Supply Chain Risk Management Blog

Regulators Push Drug Manufacturers to Proactively Manage Supply Vulnerabilities

The last three years have seen an unprecedented rise in drug shortages in both Europe and America. The number of shortages in the US has been growing steadily from 70 in 2006, peaking at 276 in 2011 . However this is not limited to the US, it is a global pandemic; in 2011 a Belgian pharmacy journal listed 21 countries that were experiencing supply shortfalls .

Action is being taken by regulators in both Europe and America to minimise any future impacts on patients. In October 2011, the US Food and Drug Administration (FDA) issued a review of their approach to Medical Product Shortages and last month the European Medicines Authority (EMA) followed suit by issuing a reflection paper, discussing the scale and origins of the problem and detailing their plans to manage the situation in the future.

Whilst the root causes of each individual product shortage will differ, many had their origins in problems at the manufacturing facilities (accounting for 43% of cases investigated by the FDA in 2011) . The frequency of these ‘manufacturing problems’ has been strongly influenced by industry wide trends, most notably:

• Generic players struggling with manufacturability of complex products whilst trying to keep their cost base to a minimum (in particular injectables such as propofol, chemotherapy agents and nutrition products)
• Regulators taking more punitive action to combat systemic quality systems failings and manufacturers who are sensitive to this more stringent regulatory environment, taking their own pre-emptive actions (voluntary plant shut downs, precautionary recalls).
• Consolidation of the outsourced supply base resulting in single incidents further up the supply chain impacting multiple downstream companies (e.g. mould contaminated intravenous antibiotics sourced from Claris triggered a recall for 5 different companies in the US)
• Progressive outsourcing to less well regulated countries with less regulatory oversight (“Today, about 70% of all APIs consumed in Europe are imported from China and India, where their factories are rarely inspected for compliance with EU standards by EU authorities” European Fine Chemicals Group)

These factors have combined to create an industry wide crisis, which has forced Regulators to redefine their own rules, including:

• Fast tracking the approval of alternative new therapies (e.g. in the US, Shire’s drug for the treatment of Gaucher disease was fast tracked in the wake of contamination at a Genzyme facility)
• Allowing imports of drugs not specifically licensed for a country (e.g. in the last month, as the result of a shortage of the Novartis rabies vaccine Rabipur, an agreement between the MHRA and Department of Health has allowed Sanofi Pasteur MSD to import the unlicensed Verorabvaccine).
• Where product scarcity already exists, recalls or production shut downs will not necessarily be enforced, even when substandard products are known to be in the market place

In the US, the FDA is coming under increasing pressure from Congress to directly intervene less and collaborate more with manufacturers to resolve manufacturing deficiencies.

In Europe, the EMA has reflected on its own role in recent shortages and issued an action plan to improve inter-regulator collaboration, early warning systems, and more importantly from a manufacturer’s perspective, putting the responsibility for supply chain resilience firmly in the hands of the Manufacturing Authorisation Holders themselves.

Actions outline the need for better and more proactive risk management of production processes supported by evidence of identified weakness and corresponding contingency plans. Industry is invited to propose solutions by Q2 2013 and implementation planned for Q1 2014.

Are the vulnerabilities in your production processes (both internal and external) fully understood, prioritised and appropriately mitigated? A quantative approach to supply chain risk management highlights the most exposed links in your supply chain and allows you to evaluate the potential cost to your business of doing nothing to mitigate that loss.

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