[20180330]LSB10115_联邦“审判权”立法：法律考虑因素 .pdf

CRS INSIGHT Prepared for Members and Committees of Congress Legal SidebarLegal Sidebari i Federal “Right-to-Try” Legislation: Legal Considerations March 30, 2018 Congress has been engaged in a vigorous debate over how patients with life-threatening conditions may access investigational therapies that have not been approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act). At the heart of this debate is the balance between permitting sufficient access to experimental medications for patients who lack other treatment options and obtaining adequate evidence of safety and effectiveness for these products. This debate is nothing new, and state and federal lawmakers are currently addressing this issue through so-called “right-to-try” laws. The general intent behind right-to-try laws is to create a pathway for such patients to obtain speedy access to experimental treatments, without clinical trial participation or the Food and Drug Administrations (FDAs) permission. Thirty-eight states have passed right-to-try laws, and Congress is now considering a similar mechanism at the federal level. The merits of right-to-try laws are contested. Supporters claim that these laws are a benefi