US Admin and GPhA moves to prevent drug shortages

In response to US President Barack Obama’s Executive Order of October 31 (The Pharma Letter November 1), at the end of last week the Obama Administration issued an interim final rule that will help prevent prescription drug shortages and the generic drug industry trade group also announced plans to address these problems.

The Department of Health and Human Services said that the rule will require manufacturers that are the only producer of certain critical drugs to report to the Food and Drug Administration all interruptions in manufacturing of products. The rule builds on the FDA’s current work to ensure Americans have access to the medicine they need.

President Obama’s Executive Order directed the FDA and the Department of Justice to take action to help reduce and prevent drug shortages, protect consumers, and prevent stockpiling and exorbitant pricing of drugs in shortage. Early notification of potential drug shortages is an essential tool in helping FDA work with drug manufacturers, hospitals, doctors, and patients to prevent or mitigate a drug shortage before it becomes a crisis.