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Thursday, 03/31/2011 2:35:41 PM

Thursday, March 31, 2011 2:35:41 PM

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0. We want to help pharma investors.

As part of a broader Obama administration transparency push, the FDA has announced it's going to start offering the public detailed explanations when it rejects a drug or asks a company for more studies. The agency is doing everything it can to improve public health by explaining its decision-making process, while continuing to protect patient confidentiality and industry trade secrets, Riley says. In the past, the FDA would tell a company exactly what was wrong with its application, but that information was confidential, and drug makers could release as much or as little detail as they wanted. "That can lead to a lot of deception," Roy says. "Companies will sometimes say, 'Oh yeah, everything's cool, we just have to dot some i's,' when what the FDA has actually said is, 'You guys are lying punks and we don't want anything to do with your drug,'" he says. Providing an explanation for a rejection will give investors a clear understanding of whether a drug maker has hit a minor snag or a major obstacle, he says.

Read more: 10 Things the FDA Won't Tell You - SmartMoney.com http://www.smartmoney.com/spending/rip-offs/10-things-the-fda-wont-tell-you-1296257904253/#ixzz1ICgNrnYl
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