Why do we assume that attractive, well-dressed individuals are more intelligent than less attractive, poorly dressed individuals? Research disproved any link between these characteristics long ago, but it is still a link many of us make today subconsciously. This is an example of the “halo effect”: the tendency for an impression made upon an individual in one area (in this case a person’s level of attractiveness and dress) to influence that individual’s opinion in another area (a person’s level of intelligence). It happens to us more often than we think.
Let’s look at another example a little closer to the pharma industry. Company A has a widely publicized potential quality issue with one of its products and Company B, which makes the same product, does not. The negative impression (halo) created by Company A’s potential issue might lead an individual to form an impression that Company A’s products, along with their quality processes, should be considered suspect. An individual might also form an impression of Company B, as it has no widely publicized quality issue, that its products must be of higher quality than those of Company A, so Company B must also have better quality processes.
In this example, the unconscious bias was formed as a result of the halo effect with no real data to support it. The negative halo generated by Company A led to an impression of other products produced by the company as well as its quality systems. It also led to an impression related to the products and quality systems of Company B. If you were a new auditor, were asked to assess both companies and were not aware that you were being impacted by the halo effect, how might you approach each differently? This is an important question and one that could impact your company’s future.
This scenario just scratches the surface of a very complex phenomena. It’s one that we, as members of the pharma industry, need to understand and become conscious of in our daily work. You can hear more about this most interesting topic during the upcoming 2022 PDA/FDA Joint Regulatory Conference where Martin Van Trieste (President Emeritus, Civica) will be joined by Shankar Vedantam (Podcast Host and Creator, The Hidden Brain) for a lively discussion on the halo effect. The Conference will be held on 12-14 September 2022 in Washington, DC. More information can be found at 2022 PDA/FDA Joint Regulatory Conference.
The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) once again are cosponsoring the PDA/FDA Joint Regulatory Conference, which is now in its 31st year. The previous two PDA/FDA Joint Regulatory Conferences were offered as virtual events due to travel and other restrictions brought about by the COVID-19 pandemic.
This year’s Joint Regulatory Conference will emphasize the role of implementing effective quality systems to ensure an ongoing state of control throughout the pharmaceutical product lifecycle by vigilantly managing quality risks. The roles of robust systems, facilities, processes, raw material quality, supplier relationships, industrial modernization and quality risk management will be emphasized.
Case studies will be presented throughout the conference to provide practical insights into these concepts and illustrate how sustainable Current Good Manufacturing Practice (CGMP) compliance establishes the foundation for drug quality and a reliable supply chain. The conference will also address international collaborations that aim to improve drug quality and benefit the consumer.
The Conference features the ever-popular FDA Center Office Updates, provided by the Office Directors of CDER, CBER, CVM, and by the Associate Commissioner of Regulatory Affairs of ORA. The FDA Center Directors and ORA’s Associate Commissioner of Regulatory Affairs will discuss recent programs, initiatives, and trends with respect to regulatory inspections and enforcement. The conference will also drill down even deeper into compliance matters. Many sessions with practical GMP solutions and case studies throughout the conference culminating in the Current GMP Compliance Trends and Topics session, which will be held near the end of the conference (a perennial standing-room-only session). Just before the closing plenary session, attendees can have Lunch with the Regulators, another popular way for attendees to hear from FDA experts.
For more information, go to: 2022 PDA/FDA Joint Regulatory Conference.