On January 6, the U.S. Department of Justice (DOJ) announced that biopharmaceutical company Athira Pharma Inc. has agreed to pay $4,068,698 to resolve allegations that it violated the False Claims Act (FCA) by failing to report allegations of research misconduct in grant applications and grant award progress reports and assurances submitted to the National Institutes of Health (NIH). The settlement resolved allegations brought forward by a whistleblower in a qui tam lawsuit.
According to the government, “Athira failed to report allegations that its former CEO, Leen Kawas, falsified and manipulated scientific images in her doctoral dissertation and in published research papers that were referenced in several grant applications submitted to NIH, including in a grant that NIH funded in 2019.”
The government alleges that by failing to report these allegations Athira “violated its regulatory obligations to disclose the allegations to NIH in grant applications and Research Progress Performance Reports, and to disclose them to the HHS Office of Research Integrity in Small Business Organization Statements, Institutional Assurances or Annual Reports on Possible Research Misconduct.”
The FCA allegations were brought forward in a qui tam lawsuit filed by Andrew P. Mallon Ph.D. Under the False Claims Act’s qui tam provisions, individuals may file lawsuits alleging government contracting fraud on behalf of the United States. In successful qui tam cases, whistleblowers are eligible to receive between 15 and 30% of the settlement or judgment. Mallon is set to receive $203,434.
“The failure of Athira to properly disclose allegations of falsified and manipulated scientific images by its former CEO to the NIH undermines public trust in taxpayer-funded research,” said Special Agent in Charge Steven J. Ryan of the HHS Office of Inspector General (OIG). “This settlement demonstrates HHS-OIG’s commitment to protecting the integrity of federally funded research.”
“The partnership between the scientific community and the federal government is built on trust and shared values of ethical scientific conduct,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “Today’s settlement demonstrates that the Justice Department will pursue grantees that undermine the integrity of federal funding decisions.”