When the sector worries about regulation it is usually about drug development and registration. But governments also regulate on monopolistic positions in life sciences. Adding to that, national security enforcement is now rising.

According to a report commissioned by PhRMA, the three largest pharmacy benefit managers continue to exclude more drugs from standard formularies, including those with expedited FDA approval. 

As they revise and interpret merger guidelines, the Federal Trade Commission and Department of Justice should pay particular attention to the anticompetitive impact of consolidation in the pharmacy benefit manager market, the generic trade group suggests.

After motion to advance fails at 17 February meeting, proposed study design will be revamped, not scrapped. Despite the 2-2 deadlock on the vote, commissioners uniformly expressed an interest in proceeding with research on PBM industry, focusing on the leading players.