FDA warns Merck to fix vaccine plant problems

[Celebration]

yikes.........

http://news.yahoo.com/s/ap/20080430/ap_on_bi_ge/merck_fda

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 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.

In a separate posting on its Web site, the agency said it issued the warning letter because Merck's response to the FDA report sent after the inspections was "inadequate to address the serious deviations noted."

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.

[mzmolly]

1. Gosh, given they are so concerned about public health above profit

this is shocking news! :sarcasm:

The letter also said the plant didn't have written procedures, tests or other laboratory controls to ensure "identity, strength, quality, and purity" of products.

Now doesn't this go against everything a certain "lab tech" asserts every time this subject rears it's head? Hmmmmm, how long have they been making vaccines again?

[mzmolly]

2. dup sorry.

[mzmolly]

3. Here's another article noting 49 safety issues.

http://consumerist.com/384688/fda-report-cites-49-safety-issues-at-merck-vaccine-plant

Thanks for posting this IJM. :hi:

[chicagomd]

4. But, but, but...

Doesn't Merck just pay off the FDA? I thought they were all in bed together to massively defraud the American public.

It looks like the FDA is actually doing its job. Shocking.

[Celebration]

5. heh

But how long has this been going on? The people at the FDA are of two minds. One mind is to placate the pharmaceutical companies to the greatest extent possible in order to facilitate switching job positions into the more lucrative private industry. The other mind is to promote public health. There is an ebb and flow of these two forces, based on many factors. In any case, the most egregious faults are addressed eventually, especially when potential whistleblowers threaten to surface. The FDA gets their actual funding from pharmaceutical companies, which is a conflict of interest by anyone's definition.

But, of course, there are many people at the FDA, in the front lines, that are genuinely interested in our public health, and I salute them. But there are also institutional forces that seek to keep their voices as quiet as possible. It is interesting to see these two forces clash, and how that plays out.

The system has been taking some major hits lately, most likely causing the tidal force to turn more towards protecting the public.

[mzmolly]

7. Agreed IJM

we may see more of this sort of thing in the future?

[mzmolly]

6. Democrats have been working on legislation to address some of the issues

and the focus on this issue may be having an impact?

[trotsky]

8. Gee, why did you stop quoting where you did?

Maybe because the very next line was:

However, in the Web site posting, the FDA said it "does not believe that the issues identified will affect the safety of the vaccines" made at West Point, or their availability.

Naw, much better to take the FOX News / sensationalist angle and try to scare people. It's second nature for the evidence-based medicine-hating crowd.

Seems to me, as chicagomd pointed out, this is a nice counterexample to the constant drumbeat of "FDA in the pocket of big pharma" that's usually found in this forum. So thanks for showing there are indeed safeguards, and that the FDA has the power to correct faults.

[Celebration]

9. Because of posting limits?

Wish I could have posted the whole thing. In any case that paragraph was several below where I stopped posting.

Also, I thought scientific evidence trumped "belief." If there was contamination visible to the naked eye, I am not sure I would put my trust in "belief" that the safety of the vaccines was not affected.

The FDA certainly is threatening strong action if they are producing 100% safe and pure vaccines.

[mzmolly]

10. Yes, suddenly it's enough to "believe" in the integrity of vaccines.

So much for that science stuff huh?

Then again the blind faith is not so sudden is it? ;)

[xchrom]

11. great example of the fda doing it's job. nt