From Pre-Market Approval to Post-Market Removal The Implications of Lifestyle Drugs for the Regulation of Herbal Remedies

Abstract

Both a popular lifestyle drug and an herbal remedy have recently been recalled due to concerns of safety. In the wake of these recalls, reforms were proposed to strengthen the FDA's post-marketing enforcement powers and resources. The emphasis on post-marketing enforcement is not surprising as the effectiveness of pre-market approval is reaching its limitations for the markets of both lifestyle drugs and herbal remedies. Moreover, consumer conceptions of both markets are conceptually converging, requiring the need for more consistent regulations. The FDCA provides sufficient post-marketing enforcement power over lifestyle drugs, but not for herbal remedies. An enhanced regulatory regime for herbal remedies would have the additional benefit of addressing the intellectual property issues that have plagued the full development of herbal remedies.