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An American woman, Leona Beneten challenged the FDA ban when the U.S Customs
seized the drug from her while returning from Europe in 1992; but the US Supreme
Court denied the FDA to overrule the ban and refused to listen to her case.
A second hearing
During his administration, President Clinton inferred and asked the FDA to re-examine
the ban; thus a new application for RU-486 was submitted. Clinical trials were then held
involving 2,100 women after the French company passed the patent rights for RU 486.
In 1996, the FDA officially approved RU-486 as an effective and safe early pregnancy
termination method along with the use of the second pill misoprostol to expel
pregnancy parts.
Further delay
Even though the FDA approved the pill in September 1996, they noted that further
experimentation and tests were required before its manufacturing and labeling
process. In February 1997, the European drug manufacturer cancelled its contract with
the U.S Population council further delaying its introduction in America.
Additionally, an amendment to a bill was passed that banned the FDA from holding
trials and approving any abortion medication in 1998. In the same year, the Clinton
administration opposed this bill and the ban was deleted.
In February 2000 the FDA postponed the approval of RU 486 until queries about its
manufacturing and distribution were solved. Finally, in the same year, it was approved
as a safe and efficient way of early pregnancy cancellation within 49 days and was
officially introduced in the U.S.
Since its acceptance, control over its access is incredibly eased. You can easily buy RU
486 online or at a local drug store with a doctors prescription, a stark difference
compared to the situation decade earlier.