products for marketing.

This is the same ex-FDA employee and publisher who in his newsletter (Food & Drug Insider Report) estimated that more than 200 upper echelon FDA bureaucrats had significant stock portfolios heavily represented by drug company stock. This practice represents a clear conflict of interest between the health-seeking public and the FDA (and indirectly, the drug companies).

An FDA official reportedly said, “We have depended on the ability to selectively target companies . . . and to issue findings without fear of being second-guessed by some tinhorn judge.” Separation of powers is not a popular constitutional doctrine at agency headquarters in Rockville [home of the FDA].

People say that without the FDA’s gatekeeper role, any company could market any product and make any claims they wished. The temptation to lie, cheat and cut corners would prove irresistible. People would be poisoned; many more would be induced to buy drugs that are ineffective. Yet this doesn’t seem true, by any stretch of imagination, unless non-FDA law is powerless to seek damages for bad drugs through the tort system.

However, this is far-less likely to be the case with the FDA dominating the legal system. Another good reason to privatize or abolish the FDA—there might then be a greater chance for justice!

References

  1. Ruwart MJ. Death By Regulation—The Price We Pay For The FDA. Oct 9, 1999 http://rkba.org/libertarian/isil/pamphlets/pam-03.txt.
  2. Herper M. The FDA Is Basically Approving Everything. Forbes Magazine. Aug 20, 2015. http://www.forbes.com/sites/matthewherper/2015/08/20/the-fda-is-basically-approving-everything-heres-the-data-to-prove-it/#13e18ad04938.
  3. Higgs R. Wrecking Ball: FDA Regulation of Medical Devices, August 7, 1995. www.Cato.org.pubs/pas/pa-235.

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