On 15 November 2016, the European Commission (“the Commission”) opened its second report on Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12...08 December 2016
Supreme Court Reverses D.C. Circuit in Medicare Equitable Tolling Case
The D.C. District Court dismissed the hospitals’ claims because the statute did not suggest that Congress intended to authorize equitable tolling. On appeal, the D.C. Court of Appeals reversed, finding that there is a presumption that equitable tolling is permitted and that there was no indication that Congress intended to disallow tolling in this particular statutory scheme.
In its review, the Supreme Court first considered whether the 180-day statutory time limit for appeal to the PRRB is jurisdictional or whether it “is most sensibly characterized as a nonjurisdictional prescription.” The Court concluded that the filing deadline is not jurisdictional. The Court then held that HHS acted within the scope of its authority when it established a three year “outer limit” for appeals to the PRRB. Finally, the Court reversed the D.C. Circuit on the equitable tolling issue, holding that the presumption of the permissibility of equitable tolling has never been extended to an agency’s internal appeals deadlines and that there was no reason to think that Congress intended for equitable tolling to be allowable in this context.
The Supreme Court heard oral argument in this case on December 4, 2012.
On 26 September 2016, a new EU-US collaboration between the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) was announced. This new collaboration is ...06 October 2016
As reported here, earlier this month the U.S. Drug Enforcement Administration (DEA) issued a decision declining to transfer marijuana out of Schedule I. As marijuana remains a Schedule I...07 September 2016