(a) No officer or employee of the Food and Drug Administration or of any other office or establishment in the Department of Health and Human Services, except as authorized by the Commissioner of Food and Drugs pursuant to this section or in the discharge of his official duties under the laws administered by the Food and Drug Administration, shall give any testimony before any tribunal pertaining to any function of the Food and Drug Administration or with respect to any information acquired in the discharge of his official duties.
(b) Whenever a subpoena, in appropriate form, has been lawfully served upon an officer or employee of the Food and Drug Administration commanding the giving of any testimony, such officer or employee shall, unless otherwise authorized by the Commissioner, appear in response thereto and respectfully decline to testify on the grounds that it is prohibited by this section.
(c) A person who desires testimony from any employee may make written request therefor, verified by oath, directed to the Commissioner setting forth his interest in the matter sought to be disclosed and designating the use to which such testimony will be put in the event of compliance with such request: Provided, That a written request therefor made by a health, food, or drug officer, prosecuting attorney, or member of the judiciary of any State, Territory, or political subdivision thereof, acting in his official capacity, need not be verified by oath. If it is determined by the Commissioner, or any other officer or employee of the Food and Drug Administration whom he may designate to act on his behalf for the purpose, that such testimony will be in the public interest and will promote the objectives of the act and the agency, the request may be granted. Where a request for testimony is granted, one or more employees of the Food and Drug Administration may be designated to appear, in response to a subpoena, and testify with respect thereto.
Notes of Decisions
Frank v. United States Food & Drugs Admin., 998 F. Supp. 2d 596 (E.D. Mich. 2014).
· cites it 12× “The FDA responded by denying the requests on the bases of both 21 C.F.R. § 20.1 and the principles of sovereign immunity protecting federal agencies from being compelled by state courts to produce employee testimony or records.”
Susan & Andrew Giza v. Sec'y of Health, Educ. & Welfare, 628 F.2d 748 (1st Cir. 1980).
“3 The district court stated that heads of federal agencies have authority to restrict testimony by their subordinates and that such had been done in this case pursuant to an FDA regulation.”
Metrex Rsch. Corp. v. United States, 151 F.R.D. 122 (D. Colo. 1993).
· cites it 2× “Defendant also claims that Plaintiff may not depose employees of the Food and Drug Administration (FDA) without first obtaining the approval of the FDA Commissioner, citing 21 C.F.R. § 20.1 . Defendant is mistaken.”
Matthews v. Storgion, 174 F. App'x 980 (6th Cir. 2006).
· cites it 2× “They cite to 21 CFR § 20.1 (a), which forbids FDA employees, “except as authorized by the Commissioner,” from providing “any testimony .”
In re U.S. Bioscience Sec. Litig., 150 F.R.D. 80 (E.D. Pa. 1993).
· cites it 3× “Legal Analysis The Government has argued, in its memorandum in support of its motion to quash, that the “FDA’s long-standing policy, codified in the agency’s regulations at 21 C.F.R. § 20.1 , is to refuse to make agency employees available to testify in litigation to which the…”
Connaught Labs., Inc. v. SmithKline Beecham P.L.C., 7 F. Supp. 2d 477 (D. Del. 1998).
“SmithKline also filed an administrative request for testimony of employees involved in the pertactin research, pursuant to 21 C.F.R. § 20.1 . While the FDA produced documents, it refused to provide *479 testimony.”
Erva Pharm., Inc. v. Am. Cyanamid Co., 755 F. Supp. 36 (D.P.R. 1991).
“Moreover, we note that pursuant to 21 C.F.R. § 20.1 (b), "Testimony by Food and Drug Administration employees,” the Commissioner has not authorized Mr.”
Connaught Labs., Inc. v. Smithkline Beecham P.L.C., 165 F.3d 1368 (Fed. Cir. 1999).
“Maintaining that the documents provided were not sufficient for its purposes, Smith-Kline also filed a request under 21 C.F.R. § 20.1 for testimony of FDA employees involved in the pertactin research, but the FDA refused to allow the testimony.”
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