AHIP Welcomes FDA Announcement on 17P Compound to Prevent Preterm Birth

   

Washington, DC– America’s Health Insurance Plans (AHIP) welcomes the announcement by the Food and Drug Administration (FDA) today that it does not intend to take enforcement action against pharmacies that continue to make available the more affordable compounded version of a drug to prevent preterm births. 

“This announcement by the FDA will ensure women with high-risk pregnancies continue to have access to a safe, effective, and affordable treatment option to prevent premature births,” said AHIP President and CEO Karen Ignagni.

AHIP recently sent a 

target="_blank">letter to the FDA

 seeking clearer guidance on the availability of compounded drugs for high-risk pregnant women following  

target="_blank">reports

 that the cost of prescription medicine aimed at preventing preterm birth is increasing from $10 to $1,500 per treatment – as much as $30,000 during a pregnancy – after the drug Makena was approved by the FDA and granted exclusivity under orphan drug status.  The letter raised concerns “about the potential for patients’ loss of access to the longstanding therapy as a result of the exclusivity granted to the newly approved drug and the extraordinary price increase established by the manufacturer” and requested that the FDA “provide clearer guidance on the availability of compounded drugs that may be needed to ensure affordable access for vulnerable populations.”   

In a 

target="_blank">statement

 released today, the FDA said that “in order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products.”

News Source : AHIP Welcomes FDA Announcement on 17P Compound to Prevent Preterm Birth