RU-486 Abortion Pill Is Made In China, After All
4 CommentsBy Ed Silverman // October 18th, 2007 // 3:22 pm
Yesterday, we wrote that Judicial Watch, a conservative group concerned with the nation’s morals, publicized documents indicating that RU-486, also known as Mifeprex, was made in China when it was approved in 2000 by the FDA. What was the point? Concern over the safety of products made in China these days, and medicines have been no exception. So the group, which opposes abortion, was using this info to raise fresh doubts about the pill. But there was nothing to say the pill is still made in China. And Danco Laboratories, which sells RU-486, declined to comment one way or the other.
Today, however, is another day and, sure enough, more documents emerge. And these indicate that the pill was being made in China as recently as last spring, when the FDA inspected a Shanghai Hua Lin Pharmaceutical manufacturing plant. Turn to page 8 and you’ll see the documents refer to active pharmaceutical ingredients used to make mifepristone, NDA 20687, which is new drug application number assigned the pill, as you can see by looking at the FDA web site (mifepristone is the chemical name for Mifeprex).
Does this really matter? All manner of products, including other APIs, continue to be made in China. Drugmakers are doing more business there all the time. And there’s nothing to suggest there are any manufacturing issues with the pill. In fact, the documents indicate the plant passed the FDA inspection. Nonetheless, Judicial Watch is adept at generating headlines and is clearly trying to create still more controversy, beyond any ongoing moral debate over the use of the pill. The real issue is whether the public will care. Right now, that’s unclear.
Atlex
It is worth pointing out that, unlike toys, pharmaceuticals meant for the US market must come from plants that have been inspected by the FDA. This doesn’t mean that everything is perfect, but there is some scrutiny to ensure GMP.
Ed Silverman
Hi Atlex,
Good point. In this case, as mentioned, the manufacturer did undergo FDA inspection and passed, which I noted in the post. But it never hurts to reiterate that. Thanks.
Regards
ed at Pharmalot
Jack
Ed,
Didn’t you say in your last post on this that the API was made in a plant that failed an inspection in 2001-ish? Either way, color me indifferent.
Ed Silverman
Hi Jack,
Yes, I believe in 1999-2000 time frame, there were difficulties. More recently, the documents indicate the plant making the APIs passed.
Cheers
ed at Pharmalot