When the FDA makes a mistake and approves a drug that turns out to be dangerous, we hear about it. When the FDA makes a drug and doesn’t approve a drug that could save lives, we don’t hear about it. From Davis Taylor at tenthamendmentcenter.com:
Most people believe government agencies like the Food and Drug Administration keep them safe. But a book by Dr. Mary J. Ruwart explodes this myth.
People often argue that without the protection of government agencies, we would face constant peril. Allegedly, without the FDA, our pharmacy shelves would be lined with unregulated products containing deadly substances, marketed by the unscrupulous.
Of course, this argument rests upon the unspoken assumption that the laws and regulations enforced by the FDA are benign, causing little or no harm, and few, if any, deaths. It also rests upon the assumption that, without government regulation, there are no market-based mechanisms for certifying the safety of drugs and products.
In her important new book, Death by Regulation: How We Were Robbed of a Golden Age of Health and How We Can Reclaim It, Dr. Ruwart provides information which thoroughly refutes these assumptions.
Dr. Ruwart holds a B.S. in biochemistry, a Ph.D. in biophysics and spent 19 years as a pharmaceutical research scientist for the Upjohn Company. She has also chaired an IRB (Institutional Review Board), consulted with nutraceutical companies and been an expert witness against the FDA. Therefore, she is intimately familiar with the impact of the FDA and the laws and regulations it enforces. Her easily digestible book focuses specifically upon the detrimental impact of the 1962 Amendments to the 1938 Food and Drug Act (“the Amendments”).
Dr. Ruwart reviews the burdensome effects of the Amendments, including a lengthening of the average period for new drug development from approximately four years to 14 years. She explains the numerous additional requirements set forth in the Amendments, and the additional development time caused by them and provides heartbreaking examples of the effect of this wait time on those with life-threatening illnesses.
For example, she discusses how, in the early years of the AIDS epidemic, United States AIDS patients often had to travel to other countries with fewer regulatory requirements to obtain new therapies still unapproved by the FDA, sometimes having the drugs confiscated upon reentry to the United States. She further discusses black market AIDS Buyers’ Clubs which quickly formed in response to the need for therapies and hired chemists to make drugs undergoing development, in violation of pharmaceutical companies’ patents. She also points out that, although making, selling and distributing these drugs without FDC approval violated the law, the FDA often took no action against most violators, “especially those in California who were well organized and vocal,” and that instead “the FDA selectively prosecuted those who were least likely to fight back.” This illustrates that organizing and fighting back against unfair laws can be effective in preventing or reducing their enforcement.