Treating the FDA [Anthrax Vaccine can't ship]

Investor's Business Daily | October 24, 2001

[snopercod]

Anthrax: Worried about a shortage of the vaccine? Well, it’s not a market failure. Blame it on bureaucratic inertia and stifling FDA rules.

BioPort, the only U.S. maker of the anthrax vaccine, can’t ship what it’s made in the last three years. Its Michigan lab failed Food and Drug Administration inspections in 1999 and 2000. It’s not because there are problems with the vaccine, but because the FDA says BioPort didn’t meet packaging standards.

BioPort’s exclusive contract to supply the vaccine to the military is a factor as well. Other makers have no incentive to produce vaccines or develop new ones, leaving little, or none, available for civilians. After the military gets its share, it’s up to the government to decide who gets what’s left. Watching Congress run as soon as the anthrax scare hit leaves little doubt as to who would have priority.

Despite the hysterics on the Hill, there is some rational thinking in Washington. President Bush signed an order Monday that would help speed up the manufacture and storage of anthrax and other vaccines.

While the U.S. wrestles with its vaccine issue, Canada tried a little fascism to prevent shortages of Cipro, Bayer’s antibiotic used to treat anthrax. The government planned to ignore Bayer’s patent, tossing the German company’s intellectual property in the street – in effect stealing the research, development and capital Bayer invested to make a patented drug. A late agreement between the two averted a lawsuit.

Democratic Sen. Charles Schumer of New York publicly flexed his patriotism and urged the U.S. to also waive the patent. The White House initially flexed its respect for property rights and declined.

Now it says it might seek a waiver so it can get a cheaper generic.

It’s fortunate that anthrax infection isn’t - nor is likely to be - widespread. These steps to "help" will likely end in widespread shortages.

[snopercod]

It's way past time for Bush to clean house in some of these agencies.

[IRtorqued]

if putting new lot numbers on lots that failed is a packaging violation. barbarous acts of shadyism going on at bioport.

[callisto]

Indexing for Anthrax_Scare_List
To find all articles tagged or indexed go here:
OFFICIAL BUMP(TOPIC) LIST
and then click the Anthrax_Scare_List topic to initiate the search! !

[snopercod]

Can you back up those allegations?

[TXFireman]

I think it's great to clean house but when it does become available do not make it mandatory

[IRtorqued]

yes

[snopercod]

I hope Upton Sinclair, the socialist muckraker who wrote The Jungle, is rotting in hell.

[aristeides]

Can we buy anthrax vaccine from Russia? When do we start mass production of the anthrax antitoxins now under development?

[historian1944]

The Russian Gov't offered as much as we needed, but I haven't heard anything about how we responded.

One curious thing I've noted is that for the last ten years, we have heard people complaining that the anthrax vaccine was killing soldiers, and causing all sorts of health problems. Now I don't hear anything. Does that mean that the claims were false or overblown, or that people now don't care?

[IRtorqued]

Some light reading
bioport vs fda

anthrax_vaccine_hidden_story

thinktwice

antrax vaccine death

[snopercod]

Thanks for that information. I read it all, but found nothing about "putting new lot numbers on lots that failed".

What I did find were these complaints:

• "poor quality control, poor record keeping and shoddy facilities."
• "the manufacturing process for anthrax vaccine is not validated."
• Bioport’s predecessor, MBPI, was under fire from the U.S. Food and Drug Administration for sloppy record-keeping after an inspection report raised questions about the anthrax vaccine’s potency and sterility.
• "despite the problems, there are no indications the result has been unsafe batches of anthrax vaccine"