Monday, September 28, 2009

Part Three: The Relationship Between the Level of Regulation under the FDCA and the Health Status of a Product’s Targeted Population

An Introduction to the History of Quack Medicine

In the late nineteenth and early twentieth centuries there was a remarkable growth in the marketing of sham products to treat and cure disease.

At that time, the rate at which quack medicines were being introduced into the market far outpaced the development of the science necessary to establish the efficacy and identify the risks associated with each new product. This scientific lag time created a period when there was an information void that
predatory commercial interests were quick to use to their advantage. As the FDA carried the burden of proof to show that a product did not work or was unsafe in order to remove the product from the market, during this lag time predatory commercial interests were able to profit from scientific uncertainty to the detriment of public health.

During this long period in U.S. history, the curative claims of the predatory sham medicine salesmen were limited only by the gullibility of their targets. In many cases, the degree of gullibility was proportional to the level of desperation of the individual for a cure. The more dire the condition, the more vulnerable an individual was to the ‘flim flam’ of the greedy snake oil salesman. And the more dire the condition, the greater the degree of harm when the sham medicine did not work, causing injury over and above the original illness and/or causing a delay in seeking effective medical treatment. Thus, this lag time between initial marketing of a sham product and the development of the science necessary to resolve uncertainties over the new product’s safety and effectiveness was very costly in terms of human suffering and loss of life. Slaying the Hydra: The History of Quack Medicines
In 1962, after a series of highly publicized public health crises, legislation was passed to close this ‘space between’ created by scientific uncertainty by switching the burden of proof for safety and effectiveness from the FDA and onto product manufacturers.

As more fully discussed in the next entries in this series,

it was not until 1962 that legislation was passed that required manufacturers to obtain premarket approval for new drugs from the FDA by producing “substantial evidence” that the product is both safe and effective for its intended use. The Drug Amendments of 1962 allowed the FDA to make the transition
from its former inefficient and costly police role of enforcing specific statutory prohibitions by removing adulterated and misbranded products from the market, to its current gatekeeper role of preventing those products from entering the market in the first place. Thus, from 1962 until 1994, manufacturers were no longer able to ‘play in the grey’ and take commercial advantage of the scientific uncertainty over the safety and effectiveness of a product to the detriment of public health.

The legislative history of the FDCA makes it clear that Congress also intended that weight loss products fall into the same regulatory category as drugs and devices specifically to deal with predatory profiteering by product manufacturers that targeted a vulnerable population of those who were overweight or obese. In the legislative record, members of Congress expressed their intent to deal with the massive number of “worthless” products being marketed for weight loss at the time. Id.

Thus, prior to the passage of The Dietary Supplement Health Education Act (“DSHEA”) and the Nutritional Labeling Education Act (“NLEA”), the FDCA appears to have required that manufacturers of weight loss supplements obtain premarket approval by establishing the safety and effectiveness of their products before distributing them.

However, the passage of DSHEA in 1994 has confused this situation. To date, it appears that DSHEA is being interpreted to shift the burden of proof back onto the FDA with relation to dietary supplements marketed to both healthy populations and vulnerable, unhealthy populations.

With this over broad interpretation, predatory commercial interests are again being allowed to exploit scientific uncertainty. The door has now been re-opened to the same deceptive advertising that ran rampant in the late nineteenth and early twentieth centuries.

And unfortunately, tens of millions of vulnerable and desperate individuals who are overweight and at grave risk of developing a serious, chronic disease are being lured into this predatory playground. The United States has now come full circle and returned to the era of the snake oil salesman. The very public health problem that the FDCA was originally promulgated to deal with, fraudulent and deceptive products that put the nation’s health at risk, has reared its ugly head once again. Id.

The next blog post in this series delves into more details regarding the history of the quack medicines to give additional perspective to the relationship between the FDCA, the FDA and predatory commercial interests.



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