Georgia Department of Community Health Requires Showing of “Medical Necessity” for FDA-Approved Drug Over Compounded Versions

April 7, 2011

By Roger C. Thies

On March 30, 2011, FDA publicly announced that it would not take enforcement action under certain conditions against pharmacies that compound hydroxyprogesterone caproate for injection for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth contrary to FDA's long standing policy to not permit pharmacy compounding of drugs that are commercially available and approved by FDA. See FDA, Compliance Policy Guide 460.200 – Pharmacy Compounding.  Please refer to our blog posting of March 31.

The Georgia Department of Community Health Medicaid Division, in reliance on FDA's refusal to enforce its own policies, has gone one step further.  According to a “Makena™ Position Statement,” in order to prescribe the FDA-approved drug instead of a compounded drug, a physician must demonstrate the medical necessity for the approved product instead of the compounded product notwithstanding FDA’s statement that “greater assurance of safety is provided by an approved product.”  This bizarre twist is a direct result of FDA deciding that a drug product’s cost and political pressure should dictate the Agency’s enforcement priorities.  Any manufacturer who decides to comply with FDA’s requests for approvals of marketed unapproved drugs and makes the investments in time and money to obtain approval must now ask itself whether it too will be punished by FDA’s apparent indifference to the Agency's enforcement policies.