"Our View" - USA Today - April 7, 2011

By Greg Divis

Every woman deserves a medication approved and regulated by the Food and Drug Administration and available when needed. Makena^TM, an FDA-approved medication, fulfills important unmet needs for women at high-risk. In comparison to non-FDA approved compounded drugs, Makena is manufactured in an FDA-regulated and FDA-compliant, sterile facility, with tight controls in place to ensure that every dose has the same quality and consistency - particularly important for a medication administered as a weekly injection.

Why will Makena cost more than a non-FDA approved compounded drug? FDA-approved medications must meet high standards for effectiveness, safety and quality. It costs money to gain this approval, maintain FDA manufacturing standards and fulfill FDA requirements. Ther-Rx has already invested or committed more than a quarter billion dollars in Makena, including greater than $60 million in additional research costs for ongoing FDA-required studies involving 1,700 mothers and more than 500 infants. These studies are four times larger than the initial government-funded trial, and broader in scope.

Since Makena’s FDA approval, we met with stakeholders, listened to their perspective and took unprecedented action. In response to their concerns, we reduced the list price of Makena by nearly 55%. We are providing additional discounts to Medicaid and health plans and have expanded our patient assistance program, all resulting in even greater cost reductions.

What does this mean for women who are prescribed Makena? Eighty-five percent of patients will pay $20 or less per injection. Those whose financial need is greatest won’t pay anything at all.

There is one important reason we took these decisive actions — we are committed to ensuring access to all mothers who are prescribed Makena. Patients deserve FDA-approved and FDA-regulated medications. Makena can help make a positive difference as all stakeholders — including insurance plans, doctors, patient advocacy organizations, and Ther-Rx — do our collective parts to provide timely patient access to FDA-approved Makena.

We listened and we acted by reducing the cost and increasing access to FDA approved Makena. We welcome the opportunity to work together with all stakeholders in advancing the care of women who need this FDA-approved medication.

Greg Divis is CEO of K-V Pharmaceutical Co. and president of its subsidiary, Ther-Rx Corp.