Dödligt virus från Kina orsakar panik (SARS-CoV-2, COVID-19)

9. The majority of documents that are responsive to FOIA requests received by CBER contain information that is exempt from disclosure (for example, trade secret, confidential commercial, and/or personal privacy information). The Federal Food, Drug, and Cosmetic Act (‘“FDCA”) prohibits the release of trade secret information to persons other than Department of Health and Human Services employees, to Congress, or to the courts where relevant in cases brought under the FDCA. 21 U.S.C. § 331(j). The Trade Secrets Act prohibits the release of trade secret information unless otherwise authorized by law. 18 U.S.C. § 1905. In addition, FDA regulations provide, infer alia, that: (a) trade secret and privileged or confidential commercial information is unavailable for public disclosure; and (b) identifying information in medical or similar files, which, if disclosed, would be an unwarranted invasion of personal privacy, is unavailable for public disclosure. 21 C.F.R. §§ 20.61, 20.63, respectively.

10. Consistent with these requirements to protect confidential information, FOIA exempts several categories of information from its disclosure requirements. 5 U.S.C. § 552(b).For example, FOIA exempts from its disclosure requirements: trade secrets and confidential commercial or financial information obtained from a person, 5 U.S.C. § 552(b)(4); and personnel, medical, and similar files if disclosure would result in a clearly unwarranted invasion of personal privacy, 5 U.S.C. § 552(b)(6).

11. As a result, it is important for FDA to perform a careful line-by-line, word-by- word review of all responsive records before producing them in response to a FOIA request to ensure exempt material is not disclosed.

...

31. There are 79 days (or approximately 11 weeks) between the December 14, 2021. status conference and Plaintiff's proposed deadline of March 3, 2022. As discussed above, CBER estimates that it takes approximately eight minutes per page to review responsive records. See, supra, J 18. ALFOI includes ten staff members — one branch chief and nine full-time staff members. See, supra, 44. In an attempt to illustrate the challenges with producing approximately 329,000 pages plus data files by March 3, 2022, we have calculated the number of pages ALFOI can expect to produce in that time using an assumption that each of those ten staff members’ could allocate all of their review time® over the next 11 weeks doing nothing but processing Plaintiff's request. Even using those unrealistic assumptions, ALFOI would only expect to be able to produce about 25,410 pages by March 3, 2022. ((10 staff members x 11 weeks x 30.8 hours/week x 60 minutes/hour) + 8 minutes/page = 25,410 pages). Thus at this hypothetical rate, which likely far exceeds what is feasible in reality, ALFOI could not reasonably be expected to produce even ten percent of what Plaintiff is asking this Court to order.

There are 79 days (or approximately 11 weeks) between the December 14, 2021. status conference and Plaintiff's proposed deadline of March 3, 2022. As discussed above, CBER estimates that it takes approximately eight minutes per page to review responsive records. See, supra, J 18. ALFOI includes ten staff members — one branch chief and nine full-time staff members. See, supra, 44. In an attempt to illustrate the challenges with producing approximately 329,000 pages plus data files by March 3, 2022, we have calculated the number of pages ALFOI can expect to produce in that time using an assumption that each of those ten staff members’ could allocate all of their review time® over the next 11 weeks doing nothing but processing Plaintiff's request. Even using those unrealistic assumptions, ALFOI would only expect to be able to produce about 25,410 pages by March 3, 2022. ((10 staff members x 11 weeks x 30.8 hours/week x 60 minutes/hour) + 8 minutes/page = 25,410 pages). Thus at this hypothetical rate, which likely far exceeds what is feasible in reality, ALFOI could not reasonably be expected to produce even ten percent of what Plaintiff is asking this Court to order.

PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY,
Plaintiff,

-against

FOOD AND DRUG ADMINISTRATION,
Defendant.

29. Following its January 31, 2022 production, ALFOI proposes to make one production at the end of each subsequent month totaling a minimum of 500 pages.® To the extent feasible, ALFOI plans to continue to prioritize records from Plaintiff's priority list. Although ALFOI proposes a minimum rate of 500 pages a month, ALFOI will produce records at a faster rate where feasible (such as with files like the CRF files discussed in the preceding paragraph). But ALFOI cannot guarantee that all records can be reviewed or produced at the rate that is possible for the CRF files. That is because other types of records will likely include more confidential information, and thus more corresponding redactions, which will require more research and production time. It is generally difficult to know whether particular records (or particular portions of a large record, such as an entire original BLA submission) will take more or less than the estimated eight minutes per page until reviewers have had an opportunity to perform at least a preliminary review of those records. As discussed above, ALFOI estimates that it takes approximately eight minutes per page to review records for a FOIA production. The CRF records discussed in paragraph 28 will take less time than that, but it is possible that other types of records will take longer than the estimated rate of eight minutes per page to review.

Putting aside that 20 rows per page is an inflated estimate of the time to review, at an average of 12,000 rows per data file, at the FDA’s proposed 20 rows per page, the 126 data files adds around 75,000 additional pages. (Dkt. No. 22 pp. 3, 9 n.6.) And assuming the FDA’s amorphous “tens of thousands of additional pages” amounts to 20,000 additional pages, then the grand total appears to be at least 451,000 pages. This is the best estimate Plaintiff has at this time. Even assuming the FDA produces the 12,000 pages it claims it will produce by the end of January, that still leaves at least 439,000 pages to be produced. This number pales in comparison to the millions of pages regularly produced in commercial litigations. Nevertheless, at the rate of 500 pages per month proposed by the FDA, the agency is asking that this Court give it at least 75 years to produce all the documents. The average life expectancy in the United States in 2020 was 77.8 years. (App000634 ¶ 6.) Thus, the FDA is asking this Court to wait until almost everyone alive today is dead to produce documents that are supposed to be “immediately released” after approval.

APPENDIX IN SUPPORT OF PLAINTIFF’S OPPOSITION TO FDA’S REQUEST FOR
AT LEAST 75 YEARS TO RELEASE PFIZER’S BLA DOCUMENT

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