Nowadays the flow of international trade is that there seems to appear economic block significantly because most countries contract FTAs, so our market condition is changing to a severe competitive situation. Korea which has 70% of foreign dependence of trade must get involved in regionalism, and also actively promote FTA more than any other countries. FTA on February in 2006, the pharmaceutical industry are anxious. The pharmaceutical industry in Korea has recently come to a crisis that it is hard to expect a growth due to structure of profit and a change for the worse of management. If Korea-U.S. FTA are contracted in this kind of situation, domestic pharmaceutical companies will be at stake. We can anticipate that FTA with the country that has a strong competitive power like U.S. affect negatively on pharmaceutical industry, because the industry doesn't have enough self-competitiveness. Considering this kind of surroundings, we need to present the policy to enhance competitiveness for damage limitation on pharmaceutical industry by Korea-U.S. FTA. Under this background, this research has groped for a direction to strengthen the competitiveness to develop pharmaceutical industry in quality. The competitive enhancement plan is presented which is divided into the government policy part, the R&D part, and the management part. Although Korea-U.S. FTA is analyzed to wither the pharmaceutical industry, it would be thought that it is a good chance to upgrade domestic pharmaceutical industry if we make the best use of it, and also to make in roads into foreign market.