Proposal to Withdraw Marketing Approval; Notice of Opportunity for a Hearing

The National Community Pharmacists Association (NCPA) appreciates the opportunity to provide feedback to FDA's Proposal To Withdraw Approval of MAKENA (hydroxyprogesterone caproate injection, 250 milligrams (mg) per milliliter (mL), once weekly). NCPA represents America's community pharmacists, including 19,400 independent community pharmacies. Together, our members represent a $78.5 billion healthcare marketplace, employ 240,000 individuals, and provide an expanding set of healthcare services to millions of patients every day. Our members are small business owners who are among America's most accessible healthcare providers. NCPA opposes FDA's proposal to withdraw approval of MAKENA. Additionally, NCPA requests that FDA have better designed studies and stronger clinical data in the event it is seeking to show that MAKEDA is not safe and effective. NCPA thanks FDA for the opportunity to provide feedback, and we stand ready to work with FDA to offer possible solutions and ideas. Please see attached for our full comments.