Regulatory health agencies around the world have responded to the COVID-19 pandemic by offering accelerated review of applications related to detection or treatment of the disease, while providing assurance that scrutiny of product quality and patient safety would not be compromised. Such a position is understandable, given the global impact of the disease and the public expectation that nothing should impede developments to minimise the human, economic and social cost.
The regulatory stance has some interesting implications for potential pharmaceutical manufacturers and marketing authorisation holders. Those with products which are relevant to the management of SARS CoV-2/COVID-19 could benefit from accelerated review, as would individuals and society as a whole. However, health agency resources are finite, which prompts three observations yet to be widely considered:
- Accelerated review of COVID-19 related applications will probably delay the review of non-COVID-19 related applications. Over the short- to mid-term, this could defer the availability of treatment for patients with other, non-COVID-19, conditions no less than the prioritisation of hospital beds to severely-ill COVID-19 patients deprives other patients of critical care.
- If accelerated review is possible for COVID-19 applications without compromising product quality or patient safety and without delaying other applications, then it may be possible to establish a routine accelerated review process for all applications.
- While maintaining that product quality and patient safety will not be compromised, the hazard from COVID-19 may allow for greater risk when assessing risk-benefit, than for other non-COVID-19 medicinal products. This may be easier to justify for COVID-19 patients who are already critically-ill, but presents interesting philosophical questions when comparing COVID-19 and other conditions which have not progressed to critical illness but may have the potential to do so.
The above three scenarios are not accusations; the response of all parties involved in tackling the COVID-19 challenge has been to find solutions as quickly and as safely as possible, in the context of data available at the time. Rather, these scenarios highlight the unchanged responsibility of developers.
Accelerated review is dependent on the applicant (whether academic institution, public sector provider or commercial company) ensuring the quality and safety of product throughout the pre-licensing development programme from concept to market. Notwithstanding the perceived urgency, the developer needs to maintain a critical scrutiny of their data and underlying assumptions continually, in order to minimise risk at the regulatory review stage and in the clinic.
Queen’s House Consulting can offer independent review to support that critical scrutiny, acknowledging that the developer is most expert in that field. A detached view can challenge assumptions and interpretations, either confirming an already-robust package of data, or prompting enhancement of the eventual regulatory process. If you are a developer and would like to explore such a service, please contact Queen’s House Consulting to discuss your particular needs.
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