China gets another pass as FDA bans Indian drugs
Believe it or not, I'm about to praise my old adversaries at the FDA you might want to mark the date, because this happens about as often as a lunar eclipse or Haley's Comet. Why the pat on the back for my least favorite government bureaucracy? They've finally made the right call about questionable generic drugs produced in a certain country in Asia
They've banned them.
You're probably assuming I'm talking about is China. Unfortunately, that country is continuing to get away with murder. The country I'm talking about is India.
The FDA banned imports of more than 30 generic drugs produced by Ranbaxy Laboratories, Ltd., India's biggest pharmaceutical manufacturer. U.S. inspections of these plants from earlier this year found multiple violations that could cause contamination, allergic reactions, and other issues - yet the company didn't bother to correct ANY of these problems.
The drugs banned include generic versions of the well-known antibiotic Cipro and the cholesterol medication Zocor. The FDA even went as far as to ban pharmaceutical ingredients produced in these plants.
The FDA has taken a hard line here: it won't approve any new Ranbaxy products for import or sale in the U.S. until the violations are corrected.
This story leads me to one obvious question: why has the FDA dropped the hammer on India's Ranbaxy Labs while Chinese drug makers get a pass? And don't forget - the FDA enacted this ban because conditions in the Indian plants could lead to issues with the drugs. Meanwhile, the FDA only issued a warning to a Chinese pharmaceutical manufacturer that was responsible for tainted batches of the blood thinner heparin that was linked to 81 deaths in the U.S.!
What's more, the drugs from the suspect Ranbaxy plants have been tested repeatedly, and no evidence of actual contamination has been found.
To be fair, the reason that the FDA is playing hardball with Ranbaxy - and I'm completely behind them on this - is because there's an ongoing criminal investigation of the company because they're suspected of submitting fraudulent reports in order to slip substandard drugs into the U.S. Naturally, Ranbaxy denies this allegation.
But something stinks about this. A report from 2007, which I've mentioned before, said that as many as two thirds of foreign drug makers have not been inspected by the FDA in person. If the FDA is genuinely concerned - and this isn't a game of international trade "chicken" - why isn't the agency warning patients in the U.S. to stop using the drugs?
And again, I come back to China. Many Chinese goods - including pharmaceuticals - are notoriously sub par, tainted, and often downright deadly. But I've not seen a Ranbaxy-like ban applied to any Chinese pharma companies. Why?
I hate to think the worst, even of the FDA. But there's a longstanding tradition of corruption in China, and it makes me wonder if there's something unsavory going on between U.S. inspectors and Chinese pharma companies that allows their bad products to avoid an out-and-out ban in the U.S. Clearly, there are problems with the system.
According to Rep. John Dingell, D-Mich of the House Energy and Commerce Committee, "The FDA is not doing its best to protect the medicines that Americans depend on for their health."
Does that lament sound familiar?
New report reveals more bad news about water bottles
I've written to you before about BPA (bispenol A), the chemical found in food cans, baby bottles, dental fillings, and all manner of plastic bottles. The FDA has essentially ignored as many as 700 published articles that question the substance's safety - and they don't show any sign of backing down anytime soon. Now they've flagrantly ignored a report published by the National Toxicology Program, a division of the FDA's sister agency, the Department of Health and Human Services. This report claims, once again, that BPA could be incredibly harmful.
BPA is suspected of being harmful to fetuses, infants, and children because it mimics human estrogen and can cause disruption of the endocrine system. Apparently, amounts of the chemical similar to those that people are exposed to, have caused brain, mood, and memory disorders in monkeys. (Some of them are so depressed they've climbed trees and refused to come down)
But seriously - this problem is incredibly widespread. Traces of BPA are found in 93 percent of Americans. So if this stuff is really as deadly as it's suspected, we're all in big trouble.
But the FDA doesn't feel that way. They're OK with taking the word of the BPA manufacturer's that the product is perfectly safe. Doesn't that make you feel good?