November 2017

Yesterday, the full House passed its tax reform proposal, the Tax Cuts and Jobs Act (H.R. 1), on a party-line vote, 227-205.  In addition to the headline changes to the corporate and individual tax systems, the bill would make numerous changes to various fringe benefit exclusions, employer deductions for fringe benefits and executive compensation, cross-border

The White House released on November 15, 2017 the Vulnerabilities Equities Policy and Process for the United States Government (“VEP”) — the process by which the Government determines whether to disseminate or restrict information about new, nonpublic vulnerabilities that it discovers.  This release was motivated by criticism following the allegations that significant cyber-attacks have exploited

On November 16, 2017, the Food and Drug Administration (“FDA” or the “Agency”) will hold a public hearing on a proposed approach for sponsors seeking to market devices referencing drugs (“DRDs”) when the drug sponsor does not wish to collaborate with the sponsor of the device. FDA will accept comments to the docket until January

In late October, the House of Representatives quietly approved a bill that would dramatically strengthen Congress’s procedures for enforcing congressional subpoenas.  In adopting the bill, the bipartisan leadership of the House Judiciary Committee highlighted the challenges that Congress faces in obtaining materials from executive branch agencies.  Significant portions of the bill, however, apply to all

During the past two weeks, the U.S. Department of the Treasury’s Office of Foreign Assets Control (“OFAC”) and the U.S. Department of State have taken a number of steps toward implementing aspects of the Countering America’s Adversaries Through Sanctions Act (“CAATSA”), a major piece of sanctions legislation passed by the U.S. Congress in July and

With the Foreign Agents Registration Act in the news and public awareness of this formerly obscure statute at an all-time high, Senator Charles Grassley (R-Iowa) introduced legislation last week to revise the statute significantly, including reversing a decision Congress made in 1995 to remove most private sector reporting from FARA and place it instead under

According to a distinguished panel of lawyers from MSD and Covington & Burling, companies involved in Digital Health deals need to ask themselves the following questions:

  • What data is required to develop and deliver the Digital Health solution, and does your company have sufficient expertise in-house to analyze the data?
  • What happens if your technology