Volume 5  Number 5  August 28, 2008
Second Opinions

The Government, the FDA and us

It was a sad day indeed when, after six years of outstanding stewardship, Dr. David Kessler left the FDA in 1996. Criticism of the Food and Drug Administration, the FDA, continues to increase over the years. Going back only three years to 2005 we have the New York Times article, about how the Agency stung by a series of drug safety scandals, then issued a blizzard of safety warnings and slowed its approval of drugs. In 2006 the FDA was reported to be facing Mounting Criticism "that it Protects Corporate Profits, Not Public Health", and 2007, in an MSNBC item on drug trial safety, we catch another glimpse of what continues to be a legislative and regulatory public health disgrace.

Early this year, 2008, The National Academy of Science's Institute of Medicine, the Government Accountability Office, and the F.D.A.'s own science board, along with numerous independent groups have raised serious questions over the effectiveness and competence of the Food and Drug Administration. Specifically, these Government agencies have all issued reports concluding as reported in the New York Times "that poor management and scientific inadequacies have made the agency incapable of protecting the country against unsafe drugs, medical devices, and (even) food."

In 1992, unfortunately, the entire regulatory landscape was changed profoundly as the result of a new law. The law required that much of the cost expended by the FDA on new drug applications would come directly from industry. In other words, to get a drug or device reviewed, the manufacturer would pay directly to the FDA. To understand how this legislation created a cozy relationship between industry and the Agency that regulates it, see this interesting interview. There it is explained that we are seeing an explosion in class action lawsuits against drug companies, which are the results of "fast track approvals" and increasing numbers of new drugs and devices being withdrawn from the market.

The FDA and Clinical Trials

The FDA had been previously attacked in a report by the HHS Office of Inspector General (OIG). The Food and Drug Administration does not know how many clinical trials are going on at any given time, how many sites are conducting them, and how many institutional review boards (IRBs) are overseeing them. According to this Government report released late last September, the FDA audited fewer than 1% of the testing sites and, according to the New York Times, when inspectors did appear, they generally showed up long after the tests had been completed. The FDA has 200 inspectors to police some 350,000 clinical testing sites, so it's not surprising that many of them audit sites only part time. Privately financed noncommercial trials have no federal oversight whatsoever.

The shocking news is that cats and dogs get better protection as research subjects in the U.S. than human beings. Animal research centers have to register with the Government, must keep track of subject numbers, have unannounced spot inspections and take care of problems or face closing, none of which applies to human drug or medical device trials. Perhaps we should persuade PETA to join the HHS in exposing the FDA.

This Inspector General report assailing the FDA makes one wonder about the overall reliability of some studies coming out of thousands of medical facilities, many reported in respected peer-reviewed medical journals. The media, feeding off this literature, helps drive the public's voracious appetite for more and more medical news advertised as "scientific breakthroughs."

Perhaps some criticism is beginning to pay off. According to USA Today in April of this year The Food and Drug Administration said it will hire more than 1,300 biologists, chemists, medical officers and others over the next several months. The hiring announcement comes as consumer advocates and lawmakers have continued to "blast the agency for lax oversight, the drug industry pushes for swifter approval of their products and medical experts decry the lack of regulatory resources." "Each month, there is a delay in bringing critical staff on board impairs the agency's ability to fulfill this mission," John Dyer, the agency's chief operating officer, said in a release. According to the article, the Agency, which currently has more than 10,000 employees wants to triple the number hired between 2005 and 2007. The goal is to do this by October. How many have actually been hired so far? After all the FDA received a $1.73 billion raise last December.

How can the overall situation be cured other than increasing employment? What will be the assignments of all theses new people? For starters, the FDA has 200 inspectors to police some 350,000 clinical testing sites, so it's not surprising that that many of them audit sites only part time. Privately financed noncommercial trials have no federal oversight whatsoever. Improving management and scientific inadequacies must be a significant goal, since, as The Times and others have pointed out, in its present state, the Agency is incapable of protecting the country against unsafe drugs, medical devices, and (even) food."

For the first 86 years of FDA's existence, from 1906-1992, all of its funding came through the U.S. Treasury. In other words, industry and the public paid their taxes, and FDA got appropriations out of the budget. If the FDA made a mistake, many of which occurred over the years, there would be a congressional hearing. The Agency would be accountable to the public through the legislative branch and explain what went wrong and why. As I pointed out above, when in 1992 the entire regulatory landscape was changed the law required that much of the cost expended by the FDA on new drug applications would come directly from industry. This clearly was the beginning of the dangerous conflict of interest invested in the FDA simply because the manufacturer would pay to get the drug or device approved. Fast track approval ensued, more drugs and devices were withdrawn from the market, and more lawsuits inspired.

Perhaps it is time for the old law to be re-instated so the funding of the FDA is again restored to the Treasury Department or some other Government Agency, accompanied by direct Congressional oversight. Should industry continue to pay part of the cost? If so, how can logistics be developed so the regulated do not take over the regulatory henhouse? That is indeed a difficult question.

Martin F. Sturman, MD, FACP

Copyright 2008, Mathemedics, Inc.

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