The Prescription Drug Plan

Guest blogger today is Murray (aka Jack). I do not use this plan. This is his experience and actual correspondence trying to get answers from the FDA about foreign supplied prescription drugs. NB

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When the Prescription Drug Plan bill was being passed our government emphasized that it was against the law for people to purchase their drugs from outside the United States. In fact, just to prove their point, they started confiscating foreign drugs coming through the U.S. postal system. The Food and Drug Administration backed our legislators by declaring that the FDA could not assure anyone that drugs from other countries were safe. This was declared despite the fact that Canada had a better track record for drug safety than the U.S.

When I got my first shipment of drugs this year from my Prescription Plan Provider, lo and behold, they came from India. Now, how can that be? I thought. What's going on here? Does the law regarding foreign drug purchases only apply to individuals and not retailers and insurance companies? Are the drugs I would purchase be suspect, but somehow the drugs the retailers purchase would be safe? Anyway, I thought I would just ask the FDA what was going on. I would ask my congressman but he won't answer. Below are copies of my correspondence with the FDA :

Name: Jack Warner
E-Mail: Vivid@aol.com

The law states that it is illegal for me to purchase drugs from other countries because they may be unsafe. I just received my first shipment of drugs from my current Prescription D plan. The drugs came from India. Isn't this illegal? Isn't my Prescription D plan providers subject to the same law as I am?
Jack

FDA Response:

Jack,
Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research.

The prescription drugs provided by your insurance plan should be approved for use in the U.S. FDA approved drug products do not have to be manufactured here in the U.S. but as part of the approval process we inspect the manufacturing facility to ensure product quality. If you were to purchase drug products outside the U.S. from unknown sources you would not know under what conditions the drug is manufactured.

Best Regards,

BD
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

So they are implying that the drugs from India I received from my Plan are safe even though they don't know what the drugs are or what manufacturing facility they came from! Silly ole me thought they would want to know this before making such a statement. And as far as I'm concerned they did come from an unknown source. Anyway I fired this back at them:

From: Vivid@aol.com
Sent: Tuesday, February 19, 2008 6:27 AM
To: CDER DRUG INFO
Subject: Re: DrugInfo Comment Form FDA/CDER Site

So are you telling me that it's OK for me to purchase my drugs from another country as long as it's from a "known" source? A source that has been approved by the FDA? If so, how do I find these known approved sources?

How do I know for sure if the drugs that my insurance company is providing came from an FDA approved source? The drugs came from Zydus in India.

Jack

FDA Response:

Jack,
We don't approve manufacturing facilities. We inspect them to ensure compliance with good manufacturing practices. We inspect facilities of companies that have an approved application for their drug. You can look up your drug on our Drugs@FDA website, http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Best Regards,

BD
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

Now tell me, did the FDA dance around my questions? Ole BD could run for senator. I mean, he says inspect and I said approved ... big deal. He still didn't tell me whether or not drugs coming from Zydus in India were safe. Maybe after I die from them he will fess up! The web site he recommends only tells you what drugs have been approved and not what manufacturers have been inspected and cleared. So I sent the FDA this:

From:Vivid@aol.com
Sent: Friday, February 22, 2008 6:27 AM
To: CDER DRUG INFO
Subject: Re: DrugInfo Comment Form FDA/CDER Site

Has the FDA ever inspected the Zydus plant in India regarding the safe production of drugs that they ship to the United States? My Prescription D insurance company uses that source to supply me with my drugs. How else will I know if my drugs are safe unless you tell me?

Jack

FDA response:

Dear Jack:

Thank you for your message to the Center for Drug Evaluation and Research (CDER), one of the five centers within the Food and Drug Administration (FDA).

We do not have that information publicly available. If you are interested, the findings for each company's inspection can be found on their Establishment Inspection Report (EIR). You can request the company's EIR through the FDA's Freedom of information Office (FOI). These reports are not prepared specifically for public distribution, but are available upon a U.S. Freedom of Information Act (FOIA) request. You can find out more about this option and how to make an FOI request at http://www.fda.gov/foi/foia2.htm.

Sincerely,

Division of Drug Information

D202D

This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

So there you have it. The FDA, the consumer's friend, is not interested in where my drugs come from, is not concerned if they are safe and will not tell me if they have inspected the plant where they are produced. They tell me to research that myself and tell me to fill out a form and send it to the manufacturer to find out if the FDA has ever inspected them. Yeah right!

These are the same people that we are depending on to insure the drugs we take are safe! They can be trusted like you and I trust Congress to stop earmarks. Who are we supposed to turn to if we think our drugs are suspect? They never even asked me what the drugs were that I was concerned about and you can bet that they never checked out Zydus. I guess my Prescription D plan can send me drugs from anywhere when drug importation is supposed to be against the law.

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Here's an article in the Washington Post on this topic.

Companies based in India were bit players in the American drug market 10 years ago, selling just eight generic drugs here. Today, almost 350 varieties and strengths of antidepressants, heart medicines, antibiotics and other drugs purchased by American consumers are made by Indian manufacturers.

Five years ago, Chinese drugmakers exported about $300 million worth of products to the United States. Eager to meet Americans' demand for lower-cost medicines, they, too, have expanded rapidly. Last year, they sold more than $675 million in pharmaceutical ingredients and products in the U.S. market.

Now take a look at the inspections numbers and read this recent letter from the FDA to the Mayor of Duluth.

Remember Fido and Fluffy and the lead in the dental materials. Follow Murray's example and write your representative and the FDA.