FDA responsible for generic drug shortages ?

An article in Forbes (http://www.forbes.com/sites/aroy/2011/06/24/drug-shortages-the-new-death-panel/) describes strong FDA enforcement of Good Manufacturing practices with zero tolerances for generic manufacturers. Any violation causes shut down of a production line, with alternate suppliers requiring lengthy permissions to ramp up to compensate. In other words, an attempt to overregulate by the FDA and prevent adaptation by competitors may the cause of a shortage, which the FDA now has to solve.  Should the FDA be required to balance its regulation with consequences for availability of drugs ? Should the approvals required by audited competitors to ramp up production be eased ? Should distributors be given advance notice to build up inventory ahead of inspections to reduce potential shortages ?

About aviyer2010

Professor
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