History of the FDA

Exhibit 7.2 presents a brief history of the FDA. For the purpose of regulation of drugs, the relevant centers are the CDER and CBER. 

The history of the FDA is a story of continuously stepping back. Is the product free of contaminants Then step back and consider the process of production. Is the product well organized and safe Examine next the hardware and software systems that control that manufacturing process. Every time one level of concern has achieved industr3rwide predominance it is possible to apply the energies used to achieve that awareness and compliance to yet another previous step. The process is, in effect, continuous quality improvement in action. 

FDA, The 1938 Food, Drug, and Cosmetic Act, History of the FDA. Available online. URL http //www.fda.gov/oc/history/historyoffda/section2.html. Downloaded April 18, 2009. 

WhatWeDo/History/default.htm. Updated June 3, 2009. The FDA gives a brief (and generally positive) overview of its history. Links listed on this webpage cover origins, important milestones, and leaders and deputies. Other links include some oral histories of the FDA and research tools. Although a bit superficial, the material outlines the development of the FDA. 

After a brief history of the FDA s increased focus on BZ-induced hostility, Wise explained ... 

I don t like the FDA any more than you do. Anyone who has studied the history of the FDA knows they have a very cozy relationship with the drug industry. They are now brazenly (and illegally) joined with the drug industry, the Post Office police, the AMA (sub rosa) and the Federal Trade Commission (FTC) in an all-out attempt to destroy the natural health movement in the U.S. 

HMG-CoA reductase inhibitors drew more attention in 1985, as Dr. Michael S. Brown and Dr. Joseph S. Goldstein of the University of Texas won the Nobel prize for medicine for their work on LDL receptors. By November 14, 1986, Merck had finished its clinical and long-term animal studies and sent its new drug application (NDA) to the Food and Drug Administration (FDA). Lovastatin, with a IND/NDA classification of 1A, was approved within 9 months, bringing its total review time (from IND to NDA approval) to 1,204 days, making it one of the most rapidly approved drugs in the history of the FDA. 

Few drugs are more controversial. More adverse reactions to the drug have been reported to the FDA than any other drug in the 24-year history of the FDA s adverse drug reaction reporting system. Thomas G. Whitde and Richard Wieland (The Story Behind Prozac. the Killer Drug) write, Based on documents recently obtained by under the Freedom of Information Act, as of September 16,1993,28,623 reports of adverse reactions to Prozac had been received by the FDA. ... 

There are several books on the history of the development of taxol, which is one of the most remarkable stories in product development. In fact, it inspired the 1992 motion picture Medicine Man, starring Sean Connery as a research botanist looking for a cancer cure in the Brazilian rain forest. For a time, it became a moral drama pitting the needs of patients of intractable ovarian and breast cancer against the passions of environmentalists to preserve an obscure Pacific yew tree. Suffness and Wall are two of the principals in this story, and they wrote (1995) It [Taxol] is not an obvious winner till the very end, and there were a number of times till the very end when it seemed highly likely that it would not be put into development at all, or that once it had been accepted, it would be dropped. More than 30 years passed between the discovery of taxol, with its potential as an anticancer drug, and its approval by the Food and Drug Administration (FDA) for clinical use. 

Brief History of the Office of Orphan Drug Development, www.fda.gov/ orphan/History.htm, accessed 15 June 2006. 

It is sometimes difficult to know when it is necessary or prudent to request a pre-IND conference with the FDA prior to the filing of an IND. This decision frequently depends on the history of the new compound. If one is dealing with a new chemical entity that has been synthesized in the United States and on which minimal preclinical and clinical investigations have been conducted, there is seldom a need to review data with the FDA prior to submitting the IND. There are, however, exceptions to this statement. They reflect the nature of the proposed indication, the use of new technology (e.g., recombinant DNA techniques), the expected human toxicity based on animal data, the design of the initial clinical trials, or appropriate efficacy criteria to be monitored. 

The chief patent holder of the sweetener is the Monsanto Co., based in St. Louis. In 1967, Monsanto entered into a joint venture with I.G. Farbenfabriken, the aforementioned financial core of the Hitler regime and the key supplier of poison gas to the Nazi racial extermination program. In view of Monsanto s Nazi, chemical warfare ties, and the fact that aspartame is a potent stand-alone poison, NutraSweet is a can of worms unprecedented in the American food industry and casts an extraordinarily long shadow across the integrity of the FDA and the American Medical Association that should have screamed bloody murder over the issue. The history of the product is laden with flawed and fabricated research findings, basically a barrage of blatant lies provided by a battery of independent medical researchers, all of which were used as the basis of FDA approval. 

Center for Drug Evaluation and Research. A Brief History of the Center for Drug Evaluation and Research U.S. Eood and Drug Administration Rockville, MD http //www.fda. gov/cder/about/history/default.htm (accessed June 2003). 

The historical file of SOPs documents what SOPs were in effect at any time during a laboratory s history. Because the FDA inspection of a study often occurs years after the completion of that study, the historical file of SOPs will be of special use to an the FDA inspector. Including the effective date on the SOP itself will aid in maintenance of the historical file and will also make it easier to ascertain if any one SOP manual contains the current version of any individual SOP. Accessory documentation of effective dates (e.g., in the transmittal memo for the distribution of SOPs) is permissible but not recommended. 

As thus articulated by the Supreme Court almost 70 years ago, a food ingredient is unlawful if FDA can show a reasonable possibility of harm under actual conditions of use. That standard has since been explicitly adopted by Congress in the legislative history of the FD C Act in 1938 (28-29), reaffirmed by the Supreme Court ( ), and applied consistently by lower courts throughout the country for many years.(30)... 

---