NurseWeek

Chinese plant to make RU-486 for U.S.

By Pamela Wiley
Health24News
October 15, 2000


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Washington (H24N). Two weeks following the controversial Food and Drug Administration (FDA) approval of the abortion drug RU-486, a factory in China has been designated as the drug’s production site. The identity of the manufacturer was previously guarded due to initial concerns about the security of its employees.

The Shangai-based Hua Lian Pharmaceutical Co., with the help of the Rockefeller Foundation, secured its production license after a lengthy and thorough FDA inspection of its facilities.

The pharmaceutical company, established in 1939, has been manufacturing mifepristone, or RU-486, tablets and capsules since 1993. According to the Shanghai Institute of Planned Parenthood Research, the drug has been distributed in China for years and has been used in half of the country’s 10 million annual abortions.

Mifepristone, commonly referred to as RU-486, has prompted medical and ethical debate. Created in 1980 by French physician Etienne-Emile Baulieu, the drug was named after the pharmaceutical company, Roussel Uclaf. The 486 refers to a serial lab number. Used in combination with prostaglandin, the drug has been responsible for approximately 500,000 abortions in Europe over the past two decades.

Even though the drug received approval last year in Austria, Belgium, Denmark, Finland, Germany, Greece, Netherlands and Spain, pressure from American pro-life groups caused the FDA to ban its importation. In June of 1998, the U.S. House of Representatives passed a bill barring the drug’s approval, but it was never signed into law. Sept. 28 of this year, the FDA approved RU-486, nicknamed the French death pill by its foes. (See related story.)

Those aligned with various pro-choice groups defend RU-486 in particular for women in developing countries, where medical facilities make conventional abortions dangerous. They say it makes for a less invasive, non-surgical procedure, and is used very soon after conception, before the embryo develops human characteristics.

Pro-life advocates usually cite religious regions for their opposition, deeming abortion as murder. Using RU-486, which usually involves only non-surgical visits to a physician, would also remove some abortions from the emotionally charged clinic atmosphere where pro-life supporters picket. Some opponents also find irony in the fact that RU-486 is being manufactured in a country that prohibits demonstrations and allegedly practices coercive abortions in the name of population control.

Despite the continuing controversy, the U.S. drug distributor Danco Laboratories plans to import RU-486 from Hua Lian and have it commercially available by month’s end.