Athira Pharma Inc., located in Bothwell, Washington, 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 to the National Institutes of Health (NIH) and Department of Health and Human Services (HHS) Office of Research Integrity in grant applications and grant award progress reports and assurances.
“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.”
“The research into neurological disorders such as Alzheimer’s and Parkinson’s Disease is critical to growing numbers of patients in our community,” said U.S. Attorney Tessa M. Gorman for the Western District of Washington. “That research must not be tainted by the misconduct highlighted in this case. To its credit, Athira immediately notified NIH of the research misconduct after the full board of directors learned of it. The company’s transparency significantly helped Athira mitigate its damages and demonstrated its resolve towards coming into compliance with the relevant law and regulations.”
“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 settlement resolves allegations that, between Jan. 1, 2016, and June 20, 2021, 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. Specifically, 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 civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the FCA by Andrew P. Mallon Ph.D. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. Mallon will receive $203,434 under today’s settlement.
The resolution obtained in this matter was the result of a coordinated effort between the Civil Division’s Commercial Litigation Branch, Fraud Section, and the U.S. Attorney’s Office for the Western District of Washington, with assistance from HHS-OIG.
The investigation and resolution of this matter illustrates the government’s emphasis on combating health care fraud. One of the most powerful tools in this effort is the FCA. Tips and complaints from all sources about potential fraud, waste, abuse and mismanagement can be reported to HHS at 800-HHS-TIPS (800-447-8477).
Trial Attorney Erin Colleran of the Justice Department’s Civil Division and Assistant U.S. Attorney Nicholas Bohl for the Western District of Washington handled the matter.
The claims resolved by the settlement are allegations only. There has been no determination of liability.