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Killing with Kindness

Government regulation almost always is biased towards inaction and prohibition.  Making a "mistake" and allowing something to happen will usually get you into far greater trouble than making a "mistake" and not allowing something to happen.  People will see the results of the former, and blame you, but are unlikely to see the consequences, even if far worse, of the latter. So it is with the Food and Drug Administration.  If  one person dies from a "bad" drug, the Luddites, like the misnamed Center for Science in the Public Interest, will demand that every future drug be subject to twice or thrice as much scrutiny.  Deny approval for a drug, killing thousands, and nothing happens.  The regulatory enthusiasts think that's just peachy-keen, a perfectly acceptable consequence of being extra careful. It long has been evident that the FDA has killed hundreds of thousands of people by delaying the entry of some important drugs to the market, and keeping some others off entirely.  Think of any new medicine which the FDA heralds with a press release citing the number of lives expected to be saved.  Multiply that number by the unnecessary regulatory delay and you get the FDA's body count. Sadly, the problem is getting worse.  Reports CNN.Money:
Federal drug approvals have plummeted by nearly a third in 2007, according to a report issued Thursday that is likely to fuel complaints that regulators are stymieing efforts to get new treatments on the market. The Food and Drug Administration approved 59 new drugs through October, down 29 percent from the same period last year, according to a report from James Kumpel, an industry analyst at Friedman, Billings, Ramsey Group. Significantly, the report says that the problem is not in the industry pipeline. Kumpel said that the ratio of applications to approvals in 2007 is shaping up to hit a 13-year low. The FDA is on track to approve 60 percent of applications for new drugs this year, compared to 76 percent in 2006.

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"While some pundits have argued that the pipeline [of applications] submitted to the FDA by the pharmaceutical industry has been weak in recent years, the facts dispute such claims," said Kumpel, in his report, released on Thursday. Kumpel found an 18 percent decline in approvals of a key category of drugs - those that are in a brand-new molecular class. The FDA approved only 14 of these new drugs, which represent the most significant medical advances because they do not piggyback onto existing treatments. In addition, Kumpel's report said approvals of biotech drugs have "fallen off the cliff" to only one new product through October, compared to four in the year-ago period.  
Only by radically rethinking federal regulation of pharmaceuticals can we end the murderous federal drug-delay.   The simplest option would be to keep the FDA, but allow drugs to be sold if they have been approved by Japan or the EU, or by a private certification agency such as Underwriters Laboratory.  It's time to strip Uncle Sam of his power of life or death over the rest of us.