1. Home
  2. |Insights
  3. |DOJ Makes Significant Inflation Adjustment to Civil Monetary Penalties

DOJ Makes Significant Inflation Adjustment to Civil Monetary Penalties

Client Alert | less than 1 min read | 07.01.16

DOJ published an interim final rule on June 30, 2016, adjusting civil monetary penalties for inflation, that nearly doubles the prior penalty amounts under the Civil False Claims Act from the existing range of $5,500 - $11,000 to a new range of $10,781 - $21,563. The increased amounts, however, apply only to civil penalties assessed after August 1, 2016, for violations that occurred after November 2, 2015, while the penalty amounts for penalties assessed or for violations that occurred before these respective dates remain unchanged.

Insights

Client Alert | 5 min read | 04.13.26

EU Pharma Package: Global (Orphan) Marketing Authorization Compromise Proposal

In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA). We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product....