Washington, D.C. – U.S. Rep. Allyson Schwartz issued the following statement today following news that KV Pharmaceuticals issued a new pricing structure for Makena, a newly-approved drug that had been priced at 100 times the cost of the compound version of the drug currently on the market. Makena is a branded drug that prevents pre-term birth in high-risk women.

Schwartz’s efforts helped lead to the announcement by the U.S. Food and Drug Administration on March 30 that no enforcement action would be taken against pharmacies that produce the compound drug--ensuring women would continue to have access to this critical drug. Additionally, CMS informed state Medicaid programs the same day that it will continue to permit coverage of the compound drug.

“Earlier this week, KV Pharmaceuticals assured my office and the stakeholder community that they would find a workable solution and ensure access to Makena for all women regardless of ability to pay. They have offered a list price that is still 45 times higher than a nearly identical, existing, effective treatment. I am deeply concerned that the initiatives set forth by the manufacturer still lack straight-forward affordability and transparency in pricing.

“It remains unclear how the company's 'patient-assistance program' will avoid arbitrarily discriminating against women with different forms of coverage—whether public, private or self-pay. Additional details would be necessary to determine the reach of the program in practice. My objective is to provide continued access to a vital preventive treatment for all at-risk women. To guarantee that no patient falls through the cracks, the company must establish a more reasonable and justifiable list price.

“I urge KV pharmaceuticals to go back to the drawing board and provide a fair and transparent price for all women.

“In the interim, I urge the FDA and CMS to keep intact policies laid out earlier this week that will ensure access to the compounded drug.”

Click here for the Congresswoman’s previous statement on this issue:

http://www.house.gov/apps/list/press/pa13_schwartz/pr_mar30_makena.html 

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