Pre-launch drug access programs can help patients access investigational therapies before they receive regulatory approval and are launched commercially. Based on their potential advantages, a growing number of pharmaceutical companies in countries around the world have recognised the potential benefits that pre-launch access programmes can offer, either as components of later-stage clinical development or to support access to therapies in countries that recognise US or EU product approvals.
With their advantages, pre-launch access programs can also present some challenges and potential risks. In many cases, they require ongoing reporting of adverse events (AEs) and are used in patient populations that do not reflect clinical research populations. Consequently, efficacy results may differ from prior clinical data. There may also be higher than expected costs to implement and maintain a programme. As they consider development of a pre-launch access plan, companies must carefully assess the potential advantages and risks and work to develop a programme designed to optimise benefit. It can be helpful to review real-world examples to identify the best options related to timing, monitoring and other factors.
IP Insights: Notable developments in IP litigation: April 2021
Sprint Communications Company LP v. WideOpenWest, Inc. et al., Case No. 1-18-cv-00361 (US District Court of Delaware) Sprint Communications filed lawsuits...