FDA Reform and Risk Perception

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  • 02/02/2012
According to an article in Reuters by Anna Edney, there has been a dispute among large and small biotech companies about how specific FDA reform legislation should be.  

The plan, drafted by Democratic Senator Kay Hagan of North Carolina, was supported by biotechnology companies to speed up approvals and make the process less expensive. It would have created a program with the flexibility to allow drugs to be cleared based on any testing that shows they may be effective. This may include early trial results, interim data and use of so-called biomarkers that measure the effects of a molecule on biological functions linked to a disease.

The unusual dispute pitted biotechnology companies struggling to finance extensive trials against larger drugmakers who often trade financial aid in return for sharing sales later, said Erik Gordon, a business professor at the University of Michigan in Ann Arbor.

“Smaller biotech companies often can’t raise enough money on their own to do the currently-required safety trials, so they want to dilute the rules to let them get approvals without having to give big pharma a cut of the action in return,” said Gordon, who is based in Ann Arbor, in an e-mail. “Big pharma says ‘don’t dilute safety measures for new drugs.’ That sounds better than ‘we want to keep our cut of the action.’”

I don't agree with Gordon.   He assumes that small and big firms have different interests.  In fact, the larger firms are partnering with or buying smaller biotech companies to sustain product development.  Why would a company invest in a product that will go through the FDA faster only to oppose reforms that would slow down approval? 

Rather,  larger companies view new approval measures and endpoints as causing uncertainty about how FDA will respond.  Smaller companies see the regulatory path as risky to begin with and regard specific requirements to approve based on a number of measures as reducing uncertainty.

It's a difference of perspectives, both of which have merit and are not at odds with the other.   I tend to side with the small companies and favor approval benchmarks that are based on a variety of response measures and post market experience.  But companies of all sizes and disease foci want to get highly effective products to market more quickly. 

My question is: how do we insure that what a product does -- as well as it's risks and benefits -- reflect consumer values more directly?

You can read the entire article here:  http://www.businessweek.com/news/2012-02-02/drugmakers-upset-approval-system-plan-biotechs-sought.html


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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