Washington, D.C. – U.S. Rep. Allyson Schwartz (PA-13) applauded the U.S. Food and Drug Administration’s (FDA) announcement today ensuring that women would be able to continue to receive access to a compounded drug that prevents pre-term labor. Schwartz has been actively engaged with the FDA and stakeholders to identify a prompt resolution regarding a newly approved drug, Makena, which was set at a cost that is nearly 100 percent greater than the current cost of the proven and effective compounded drug currently being used to prevent pre-term labor.  

The statement by the FDA today counters inaccurate claims by the pharmaceutical company that the agency would take enforcement action against the compounding pharmacies.

The news follows the agency’s approval of the drug Makena, a branded version of the drug that the manufacturer, KV Pharmaceuticals, has priced at $1,500 per injection, totaling $30,000 for the treatment over the course of the pregnancy. The compounded version of the drug, 17P, has been used for nearly thirty years at a cost of $10 to $20 per injection.

Now that Makena has been granted market exclusivity and orphan drug status by the FDA, the sticker shock to both private and public payers—including the Medicaid program—will have dire health and financial consequences without continued availability of the compounded drug.

“Women deserve to have continued access to a critical drug that dramatically decreases the potential of pre-term labor. Anything less is simply unacceptable,” Schwartz said. “I commend the Food and Drug Administration for its decision today to support access to the compounded drug. While the agency retains its right to revisit the decision at any time, I strongly urge the FDA to maintain this policy until KV Pharmaceuticals significantly reduces the list price for Makena. The price of Makena, as set by KV Pharmaceuticals, could put this lifesaving treatment out of reach for many women, either in their own ability to pay for the treatment, or if insurance companies deem the cost to be too great.  It is an affront to the health of women and babies.”

Earlier this month, Schwartz’s office contacted senior officials at the FDA to urge the agency not to take action against pharmacies or providers who determine that the use of a compounded preparation of 17P is clinically appropriate for their patients. 

To date, the company has declined to speak with the Congresswoman about its efforts to find a workable solution to the unreasonable list price.  

“I welcome the opportunity to work with the manufacturers to ensure Makena is affordable for all women, and hope they are willing to work together on a long-term solution to its flawed pricing structure,” said Schwartz.

Along with Reps. Louise Slaughter, Joe Courtney and 19 other members, Schwartz is sending a letter to KV Pharmaceuticals today urging the company to re-evaluate its pricing structure to ensure women at all income levels have access to this life-saving drug.

“The FDA announcement today was an important first step, but there is more work to be done,” said Schwartz.  

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