US Senate takes aim at prescription drug shortages
pharmafile | February 15, 2011 | News story | Manufacturing and Production | Merck, Zostavax, shortages, supply chain
A bill aimed at tackling the ongoing problem of prescription drug shortages in the US has been introduced in the Senate.
Senators Amy Klobuchar and Bob Casey tabled the Preserving Access to Life-Saving Medications Act earlier this month to help tackle shortages of life-saving medicines – particularly anaesthetics, cancer drugs and other medicines such as Merck & Co’s shingles vaccine Zostavax – that have reached ‘unprecedented’ low levels.
Meanwhile, the American Society of Health-System Pharmacists currently lists 150 “medically necessary” drugs that are in short supply, which is double the number from five years ago, according to Klobuchar.
The main elements of the bill are that pharmaceutical manufacturers will be obliged to notify the FDA whenever a factor arises that may result in a drug shortage, while the agency will be obliged to provide up-to-date, public notification of any shortage situation and the actions it will take to address them.
The lack of FDA authority to require notification of measures such as market withdrawals was held up to be a significant contributor to drug shortages in an ASHP summit on the topic held in November 2010.
“Physicians, pharmacists and patients are currently among the last to know when an essential drug will no longer be available – that’s not right”, said Klobuchar.
“This common-sense solution will help set up an early warning system so pharmacists and physicians can prepare in advance and ensure that patients continue to receive the best care possible.”
According to the FDA’s website, more than 50 medicines are currently on the shortages list[http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm], generally because of manufacturing delays, increased demand or other issues such as manufacturing site closures, recalls, quality defects or difficulties in sourcing raw materials.
In the case of Zostavax, the low supplies have been caused by a Centers for Disease Control and Prevention (CDC) recommendation that the shot should be given to everyone over 60, causing a sharp hike in demand.
Phil Taylor
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