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The Role of FDA Benefit-Risk Assessment in Regulatory Decision Making

April 7th, 2015 by Zuhdi Hussein

FDA RegulationsPharmaceutical manufacturers can't sell their products without first convincing regulators of their safety. Firms that fail to do so sustain fiscal losses when they can't bring the drugs they've invested in to market.

 Although there are many strategies for proving your products' worth, one of the most effective ways to prepare is to learn how regulators think in order for your firm to satisfy its obligations. Tailor your GMP manufacturing processes to accommodate regulatory tendencies, and you'll find it easier to navigate the approval process.

What Is Benefit-Risk Assessment?

According to the FDA's Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making, the agency's main concern for new drugs is ensuring they can be used safely and effectively under approved conditions. Safety is not, however, an absolute concept; instead, the FDA thinks in more relative terms.

Because every drug product has the potential to cause harm as well as induce positive effects, regulators use a benefit-risk assessment that attempts to comprehensively account for all kinds of possibilities. Compliance consulting may help some manufacturers come to terms with this overhaul.

Why Should Manufacturers Be Concerned About FDA Benefit-Risk Assessment?

Although the agency has long employed benefit-risk assessment strategies, in 2010, it responded to criticisms about its methodologies by adopting a more structured approach. The subsequent reauthorization of the Prescription Drug Users Fee Act (PDUFA) in 2012 therefore incorporated a five-year draft plan for how the FDA would enhance and standardize its own use of benefit-risk assessment.

Regardless whether their products and processes were previously compliant, manufacturers now have to ensure their methods meet the new FDA standards to gain market approval.

Through 2015, the agency will implement its new framework in reviewing New Molecular Entity New Drug Applications (NME NDAs) and original Biologics License Applications (BLAs). While Efficacy Supplements for New/Expanded Indications won't adopt the framework until 2016, all original NDAs will use it by 2017. 

How Does the FDA's New Framework Incorporate Benefit-Risk Assessment in Its Decisions?

The FDA framework for benefit-risk assessment incorporates categories for key decision factors

  • Analysis of Condition and Current Treatment Options
  • Benefit and Risk
  • Risk Management

Each of these factors is further evaluated with two considerations

  • Evidence and Uncertainties
  • Conclusions and Reasons

Even without examining these decision factors and considerations further, we can easily observe that the nature of treatment, intended application, patient status and other factors under which a drug is used all play a role in whether it ultimately gains FDA approval.

Pharmaceutical companies must assess their products more comprehensively to predict potential conflicts and problems that could lead to regulatory denial.

While using quality risk management systems and techniques to control production is still a good idea in general, the hurdles your organization has to surmount beforehand are only growing steeper.

Contact GxP-CC consultants to learn how to adapt to the changing regulatory landscape.



Posted in compliance consulting, FDA Benefit Risk Assessment, FDA Drug Approval Process, FDA & European Regulations, GMP Manufacturing Processes, GxP CC, PDUFA, Prescription Drug Users Fee Act

About this author:

Zuhdi Hussein

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