FDA Premarket Approval

For more than 20 years, Proctor & Gamble has been trying to obtain premarket approval by the Food and Drug Administration (FDA) for Olestra--a noncaloric fat substitute covered by four U.S. patents. The first patent expired in 1988, and others will expire in 1994. Legislation has been introduced in Congress to extend Olestra's existing patents for another 10 years, beginning on the date of FDA approval. Proctor & Gamble believes that patent term extensions are justified because it views Olestra as a novel food additive for which FDA had no established regulatory approval path. The company contends that approval was delayed because it had to help FDA pioneer new scientific and administrative procedures to review the substance. This report examines the circumstance relating to actions by FDA and Proctor & Gamble during the last 21 years.

GAO found that factors contributing to the extended period of time it is taking the Food and Drug Administration (FDA) to approve the product include: (1) the lack of a clear approval process for macroingredient food additives; (2) the broad range of the product's original intended uses; (3) the time spent developing testing protocols and conducting tests; and (4) a FDA requirement to conduct a study of the product's effects on pigs. GAO also found that: (1) 21 years have elapsed since the company obtained its first patent for the product; (2) although the company's competitors believed that its decision to concentrate all of its resources on getting the product approved as a drug cost it valuable time, the company believed that FDA would more readily approve the product as a drug than as a food additive; (3) FDA stated that, had the company focused earlier on the product's use as a food additive, it could have had more quickly resolved current safety questions; and (4) although in 1987, the company submitted a food additive petition citing the product's intended uses, the petition created major challenges for FDA, since the company's test results and other data applied to various formulations and potentially broad uses for the product.