QDIS Blog

Here is the first of what I am sure will be plenty of approvable letter from the FDA this year. Pfizer received an approvable letter for dalbavancin, a once weekly two dose antibiotic useful for methicillin resistant bacteria. Note that this drug came to Pfizer by way of their acquisition of Vicuron.

PharmaLive: Pfizer Receives Approvable Letter from FDA for Dalbavancin :

Basically the FDA wants more evidence regarding non-inferiority as the basis for approval.

I personally think that antibiotics is NOT an area where the FDA needs to be seen as holding things up. With the rising number of MRSA infections occurring even outside the hospital the need for new antibiotics is growing and will continue to grow. Having been affected by this personally and knowing that only vancamycin worked in that case the need for new antibiotics will continue to be of concern.

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Email Ed Vawter

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It will be interesting to see how things develop with regards to new drug approvals and the FDA in 2008.
My guess is that for new drugs for which treatment already exists that the FDA will continue to demand evidence of not only of safety and effectiveness but also that is is an improvement over the currently available treatments. This seems to be shared by Fierce Biotech.

The FDA: Caught between a rock and a hard place - FierceBiotech

I can understand the FDA reacting to recent situations such as Vioxx but they do indeed seem to be sending a mixed message; emphasizing the need for speeding drugs to market but then seeming to have set a higher standard. THe FDA says therre jave been no policy changes but the fact that only 15 new drugs were approved in 2007 seems to indicate otherwise.

I just hope that we can have a open and honest discussion about risk management and acknowledge that all drugs have risk and many times that full impact of that will not be determined until after the drug has gone on the market.

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