Bringing Dormant GRAS(E) to Bloom: Reviving the GRASE Concept for Drugs

Abstract

The cost of getting a new drug to market was estimated at $802 million in 2003, and more recent estimates have placed the cost at $1.3 billion and $1.7 billion. Making the commercial drug development process even more difficult, the time from initial development to use of a drug for patient treatment can be fifteen years. This expensive and time-intensive process produces many undesirable side effects including a low incentive to develop drugs for diseases primarily affecting the poor and competition from foreign countries with quicker approval processes. A partial solution may be found in § 321(p)(1) of Food, Drug, and Cosmetic Act, which could save certain drugs from the costs associated with the New Drug Application (NDA) required by the Food and Drug Administration (FDA) to get a new drug to market. The statutory provision applies to drugs that are “generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed.” Drugs falling within this provision have been referred to as “generally recognized as safe and effective,” or GRASE for short. The GRASE provision provides a mechanism to get these kinds of drugs to market more quickly. Despite the potential cost and time-saving benefits of GRASE, the standard for getting a drug designated as GRASE has been set so high that the provision has fallen out of use. The current GRASE system is broken and needs fixing. This Note presents previous proposals for lowering the cost and time requirements of FDA’s drug-approval process, concludes that the GRASE concept should be revived, and argues that a GRASE Notification System should be implemented because this system could lower the cost associated with drug development.