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The FDA is a federal administrative agency born out of the new deal era that was created to enforce the Pure Food and Drug Act of 1906. In essence, the intention of the FDA was to ensure a certain quality of the food, medicine, and cosmetics that citizens use in everyday life. This Act in 1938 did a few additional things:
- Extended FDA’s oversight to include cosmetics and therapeutic devices.
- Mandated that new drugs must be shown safe before selling and advertising can begin.
- Mandated that safe tolerances be set for unavoidable poisonous substances.
- Authorized factory inspections.
- Increased the ability of the FDA to prosecute manufacturers at fault.
In 1962, additional amendments to the scope of the FDA’s oversight were added to include:
- Drug manufacturers being required to prove to FDA the effectiveness of their products before advertising them.
What a keen eye will notice in reading the legislation is that nothing under the FDA’s statutory authority involves the decisions physicians make every day for their patients. In fact, the Federal Food, Drug, and Cosmetic Act, section 1006 expressly state that nothing in this act shall be construed to limit of interfering with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate doctor-patient relationship.
Therefore, it is concerning that; on its face, it appears the FDA did just that over the past 28 months. Amazingly, our state authorities and corporate interest in the delivery of medicine pointed to the FDA limiting the use of medicines physicians could prescribe and pointed to the FDA’s statements and proclamations to justify this interference. These state authorities knew that the FDA had no role in this area and, in fact, is expressly prohibited in their governing legislation.
As we discuss today on the show, thankfully, a brave number of doctors are suing the FDA for this violation and interference in the sacred physician-patient relationship. The FDA must be constricted to its legislated authority and also removed from impeding the fundamental rights patients have in relationships with their physicians.
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