Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC office, and articles from members of AGG outside the Food and Drug Practice.

In this Issue

• It Starts and Stops at the Top:
  FDA Issues Warning Letters for Lack of Corporate Oversight
• INSYS Therapeutics Reaches Settlement in Connection with Marketing of Opioid Painkiller
• FDA Allows Off-label Communications to Payors, Formulary Committees, and Similar Entities. What’s Next?

Industry Insights

It Starts and Stops at the Top:
FDA Issues Warning Letters for Lack of Corporate Oversight
By: Alan G. Minsk

The Food and Drug Administration issued two Warning Letters recently to pharmaceutical manufacturers where lack of corporate oversight was an issue. These Warning Letters reaffirm that senior management cannot delegate or contract away its regulatory responsibilities. More >

INSYS Therapeutics Reaches Settlement in Connection with Marketing of Opioid Painkiller
By: Sara M. Lord and Ryan J.S. Kerr

INSYS Therapeutics, Inc. announced that it has reached an agreement in principle with the U.S. Department of Justice (DOJ) to settle DOJ’s investigation into INSYS’s marketing of the opioid painkiller Subsys. DOJ alleged that INSYS paid improper kickbacks to prescribers in the form of payments for speeches, jobs for prescribers’ relatives and friends, and payments for meals and entertainment. The agreement in principle calls for the company to pay $150 million over five years, with the potential for additional contingency-based payments. This agreement in principle is subject to the negotiation of final settlement documents with the government. More >

FDA Allows Off-label Communications to Payors, Formulary Committees, and Similar Entities. What’s Next?
By: Seth S. Ray

In June, FDA issued two final guidance documents on medical product communications for drug and device manufacturers. The first guidance concerns “Medical Product Communications That Are Consistent With the FDA-Required Labeling.” As you will recall, the second guidance on “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities,” allows manufacturers to provide certain types of information (not limited to health care economic information) about unapproved uses of approved or cleared drugs and devices. More >