End Mifepristone Distribution Restrictions: Authors
After two decades of actual use of mifepristone to end early unwanted pregnancies, additional research, and a comprehensive review by the National Academies of Science, Engineering, and Medicines, there may no longer be a need for the distribution restrictions that were imposed when the drug was first approved in 2000. That’s the opinion of Jane Henney, the first woman to be FDA commissioner, who was in office when the drug was approved, and Helene Gayle, CEO of the Chicago Community Trust, who headed the National Academies review of mifepristone.
Writing in the New England Journal of Medicine, they say that the years of experience with the drug indicate that it is extremely safe and effective. “Since its approval in 2000, more than 3.7 million women have used mifepristone to end an early pregnancy in the United States,” they write. “It is approved for use up to 70 days into a pregnancy. Nearly two decades of data on its use and effects on patients provide significant new insights into its safety and efficacy. Mifepristone is more than 97% effective. Most adverse effects are mild, such as cramping or abdominal pain, and the rate of serious adverse events is very low: such events occur in less than 0.5% of patients, according to FDA. Many drugs marketed in the United States have high adverse event rates and are not subject to restricted distribution…. The accumulated knowledge about mifepristone strongly suggests that the current restricted distribution system is not aligned with the limited risks that are now known to be posed by the drug.”
Henney and Gayle say the National Academies experts recommended that FDA reconsider the distribution restrictions and note that the agency has approved clinical trials for alternative distribution models for mifepristone in the U.S.
“Recent media reports indicate that, as access to clinics that satisfy the FDA restrictions shrinks, people are increasingly turning to the Internet to source mifepristone on their own from foreign manufacturers,” the two write. “FDA cannot effectively control Internet sales, which are likely to grow further, nor can the safety of these foreign-sourced products be ensured. Women should have access to FDA-approved products whose safety and effectiveness are confirmed. Since the evidence available today indicates the current restrictions are overly prescriptive, we urge FDA to reevaluate whether they are still necessary.”