The new drug approval and OTC Drug Review processes play an essential role in ensuring that OTC drugs are both safe and effective for their intended uses. OTC drugs marketed in the United States (U.S.) have been estimated at between 100,000 to 300,000 products. There are also an ever-increasing number of these products imported from foreign manufacturers and distributors. Consumers in this country spend several billions of dollars on these drug products every year. Moreover, with escalating health care costs in the U.S. more and more consumers are self-medicating with OTC drugs.
Thus, it is essential that marketed OTC drugs are safe and effective. Manufacturers of drugs that lack required approval or that are not marketed in accordance with the OTC Drug Review, have not demonstrated that their OTC drug products are safe and effective. Therefore, it is essential for FDA to take steps to ensure that manufacturers of these products comply with the Federal Food, Drug, and Cosmetic Act (the Act) and (1) obtain the required scientific evidence for FDA approval, (2) meet the provisions of final monographs and other rules under the OTC Drug Review, (3) or remove the products from the market.
With the expansion of FDA’s authority under the 1962 amendments to the Act, the agency undertook the Drug Efficacy Study Implementation (DESI) project to evaluate the efficacy of hundreds of drug products, including some 400 OTC drug products, reaching the marketplace in the U.S. between 1938 and 1962 based solely on safety considerations. Agency action against the OTC drug products evaluated under this process was postponed in many cases pending the conclusion of FDA’s OTC Drug Review, launched in 1972, and the development of OTC drug monographs and other rules under that review. In addition, many ingredients previously marketed only in prescription drug products were switched to OTC status under the OTC Drug Review.
OTC drug products not covered by an approved application must, otherwise, be covered by a final OTC drug monograph established under FDA’s OTC Drug Review to be regarded as both safe and effective. Final OTC drug monographs and rules have been established for many OTC drug products, but many products remain under ongoing rulemakings under the OTC Drug Review. To be covered by that review, a product’s formulation, including the concentration of its active ingredients, its labeling, indications for use, and dosage form must have existed in the marketplace in the U.S. on or before the inception of the OTC Drug Review; or FDA has included the formulation, concentration of active ingredients, labeling, indications for use, and dosage form in the review in accordance with existing regulations (e.g., 21 C.F.R. §§ 330.14 and 330.10(a)(12), and 21 C.F.R. § 10.30). If these provisions are not met, the OTC drug is not eligible for evaluation under the OTC Drug Review. Rather, FDA approval of a new drug application (NDA) under section 505 of the Act (21 U.S.C. § 355) would be required before such drug could be legally marketed in the U.S.