imports

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?

How will you be affected by the latest FDA mix-up?

Even I've grown tired of hearing myself beat on the U.S. Food and Drug Administration (FDA). Believe me, I'd like to lay off these guys, but they keep making the gaffes that make me nuts. And I feel compelled to pass this info on to you because everyone should know that the government agency that's allegedly responsible for protecting is often, well out to lunch.

And this time, it's a big screw up.

The good news is that FDA officials were in China to look into the safety of a Chinese-made drug that's found in heparin, a blood thinner made by Baxter International, that's been linked to four deaths due to allergic reactions. The bad news? They actually evaluated the wrong factory.

The next time you reach for your prescription bottle, remember that it's been approved by the Keystone Kops.

Instead of inspecting the suspect manufacturer, the FDA confused it with another company in the agency's database that has a similar name. Worse still, even though they THOUGHT they had the suspect company, the company that they were inspecting had a history of positive inspections SO THEY DIDN'T RE-INSPECT IT. You can't make this stuff up, unfortunately.

After discovering the error a month after the fact, the FDA immediately dispatched investigators to the suspect company.

Keeping in mind that there are over 2,000 characters in written Chinese and who knows how many dialects of that language, I'm inclined to say that it was an honest mistake for Western bureaucrats to get a little mixed up with the name of a Chinese company. Given all the recent news stories about shoddy and potentially deadly products from China that have been finding their way into America, it's hard to believe that the FDA wouldn't check and triple check the DRUGS coming from the same place-ESPECIALLY when the ingredient in question could possibly be linked to DEATHS.

In my opinion, the U.S. government should have immediately banned ALL Chinese imports the second the first tube of poisoned toothpaste was discovered. But of course, that would cost big business too much money. And you know that Big Pharma has repeatedly assured their friends in the FDA that the Chinese companies who supply many ingredients to for Big Pharma's vastly lucrative drug brands (at cut-rate prices) are surely on the up-and-up.

So of course the FDA had no need or desire to do the most logical thing: RE-INSPECT EVERY SINGLE CHINESE DRUG PLANT THAT EXPORTS INGREDIENTS TO THE U.S. And to halt the sale of drugs containing those ingredients until, in the case of heparin, the source of the allergic reactions that caused the deaths could be determined.

Am I nave to think that the government agency charged with the inspection of drugs sold in the U.S. should do their job? To be fair, the FDA did tell physicians across the country to immediately cease the use of the Baxter's brand of heparin, which has had as many as 350 reported cases of side effects in just 2008 (there were 100 reported cases last year). And Baxter has recalled nine lots of the injectable drug and stopped production while the source of the allergic reactions is investigated.

But like so much with the FDA and Big Pharma, the measures are just temporary and don't go far enough. I write so many negative things about the FDA and Big Pharma that you may get the impression that I think they're out to harm people. I know that's not the case. And I'm not at all surprised that both the FDA and Baxter International have done the right thing and brought an immediate halt to the distribution and manufacture of heparin while these lethal side effects are investigated. What bothers me is that, because of money, they won't take the logical next step which - to my mind - is to stop the use of Chinese drug imports as ingredients in drugs sold in the U.S.

I don't believe the Chinese can be trusted to follow safety regulations that are up to U.S. standards. Plain and simple. This country has exhibited a complete disregard for the safety of the drugs, food, and goods distributed within their own country - why should we expect them to have a higher standard for good meant for export?

The global economy is likely to be a dangerous economy. We need to hope and pray that our government is on its toes. If the FDA is going to allow the import of drugs from China, they need to watch both the Chinese and the U.S. drug manufacturers very, very closely. There's a great deal of money at stake, but patients within the American health care systems shouldn't become victims of a growing economy.

Unfortunately, this is the FDA we're talking about. I know that they don't always make the right decision. Now I'll always be wondering if they're even in the right place at the right time.