Audio Transcript

To summarize, for a drug to be marketed legally, it must either get FDA approval, or comply with an OTC drug monograph, unless the drug is GRASE, or grandfathered, or pending a final DESI finding on whether the drug is effective; or is covered by the FDA's OTC Drug Review and its OTC drug monograph is pending.

Remember, GRASE refers to a drug that is generally recognized as safe and effective.

This is not an easy standard to meet. First, a drug product must have been subjected to adequate and well controlled clinical investigations that establish its safety and efficacy. Second, those investigations must have been published in the scientific literature so that they are available to qualified experts. Third, experts must generally agree, based on those published studies, that the product is safe and effective for its intended uses. A product's general recognition as safe and effective must be demonstrated by at least the same quality and quantity of data necessary to support FDA approval for marketing.

Grandfathered refers to an exception which only applies to drugs that were already available when the 1938 and 1962 laws were passed, and only if there has been no change in the drug or its labeling since that time. If a firm claims that its product is grandfathered, it is that firm's burden to prove that assertion. FDA does not consider a drug to be grandfathered if there has been any change in, for example, the formulation, dosage form, potency, route of administration, indication, or intended treatment patient population. Current regulations specify the kinds of information, labeling, and data that are necessary to demonstrate exemption from the new drug application process under these "grandfathered" provisions. (see 21 U.S.C. 321(p))

To be covered by FDA's OTC Drug Review, a product's formulation, labeling, dosage form, and method of application must have existed in a commercially marketed OTC drug in the United States on or before the inception of the OTC Drug Review. The OTC Drug Review began on May 11, 1972. Most OTC drugs covered by that review are the subject of a final monograph, a final rule, or pending OTC drug monograph.

The FDA believes it is not likely that any currently marketed drug product is grandfathered or is otherwise not a new drug. However, the FDA recognizes that it is at least theoretically possible. In light of the strict standards governing exceptions to the approval process, it would be prudent for firms marketing unapproved products to carefully assess whether their products meet these standards.

Whether the unapproved drug existed before 1938, or is a more recent addition to the market, the lack of evidence demonstrating that these unapproved drugs are safe and effective is a significant public health concern.