A Preview of the FDA From the Mind of IOM and Senator Grassley

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  • 10/23/2006
I had the opportunity to be briefed by the chair and staff of the IOM committee responsible for the drug safety report that came out recently. I was pretty rough on the study when it first came out and was hoping that a second pass might lead me to a sunnier set of conclusions.

But the thrust of the IOM report -- increasing the amount of time and money the FDA spends on claims data from HMOs to search for safety signals in order to generate post market studies to seek out rare safety problems -- is simply asking for troubling instead of eliminating it in the first place. And worse, it smacks of self dealing: after all once the IOM group decided to have nothing to do with anyone who had expertise in the science of drug development it was left with people that had ties to HMOs and the CERTs who just happen to rely on the purchase of claims data and contracts for data dredging to form the "expert" panel.

And the idea of increasing the number of safety reviews and adding people from the Office of Drug Safety to "restore the balance" between efficacy and safety as IOM safety chair Sheila Burke stated is overkill. What is preclinical, Phase I and Phase II dosing studies but safety related research? Or am I missing something? Maybe Ms. Burke could point to some evidence apart from the so -called culture gap she kept on referring to in her meeting and in the report since it was not to be found.

Finally, the IOM folks claimed that they did not believe that their recommendations would slow down drug approvals in any way and that they were not responsible for the actions of members of Congress who used the IOM report to support their pet regulations....Fat chance. It is already happening.

Following on the heels of Senator Grassley and Congressman Waxman beating up on the FDA for using non-inferiority trials to approve antibiotics we now see the FDA rejecting two new antibiotics just after asking sponsors to provide data that they were as effective as existing drugs. Now the FDA is asking Replidyne for example to conduct four additional trials to demonstrate faropenem's superiority - compared to a placebo or existing drug right after the company had completed 11 late-stage clinical trials and a safety database of more than 5,000 patients. The additional research will take at least two years and require millions more.

The company said it was disappointed. What it was cannot be published on a family blog. And unfortunately it is a harbinger of what will happen when the folks from the Office of Drug Safety empowered and encouraged by Grassley et al make their way on to the committees reviewing drugs will be doing. Drug development, even in those areas where medicines are badly needed, will become more expensive and more time consuming. And why in the world would a company take the Critical Path seriously after a stunt like this?

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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