KV Pharmaceutical Goes After the FDA, Again

Published: Mar 15, 2013

If at first you don’t succeed… KV Pharmaceutical is not giving up in its fight with the FDA. The embattled drugmaker is appealing the dismissal last fall of a lawsuit that claimed the agency abdicated its responsibility to prevent some compounding pharmacies from offering lower-cost versions of its controversial Makena treatment for premature births. The move is the latest attempt by KV to salvage Makena, which was approved two years ago, but quickly became the subject of a heated debate over its pricing. The drug was granted orphan status, which confers seven years of market exclusivity, and KV charged $1,500 compared with $10 to $20 a week for compounded versions. Shortly afterwards, the FDA took the unusual step of deciding not to prevent compounded versions. How so? Normally, the FDA would have banned the sale of older, unapproved drugs. But the Obama adminstration was concerned about harsh publicity over Makena pricing since a federal agency had allowed a monopoly to develop. The FDA decision not to pursue enforcement actions against compounders, unless there was a safety issue, was significant because the agency was dragged into a debate over cost, which we wrote in an earlier story. But, as we reported last fall, a federal judge found that the FDA appropriately exercised its discretion in whether to pursue enforcement actions against compounders. She also ruled that the agency clearly conveyed the circumstances under which such actions may be taken and when compounding was permitted without violating the law. In effect, she decided that KV failed to bring any appropriate claims. KV had argued, among other things, that the FDA denied its right to incentives under the law, notably the Orphan Drug Act, and failed to uphold the Food, Drug & Cosmetic Act. In doing so, the drugmaker charged the agency undermined the seven-year market exclusivity that was granted Makena when the drug was approved and, therefore, hurt its ability to compete against compounders and caused “irreparable harm.” In fact, KV subsequently filed bankruptcy and blamed the FDA for its predicament.

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