Kirsten Gillibrand and Experts on Cybersecurity for US Drug Manufacturers

Cybersecurity Threats to Drug Manufacturers

• ⚠️ Domestic and global drug manufacturers are frequent targets of cyber attacks by competitors, nation-states, and non-state actors.
• 🎯 These attacks can disrupt the supply chain, impacting the availability of essential drugs and their components.
• 💡 A company cutting corners on manufacturing quality may also be neglecting cybersecurity investments.

Vulnerabilities and Resilience

• 🌐 Cyber attacks know no borders, posing a risk to both international and US-based pharmaceutical companies.
• 🔗 Every node in the pharmaceutical supply chain is considered at risk, not one more than another.
• 🚨 The Merc ransomware attack in 2017 resulted in over a billion dollars in potential damages, highlighting the tangible threat.
• 📈 Geopolitical conflicts are expected to increase the threat of cyber attacks on critical infrastructure, including drug manufacturing.

Federal Support and Agency Collaboration

• 🤝 Partnerships with agencies like CISA, the FBI, and DHS are crucial for robust cybersecurity protections.
• 🏢 Integrating cybersecurity from the initial infrastructure build, rather than layering it on later, is a key strategy.
• 📉 The office within ASPR responsible for targeted investments has experienced a flat budget, limiting its ability to support manufacturers.
• 🗺️ A centralized authority and clearly defined roles, goals, and outcomes among agencies like HHS, FDA, CMS, and DoD are recommended to coordinate drug shortage activities.

Proposed Support and Funding

• 💰 Long-term, sustainable funding is essential for agencies tasked with supporting domestic manufacturing and cybersecurity.
• 📈 Support mechanisms like a strategic antibiotic manufacturing fund with targeted grants and low-interest loans, similar to the CHIPS Act, are proposed.
• 🧾 Tax incentives for domestic API production, including immediate expensing of new equipment and enhanced R&D deductions, are suggested.
• 🔍 Supply chain visibility is deemed critically important for patients, doctors, and hospitals to understand medication origins.
• 🛡️ Essential medicines should be recognized as national security assets, making manufacturers eligible for industrial-based support.

Serialization and Tracking

• 🏷️ New regulations like DSCSA and serialization improve the ability to track every batch, case, and bottle down to the consumer level.
• ✅ This enhanced tracking capability is vital for quickly identifying and managing product recalls.