Pharmaceutical Industry Benefits from the risk-assessment framework

Pharmaceutical Industry Benefits from the risk-assessment framework


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To: Mike Doryen, FDA Managing Director.

From: Albert Bourla, CEO Pfizer Company.

Subject: Using a structured benefit-risk assessment (BRA) framework to evaluate an investigational product’s benefits and risks provides more significant benefits.

The Food and Drug Administration (FDA) has developed and is currently implementing structured frameworks that help benefit-risk analysis for making drug licensing decisions. The BRA framework has proved to be efficient, especially in decision-making processes. For this reason, I am writing this memo to recommend that indeed, the FDA and pharmaceutical companies benefit when using a structured BRA framework.

Supporting Argument #1: Benefit-risk assessment (BRA) framework has enabled drug manufacturing companies to improve transparency, traceability, and accountability in the benefit-risk decision making (Pignatti et al., 2015).

Discussion: Since introducing the BRA framework by the Food and Drug Authority (FDA), pharmaceutical companies, regulatory agencies such as Health Technology Agencies (HTA) have adopted qualitative and quantitative measures in decision-making processes. Qualitative and quantitative frameworks have promoted the use of risk analysis tools which help draw detailed insights regarding the risks and threats posed compared to the benefits (Guo et al.,(2010); FDA, (2013); Leong et al., (2015)). The HTA has included several decision-making techniques after conducting a thorough evaluation of the benefits gained compared to the risks incurred (Cherny et al., (2015); Schnipper et al.,(2015)). The pharmaceutical companies’ portfolio management departments have also maximum benefitted from the framework. This is because they have been able to use quantitative techniques and algorithms to analyze and optimize the portfolio of the produced drugs (Hassanzadeh et al.,2011; Jekunen, 2014).

Supporting Argument #2: A structured BRA framework has promoted more communications between pharmaceutical industries and regulatory agencies, health experts, and patients (Pignatti et al., 2015). Improved communication means that the stakeholders can reach a consensus before making critical decisions.

Discussion: In a dynamic and ever-changing society, demand for transparency in the decision-making processes usually is a challenge. The fact that the framework has promoted transparency to the stakeholder means that pharmaceutical companies have benefitted more (Hassanzadeh et al.,2011; Jekunen, 2014). Transparency increases employee engagement removes barriers to innovation and promotes clear-eyed leadership.

Opposing Argument 1: A structured framework for evaluating the benefits and risks in pharmaceutical companies does not provide mechanisms through which pharmaceutical companies can create a positive benefit-risk balance (Breckenridge, 2010).

Discussion: The rapid development of science implies that stakeholders also have to change their expectations. It is the requirement that each stakeholder knows the mechanisms of balancing risks and benefits in pharmaceutical companies (European Medicine Agency, 2011a).

Rebuttal: The benefit-risk balance has been expressed honestly and transparently through the framework, which helps improve the passage of crucial information in the differences between the potential risks and the likely benefits in pharmaceutical industries.

Opposing Argument 2: The structured BRA framework does not provide adequate information regarding the risks of drugs launched by pharmaceutical companies (Guo et al.,2010; FDA, 2013; Leong et al., 2015).

Discussion: The framework does not describe the treatment efficacy of pharmaceutical products. Moreover, it does not provide adequate information on the proportion of the possible risks that the study patients are likely to encounter.

Rebuttal: Despite the benefit-risk framework not effectively laying out the risks posed by the drugs before they are launched for human consumption, pharmaceutical companies attach the dangers posed to patients on their products.





Eichler, H. G., Baird, L. G., Barker, R., Bloechl‐Daum, B., Børlum‐Kristensen, F., Brown, J., … & Hirsch, G. (2015). From adaptive licensing to adaptive pathways: delivering a flexible life‐span approach to bring new drugs to patients. Clinical Pharmacology & Therapeutics97(3), 234-246.

Walker, S., McAuslane, N., Liberti, L., Leong, J., & Salek, S. (2015). A universal framework for the benefit-risk assessment of medicines: is this the way forward?. Therapeutic Innovation & regulatory science49(1), 17-25.

Gyawali, B., De Vries, E. G. E., Dafni, U., Amaral, T., Barriuso, J., Bogaerts, J., … & Cherny, N. I. (2021). Biases in study design, implementation, and data analysis distort the appraisal of clinical benefit and ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) scoring. ESMO Open6(3), 100117.

Hassanzadeh, T., & Kanan, H. R. (2014). Fuzzy FA: a modified firefly algorithm. Applied Artificial Intelligence28(1), 47-65.

Jekunen, A. (2014). Decision-making in product portfolios of pharmaceutical research and development–managing streams of innovation in highly regulated markets. Drug design, development, and therapy8, 2009.

Psaty, B. M., Meslin, E. M., & Breckenridge, A. (2012). A lifecycle approach to evaluating FDA approval methods and regulatory actions: opportunities provided by a new IOM report. Jama307(23), 2491-2492.

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