FD&C Act and Drug Approval

Manufacturers of drugs that lack required approval, including those that are not marketed in accordance with an OTC drug monograph, have not provided the US Food and Drug Administration (FDA) with evidence demonstrating that their products are safe and effective. Many health-care providers may be unaware that unapproved drugs exist because drug product labels do not document FDA approval.

Under the Federal Food, Drug, and Cosmetic (FD&C) Act, all “new drugs” are required to obtain approval under section 505 prior to marketing. Most drugs are considered new drugs under the FD&C Act, but a drug may be excluded from being deemed a new drug (and, therefore, not required to obtain approval under section 505) if it is “generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective [GRAS/E] for use under the conditions prescribed, recommended, or suggested in the labeling thereof.” The GRAS/E standard is outlined in Table 2. The FDA believes that it is not likely that any currently marketed prescription drug is GRAS/E⁶ because the standard is very high. Even though there may be excellent clinical studies of various prescription drug products reported in the literature, it is highly unlikely that these reports have the same quality and quantity of scientific data as that in an NDA.

FD&C Act and Drug Approval

The Federal Food and Drugs Act of 1906 brought drug regulation under federal law. That act prohibited the sale of adulterated or misbranded drugs but did not require that drugs be approved by the FDA. The act has since been amended a number of times, often in response to tragedies. The 1938 amendment to the FD&C Act required that the FDA review and approve new drugs for safety but not effectiveness before they could be sold legally in interstate commerce. The FD&C Act made it the sponsor’s burden to show the FDA that the drug was safe through the submission of an NDA. Between 1938 and 1962, the FDA considered drugs that were identical, related, or similar (IRS) to an approved drug to be “covered” by that approval, and allowed those IRS drugs to be marketed without independent approval.