Reason tells usthat the Food and Drug Administration (FDA) is responsible for protecting and keeping safe and secure the health and wellbeing of the public. We also believe that FDA regulates and monitors the security and safety of the veterinary drugs, medical devices, biological products, food supply, cosmetics and products that emit radiation.It is also a given fact that FDA has the responsibility of advancing the health of the public by enabling those stakeholders in the innovations of medicine to create more effective, affordable and safer medicine. FDA does this by keeping the public informed about science-based information that the public need to know about foods and medicines that they consume. As a regulatory Authority, FDA as well regulates the manufacturing, distribution and marketing of tobacco products in order to protect the public health.
With all these sworn functions of FDA, we will definitely think that FDA can never be manipulated nor will it work against the interest of the public. But what if FDA, in its long history, can be proven to work against the interest of the public? Will you still trust it?
The Controversies Surrounding the FDA
Many non-government and government organizations in the past had criticized FDAforunder-regulation and over-regulation. Some of the allegations against FDA’s over-regulations include the following:
- Alleged problems in the approval process of drugs.
- Allegations that the regulations of FDA causes the increase in prices of drugs.
- Allegations of censorships in drug and food labeling.
On the other hand, the allegations against FDA regarding under-regulation include the following:
- Allegations that FDA used to cover up exportation of products that are unsafe.
- Allegations that FDA approved of unsafe drugs.
- Allegations that FDA approves food additives that are unsafe.
- Allegations that FDA approves unsafe processing technologies.
- Allegations that FDA is influenced by Pharmaceutical industry.
- Allegations of bias against donation of blood by gay men and many more.
- Allegations against management of FDA scientists.
With all these allegations at hand against FDA, we can only ask whether FDA really has been involved in under-regulation and over-regulation to favor someone or some entities.
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Can FDA be manipulated?
The question as to whether FDA can be manipulated also opens up a Pandora of questions that necessitate further answers. On the one hand, if your answer to this question is affirmative, then it behooves you to also ask whether there were times when the FDA had been manipulated in the past.
The industries involved in the manufacture and production of food and drugs involve multi-billion dollars. Hence, if some devious companies want to manipulate FDA, they simply have to control the person who headsthe FDA.
The abovementioned allegations definitely have their basis. On the one hand, the appointment of the head of FDA can be manipulated and influenced. One instance was in the 1970s, when G.D Searle produced internal studies claiming that aspartame is safe. The internal scientific research of FDA, on the other hand, revealed that aspartame causes massive holes and even tumors in the brains of rats. Hence, with these scientific studies, FDA initiated an investigation into G.D Searle for making false statements and for hiding material facts about aspartame. To save itself, Searle tapped Donald Rumsfeld, the former Secretary of Defense of Ford’s administration. Searle made Rumsfeld the CEO of Searle, and hence, Searle immediately increased its political influence on the case. After a few months, Samuel Skinner, the one who handled the case of Searle received a good offer and withdrew from the ongoing investigation and resigned his U.S. Attorney Office’s post to go and work for the law firm of G.D. Searle. This tactic stalled the case. The statute of limitation likewise ran out and the investigation against G.D Searlewas dropped.
Another good example of how FDA can be manipulated was that of Dr. JereGoyan’s case. Dr. Goyan was the FDA commissioner in the 1980s. At that time, Goyan was about to sign a petition banning the use of aspartame. It was said that Rumsfeld called Reagan and ask Reagan a favor for the Searle. Reagan then fired the non-cooperative Goyan and replaced him with Dr. Arthur Hayes Hull. Hull then approved NutraSweet a product of G.D. Searle, and did Searle a favor.
FDA Had Failed in the Past to Protect Consumers
When Dr. Herbert L. Ley, Jr. resigned as the commissioner of FDA, he issued a warning in an interview to NY Times about the inability of FDA to safeguard and protect consumers. He said that people are misled to think that FDA is really bent on protecting their interests. He stated that it isn’t the case. Dr. Ley was critical of Congress and how the pharmaceutical companies’ lobbyists are very much effective in influencing FDA’s regulations. He even stated that he—as the head of FDA—is in constant and sometimes unmerciful pressuresfrom the different drug and pharmaceutical companies, and he insinuated that there are many powerful politicians who are always working hard in behalf of their patrons.