Saturday, November 17, 2007

Federal drug approvals plunge

The American and Canadian drug approval systems often share information and make similar decisions. I suspect the decrease in approvals of new products in the States has likely resulted in some of these products not being approved in Canada. Quite often, these drugs have received approval in other Western countries. Examples would include rimonabant and Arcoxia.

The pendulum has swung regarding North American drug approvals. In the wake of the Vioxx scandal, I suppose it was inevitable. But I wonder how many benficial new medications won't be approved because of the now exceedingly cautious regulatory bodies?

From 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.

"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. ...more

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