Case 1:23-cv-02378-RBW Document 1 Filed 08/16/23 Page 1 of 10
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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF COLUMBIA
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`Civil Case No. 1:23-cv-02378
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`PROTECT THE PUBLIC’S TRUST
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`712 H Street, N.E.
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`Suite 1682
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`Washington, D.C. 20002,
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`Plaintiff,
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`v.
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`U.S. FOOD AND DRUG ADMINISTRATION
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`10903 New Hampshire Avenue.
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`Silver Spring, MD 20993
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`Defendant.
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`_________________________________________ )
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`COMPLAINT
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`1. Plaintiff Protect the Public’s Trust brings this action against the U.S. Food and Drug
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`Administration under the Freedom of Information Act, 5 U.S.C. § 552 (“FOIA”), seeking
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`relief to compel compliance with the requirements of FOIA.
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`JURISDICTION AND VENUE
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`2. This Court has jurisdiction over this action pursuant to 5 U.S.C. § 552(a)(4)(B) and 28
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`U.S.C. § 1331.
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`3. Venue is proper in this Court pursuant to 5 U.S.C. § 552(a)(4)(B) and 28 U.S.C. § 1391(e).
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`PARTIES
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`4. Plaintiff Protect the Public’s Trust (“PPT”) is a nonprofit corporation dedicated to restoring
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`public trust in government by promoting the fair and equal application of the rules and
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`standards of ethical conduct to all public servants. Consistent with Justice Brandeis’s
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`aphorism that “Sunlight is said to be the best of disinfectants; electric light the most
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`efficient policeman,” PPT seeks to promote transparency and broadly disseminate
`1
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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF COLUMBIA
`
`
`Civil Case No. 1:23-cv-02378
`
`)
`
`PROTECT THE PUBLIC’S TRUST
`)
`
`712 H Street, N.E.
`
`
`
`)
`
`Suite 1682
`
`
`
`
`)
`
`Washington, D.C. 20002,
`
`
`)
`
`
`
`
`
`
`
`)
`
`
`
`
`Plaintiff,
`
`)
`
`
`
`
`
`
`
`)
`
`v.
`
`
`
`
`
`)
`
`
`
`
`
`
`
`)
`U.S. FOOD AND DRUG ADMINISTRATION
`)
`10903 New Hampshire Avenue.
`
`
`)
`Silver Spring, MD 20993
`
`
`
`)
`
`
`
`
`
`
`
`)
`
`
`
`Defendant.
`
`
`_________________________________________ )
`
`
`COMPLAINT
`
`1. Plaintiff Protect the Public’s Trust brings this action against the U.S. Food and Drug
`
`Administration under the Freedom of Information Act, 5 U.S.C. § 552 (“FOIA”), seeking
`
`relief to compel compliance with the requirements of FOIA.
`
`JURISDICTION AND VENUE
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`2. This Court has jurisdiction over this action pursuant to 5 U.S.C. § 552(a)(4)(B) and 28
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`U.S.C. § 1331.
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`3. Venue is proper in this Court pursuant to 5 U.S.C. § 552(a)(4)(B) and 28 U.S.C. § 1391(e).
`
`PARTIES
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`4. Plaintiff Protect the Public’s Trust (“PPT”) is a nonprofit corporation dedicated to restoring
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`public trust in government by promoting the fair and equal application of the rules and
`
`standards of ethical conduct to all public servants. Consistent with Justice Brandeis’s
`
`aphorism that “Sunlight is said to be the best of disinfectants; electric light the most
`
`efficient policeman,” PPT seeks to promote transparency and broadly disseminate
`1
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`Case 1:23-cv-02378-RBW Document 1 Filed 08/16/23 Page 2 of 10
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`information so that the American people can evaluate the integrity and ethical conduct of
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`those who act in their name. Louis Brandeis, OTHER PEOPLE’S MONEY AND HOW BANKERS
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`USE IT (1914), https://louisville.edu/law/library/special-collections/the-louis-d.-brandeis-
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`collection/other-peoples-money-chapter-v.
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`5. Defendant U.S. Food and Drug Administration (“FDA”) is a federal agency within the
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`meaning of FOIA, 5 U.S.C. § 552(f)(1). FDA has possession, custody, and control of
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`records responsive to PPT’s FOIA request.
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`STATEMENT OF FACTS
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`6. As Attorney General Garland has made clear, FOIA is “a vital tool for ensuring
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`transparency, accessibility, and accountability in government” whose “‘basic purpose . . .
