This year the U.S. Food and Drug Administration (FDA) is marking the anniversary of the Kefauver-Harris amendment, passed 50 years ago. The legislation gave FDA weight to require drug manufacturers prove their products were safe and effective before receiving approval to market them in the U.S. Before the amendment, drugs could be sold 60 days after companies filed with the FDA, if the agency did not object, and drug manufacturers routinely sent new medications to doctors asking them to ” try them out ” on their patients. The amendment has its roots in then-FDA medical officer Frances O. Kelsey’s refusal to approve Kevadon (more commonly known as thalidomide) for morning sickness during pregnancy. Thalidomide was later shown to cause serious birth defects. Senator Estes Kefauver of Tennessee and Representative Oren Harris led the effort to pass the amendment. Read more.
FDA marks 50 years of Kefauver-Harris amendment
*Online Bonus Content: This has not been peer reviewed. The views and opinions expressed here are those of the author and do not necessarily reflect the opinions or recommendations of the American Nurses Association, the Editorial Advisory Board members, or the Publisher, Editors and staff of American Nurse Journal.
Get your free access to the exclusive newsletter of American Nurse Journal and gain insights for your nursing practice.NurseLine Newsletter
*By submitting your e-mail, you are opting in to receiving information from Healthcom Media and Affiliates. The details, including your email address/mobile number, may be used to keep you informed about future products and services.
