Industry news

Drug Shortages

In the past two weeks both the FDA and the EMA have made moves to try to respond to growing concern over drug shortages. These measures are:

US FDA

The FDA proposed a new rule that would require drug manufacturers to notify the FDA at least six months in advance of a possible interruption in supply, or no later than five days after the interruption takes place. The agency would post a public noncompliance letter for drug makers that fail to warn it about potential shortages. The new rule for notification would cover medically important prescription drugs, including certain biologics, and would also include decisions made by a firm to stop making a particular drug.

EU EMA

The EMA launched a public catalogue containing information on supply shortages of medicines. The catalogue provides information on the reason for the shortage and the current status of the shortage; information on the extent of the shortage; specific information for patients and health care professionals; and links to relevant related documents.

Unfortunately, this catalogue does not give a complete overview of all medicine shortages occurring in the EU, as most shortages are dealt with at a national level.