FDA panel backs added risk review on diabetes drugs
A FDA advisory panel has voted 14-2 to recommend that the developers of diabetes drugs specifically demonstrate that their experimental therapies don't increase cardiovascular risks. And if as expected the agency follows the recommendation, developers in the diabetes field are looking at more complex trial demands that are likely to add significant cost to the trials process. The Wall Street Journal nominates AstraZeneca and Bristol-Myers Squibb as the first two biopharma companies to face the new standard. Their diabetes drug saxagliptin is headed to the FDA for a review.
- read the report in the Wall Street Journal
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Comments
By Anonymous | Posted 10:14am | July 7, 2008
The "added risk review " of experimental diabetes drugs will have the end result of fewer new compounds available to treat diabetes,and is entirely in keeping with the continuing madness at the FDA.
Most Americans recognize that diabetes is inherently a serious affliction with significant risks in it's own right, including cardiovascular risks.
The general concensus among those in the industry to which I speak is that there is a rampant lack of common sense in the leadership of the FDA.
I would attribute it more to a vicious agenda designed to gradually deprive Americans of effective treatments through the private enterprise system, driving us toward an even more government-controlled health care system and at the continuing cost of hundreds of thousands of lives.
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