FDA warns Merck to fix vaccine plant problems

[UpInArms]

Source: Associated Press

TRENTON, N.J. - The Food and Drug Administration has ordered Merck & Co. to correct numerous manufacturing deficiencies at its main vaccine plant, the latest in a string of setbacks for the drugmaker.

The agency on Wednesday released a warning letter sent to Merck's chief executive, Richard T. Clark, that states FDA inspectors determined manufacturing rules are not being followed at the plant in West Point, Pa., just outside Philadelphia.

The plant, which recalled two vaccines in December over sterility problems, makes a number of children's vaccines and four for adults.

The nine-page letter states FDA found "significant objectionable conditions" in the manufacture of vaccines and drug ingredients during repeated inspections from Nov. 26 to Jan. 17.

<snip>

According to the heavily redacted warning letter, Merck officials didn't thoroughly investigate when vaccine batches inexplicably failed to meet specifications, even if batches had been distributed, and some combination measles-mumps-rubella shots that failed "visual inspection for critical defects" were distributed anyway.

Read more: http://news.yahoo.com/s/ap/20080430/ap_on_bi_ge/merck_fda?_ylt=Ajsq0mD3Zf4F0FAxv9wgreWb.HQA

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note to Mods: This article is about 2 hours past the 12 hour limit, but I thought it should be seen regardless as it is not being adequately covered in the media.

[Phred42]

1. How bad does it have to be to force the "BUSH" FDA to step in?

This is an example of the failure of Conservative Ideology.

If the CEO and Sr Staff at Merck had a conscience between them, it wouldn't have gotten so bad that even the Bushies had to do something.

[glowing]

3. Great point.. Bushes FDA really doesn't do much regulating..

your right.. must be really bad if they are stepping in.

[glowing]

2. and vaccines are safe.

[Robb]

4. And that's a major concern

Public perception of vaccines not being safe will hurt far more than this potential contamination might've.

This needs to be fixed, and fast.

[bronxiteforever]

5. Great point!

[glowing]

7. How many people were adversly affected by the vaccines that made the

FDA step up and take action? Did you know that if they are mandated vaccines, then you cannot sue the vaccine maker.. Where's the checks and balances?

[ekwhite]

6. Here is my take on the warning letter

I work for a pharmaceutical company not involved with Merck in any way, so I have a small amount of knowledge in these matters.

Hundreds of warning letters are issued each year by the agency. What IS important is the content of warning letter, and this one is ugly. From my read, it shows a consistent and sustained failure of Quality Assurance and Quality Control in the vaccine facility.

My take is that this warning letter, if not corrected immediately, will lead to a consent decree - a legal agreement requiring them to undertake certain corrective actions to continue to manufacture product. The corrective actions typically require release of the product by an independent third party, hired by the company, that is required to report regularly to the agency the status of the corrective actions. This will most likely cost Merck millions in dollars, both in payment for the third-party auditor, and in the cost of the corrective actions.

Here is a link to the content (http://www.fda.gov/foi/warning_letters/s6756c.htm).

[AnneD]

8. That was my take on it too...

they are in deep doodoo.

[doodadem]

10. You have to wonder

Merck has laid off a bunch of their QA staff in the past few years (I've gotten them as candidates). You have to wonder if that's why quality is falling thru the cracks.........

[InsultComicDog]

9. I live so close to that plant I can walk to it

It's about a mile from here.

From my own perspective I am concerned about their disposal practices, but that's not even mentioned here.

[ekwhite]

11. That could be a concern

Doesn't that plant make all kinds of pharmaceuticals, not just vaccines? Some of the chemicals they are using could be extremely hazardous, depending on their processes.