As mandated by the Food and Drug Administration Safety and Innovation Act (FDASIA), the FDA just posted a draft of its “Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision Making.” There is a 60-day public comment period on the draft, and any individual or group wishing to submit comments may do so.

The draft document provides insight into FDA’s basic structure for a benefit-risk framework, which includes:

• Analysis of a condition and its current treatment options
• Possible projected benefits,
• Possible projected risks and
• Risk management ideas.

According to the draft, possible additions to the framework include:

• The ability to revise review templates, so structured benefit-risk assessment in human drug review processes can be incorporated;
• The ability to develop a framework for reviewing a drug’s benefit-risk assessment post-market;
• The ability to characterize uncertainty by identifying the efficiency the benefit-risk assessment (based on pre-market clinical trial data) translates to the post-market—once the drug has been approved and circulated amongst a wider patient population.

FDA plans to implement the new benefit-risk framework by using a multi-step process. The timeline is as follows: New Molecular Entity (NME) New Drug Applications & Original Biologics: 2014-2015, efficacy supplements for new/expanded indications: 2016, and all original NDAs: 2017.

Jennifer Bernstein is the Vice President of JC White Consulting, where she focuses on legislative and regulatory developments within the pharmaceutical, biotechnology and medical device sectors.. A consultant, Jennifer works for several healthcare clients, coordinating their activities with patient groups. Jennifer Bernstein joined Global Genes as a policy liaison, focusing on legislation and policy activities and covering topics pertinent to RARE disease.