K-V won US Food and Drug Administration (FDA) approval for Makena in February but controversially charged $1,500 (€1,000) a shot. A formulation of hydroxyprogesterone, the active pharmaceutical ingredient (API), is sold by compounding pharmacies for $15 a shot, but K-V has questioned its purity.
“According to the analysis of this information provided by K-V, there is variability in the purity and potency of both the bulk APIs and compounded hydroxyprogesterone caproate products that were tested”, the FDA said.
The FDA has “carefully reviewed the data” but is yet to validate the K-V analyses. To generate its own evidence the FDA is sampling and analysing compounded hydroxyprogesterone caproate products and bulk APIs.
While the FDA’s response fell short of validating the K-V data it did remind physicians of the different regulatory pathways faced by approved and compound products. Before a product, such as Makena, is approved the API source, manufacturing process and quality checks are all assessed.
“Therefore, as with other approved drugs, greater assurance of safety and effectiveness is generally provided by the approved product than by a compounded product”, the FDA said.
Shares in K-V closed up 91 per cent after the FDA released its statement.
The analysis
K-V said API used by compounding pharmacies comes primarily from plants in China that are neither registered nor inspected by the FDA. Also, K-V said some of the companies claiming to be original manufacturers are actually re-sellers, re-packagers, brokers or distributors of APIs produced in China.
An independent laboratory, commissioned by K-V, found seven of 10 API samples originated in China. The other three came from US-based resellers of, what K-V believes to be, Chinese produced APIs. In many cases paperwork needed to trace an API back to the source was lacking.
K-V claims eighty per cent of the samples failed to meet at least one FDA standard for unknown impurities and half were incompliant with US Pharmacopeia requirements for potency.