Eisai is asking the courts to force the Drug Enforcement Administration to schedule the epilepsy drug the FDA approved in January. The DEA schedule designation determines how tightly controlled the drug is, and the company cannot distribute the medication without the DEA’s decision. Eisai ran into a similar situation with its weight-loss drug Belviq, in that the FDA approved the drug in 2012 but the DEA did not find a place on its drug schedule until 2013. Eisai is asking that the starting point for Belviq’s patent status be pegged to the later date.
Agency for Healthcare Research and Quality will have a new director this month: Richard Kronick will replace Carolyn Clancy, reports Modern Healthcare. Kronick’s most recent post has been as the HHS deputy assistant secretary for planning and evaluation, but his background includes serving as the Clinton administration’s senior healthcare advisor from 1993 to 1994.
Research finds that mWellness runs into the same adherence issues as every other health-centric routine. MobiHealth News says a report published in the Journal of Medical Internet Research found that a test group that was offered health-centric apps, devices and tools to manage health for a year divided into two groups: “sustained users” which mean using the tech at least once a month and “non-sustained” users, which meant less than once per month. The difference: sustainers lost around 2.6 lbs, while the offliners gained 1.3 lbs. They also found that less than 30% of the test group fell in the sustained-use category.
