Over-regulation by government leads to drug shortages

LETTER — Posted Jan. 2, 2012

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It becomes more obvious with each passing day that the solution to the worsening drug shortage crisis is to be found in fewer regulations, not more. The excessive federal and state regulatory burden placed on pharmaceutical manufacturers is the primary cause of drug shortages.

When high costs, delays in approval and limited reimbursement stand in the way, manufacturers will choose the path of least resistance to the obstacles mounted by the federal government.

They will choose to produce products with the largest financial return and the highest demand, frequently to the detriment of our patients.

Blame the government, not the manufacturers. Make it easier to produce the drugs we need and allow fair reimbursement by decreasing regulatory burden, and I will bet the shortages will rapidly become a thing of the past.

You can't regulate away shortages; you can only deregulate your way out of shortages. Identify the offending regulatory obstacles, and get rid of them. Don't add to them.

Roman M. Hendrickson, MD, Sheridan, Mont.

Note: This item originally appeared at http://www.ama-assn.org/amednews/2012/01/02/edlt0102.htm.

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