Regulatory Focus™ > News Articles > FDA Maintains Compounding Exemption for KV Pharmaceuticals' Makena

FDA Maintains Compounding Exemption for KV Pharmaceuticals' Makena

Posted 18 June 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has announced the results of an investigation into compounded versions of KV Pharmaceutical's Makena (hydroxyprogesterone caproate), used to prevent pre-term births, which the company alleged were compounded to a lesser standard than allowed under the company's approved New Drug Application (NDA). The agency said in a statement it would continue to allow compounding of the drug after its investigation yielded no significant concerns regarding compounding samples.

The result of the investigation mark another chapter in a long-running and controversial battle between KV Pharmaceuticals and FDA, which began in 2011 after the company won approval for Makena. While the product had been on the market for years-produced by compounding pharmacies largely for the same indication it is now marketed for-KV Pharmaceuticals put the product through clinical testing and obtained marketing exclusivity from FDA as a result.

The approval raised a firestorm of controversy for both KV Pharmaceuticals and FDA after the company announced the drug -which previously cost $20 per injection-would now cost $1,500 per injection. The company relented after withering criticism and lowered the drug's price to $690 per injection and instituted a patient assistance plan to help consumers afford the treatment regimen, which can cost more than $30,000 for a full course of treatment.

Compounding as Enforcement Discretion--and a Source of Controversy

FDA, however, seemed to have a different solution in mind: allow compounding pharmacies to continue to make the drug themselves, allowing patients to continue to obtain access to low-cost versions of the drug. In a 3 February 2011 statement, the agency said while "greater assurance of safety is provided by an approved product," it was allowing licensed pharmacists to compound the drug under "certain conditions."

Quality concerns threatened to derail this enforcement discretion-focused strategy in November 2011 after KV Pharmaceuticals raised concerns about the quality of injectable versions of Makena compounded by pharmacists, saying it had obtained samples with quality defects posing risks to patients.

The agency's investigation into these claims failed to substantiate KV Pharmaceuticals' concerns, and the agency said it was largely rejecting the company's claims after the majority of samples contained either no contaminants or ones posing no danger to patient safety.

The agency said it would continue to allow compounders to manufacture Makena on a small scale under its oft-used doctrine of enforcement discretion. Large-scale manufacturing, however, will still be seen as circumventing "important public health requirements."

"The compounding of any drug, including hydroxyprogesterone caproate, should not exceed the scope of traditional pharmacy compounding," FDA added.


Read more:

FDA - Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena)

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