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`is to ensure an informed citizenry,’ which is ‘vital to the functioning of a democratic society
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`[and] needed to check against corruption and to hold the governors accountable to the
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`governed.’” Merrick Garland, Memorandum for Heads of Executive Departments and
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`Agencies: Freedom of Information Act Guidelines, 1 (Mar. 15, 2022) (quoting Nat’l Labor
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`Rels. Bd. v. Robbins Tire & Rubber Co., 437 U.S. 214, 242 (1978)) (“Garland Memo”).
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`I.
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`FOIA Request Control # 2023-3161
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`7. On or about April 17, 2023, PPT submitted a FOIA request (attached as Exhibit A) to FDA
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`seeking the following:
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`From January 1, 2020, through April 12, 2023, records of communications between
`the identified special interest groups, also referred to as patient and consumer
`advocacy groups, and the list of FDA officials pertaining to those groups’ input on
`proposed Animal Drug User Fee and Animal Generic Drug User Fee commitments.
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` Center for Veterinary Medicine Officials:
`a) Director Tracey Forfa, JD
`b) Associate Director Roxanne Schweitzer
`c) Director Matthew Lucia, DVM
`d) Director, Timothy Schell, PhD
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`2
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`Case 1:23-cv-02378-RBW Document 1 Filed 08/16/23 Page 3 of 10
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`e) Director Regina Tan, DVM, MS
`f) Director Dorothy Bailey, DVM (Acting)
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`Organizations:
`1. Animal Equality
`2. Animal Legal Defense Fund (ALDF)
`3. Animal Liberation Front (ALF)
`4. Animal Rights National Conference
`5. The Animal Welfare Institute (AWI)
`6. The Animal Welfare League (AWL)
`7. Center for Biological Diversity (CBD)
`8. Compassion in World Farming (CIWF)
`9. Farm Sanctuary
`10. Humane Research Council (HRC)
`11. Humane Society of the United States (HSUS)
`12. In Defense of Animals (IDA)
`13. International Fund for Animal Welfare (IFAW)
`14. The Jane Goodall Institute
`15. Mercy for Animals
`16. The Nonhuman Rights Project
`17. People for the Ethical Treatment of Animals (PETA)
`18. Physicians Committee for Responsible Medicine (PCRM)
`19. Sea Shepherd Conservation Society
`20. The Wildlife Conservation Society (WCS)
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`8. The release of these documents is in the public interest because they will help the public
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`understand the process of advocacy group input associated with FDA user fees on proposed
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`Animal Drug User Fee and Animal Generic Drug User commitments, including from
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`animal drug product user fees. Animal Drugs and Feeds user fees are anticipated to total
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`$58 million in FY2023. See Congressional Research Service, The Food and Drug
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`Administration
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`(FDA)
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`Budget:
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`Fact
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`Sheet
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`at
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`5
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`(Dec.
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`9,
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`2022),
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`https://crsreports.congress.gov/product/pdf/R/R44576. The records sought by this request
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`will promote transparency of such fee programs including FDA’s user fee negotiations.
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`United States Food and Drug Administration, FDA: User Fees Explained (Oct. 3, 2022),
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`https://www.fda.gov/industry/fda-user-fee-programs/fda-user-fees-explained.
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`3
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`Case 1:23-cv-02378-RBW Document 1 Filed 08/16/23 Page 4 of 10
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`9. On April 19, 2023, PPT received an email entitled, “FDA Receipt of FOIA Request Control
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`# 2023-3161,” including an Acknowledgement Letter.
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`10. In its Acknowledgement Letter, FDA indicated “[w]e will respond as soon as possible” but
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`“[d]ue to an increase in the number of incoming requests, we may be unable to comply
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`with the twenty-working-day time limit in this case, as well as the ten additional days
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`provided by the FOIA.”
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`11. On May 12, 2023, having received no update on FOIA Request Control # 2023-3161, PPT
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`contacted FDA and inquired, “[p]lease also provide any updates you may have on the
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`search process.”
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`12. On June 5, 2023, the FDA responded indicating only that PPT’s request “is pending with
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`our Center for Veterinary Medicine.”
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`13. As the Garland Memo makes clear, “Timely disclosure of records is also essential to the
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`core purpose of FOIA.” Garland Memo, at 3.
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`14. As the record described above indicates, more than 115 days have elapsed since the FDA
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`acknowledged receipt of PPT’s request.
