The Secret to FDA Approval

What is the FDA?

The Food and Drug Administration is a Federal agency that operates within the United States Department of Health and Human Services. The Food and Drug Administration is one of the country’s federal executive departments and is responsible for protecting and promoting public health through the supervision and regulation of tobacco products, food safety dietary supplements, prescription, as well as over-the-counter pharmaceutical drugs, biopharmaceuticals, vaccines, medical devices, electromagnetic radiation emitting devices, cosmetics, veterinary products and vaccines.

In addition to the regulation over the aforementioned products, the Food and Drug Administration enforces other laws, most notably Section 361 of the Public Health Service Act and associated legislation, which may or may not be related to food and drugs. In this format, the Food and Drug Administration is responsible for the regulation of sanitation requirements on interstate travel and the control of disease on products ranging from household pets to the donation of sperm intended for assisted reproduction.

What is the FDA Approval Process?

For a new drug to reach the pharmacy shelves it must be approved by the Food and Drug Administration. The FDA approval process is lengthy; the drug is tested and exhaustively examined to ensure that ingestion is safe and with limited side effects. On average, it takes 12 years and over $350 million dollars to get a new drug from the laboratory onto the pharmacy shelf.

When a company develops a new drug, it must undergo around three and a half years of laboratory testing, before an application of the substance is offered to the U.S. Food and Drug Administration. When offered, the FDA can officially begin testing the drug on human beings. That being said, only one in roughly 1000 of the compounds that enter the FDA’s laboratory testing state will ever make it to human testing.

If the FDA awards a drug the green light, the investigative substance will then enter three distinct phases of clinical trials. Phase 1, uses approximately 20-80 healthy volunteers to establish a drug’s safety profile. After a year of testing, the drug will enter phase 2, which will utilize between 100 and 300 patient volunteers to assess the substance’s effectiveness in treating the underlying condition.

After roughly two years, assuming the drug makes it through, it will enter phase 3, where 1000 to 3000 patients in clinics and hospitals, who are monitored carefully, will be tested to determine the effectiveness of the drug. During this stage, scientists and those agents of the FDA will painstakingly analyze the reactions and adverse side effects (if any) of the drug.

Following the clinical trials the company responsible for producing the drug will then submit an application to the FDA for approval; this process can take up to an additional two and a half years. After final approval, the drug becomes available for physicians to prescribe, however, during this stage, the company will continue to observe and report cases of adverse reactions and other clinical data to the FDA.