Planned Parenthood Calls on FDA to Ensure Continued Patient Safety
Joins Rep. Waxman (D-CA) in Calling for More Information
New York — Planned Parenthood Federation of America (PPFA), the nation’s leading reproductive health care provider and advocate, joined Rep. Henry Waxman (D-CA) today in asking the U.S. Food and Drug Administration (FDA) to share their plans for continuing to ensure the safety of drugs manufactured by Shanghai Pharmaceutical Group for the United States. The New York Times reported last week that Shanghai Pharmaceutical Group, and its subdivision, Shanghai Hualian, are under investigation for producing tainted leukemia drugs in China. Reports indicate that these drugs were not imported into the United States and that no other drugs produced by the company have been found to be faulty. Among the many drugs produced by Shanghai Hualian is mifepristone, one of two drugs used in medication abortion.
“The FDA is charged with protecting the safety of the American drug supply. As a patient advocate for more than 90 years, Planned Parenthood joins Rep. Waxman in urging the FDA to fully inform the public about how it has ensured and will continue to ensure drug safety,” said PPFA President Cecile Richards. “With more drugs produced internationally, the American public needs reassurance that the FDA is closely monitoring facilities at home and abroad, and Congress and the administration must provide adequate resources to the FDA to ensure continued high standards.”
As chairman of the Committee on Oversight and Government Reform, Rep. Waxman has asked the FDA to provide more information on all FDA-approved facilities owned and/or operated by Shanghai Pharmaceutical Group.
“For 91 years, Planned Parenthood has closely monitored patient experiences to ensure the highest standard of care at our health centers,” added PPFA Vice President of Medical Affairs Vanessa Cullins, M.D. “We, along with the rest of the public health community, look to the FDA to ensure that all drugs entering the United States are safe and effective. We expect the FDA to fulfill its mission and provide information on and assurances for continued monitoring in the upcoming briefing with Rep. Waxman.”
According to The New York Times, Shanghai Hualian is the sole manufacturer of mifepristone. As the nation’s most trusted reproductive health care provider, Planned Parenthood Federation of America is reassured that the plant recently passed inspection by the FDA in May 2007. FDA officials have stated that the facility that manufactures mifepristone is not linked to the problems at the facility that makes leukemia drugs.
February 04, 2008