In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice (“DOJ”) has been particularly aggressive in using the False Claims Act to pursue recoveries from individuals, health care providers, and drug manufacturers that participate in federal health benefit programs. In fact, from 2009 to 2016, DOJ collected $19.3 billion from health care False Claims Act settlements and judgments, with $2.5 billion recovered in fiscal year 2016, alone. (More DOJ false claims statistics can be found here.) DOJ’s enforcement efforts are not solely targeted against garden variety billing fraud, but also involve claims arising from alleged violations of health care regulatory requirements. Among other things, the DOJ has been targeting claims for reimbursement for off-label uses of regulated products. DOJ’s aggressive policy of holding manufacturers accountable for off-label claims under the False Claims Act is entirely consistent with FDA’s stance on off-label communications as described in the January memo. However, recent court interpretations of off-label communications as protected First Amendment speech, as well as interpretations of the causality component of False Claims Act claims, have apparently caused DOJ to reconsider its strategy with respect to such cases. Continue Reading The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 5

On Monday, ML Strategies (MLS) posted its weekly Health Care Update, which provides information from the previous week on a variety of important health care-related topics like implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and state and federal health regulatory developments.

In this week’s Update, MLS highlights two major developments for prescription drug manufacturers (among other topics):

  1.  the Medicaid Outpatient Drug Rule went to the White House’s Office of Management and Budget for final review; and
  2.  a federal district court judge ruled in Amarin Pharma, Inc. v. FDA that a drug manufacturer could market to health care professionals off-label uses for a prescription drug provided the manufacturer’s statements were truthful and non-misleading.

The Medicaid Outpatient Drug Rule could set standards for the Medicaid Drug Rebate Program and also provides for significant changes to what is and is not included in the Average Manufacturer Price (AMP) calculation, as well as how “best price” would be calculated for rebates.  Modifying the AMP calculation for the Medicaid program appears to be a priority for Congress, as the House also expressed interest in this issue when it passed the 21st Century Cures Act.

The Amarin Pharma decision is another significant victory for the drug industry (following the 2012 United States v. Caronia decision that drug manufacturers should be allowed to share and discuss with providers materials that support off-label claims).  Industry stakeholders must now wait to see how the FDA will react to Amarin Pharma and whether it will apply the decision in its off-label oversight framework.

To access past MLS Health Care Updates click here.