If the FDA "bulks up" on its drug safety staff will that mean a slower process for getting drugs approved?

Oldman answered one year ago …

The increased funding is not just for reviews of domestic Rx, but also for screening of pharmaceutical processes and importations of intermediates.

As an example, heparin is a sulonated sugar. It's used as a short-lived anti-clotting med. for patients who may be on regular "blood-thinners" with longer half-lives, but who need the shorter acting anticlotting drug to be administered so they can undergo surgery, without bleeding to death, because heparin infusions can be "titrated" to control clotting, over a short period.

In the last 16 months there were 81 deaths and 475 allergic reactions to heparin, because the intermediates in its production were "doped" with a hypersulphonated mimic: a chondroitin sulfate (very similar to the one in the special calcium, chondroitin sulfate, MSM mix used by arthritics and people concerned with loss of cartilage or bone density, as a "mineral supplement").

Who did the doping appears to be the Chinese supplier of the intermediate (so the sulphonation index for the heparin precursor "looked" more potent) and the processors here in the U.S., had no idea that the intermediate was dangerously "doped" and the major U.S. Rx Co., Baxter-Travenol, had to recall millions of doses of their i.v. heparin. Bear with me a bit:

Unfortunately, a lot of kidney dialysis patients receiving this heparinX solution died or had severe allergic reactions. This happened worldwide. It took the FDA researchers 8 months to figure this out...because they didn't have the resources to do a "CSI" type forensic investigation.

What's even more interesting, the mechanism of the acute allergic reaction and infections that resulted has now been worked out...it appears that the hypersulphonated "contaminant" prevented the white cells from destroying the bacteria that they had trapped. So a good general finding is: if you have an infection -STOP taking chondroitin sulphate - until the infection clears, or it may cause a systemic allergic reaction and a severe, disseminated infection.

So out of all the misery, another minor advance of science.

Last year it was gluten that was "contaminated" with a byproduct of plastic shopping bag plastics (what is sold as "stabilizer" for Chlorine in swimming pools...also Chinese) caused a lot off kidney failure in pets, that were fed the gluten protein in their chow.. The year before, it was phony Colgate toothpaste that contained diethyelene glycol (to make it sweet) except it's poisonous, as is the antifreeze in your car's radiator. Not too many U.S. citizens died, but in the Caribeean and Mexico, there were a lot of kids and elderly who died. The Chines mfr and the head of their Pharmaceutical registration agency were executed.

It's also fish and shellfish that come from heavy-metal contaminated "ponds" , from countries that export (Thailand, VietNam, Chile) these to the U.S....and the FDA + USDA haven't sufficient stations in those areas to check the shippers, breeders. It's also mislabeling of food and dietary supplements (remember kids getting high and stroking out on ephedra-containing cough syrups and cold remedies?)

A lot of Congrssional pressure was put on the agencies responsible for monitoring drug and food safety, becaus there are a lot of crafty people who want to peddle crap with a bogus certificate.

I'm sorry about the lengthy history of this recent belated funding increase, but we all expect the FDA and the USDA to be there...but half of their senior people will be retiring in the next few years, and their staffing has really shrunk vs. the amount of chicanery going on worldwide.

As far as the review of the efficacy and safety of new, uncontaminated U.S. Rx, the Pharmaceutical Industry is paying for about 1/3 of the screening costs as a direct "tithe" to the FDA. But it's their records and processes that need more surveillance, as the recent Merck Vioxx scandal has shown, and the conflict of interest factor that Grudun pointed out is only a tiny component of the inefficiency at the FDA. A lot of the FDA research personnel are good, but undersupported when they question things, because the agency's resources have been allowed to wane.