Mr Sean Griffin

Sean Griffin

Updates

Healthcare & Life Sciences

Lethal injection opinion from DOJ OLC threatens FDA's claims-based interpretation of 'intended use'
USA | 10 July 2019

In a recent opinion, the Office of Legal Counsel (OLC) in the US Department of Justice concluded that an article intended to effectuate capital punishment by a state or the federal government is not subject to regulation by the Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act. The OLC's opinion appears to have been issued as a result of litigation involving the FDA's obligation to block the entry of misbranded and unapproved drugs used under state lethal injection protocols.

Court vacates Medicare Advantage overpayment rule and curtails DOJ's pursuit of False Claims Act damages
USA | 03 October 2018

The US District Court for the District of Columbia recently vacated CMS's 2014 final overpayment rule, applicable to the Medicare Advantage programme, granting summary judgment to UnitedHealthcare that the final rule violated the Medicare statute, was inconsistent with the Affordable Care Act and the False Claims Act and violated the Administrative Procedures Act. Because the decision vacates the overpayment rule entirely, further rulemaking may be necessary.

FDA draft biologics guidance would rescind innovator exclusivities
USA | 13 April 2016

The Food and Drug Administration recently released a draft guidance regarding the implementation of the 'deemed to be a licence' provision of the Biologics Price Competition and Innovation Act. The guidance takes the surprising step of limiting innovator exclusivities as part of 'deeming' products to be licensed as biologics under Section 351 of the Public Health Service Act.