1. November 2011 15:40
Barack Obama has outlined a number of measures aimed at tackling the prescription drug shortages in the US.
The President has signed an Executive Order directing the FDA to broaden the knowledge of potential medicine shortages and has asked them to exercise regulatory reviews to help prevent future shortages.
The Order also states that the FDA should work with the Department of Justice to examine whether prescription shortages have led to illegal price gouging or stockpiling of medication.
“This is a problem we can't wait to fix,” said the President. “The shortage of prescription drugs drives up costs, leaves consumers vulnerable to price gouging and threatens our health and safety.”
Previously, the FDA has only had the power to direct drug makers to inform them of the discontinuation of a medication when it is available through a single manufacturer. The Executive Order now states that the Agency can take further action, asking drug manufacturers to provide adequate advance notice of discontinuances or other actions that could lead to shortages.
The Order also requires the FDA to review new manufacturing sites, drug suppliers and production changes.
A statement from the White House said: “While the causes and many of the solutions are outside of the FDA's authority, including the need for additional manufacturing capacity in the private sector, the Administration will continue its ongoing work with manufacturers and other stakeholders to help address drug shortages.”
It is estimated that typical grey market vendors mark prices up by an average of 650%, as a results of prescription drug shortages.