As expected, Sen. Charles Grassley (R-Iowa) is making rumblings about his soon-to-come bill to create an independent drug safety review office that will have increased capabilities for issuing warnings to drug manufacturers. Several critics, including Sen. Grassley, have been going after the FDA for its internal structure that supposedly intimidates certain FDA scientists from waving red flags about approved drugs to their superiors, because those superiors have already approved the drug and the scientists fear retaliation.
I am really looking forward to seeing what his proposal is, for several reasons ...
First, the FDA does need to look at some of its internal workings and correct some issues. It's not surprising to find out that there may have been a cover-up, nor is it surprising to hear that underlings fear retaliation from their bosses. In an ideal world, none of this would occur. But we're talking about the Earth, and with how we've grown our society, it's not a bit astonishing. Dismaying and distasteful, perhaps, but not astonishing.
Second, having this kind of debate will also make Dr. Lester Crawford, the newly-appointed permanent Commissioner of the FDA, corral the troops and have a forum for showing the American public how the FDA is doing some things right. Sadly, we've been hearing too much about how it does things wrong.
Third, the debate might even bring up what the FDA should and should not be policing and what the best ways are for it to request and receive information and even what information the FDA needs to have to do its job. We're entering a great new era of more electronic information and with e-clinical trials, clinical trial databases, and security rules being bandied about, this could be a opportune time for the FDA to figure out new rules of engagement when it comes to clinical trials that make sense for the drug companies and make sense for the FDA.
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