Meaningless red tape causing US medicines shortages; Oversight Report

A recent report from the US House Committee on Oversight and Government Reform documents a critical shortage of generic injectable medications that has occurred following enforcement activity by the Food and Drug Administration at companies and facilities where the drugs are made.

Chairman Darrell Issa (Republican, California) said the Committee has learned that FDA regulatory activity has effectively shut down 30% of the total manufacturing capacity at four of the country's largest producers of generic injectable medications. In response to FDA action, companies that produce generic injectable drugs have taken their manufacturing off-line simultaneous to other generic competitors doing the same.

Of the 219 drugs listed on the American Society of Health System Pharmacists (ASHSP) shortage list as of February 21, 2012, at least 128 - 58% of the drugs on the shortage list – were produced by at least one facility undergoing FDA remediation.