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`15. Yet the FDA still has not made a determination of whether it will comply with PPT’s
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`request. See Citizens for Responsibility and Ethics in Washington v. Fed. Election Comm’n,
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`711 F.3d 180 (D.C. Cir. 2013). The FDA has not produced responsive documents to PPT,
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`has not communicated to PPT the scope of the documents it intends to produce and
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`withhold, along with the reasons for such withholding, and has not informed PPT of its
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`ability to appeal any adverse portion of its determination.
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`4
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`Case 1:23-cv-02378-RBW Document 1 Filed 08/16/23 Page 5 of 10
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`16. Through the FDA’s failure to make a determination within the time period required by law,
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`PPT has constructively exhausted its administrative remedies and seeks immediate judicial
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`review.
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`II.
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`FOIA Request Control # 2023-3162
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`17. On or about April 17, 2023, PPT submitted a FOIA request (attached as Exhibit B) to FDA
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`seeking the following:
`
`From January 1, 2020, through April 12, 2023, records of communications between
`the identified special interest groups, also referred to as patient and consumer
`advocacy groups, and the list of FDA officials pertaining to those groups’ input on
`proposed tobacco user fee commitments.
`
`Center for Tobacco Products officials:
`a) Director, Dr. Brian King
`b) Deputy Director, Michele Mital
`c) Janelle R. Barth
`d) Kathleen Crosby
`e) Matthew Farrelly, Ph.D.
`f) May Nelson
`g) Ann Simoneau
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`Organizations:
`1. Bloomberg Philanthropies
`2. Bloomberg Initiative to Reduce Tobacco Use
`3. Bill and Melinda Gates Foundation
`4. Bureau of Investigative Journalism
`5. CDC Foundation
`6. Global Centre for Good Governance in Tobacco Control
`7. International Union Against Tuberculosis and Lung Disease
`8. Johns Hopkins University Bloomberg School of Public Health
`9. New Venture Fund
`10. Stopping Tobacco Organization and Products (STOP)
`11. Vital Strategies
`12. University of Bath
`13. University of Illinois at Chicago
`14. World Health Organization Tobacco-Free Initiative
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`18. The release of these documents is in the public interest because they will help the public
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`understand the process of advocacy group input associated with FDA user fees from
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`5
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`Case 1:23-cv-02378-RBW Document 1 Filed 08/16/23 Page 6 of 10
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`manufacturers and importers of tobacco products. User fees from manufacturers and
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`importers of tobacco products are anticipated to total $677 million in FY2023. See
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`Congressional Research Service, The Food and Drug Administration (FDA) Budget: Fact
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`Sheet at 5 (Dec. 9, 2022), https://crsreports.congress.gov/product/pdf/R/R44576. The
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`records sought by this request will promote transparency of such fee programs including
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`FDA’s user fee negotiations.
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`19. On April 19, 2023, PPT received an email entitled, “FDA Receipt of FOIA Request Control
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`# 2023-3162,” including an Acknowledgement Letter.
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`20. In its Acknowledgement Letter, FDA indicated “[w]e will respond as soon as possible” but
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`“[d]ue to an increase in the number of incoming requests, we may be unable to comply
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`with the twenty-working-day time limit in this case, as well as the ten additional days
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`provided by the FOIA.”
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`21. On May 12, 2023, having received no update on FOIA Request Control # 2023-3162, PPT
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`contacted FDA and inquired, “[p]lease also provide any updates you may have on the
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`search process.”
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`22. On June 5, 2023, FDA responded, indicating only that PPT’s request, along with three
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`other PPT requests, is “pending without our Center for Tobacco Products.”
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`23. As the Garland Memo makes clear, “Timely disclosure of records is also essential to the
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`core purpose of FOIA.” Garland Memo, at 3.
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`24. As the record described above indicates, more than 115 days have elapsed since the FDA
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`acknowledged receipt of PPT’s request.
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`25. Yet the FDA still has not made a determination of whether it will comply with PPT’s
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`request. See Citizens for Responsibility and Ethics in Washington v. Fed. Election Comm’n,
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`
`
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`6
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`
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`Case 1:23-cv-02378-RBW Document 1 Filed 08/16/23 Page 7 of 10
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`711 F.3d 180 (D.C. Cir. 2013). The FDA has not produced responsive documents to PPT,
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`has not communicated to PPT the scope of the documents it intends to produce and
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`withhold, along with the reasons for such withholding, and has not informed PPT of its
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`ability to appeal any adverse portion of its determination.
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`26. Through the FDA’s failure to make a determination within the time period required by law,
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`PPT has constructively exhausted its administrative remedies and seeks immediate judicial
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`review.
