Increased FDA Scrutiny Leads to Fall in Number of New Drugs
In a front page story, the Wall Street Journal notes a major decline in the number of new drugs being produced by large pharmaceutical companies. Industry spokesmen confirm that the number of "large scale projects" has been cut dramatically in recent months because of rising scrutiny from Food and Drug Administration (FDA) regulators.
In the aftermath of several headline grabbing medication related stories - some invovling numerous patient deaths - and incidents of medication contamination, the agency has taken steps to step up how strictly it scrutinizes new drug candidates.
One drug company CEO notes that the FDAs increasing focus on safety and decreasing tolerance of side effects has dramatically cut the odds that many large drug projects will produce any products that ultimately make it to market. As a result, those projects have been halted.
Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research "denies that the agency has become 'more conservative' about drug safety," but acknowledges that last year, "the FDA approved just 19 new medicines, the fewest in 24 years, and announced about 75 new or revised 'black-box' warnings about potential side effects,...twice the number in 2004."


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