去年FDA在被起诉以后，按照要求披露了9000页的文件。此后，它开始找借口，推辞说Pfizer申请的数据和文件高达30多万页，需要75年才能披露完毕。法官命令它于3/1号前必须每月披露5.5万页。结果FDA开始发起法律动议，说自己没有能力提供这么多页。虽然这项起诉本来不关Pfizer什么事，结果Pfizer纠集了一个100多位律师的团队加入诉讼，想把第二批的披露推迟到5月以后，并且找出各种理由减少披露页数，美其名曰为尽快公开文件提供帮助。 法官的这一最终判决给FDA和Pfizer狠狠扇了一大嘴巴。 In accordance with the Parties’ agreed production schedule detailed in the Joint Status Report, the Court ORDERS that: 1.TheFoodandDrugAdministration’s(“FDA”)rollingproductions will each be due on the first business day of each month, instead of once every thirty days. 2.TheFDAwillproduce10,000pagesforthefirsttwoproductions, which will be due on or before March 1 and April 1, 2022. 3. The FDA will produce 80,000 pages on or before May 2, June 1, and July 1, 2022; 70,000 pages on or before August 1, 2022; and then 55,000 pages on or before the first business day of each month thereafter. 4. TheFDAcan“bank anyprocessedpagesinexcessofitsmonthly quota, such that, for example, if the FDA produces 90,000 pages in May 2022 (or 65,000 pages in September 2022), it would bank 10,000 pages. Then, in a subsequent month, if the FDA is unable to produce the full amount of pages required, it can apply the banked pages toward its quota for that month. PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY, Case 4:21-cv-01058-P Document 56 Filed 02/02/22 Page 2 of 2 PageID 2150 5. For the SAS files that duplicate the data in CRF files, the FDA will count every 40 rows as one page instead of every 20 rows as one page. SO ORDERED on this 2nd day of February, 2022. https://phmpt.org/wp-content/uploads/2022/02/056-ORDER-GRANTING-IN-PART-THE-MOTION-TO-MODIFY-THE-PRODUCTION-SCHEDULE-AND-ADDOPTS-THE-JOINT-STATUS-REPORT-MODIFIED-AGREED-PRODUCTION-SCHEDULE.pdf
法官的这一最终判决给FDA和Pfizer狠狠扇了一大嘴巴。
In accordance with the Parties’ agreed production schedule detailed in the Joint Status Report, the Court ORDERS that:
1.TheFoodandDrugAdministration’s(“FDA”)rollingproductions will each be due on the first business day of each month, instead of once every thirty days.
2.TheFDAwillproduce10,000pagesforthefirsttwoproductions, which will be due on or before March 1 and April 1, 2022.
3. The FDA will produce 80,000 pages on or before May 2, June 1, and July 1, 2022; 70,000 pages on or before August 1, 2022; and then 55,000 pages on or before the first business day of each month thereafter.
4. TheFDAcan“bank anyprocessedpagesinexcessofitsmonthly quota, such that, for example, if the FDA produces 90,000 pages in May 2022 (or 65,000 pages in September 2022), it would bank 10,000 pages. Then, in a subsequent month, if the FDA is unable to produce the full amount of pages required, it can apply the banked pages toward its quota for that month.
PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY, Case 4:21-cv-01058-P Document 56 Filed 02/02/22 Page 2 of 2 PageID 2150
5. For the SAS files that duplicate the data in CRF files, the FDA will count every 40 rows as one page instead of every 20 rows as one page.
SO ORDERED on this 2nd day of February, 2022.
https://phmpt.org/wp-content/uploads/2022/02/056-ORDER-GRANTING-IN-PART-THE-MOTION-TO-MODIFY-THE-PRODUCTION-SCHEDULE-AND-ADDOPTS-THE-JOINT-STATUS-REPORT-MODIFIED-AGREED-PRODUCTION-SCHEDULE.pdf
原始实验数据，各个年龄的疫苗二期三期实验，前前后后参加的应该有差不多快十万人。