The FDA has formed a new Risk Communication Advisory Committee. This committee will come up with better strategies to approve drugs, and handle situations that arise with drugs that are FDA approved.
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Host: You have been appointed to the FDA's Risk Communication Advisory Committee. What is it? Dr. Mona Khanna: Well, one of the things that we've been seeing lately again as a trend is that people are very, very concerned when we find out that there are side effects to a certain medication and then we here people say, well, maybe it wasn't studied enough and maybe if we had -- the FDA had not been so quick to approve it, perhaps, we could have become aware of these side effects and these adverse effects, so that we wouldn't have given it to large numbers of people and they wouldn't have gotten sick or sick due to taking the medication. So what the FDA has decided to do is assemble a panel of experts and the public, so the experts on this panel are people who are skilled in risk communication, are journalists on the panel, there are people who are experts in statistical analysis, experts in content fields such as one particular type of specialty in medicine, and then the general public to kind of add the real-world experience to the panel, put all these heads together so that we can help the FDA and advise the commissioner about when something happens about coming up with strategies for FDA-approved drugs, when something happened with the medication that's already been approved, how to handle it and how to approach some of the dilemmas that right now nobody is really addressing. Host: Why is the FDA's job so difficult? Dr. Mona Khanna: The FDA is always under the gun. One of the problems is when it fast-tracks medication such as medications for HIV, which it has had to do in the past 20 years, because there was such a devastating and debilitating diagnosis, then it can come under criticism for why you didn't study enough. On the other hand, when we have people dying or getting severally disabled from other conditions, then the FDA comes under scrutiny for, you're not approving these medications quick enough, so you really have to find that balance. You have to find that fine line that you don't cross, but that you're able to benefit the most people. It's always about the cost benefit ratio and the FDA has been very conservative to this point. The purpose of our panel is to help advise the FDA about how to do a better job with that fine line. Host: Will the general public notice a difference in having this committee in place? Dr. Mona Khanna: Well, the committee has just been appointed in October of 2007 and what we expect to do is get all the paperwork in. It is a government bureaucracy as you know. Once we're able to do that, we're able to convene. We expect then to start talking a little bit about strategy and how we hope to have an effect on the commissioner. I'm not entirely sure that you'll see something that says, this is coming out of the RCAC, which you may see though is, our advice being taken to the highest levels and affecting the commissioner in press releases or policies that come out from the office.

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