Thursday, March 20, 2008

Qualify your vendors: Heparin from China

FDA has user fees to review drug applications but this administration has forced budget cuts that have decimated it's ability to inspect manufacturing plants not just for drugs, but for devices, biological products, food, and veterinary medicine. FDA inspectors wait until the agency can bundle up foreign establishment inspections, and then only give FDA inspectors a few days in each site to spot-check records.

That means facilities must police themselves.

Instead, the Heparin contamination is just another example of how US companies have downsized their operations and their Quality units to please shareholders, and now these companies obtain many of their components from the third world where corruption is common, contamination from dirty water and unhygienic practices is unavoidable, and subcontractors think nothing of exchanging expensive ingredients and equipment with unacceptable replacements. US companies don't know their vendors, they don't adequately audit them, and they don't know where their vendors get their supplies, either. This despite the fact that the idea of qualifying vendors has been around since 1951.

WSJ writes without much new insight that "The recent problems with heparin from China highlight the difficulty of monitoring the often diffuse and poorly regulated supply chains there -- for both Chinese drug makers and the multinational pharmaceutical companies that buy from them."

Like many regulated companies, this one falls into the trap of bragging that it built a new "GMP facility;" then fails to make sure the people and products brought into its new walls are free from contamination.

WaPo quotes William Hubbard, a former FDA official, who says it is not surprising that tainted drugs supplied though agency-approved channels are showing up from abroad. "The history of some of these developing countries in terms of substituting or counterfeiting concerns is a long and well-documented one," he said. "And at this point, the FDA doesn't have the resources or system in place to make sure some of these bad drugs don't get through to the public."

In the meantime, FDA budget is still a fraction of NIH's, and increases for FY09 are barely enough to cover cost of living adjustments, and certainly won'y allow improvements in inspections. Even industry wants to give FDA more money.

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