(Dunn 1938) The problem was that Act contained a definition for a "new drug" (one in need of prior approval to market), as any drug "the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling." FDCA § 201(p) (1). The manufacturers set out to establish then, that anything GRAS/GRAE therefore was not a new drug, and needed no FDA blessing.

Many medicines are ancient, and the active ingredients of many drugs on were first introduced before 1938. To make matters worse, between 1938 and 1962, the FDA considered drugs that were identical, related, or similar (IRS) to any approved drug to be covered by that approval, permitting IRS drugs to be marketed without independent approval.

Naturally, some companies brought drugs onto the market between 1938 and 1962 based on their own conclusion that the products were generally recognized as safe and effective (GRAS/GRAE), or based on an opinion letter from FDA that they were not new drugs. Conversely, a medicine would not be considered a new drug if it is generally recognized as safe and effective (GRAS/GRAE) and has been used to a material extent and for a material time. See 21 U.S.C. 321(p) (1) and (2).

The impact on the over-the-counter market (drugs that are available to consumers without a prescription) was as expected. As with prescription drugs, the FDA oversees OTC drugs to ensure that they are properly labeled and that their benefits outweigh their risks. The basis for FDA oversight is similar to the...

What are the FDA regulatory steps in getting a drug approved and ready to market?
The FDA regulates drug entry on the market (unlike most products) before their first sale. New drugs, medical devices, and food additives must obtain the FDA's stamp of approval as "safe," and drugs and devices have to additionally meet an "effectiveness" standard. They employ a review that takes years, in which FDA scientists request and study the manufacturer's empirical research to evaluate "safety and effectiveness." After a product is on the market, the item is monitored and later information can lead to withdraw of the FDA's original approval based upon new safety concerns.

In abbreviated terms, the long and winding road for a new drug to reach the market goes as follows:

1. The inventor company starts with preclinical (animal) testing.

2. If they decide it works, they prepare an investigational new drug application (IND) that discloses exactly what the sponsor proposes for human testing in clinical trials.

3. If trials are approved, they start with Phase 1 studies that usually include 20 to 80 people.

4. If the product seems to have merit (and no one dies) Phase 2 studies are begun on a few dozen to about 300 people.

5. Drugs that still have promise and are safe then proceed to Phase 3