FDA and HIV drug approval

Here’s an interesting skirmish in the global economics and politics of the drug industry.

An organization that is deeply involved in funding HIV drug disbursement to developing countries is rattling the cage of the FDA. They’re putting pressure on to get the US FDA to approve a three-in-one pill for HIV treatment made by an Indian pharmaceutical company. The drugs evidently are generics so the price—especially if made in India—can be very low compared to similar compounds made by US and European Big Pharma companies. The FDA is important because it is considered the gold standard for drug quality. Also no US funds could be spent for international programs using drugs not approved by the FDA.

What the Global Fund to Fight AIDS seems to be implying is that the FDA is dragging its feet, perhaps to give US pharmaceutical companies time to develop competitive products. Could it be about the money? Well, the grants to finance drug purchases could rise from $1.65 billion to $3.5 billion next year. So…

The challenge being tossed down is for the FDA to prove it’s interested in saving lives and is not just a drug company lackey. A cynical thought that occurs to me is that it also wouldn’t be in the best interests of existing drug companies to see an Indian company get an infusion of a billion or two dollars from making cheap HIV drugs. The last thing they want is a Wal-Mart-of-drugs emerging in that low cost part of the world.

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