Bioshield legislation like a bad prospect

The federal government’s new combination of laws called Bioshield looks like a classic case of the guy who’s all gungho. He tells you “Oh, yes, I really want what you’re offering. That’s exactly what I’m looking for…but I’m not ready to buy it yet. Why don’t you keep working on that. And by the way, here are the other features I’d like you to put in there… Money for development? No, don’t be silly that’s your job. Be your partner in taking the risks on this? No, no. That might cost me serious money or damage my reputation. You just go ahead and get that thing ready and we’ll let you know when we’re ready to move.”

That’s a quick and dirty impression gleaned from last week’s Washington Post on this new legislation that for ten years authorizes the use of federal money for drugs and vaccines to counteract a range of pathogens. Health officials can sign a contract to buy drugs under development, but don’t have to actually buy anything until tests prove the treatments work. The catch-22 is that no proof can be given that a certain drug effectively prevents or cures damage to human beings from any agent–because you can’t use unproven drugs on real people.

But the Food and Drug Administration is allowed to use unapproved products in emergencies and the National Institutes of Health can speed up biodefense research.

But apparently the drug companies who develop the agents will be the ones to bear the brunt of any lawsuits filed in case the agents don’t work. Talk about getting it both ways.