Regulators sometimes are an irritation to drugmakers, and Japan's Eisai has been really, really irritated as of late. The drugmaker, which this week lashed out at the U.K.'s cost watchdog as too restrictive, has lost its bid to force the Drug Enforcement Agency (DEA) to schedule Fycompa so it can get it launched in the U.S. The seizure drug was approved by the FDA a year ago.
In August, Eisai filed a lawsuit against the DEA saying its delay to classify the controlled substance was "unreasonable and egregious" and asked the U.S. appeals court in the District of Columbia to intervene. But according to the FDA Law Blog, the court has said no. It says the DEA responded to the legal action by "proposing" to put the the seizure drug, which the FDA approved in October 2012, on the Schedule III.
This is not the first time Eisai has found itself unable to market an approved drug while waiting around for the DEA to make a decision. It is a marketing partner for Arena Pharmaceuticals' ($ARNA) diet drug Belviq, and the two had to bide their time from June 2012 to last May until the DEA acted.
Eisai executives of late have found themselves in fights with regulators across the world over matters that they think seem unreasonable. Deputy President Yutaka Tsuchiya said this week that he had complained to officials in the U.K. that the routine refusal by the National Institute for Health and Care Excellence (NICE) to approve drugs for reimbursement is a big problem. He told Health Secretary Jeremy Hunt the company would pull its investments out of that country unless the watchdog is reformed. Those investments are not inconsequential. The drugmaker has invested £100 million ($161.5 million) on a new European headquarters and factory in the U.K.
And that dust-up followed one in June. Fed up with Germany's pricing authority, Eisai said it would stop selling Fycompa in that country. The cost regulator there had refused to approve the drug for brand pricing, saying that its benefits were unproven compared with older drugs such as GlaxoSmithKline's ($GSK) Lamictal. Eisai said it was "appalled" by the decision.
- read the FDA Law Blog post