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`COUNT I
`Violation of FOIA, 5 U.S.C. § 552
`Wrongful Withholding of Non-Exempt Responsive Records in Response to FOIA Request
`Control # 2023-3161
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`27. PPT repeats and incorporates by reference each of the foregoing paragraphs as if fully set
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`forth herein.
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`28. PPT properly requested records within the possession, custody, and control of FDA.
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`29. FDA is an agency subject to FOIA, and therefore has an obligation to release any non-
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`exempt records and provide a lawful reason for withholding any materials in response to
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`a proper FOIA request.
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`30. FDA is wrongfully withholding non-exempt agency records requested by PPT in FOIA
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`Request Control # 2023-3161 by failing to produce non-exempt records responsive to its
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`request.
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`31. FDA is wrongfully withholding non-exempt agency records requested by PPT in FOIA
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`Request Control # 2023-3161 by failing to segregate exempt information in otherwise
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`non-exempt records responsive to the request.
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`32. FDA’s failure to provide all non-exempt responsive records violates FOIA.
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`7
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`Case 1:23-cv-02378-RBW Document 1 Filed 08/16/23 Page 8 of 10
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`33. Plaintiff PPT is therefore entitled to relief requiring Defendant FDA to promptly produce
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`all non-exempt records responsive to FOIA Request Control # 2023-3161 and provide
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`indexes justifying the withholding of any responsive records withheld under claim of
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`exemption.
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`COUNT II
`Violation of FOIA, 5 U.S.C. § 552
`Wrongful Withholding of Non-Exempt Responsive Records in Response to FOIA
`Request Control # 2023-3162
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`34. PPT repeats and incorporates by reference each of the foregoing paragraphs as if fully set
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`forth herein.
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`35. PPT properly requested records within the possession, custody, and control of FDA.
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`36. FDA is an agency subject to FOIA, and therefore has an obligation to release any non-
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`exempt records and provide a lawful reason for withholding any materials in response to
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`a proper FOIA request.
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`37. FDA is wrongfully withholding non-exempt agency records requested by PPT in FOIA
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`Request Control # 2023-3162 by failing to produce non-exempt records responsive to its
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`request.
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`38. FDA is wrongfully withholding non-exempt agency records requested by PPT in FOIA
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`Request Control # 2023-3162 by failing to segregate exempt information in otherwise
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`non-exempt records responsive to the request.
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`39. FDA’s failure to provide all non-exempt responsive records violates FOIA.
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`40. Plaintiff PPT is therefore entitled to relief requiring Defendant FDA to promptly produce
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`all non-exempt records responsive to FOIA Request Control # 2023-3162 and provide
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`indexes justifying the withholding of any responsive records withheld under claim of
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`exemption.
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`8
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`Case 1:23-cv-02378-RBW Document 1 Filed 08/16/23 Page 9 of 10
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`Protect the Public’s Trust respectfully requests this Court:
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`REQUESTED RELIEF
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`(1) Assume jurisdiction in this matter and maintain jurisdiction until the Defendant
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`complies with the requirements of FOIA and any and all orders of this Court.
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`(2) Order Defendant to produce, within ten days of the Court’s order, or by other such date
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`as the Court deems appropriate, any and all non-exempt records responsive to PPT’s
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`FOIA Request Control # 2023-3161 and FOIA Request Control # 2023-3162 and
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`indexes justifying the withholding of all or part of any responsive records withheld
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`under claim of exemption.
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`(3) Enjoin the Defendant from continuing to withhold any and all non-exempt records
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`responsive to PPT’s FOIA Request Control # 2023-3161 and FOIA Request Control #
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`2023-3162.
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`(4) Award PPT the costs of this proceeding, including reasonable attorney’s fees and other
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`litigation costs reasonably incurred in this action, pursuant to 5 U.S.C. § 552(a)(4)(E).
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`(5) Grant PPT other such relief as the Court deems just and proper.
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`Case 1:23-cv-02378-RBW Document 1 Filed 08/16/23 Page 10 of 10
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`Dated: August 16, 2023
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`Respectfully submitted,
`PROTECT THE PUBLIC’S TRUST
`By Counsel:
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`/s/Gary M. Lawkowski
`Gary M. Lawkowski
`D.D.C. Bar ID: VA125
`Glynis R. Gilio
`D.D.C. Bar ID: 1780627
`DHILLON LAW GROUP, INC.
`2121 Eisenhower Avenue, Suite 608
`Alexandria, Virginia 22314
`Telephone: 703-574-1654
`GLawkowski@Dhillonlaw.com
`Telephone: 703-636-9451
`GGilio@Dhillonlaw.com
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`Counsel for the Plaintiff
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