줄기세포기반치료에 대한 미국의 규제 경향 고찰

Abstract

Stem cell-based therapy is a method using biological products based on stem cell in order to treat and prevent diseases. When FDA tries to apply its traditional regulations of drug market approval to the stem cell-based therapy, there’re different views on it according to the unique characteristics of stem cell-based therapy itself. The balancing test between expedited application to the patients and securing safety for them should be conducted properly. Even though the federal courts concluded that stem cell-based therapy should be the subject of FDA’s traditional regulation on drug market approval, the profit clinics that are conducting autologous stem cell therapy without getting market approval from FDA are increasing and FDA does not execute its regulatory power on them. This is because the commingling of public interest for expedited application to the serious condition or life threatening disease patients and securing safety and efficacy of stem cellbased therapy. To resolve these issues, FDA have conducted expedited programs for long time without going through all the procedures that the traditional FDA market approval required. The use of accelerated approval, fast track, breakthrough therapy designation is decided after clinical trial phase II is completed. The use of expanded access or compassionate use can be decided to the terminally ill patients after clinical trial phase I is completed. The right to try laws in the State level can also decide the use of stem cell-based therapy after clinical trial phase I is completed. All the expedited programs in the U.S. are administered in the level of statutes. In Korea, the Supreme Court concluded that stem cell-based therapy is drug and can be applied to the patients after MFDS’s traditional drug market permission. The same MFDS’s traditional drug market permission is required for cell therapy as biologics to the patients. The expedited program like fast track is also allowed. However, all these pathways are provided on the level of agency rules not the level of statutes. However, expanded access or compassionate use is only stipulated in the statute. We should prepare expedited programs like those of the U.S. on the level of statutes to guarantee both the pharmaceuticals and the patients all together.