CHAPTER § 1.08 Obtaining Admissible Evidence and Testimony from FDA

• Jurisdiction: United States

§ 1.08 Obtaining Admissible Evidence and Testimony from FDA

[1] Records and Documents

FDA is a valuable source of information for private litigation. FDA maintains a variety of official records relating to the products subject to its jurisdiction. Examples of such records include submissions made by industry to FDA, internal memoranda created by FDA employees, and official FDA correspondence reflecting the Agency's review and consideration of safety, efficacy, manufacturing, marketing, and other issues related to approved and investigational drug products. Records and documents may be obtained from FDA through a Freedom of Information Act ("FOIA")⁶⁶¹ request or a subpoena duces tecum for records issued in connection with the pending litigation.⁶⁶²

FOIA is a federal disclosure law establishing a presumption that records and documents in the possession of federal agencies are publicly accessible.⁶⁶³ Under FOIA, the burden is on the government agency to justify the need for secrecy. Agencies are required to provide the fullest possible disclosure of records and documents, and an agency must make a case for withholding documents in terms of the exemptions to the rule of disclosure.⁶⁶⁴ Importantly, the application of FOIA exemptions is not mandatory. Agencies may make discretionary disclosures of exempt information where they are not otherwise prohibited from doing so.⁶⁶⁵

FOIA requests are routinely filed with FDA and are handled by the Division of Freedom of Information ("DFOI"), a dedicated office within the Agency.⁶⁶⁶ FDA will generally disclose public, non-privileged information in response to a FOIA request.⁶⁶⁷ Conversely, the Agency is not authorized to disclose non-public trade-secret and/or confidential commercial information, and will not disclose records it deems exempt from disclosure.⁶⁶⁸ Depending on the scope of the request, the number of records sought, and the extent to which those records contain nonpublic information exempt from disclosure, FOIA requests can take several months to over a year to process.⁶⁶⁹ FOIA requests that are narrowly tailored and planned in advance, however, may yield records and other helpful information within litigation deadlines.⁶⁷⁰

[a] Public and Electronic Reading Rooms

The 1996 FOIA amendments mandated the creation and maintenance of publicly accessible "reading rooms" that contain FOIA response materials and other information routinely available to the public.⁶⁷¹ These databases have electronic search and indexing features and should be examined submitting a FOIA request. The types of documents available in FDA's public reading rooms are detailed in the Code of Federal Regulations, and include FDA records that have previously been released in response to FOIA requests.⁶⁷²

[b] Submitting a FOIA Request

FDA requires that all FOIA requests be submitted in writing to the DFOI. FOIA requests may be submitted for copies of existing records that were not prepared for routine distribution to the public. The term "records" includes any handwritten, typed, or printed document and documentary material in other forms, such audio or video recordings. A FOIA request must reasonably describe the desired records but need not specifically identify the records or be designated as a "FOIA request."

After DFOI receives a FOIA request, it is entered into the Agency's tracking system and assigned a control number. DFOI then delegates the request to the appropriate Agency component for processing. For example, a request for a drug-approval document would be processed by CDER. The assigned Agency component searches for the requested records and reviews them to determine whether they contain non-public information as defined under the FOIA or any federal regulation.⁶⁷³ Records that clear these thresholds are then released to the requestor, and any applicable processing fees are assessed.⁶⁷⁴ FDA informs a requestor in writing if no records responsive to the request were found. FDA also sends written notice if records were located but the Agency denied access to them under a statutory or regulatory exemption.⁶⁷⁵

If FDA denies an initial FOIA request, or fails to issue a determination within the 20-day statutory deadline, an administrative appeal can be made to the Deputy Assistant Secretary for Public Affairs at HHS.⁶⁷⁶ If the appeal is denied or the requestor believes that the appeal decision is unfavorable, the requestor can seek judicial review of the matter in federal court.⁶⁷⁷ Federal courts have jurisdiction to enjoin the Agency from withholding agency records.⁶⁷⁸ In a federal action to demand release of withheld FDA records, a requestor can argue in its complaint that FDA's decision to deny release of the records was either "arbitrary and capricious" or an "abuse of discretion" in violation of the Administrative Procedures Act ("APA").⁶⁷⁹ Whether a court will ultimately order FDA to disclose the records turns on the specific facts of each case.

[c] Subpoena for Records

A second method of obtaining records and documents from FDA is to serve an FDA employee with a subpoena duces tecum. The chief advantage of a subpoena over a FOIA request is that the Agency is required to produce records by a court-established deadline. Additionally, the Agency's failure to comply with a subpoena can result in various penalties at the court's discretion. FDA typically processes a subpoena as an expedited FOIA request.⁶⁸⁰ This means that the Agency will decline to produce information exempt from disclosure under FOIA, or information that is subject to the work-product doctrine, the attorney-client privilege, or the governmental deliberative-process privilege.⁶⁸¹

Under Federal Rule of Civil Procedure 45, a litigant may use a subpoena to command the production of designated documents. Rule 45 also permits the person served with a subpoena to object to the production of such documents. FDA regulations direct Agency employees served with subpoenas to appear in response to the subpoena, decline to produce the demanded records on the ground that such action is prohibited by FDA regulations, and state that a request for the production of Agency records should follow the procedures outlined in Chapter 21, Part 20 of the Code of Federal Regulations.⁶⁸² If FDA takes this position, the serving party may move the court for an order compelling production of the records. If the court decides in favor of the serving party, FDA regulations require that the Agency comply with a final court order mandating disclosure of the records it originally declined to produce.⁶⁸³

[2] Obtaining Testimonial Evidence from FDA

[a] Written Requests for Testimonial Evidence

Absent the express authorization of the Commissioner of FDA or her or his designated agent, Chapter 21, Section 20.1 of the Code of Federal Regulations prohibits Agency employees from testifying before a tribunal concerning any function of the FDA or any information acquired in the discharge of the employee's official duties.⁶⁸⁴ FDA regulations instruct parties who seek testimonial evidence from FDA to submit a written request to the Commissioner of FDA.⁶⁸⁵ The Commissioner will grant a request for testimony if FDA determines that it is in the public interest and promotes the objectives of the Agency and the FDCA.⁶⁸⁶ By its terms, Chapter 21, Section 20.1 of the Code of Federal Regulations vests discretion with the Commissioner to deny requests...