European Drugmakers Propose Approach to Prevent Shortages

Europe’s brand and generic drugmakers are proposing a coordinated approach for regulators and industry to quickly identify and respond to drug shortages caused by manufacturing and quality issues.

The centerpiece of the scheme is a uniform template drugmakers would use to report problems that could cause shortages. The form would ensure consistency in the information gathered and improve coordination by regulators in the affected countries. Supply interruptions would be color-coded: red for high risk, yellow for medium risk and green for low risk.

Drugmakers would be required to include details about themselves and the product, the causes of the potential shortage, expected duration, steps planned or taken to address the shortage, the affected countries, notification to other parties and the name of the person completing the form and the date.

Information generated by the notification system could be used to assess the extent and nature of disruptions caused by manufacturing and quality issues, and any trends, drugmakers say.

The framework was proposed by the European Federation of Pharmaceutical Industries and Associations, the European Generic Medicines Association, the Association of the European Self-Medication Industry and the Plasma Protein Therapeutics Association.

The groups hope eventually to expand the system to all players in the drug distribution chain.
Read the joint statement at www.fdanews.com/01-15-EU-Supply.pdf. — Jonathon Shacat