By: | WSPA-TV
Published: August 01, 2012
Published: August 01, 2012
COLUMBIA, SC --
South Carolina's Department of Health and Human Services is vowing to fight a
lawsuit filed against it by a pharmaceutical company. K-V Pharmaceutical has
also filed separate lawsuits against Georgia and the U.S. Food and Drug
Administration.
Regardless of the outcome it will cost state taxpayers money, either in the cost of defending the lawsuit or in added Medicaid costs. A spokesman for DHHS says the agency doesn't have an estimate for how much the lawsuit may cost.
The lawsuit is about a drug given to pregnant women to prevent pre-term births. Since 2005, South Carolina has been using a generic version of the drug known as 17P. It's actually a hormone, hydroxyprogesterone caproate.
According to DHHS, "The use of compounded 17P is accepted by doctors as a safe and effective therapy to fight prematurity, and since 2005 SCDHHS has worked closely with physicians statewide to make it readily available to women at risk of pre-term births. SCDHHS, the March of Dimes, the SC Chapter of the American College of Obstetrics and Gynecology and the South Carolina Hospital Association are working together through the statewide Birth Outcomes Initiative to actively promote the use of 17P."
But K-V Pharmaceutical is suing, arguing that South Carolina and Georgia should be using only its version of the drug, named Makena. In a release, the company says, "In certain states, Medicaid participants, in particular, have been denied access to the only FDA-approved medication for their condition - despite the clinical judgment made by many healthcare providers that FDA-approved Makena® is the appropriate choice for their patients, and despite FDA’s repeated statements that Makena® offers greater assurance of safety and effectiveness than compounded 17P formulations."
To continue reading article click here.
Regardless of the outcome it will cost state taxpayers money, either in the cost of defending the lawsuit or in added Medicaid costs. A spokesman for DHHS says the agency doesn't have an estimate for how much the lawsuit may cost.
The lawsuit is about a drug given to pregnant women to prevent pre-term births. Since 2005, South Carolina has been using a generic version of the drug known as 17P. It's actually a hormone, hydroxyprogesterone caproate.
According to DHHS, "The use of compounded 17P is accepted by doctors as a safe and effective therapy to fight prematurity, and since 2005 SCDHHS has worked closely with physicians statewide to make it readily available to women at risk of pre-term births. SCDHHS, the March of Dimes, the SC Chapter of the American College of Obstetrics and Gynecology and the South Carolina Hospital Association are working together through the statewide Birth Outcomes Initiative to actively promote the use of 17P."
But K-V Pharmaceutical is suing, arguing that South Carolina and Georgia should be using only its version of the drug, named Makena. In a release, the company says, "In certain states, Medicaid participants, in particular, have been denied access to the only FDA-approved medication for their condition - despite the clinical judgment made by many healthcare providers that FDA-approved Makena® is the appropriate choice for their patients, and despite FDA’s repeated statements that Makena® offers greater assurance of safety and effectiveness than compounded 17P formulations."
To continue reading article click here.
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