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How The FDA Approves New Drugs



Until June 1938 with the signing of the Food, Drug, and Cosmetic Act (FDCA) by President Roosevelt, there had been no federal oversight of the development and manufacture of drugs intended for distribution to the American public.  The FDCA required that drug makers submit evidence of a pharmaceutical product’s safety to the Food & Drug Administration (FDA) before the drug could be marketed to the public.

Reforms were initiated in the late 1950s and early 1960s that led to stricter requirements on the part of drug manufacturers to ensure the safety and effectiveness of their products through properly administered clinical data management that consisted, in part, of more thorough application processes and well-controlled clinical trials.  The FDA approved over 200 new drugs almost every year for the 15 years prior to 1962.  Since 1962 there have been less than a dozen years in which the FDA approved more than 100 new drug applications.

According to the FDA, today’s drug approval process is recognized worldwide as the gold standard due to the rigorous tests that must be performed prior to final approval. The FDA’s Center for Drug Evaluation and Research (CDER) is responsible for approving the manufacture, labeling, and marketing of prescription drugs and the oversight of several other consumer products like sunscreen, fluoride toothpaste, and dandruff shampoo.

So how does a drug gets approved for market distribution by the FDA?  When someone discovers a medicinal use for a natural or artificial substance or chemical compound, they submit an Investigational New Drug (IND) application to the FDA.  If there are no red flags, human trials under a strict clinical data management program may begin.  This involves administering doses of varying sizes to humans of a broad demographic range (elderly, children, women, etc.) to determine the safety and efficacy of the drug.

If the clinical trials produce results that demonstrate the effectiveness of the drug within the FDA’s standards and show that the benefits outweigh any potential risks or side effects, a New Drug Application (NDA) is then submitted to the FDA.  When the NDA is approved, the new drug can be manufactured and distributed to the general population, but only in the form and containing the labeling that was approved by the FDA as part of the New Drug Application.

New drugs are usually patented to protect their ingredients, composition, and other design factors.  Once that patent period expires, the information may be utilized by anyone who wishes to develop a generic form of that drug.  Generic and over-the-counter drugs that are not new do not have to go through the same approval process.  They can submit abbreviated applications stating they will be copying the design and labeling of a previously approved drug. They are then permitted to produce and distribute their products without going through the same rigamarole as the original drug manufacturer.

Over the past half a century, the government has created or revised numerous laws and regulations regarding the design and manufacture of prescription and OTC medications.  Some of these laws have made the process for drug approval more exacting, while others have usurped consumer rights in the area of product liability for design defects and mislabeling.  The U.S. drug market is a multi-billion dollar juggernaut with a forward momentum that shows no signs of slowing down at any point in the future.