Massive Chinese Recalls, but FDA Silent Over RU-486 Chinese Manufacturers
By Peter J. Smith
WASHINGTON, D.C., July 26, 2007 (LifeSiteNews.com) - For weeks the US Food and Drug Administration has been warning the American public about tainted Chinese imports of contaminated pet food, poisonous toothpaste, and an outbreak of botulism. However the federal agency has failed thus far to issue warnings over the possible contamination of RU-486, a chemical abortion pill made exclusively in China, which has led to at least 6 documented deaths in North America and hundreds of severe adverse effects in women.
As the Chinese scandals began to unfold, pro-life Congressman Chris Smith (R-NJ) and co-chairman of the Bipartisan Pro-life Caucus called on the FDA to investigate Danco, a company established in the Cayman Islands solely for the purpose of selling its only product, RU-486, in the United States. Smith wanted to ascertain its relationship with the Shanghai based manufacturing company, Hua Lin Pharmaceuticals.
"As the serious problem with tainted products coming out of China becomes more clearly evident and the deadly effect of RU-486 on women’s lives also becomes more increasingly evident, I ask that you take a serious and comprehensive look at the companies involved in the marketing and manufacture of RU-486," stated Rep. Smith in a July 3 letter.
Smith’s concerns were publicly validated barely a week after his letter, when the Chinese State Food and Drug Administration (SFDA) ordered Hua Lin to suspend its sale of Methotrexate, a cancer drug also used off-label by abortion clinics as a chemical abortifacient, for possible taint after receiving complaints of severe side-effects.
The SFDA has been reeling from widespread corruption and scandal in its ranks. The former SFDA head, Zheng Xiaoyu was executed this May on corruption charges, and the SFDA reports that it may take at least 5 years to clean up the morass of false and deficient drugs approved by Zheng’s administration. The Chinese government has also revoked the production licenses of five drug makers over the last year and penalized 128 others.
Smith’s letter to the FDA pointed out that Hua Lin, the manufacturer of Mifepristone or RU-486, has had a history of violating US health regulations. He cited two FDA visits to Hua Lin manufacturing sites in 1999 and 2000 revealing "serious problems including possible mixing of fresh materials with waste material barrels and use of impure source ingredients." The FDA also revealed back in 2000 that Hua Lin had a decade of violating US regulations before approving the drug that year.
Wendy Wright, President of Concerned Women for America, which has vigorously protested the FDA’s abandonment of its typically rigorous standards to approve RU-486 and now Plan-B "emergency contraception," told LifeSiteNews.com that a number of officials in the FDA have a mindset that "it’s better to have this on the market because women are at greater risk of getting pregnant than they are of dying from this product."
"If the FDA treated RU-486 like any other drug or food product then it would need to pull RU-486 from the market," said CWA’s Wright. "One problem is that RU-486 and abortion overall is treated with a greater preference by government officials than almost anything else."
"I think if most women customers were told outright that there is a risk of dying from this product… they would probably not use that product," said Wright. "But instead with the FDA’s stamp of approval women are assuming that the drug is safe and effective."
Representative Smith spoke with LifeSiteNews.com about his struggle to get the FDA to reconsider its negligent approval of RU-486 for woman.
"Most Americans would be shocked that this dangerous baby pesticide is being brought in from China by a company incorporated in the Cayman Islands," said Smith. "I mean that has fraud written all over it."
"The Population Council has the rights to [RU-486] in the United States. It’s a non-governmental organization without the deep pockets of a Merck or a Johnson and Johnson, so when women get harmed or die whom do you sue? Danco, a company in the Cayman Islands?" continued Smith saying it was "exceedingly hard" for injured women or dead women’s survivors to take legal action. Smith called the over 600 severe adverse effects and 6 deaths recorded by the FDA just "the tip of the iceberg" since no effective monitoring system for RU-486’s effect on the general population is in place. (see related: https://www.lifesitenews.com/ldn/2006/jan/06010301.html)
"Sham trials brought it here in the first place," Smith said, noting that FDA standards were sacrificed in order to fulfill the Clinton administration’s priority of bringing RU-486 to the United States.
"We’re going to keep pressing the FDA for some answers," said Smith. He has requested the FDA to send him a history of documentation from its first approval process of RU-486 by August 2. Smith said that if he has no answers from the FDA after August 2, he plans to ratchet up the pressure for the FDA to look into health concerns over the deadly abortion pill.
See related coverage by LifeSiteNews.com:
FDA Reveals 607 Adverse Events Related to RU-486 Abortion, Including Five Deaths
Two More Women Die After Medical Abortion with Abortion Pill RU-486, FDA Warns