ABSTRACT
INTRODUCTION It often comes as a surprise to members of the American public, medical professionals, Congress, and even legal professionals that thousands of drug products now on the market have never been reviewed and approved as safe and effective by the U.S. Food and Drug Administration (FDA), notwithstanding the comprehensive review and approval systems laid out for both prescription and over-the-counter (OTC) drugs in the Food, Drug, and Cosmetic Act (FDCA or the Act) and the FDA’s implementing regulations and regulatory programs (1). FDA estimated that there were “perhaps as many as several thousand” such drug products on the market in mid-2006, and other estimates over the years have been even higher. Indeed, the FDA has conceded that the exact number of such products is not and probably cannot be known precisely (2). Historically, the visibility of such products has flared when unapproved drug products have been the cause of high-profile safety risks (3), and subsided in periods when FDA has focused primarily on other issues such as implementing the major statutory amendments of 1962 and 1984 that put into place the current regulatory scheme for both prescription and OTC drugs. Since 2006, however, the FDA has made concerted efforts to bring both individual products and broad classes of marketed unapproved drugs under the NDA approval process, or to remove them from the market. This chapter will provide an overview of the history and current regulatory status of marketed unapproved drugs in the United States, and FDA’s current policy for dealing with such products.
