FDA won't take action against pharmacies that compound Makena

FDA said it wouldn’t take action against compounding pharmacies that continue to supply 17-alpha hydroxyprogesterone caproate (Makena, KV Pharmaceutical, Ther-Rx).

In February, FDA approved the drug Makena (17P) for the reduction of the risk of certain preterm births in women who have had at least 1 prior preterm birth. Previously, the agent had only been available from pharmacies that had compounded the drug.

Following FDA approval, KV sent cease-and-desist letters to the pharmacies, suggesting that the agency would take action against them if they continued to synthesize the drug now that they had regulatory approval and market exclusivity.

FDA said in a statement that "this is not correct" and that it will not take action against these pharmacies. “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. As always, FDA may at any time revisit a decision to exercise enforcement discretion,” the statement read.

According to the FDA, KV Pharmaceutical received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by the National Institutes of Health to demonstrate the drug’s effectiveness. It also obtained 7 years of exclusivity under the Orphan Drug Act, obtained approval under FDA’s accelerated approval program, and received expedited review.

Because Makena is a sterile injectable with a risk of contamination, greater assurance of safety is provided by an approved product. However, under certain conditions, a licensed pharmacist may compound a drug product using ingredients that are components of FDA-approved drugs if the compounding is done for an identified individual patient based on a valid prescription for a compounded product that is necessary for that patient. FDA prioritizes enforcement actions related to compounded drugs using a risk-based approach, giving the highest enforcement priority to pharmacies that compound products that are causing harm or that amount to health fraud.

“This is an ongoing tale of 2 parallel issues that periodically intersect in the real world marketplace,” Randy Vogenberg, PhD, told Formulary. Vogenberg is principal at the Institute for Integrated Healthcare in Sharon, Mass., and executive director of the Biologic Access & Finance program at The Jefferson School of Population Health in Philadelphia. “On one hand is the authority to compound a prescription and the oversight role by FDA versus state boards of pharmacy. The other is small-volume or off-label use of ‘old’ products that can fall into a regulatory as well as reimbursement purgatory.

“In this case, which started before the economic recession and good intentions by FDA, today we see the old issues coming to the forefront again along with intense economic repercussions on consumers resulting from the manufacturer-based pricing of the FDA-approved product,” continued Vogenberg, who is also author of Pharmacy Benefits: Plan Design and Management. “In some ways, this can be the warning canary to all stakeholders that a true fix is needed in law, regulation, and the overlapping reach among state or federal agencies. It shows us again to be wary of unintended consequences of well-intended actions that reflect how our market operates in the real world, not the world of the Washington Beltway.”