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.
KV, we wrote earlier, also claimed the FDA failed to block active pharmaceutical ingredients that were being illegally used by compounders, but the judge noted that the agency would not be able to distinguish upon arrival in the US which batches of ingredients might be destined for large-scale and, therefore, illegal compounding versus ingredients that could be appropriately used by a compounder to fill a valid prescription for an individual patient.
In its appeal, KV reiterates its stance, charging the FDA improprely succumbed to political pressure rather than exericse its obligation to enforcement the law and prevent compounded versions of Makena. The drugmaker points to a March 2011 press release in which the agency stated compounders would not be pursued "in order support access to this important drug" (read here).
"First, FDA’s statement involves active solicitation of unlawful conduct, not mere non-enforcement. Second, FDA’s statement announces a policy applicable to more than 1,000 compounders, not a single-shot decision not to proceed in a particular case involving a particular party or parties. Third, FDA’s action in making a public statement intended to elicit unlawful conduct that otherwise would not have occurred is an abdication of FDA’s responsibility to administer the" Food, Drug & Cosmetic Act, KV writes in its appeal (which you can read here).
"Had FDA merely decided against enforcement, and had not made that decision public, commercial-scale compounders would not have entered the market and KV would not have needed to bring this case," the drugmaker wrote. But "this case focuses on FDA's issuance of a press release that was the equivalent of an order or license, not on a mere decision not to enforce."
premature baby pic thx to cesar rincon on flickr