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

The Food and Drug Administration won't have 75 years to release thousands of pages of documents it relied on to license its COVID-19 vaccine. Instead, the federal agency will have just over eight months to do so, per a federal judge's ruling.

The timeline ordered Thursday by U.S. District Judge Mark Pittman radically shortens the timeline under which the FDA has to produce troves of documents. The order stems from a Freedom of Information Act document lawsuit by a coalition of doctors and scientists with the nonprofit Public Health and Medical Professionals for Transparency. The group seeks an estimated 450,000 pages of material about the vaccine-creation process during the COVID-19 pandemic, which came into full force in the United States in March 2020.

Rather than producing 500 pages a month, the FDA's proposed timeline, Pittman ordered the agency to turn over 55,000 a month. That means all the Pfizer vaccine data should be public by the end of September rather than the year 2097, the deadline that the FDA wanted.

In June 2019, Scott Gottlieb joined the board at Pfizer approximately 2 months after departing the FDA, where he oversaw the entire agency and all of its employees. FDA official Mary Malarkey (real name), who submitted the FDA’s approval letter for the vaccine, worked at FDA during Gottlieb’s tenure. Gottlieb recently appeared on CBS’ Face The Nation to discuss Coronavirus. As NATIONAL FILE reported, the National Institutes of Health has a financial intellectual property stake in the Moderna vaccine.

Because FDA has expressed concern about whether it can adequately review the volume of material in time to protect against the disclosure of confidential commercial information, Pfizer seeks leave to intervene, at the Court’s and Government’s suggestion, for the limited purpose of helping FDA and the Court ensure expeditious action as ordered by this Court and ensuring that Pfizer is informed of relevant developments in relation to the case. Pfizer recognizes that it is the Government’s province to make the relevant determinations under FOIA, but Pfizer hopes that engaging in a dialogue with the Government where it has questions about Pfizer’s view regarding certain portions of the BLA will make it easier for the Government to meet the production schedule ordered by this Court.

In June 2019, Scott Gottlieb joined the board at Pfizer approximately 2 months after departing the FDA, where he oversaw the entire agency and all of its employees. FDA official Mary Malarkey (real name), who submitted the FDA’s approval letter for the vaccine, worked at FDA during Gottlieb’s tenure. Gottlieb recently appeared on CBS’ Face The Nation to discuss Coronavirus. As NATIONAL FILE reported, the National Institutes of Health has a financial intellectual property stake in the Moderna vaccine.