A top Republican lawmaker raised new questions on Wednesday about whether U.S. officials thoroughly investigated the Chinese firm that is manufacturing the abortion pill for export to the United States.
In a letter to the Food and Drug Administration (FDA), House Commerce Committee Chairman Thomas Bliley said evidence "suggests the FDA did not fully explore the background and conduct" of the manufacturer of the pill, known as RU-486 or mifepristone.
Bliley said documents the FDA provided to the committee showed a history of manufacturing irregularities and misstatements by the maker, Shanghai's Haulian Pharmaceutical.
Among them, the company, previously known as Shanghai Pharmaceutical Factory £12, was identified by a 1998 California Health Department study as shipping a traditional Chinese medicine that was contaminated with an unapproved drug.
Bliley, a Virginia Republican, said FDA officials told his staff that the company's past record was not relevant to its current manufacture of mifepristone. The agency has said repeatedly that the supplier of mifepristone to the United States meets all U.S. manufacturing standards.
But Bliley said what he learned about the company's history "may call into question the integrity" of FDA's approval of mifepristone, which was announced Sept. 28.
"I am astonished by FDA's inability, failure and disinterest in investigating certain information" about the company, Bliley wrote to FDA Commissioner Jane Henney.
An FDA spokeswoman said the agency was preparing a response to a letter Bliley sent last month about the abortion pill's approval and would review the new letter. The agency has refused to publicly disclose the manufacturer, citing concerns about anti-abortion violence, but media reports later identified it.
The approval has been politically controversial, with abortion opponents denouncing the decision and trying to curb its use. Pill supporters say they hope it will give women more access to abortion and more privacy in ending a pregnancy.
Private company Danco Laboratories will distribute and market the pill in the United States under the brand name Mifeprex. It should become available to physicians shortly.