Regulatory Focus™ > News Articles > Upcoming FDA/IOM Meeting to Focus on Uncertainty During Regulatory Approvals

Upcoming FDA/IOM Meeting to Focus on Uncertainty During Regulatory Approvals

Posted 08 November 2013 | By Alexander Gaffney, RAC

An upcoming meeting between the Institute of Medicine (IOM) and the US Food and Drug Administration (FDA) will explore two facets of the benefit-risk assessment process that officials say could benefit from increased attention.


Under Section 905 of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), FDA is charged with implementing a "structured risk-benefit assessment framework in the new drug approval process to facilitate the balanced consideration of benefits and risks, a consistent and systematic approach to the discussion and regulatory decision-making, and the communication of the benefits and risks of new drugs."

Some within industry and several patient groups have long complained that FDA's benefit-risk assessment framework is too rigid and errs on the side of risk aversion, and that a recalibration of this balance is needed.

This assessment process hinges on a wide range of variables. Some, such as interim clinical trials data, are both complex and imperfect, leaving regulators to grapple with uncertainty when attempting to come to an approval decision.

Upcoming Meeting

IOM and FDA's upcoming meeting is set to examine two of these variables:

the translation of pre-market clinical trial data to the post-market setting in which an approved drug is used in a much wider patient population

new findings that emerge in a post-marketing setting where the basis for the finding comes from sources of varying levels of rigor

In a statement, IOM said it and FDA will be trying to figure out a more "systematic and structured" way of communicating the certainty of their conclusions to the public, as well as the implications of uncertainty on regulatory decision-making.

"Specifically, the workshop will explore potential analytical and communication approaches and identify key considerations on their development, evaluation, and incorporation into the assessment of benefits and risks in pharmaceuticals," IOM continued.

"FDA envisions that this framework will serve as a template for product reviews, as well as a vehicle for explaining the basis for FDA's regulatory decisions."

The meeting will take place on 13 February 2014.

IOM Meeting

Tags: Benefit-risk, IOM

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