![]() It's such a big deal that in states like Illinois, the law disallows the use of the unduly burdensome exemption if the gov agency doesn't respond within the time limits of the statute. These processes should be built with that in-mind, especially considering the importance of the information. Keep in mind, these people are aware of the existence of FOIA and the possibility that these records would be subject to FOIA. Generally there are ways to make sure these issues don't happen - from the beginning. If it's because private information is typed in a form, that form should be broken up in a way so that the important private information is typed into another field. For example, if everything's on paper, then the process failure is in a lack of transcription. If there's a problem where the release of 450,000 pages of patient information is so difficult that it can't be done, then there's a fundamental process fuckup that should be corrected. (disclaimer: my experience with FOIA is mostly at the state level and though I've read, used, and litigated federal FOIA issues, I'm no expert there) Once the companies had emergency use authorization in hand, they were ready to ship doses immediately. government’s Operation Warp Speed, were also churning out doses during clinical trials in the hopes that the vaccines would work. > In a final jolt of speed, some pharmaceutical companies, bolstered by big vaccine contracts and research cash from the U.S. The same article cites precisely one of those parallelization steps I'm talking about: Based on this comparison, that’s roughly 730 days - nearly two years - saved in recruiting alone. When volunteer recruitment began for clinical trials of the rabies mRNA vaccine in 2013, it took 813 days to get 101 participants enrolled. > For instance, it took just under 16 weeks to recruit and enroll more than 43,000 volunteers for the final phases of testing Pfizer’s vaccine. (Some steps got easier, too, for the same "everyone really wants a solution yesterday" reasons, like recruiting trial volunteers. The acceptable costs of parallelization similarly went up. Without appropriate limits on employment after leaving the FDA, staff might be tempted to put the interests of future employers, whose favor they wish to gain, ahead of public health. A 2018 study found that 11 of 16 FDA medical reviewers involved in approving 28 products now work for the companies whose products they regulated. To be clear, the revolving door between the FDA and the pharmaceutical industry is not limited to opioids. Last January, the head of the FDA’s analgesic division retired from the FDA to start her own consulting business, which promises drug makers “help” to “successfully and efficiently bring your products to market” with “more than 30 years of experience at the FDA.” Over the past 20 years, several other FDA staff involved in opioid approvals also left the FDA to work for opioid makers. For example, the 2 principal FDA reviewers who originally approved Purdue’s oxycodone application both took positions at Purdue after leaving the agency. But the FDA’s conduct is all the more troubling in light of the close relationship between the agency officials responsible for opioid oversight and opioid manufacturers. The FDA has never been held to account for its improper handling of the opioid crisis. It's about being suspicious of the pharmaceutical industry and the FDA, which has a revolving door that has been abused. It can't be done in my generation, but maybe in the next when this COVID saga is largely memory holed The only way to win back trust is to hold them accountable, for better or for worse, even if it feeds vaccine conspiracies. Quite frankly, the FDA would rubber stamp a pile of cow poop if it were politically expedient. You couldn't find a better way to destroy the credibility of the FDA than to "never" have meaningful transparency on the fastest, most hastily produced, many corners cut drug. Isn't it suspicious that the FDA is doing this, and that the public have a right to know and see the underlying documents within 90 days of drug approval? Isn't is Phizers responsibility to submit the documents in a way that protects privacy?Īll the norms are lost here. I don't think you read the part where the FDA has 18,000 employees. ![]() I don't think you have thought this through. ![]() So your for using power to totally destroy all the hard won battles for transparency, destroy trust in public institutions, and feed conspiracy theories?
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