Harkonen v. U.S.D.O.J.

The Department of Justice’s and the Office of Management and Budget’s exclusion of press releases from their definition of dissemination under the Information Quality Act is within their discretion.

The Information Quality Act (IQA) required the U.S. Department of Justice (DOJ) to draft guidelines, in addition to the Office of Management and Budget (OMB) guidelines, to ensure the “quality, objectivity, utility, and integrity of information” disseminated from the agency, and to create procedures that would allow an individual to seek corrections to information violating the guidelines. The OMB and DOJ chose not to include information made through press releases under there definition of dissemination. Medical doctor, W. Scott Harkonen, was the CEO of and member of the Board of Directors for InterMune, Inc. when InterMune developed a new drug, Actimmune, which was approved by the Food and Drug Administration (FDA) and placed into the market. InterMune then wanted to use Actimmune to treat idiopathic pulmonary fibrosis and InterMune entered Phase III clinical trials. Upon meeting with the FDA, Harkonen was told that the clinical trial did not meet the primary endpoint and that the FDA would not grant approval. Harkonen later issued a press release that praised Actimmune’s results and downplayed its failures, contrary to the findings of the FDA. Harkonen was then convicted of wire fraud making the false statements and the DOJ issued a press release concerning the conviction. Harkonen requested for a correction under the IQA in response, asking that the DOJ retract their statements. Harkonen’s request was denied on the grounds that it was outside the scope of the guidelines. Harkonen filed suit, alleging that the denial of his request and the exclusion of press releases from the guidelines were arbitrary and capricious, an abuse of discretion, and contrary to law. On appeal, the Ninth Circuit held that Congress left discretion to the OMB and DOJ under Chevron. Therefore, their characterization of discretion was not arbitrary or capricious and the panel denied Harkonen’s claims. AFFIRMED.