WHAT IS THE FDA’ S OFFICE OF SUPPLY CHAIN RESILIENCE( OSCR)?
The OSCR was established to enhance the FDA’ s capacity to prevent and mitigate supply chain interruptions and enhance resilience in the US medical device supply chain.
It promotes the availability of safe and effective medical devices for patients by:
• Developing strategies, analyses and informational products to help prevent and mitigate medical device supply chain disruptions and shortages;
• Identifying supply chain risks and providing actionable information on those risks to medical device manufacturers, medical device distributors, health care delivery organisations, patients, healthcare workers and government partners;
Companies like Roche and Merck are preparing for disruptions by increasing domestic investment. Roche has pledged US $ 50bn in US production over five years and is seeking exemptions for critical imports. However, even with this commitment, executives admit that shifting manufacturing entirely to the US would sharply raise costs.
“ Making all goods in the US that are used there would inflate manufacturing costs,” Roche CEO Thomas Schinecker points out.
• Developing communication channels across the medical device ecosystem to enhance collaborations for development of prevention and risk reduction strategies;
• Collaborating with government partners and medical device stakeholders to triage supply chain disruption and / or shortage signals, determine potential impacts and provide public health information to support an informed response.