THE FOOD AND DRUG ADMINISTRATION (FDA OR USFDA)

The Food and Drug Administration is an agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.

The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services.

The agency also has 223 field offices and 13 laboratories. In 2008, the FDA started opening offices in foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.

The 1906 Pure Food and Drug Act

The Pure Food and Drug Act of June 30, 1906 is a United States federal law that provided federal inspection of meat products and forbade the manufacture, sale, or transportation of adulterated food products and poisonous patent medicines. The Act was passed due to public education and exposes from Muckrakers such as Upton Sinclair and Samuel Hopkins Adams, social activist Florence Kelley, researcher Harvey W. Wiley, and President Theodore Roosevelt.

The 1938 Food, Drug, and Cosmetic Act

In the late 1930s, a pharmaceutical manufacturer distributed a sulfa medication to treat pediatric patients. The medication contained a highly toxic chemical similar to antifreeze that resulted in the death of hundreds of children. In response, the United States Congress passed the 1938 Food, Drug, and Cosmetic Act, which imposed strict regulations on the manufacturing of food, medication, and cosmetics. The 1938 Food, Drug, and Cosmetic Act requires that:

o   Medication be proved safe before being sold.

o   The tolerance levels of medication be determined to assure patients are not poisoned.

o   Medication manufacturing facilities must pass government inspection.

o   Cosmetic and therapeutic devices be regulated.

The 1952 Durham-Humphrey Amendment to the Food, Drug, and Cosmetic Act

Anyone could distribute medication so long as the medication was proved safe. This changed in 1952, when Congress determined that some medications were not safe unless the medication was directly supervised by a medical practitioner. These medications are those that are given by injection; depress the nervous system (hypnotics); dull the senses, relieve pain, and induce sleep (narcotics); are habit forming; and are still under investigation. Congress passed the 1952 Durham-Humphrey Amendment to the 1938 Food, Drug, and Cosmetic Act that divided medications into two categories:

o   Legend Medication: These are medications that must be prescribed and directly supervised by a medical practitioner and are known as a controlled substance. These include opioids, hypnotics, and potentially habit-forming or harmful medication. The medication label must read: “Caution: Federal law prohibits dispensing without a prescription.”

o   Over-the-Counter Medication: These are medications that do not need direct supervision by a medical practitioner. No prescription is required to purchase these medications.

The 1962 Kefauver-Harris Amendment to the Food, Drug, and Cosmetic Act

Manufacturers only had to prove that their medication is nontoxic to sell their medication. With the 1962 Kefauver-Harris Amendment to the 1938 Food, Drug, and Cosmetic Act, manufacturers also had to prove the effectiveness of the medication before it could be administered to patients. In addition, the 1962 Kefauver-Harris Amendment authorized the Food and Drug Administration, who oversees the pharmaceutical industry, to evaluate testing methods used by pharmaceutical manufacturers. This act also required the use of standard labeling on medication containers, specifically requiring that the label display contraindications for using the medication and possible adverse reactions that the medication might cause.

The 1970 Comprehensive Drug Abuse Prevention and Control Act

In an effort to contain widespread abuse of legend (prescription) medication, Congress passed the 1970 Comprehensive Drug Abuse Prevention and Control Act. This act categorized legend medication into five schedules based on the medication’s potential for abuse. In addition, this act limited the number of refills for legend medication and required that practitioners use specially designated prescription pads when prescribing the medication.