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Gov't Accountability Project v. FDA, No. 12-1954, 2016 WL 4506967 (D.D.C. Aug. 26, 2016) (Jackson, J.)


Gov't Accountability Project v. FDA, No. 12-1954, 2016 WL 4506967 (D.D.C. Aug. 26, 2016) (Jackson, J.)

Re: Request for records concerning total sales of antimicrobial drugs labeled for use in food-producing animals during the year 2009

Disposition: Denying defendant's motion for summary judgment; denying plaintiff's motion for summary judgment; denying intervenor's motion for summary judgment

  • Exemption 3: The court holds that "Section 105 of [the Animal Drug and User Free Amendments of 2008 ("ADUFA")] is not a withholding statute under Exemption 3[.]" The court finds that "Section 105 of ADUFA does not likewise prohibit all public disclosure in unambiguous terms, nor does it mention FOIA; so it is reasonable to infer that Congress did not intend this section to serve as an all-purpose anti-disclosure statute within the meaning of FOIA Exemption 3." The court also notes that because it "disagrees with the agency's assertions regarding the nature of Section 105 of ADUFA, and it concludes that that statute is not a withholding statute for Exemption 3 purposes[,]" it "'do[es] not need to consider whether the statute meets the additional conditions of 5 U.S.C. § 552(b)(3)(A) or (B),' . . . nor must it address whether the FDA has read § 360b(l)(E) too broadly in withholding on Exemption 3 grounds the particular information it redacted[.]"
  • Exemption 4: The court holds that "summary judgment cannot be granted in favor of any party." The court first notes that "[e]veryone agrees that this case does not involve trade secrets, and that the information redacted . . . is commercial and obtained from a person." "Thus, the sole dispute regarding the agency's invocation of Exemption 4 is whether the withheld information is 'privileged or confidential.'" The court then finds that "although Defendants have carried their burden of showing that antimicrobial animal drug sponsors face actual competition, there is a genuine dispute of material fact regarding whether or not the drug sponsors whose information is reflected in [the d]ocument . . . would be likely to face substantial competitive injury as a result of the government's disclosure of the redacted data." "In short, both sides have presented credible arguments regarding a material issue – i.e., whether disclosure of the redacted data likely will cause substantial competitive injury to the sponsors who submitted the information – and both have submitted evidence in support of their respective positions." "Thus, this genuinely disputed remaining question of fact precludes the granting of summary judgment with respect to the Exemption 4 issue that is presented in this case."
Court Decision Topic(s)
District Court opinions
Exemption 3
Exemption 4
Updated January 14, 2022