June 26, 2000
RU 486 may be less available due to tough FDA restrictions
___WASHINGTON (BP)--The abortion drug commonly known as RU 486 continues to move toward introduction into the United States, but its advocates fear recently revealed rules tied to its approval by the Food and Drug Administration may severely restrict its use.
___The FDA has proposed the abortion drug be approved with the following guidelines, according to a June 7 report in the Washington Post:
___There would be a national registry of all physicians who prescribe RU 486.
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___If the FDA's proposed guidelines are approved, they apparently would dramatically restrict the number of doctors who would prescribe the drug. For one thing, the process would not be nearly as secretive as abortion rights advocates had expected.
___"What the FDA is talking about would so violate physicians' privacy and security concerns that (RU 486) could be approved by the agency but never really be on the market," said Planned Paretnhood Federation of America President Gloria Feldt.
___Population Council spokeswoman Sandra Waldman told the newspaper the FDA proposals "are more restricted than we expected." The Population Council is a New York-based, non-profit group that holds the patent to the drug.
___News of the FDA's proposed guidelines came after a representative of the Danco Group, a New York pharmaceutical company arranging for manufacture of the drug, revealed them at a June 2 meeting of abortion rights advocates.
___The Danco representative said the proposals had arrived in a letter from the FDA the previous day.
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