The U.S. Food and Drug Administration (FDA) wants an 18-month pause in litigation over its refusal to hand over key safety data on the COVID-19 vaccines.

The request is opposed by two groups that sued the FDA, trying to force the release of the records on possible COVID-19 vaccine side effects following Freedom of Information Act (FOIA) denials.

FDA officials say a federal court should implement the pause because of orders in other cases that require the agency to produce a certain amount of records each month.

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Yet the company, founded in 2016, didn’t seek permission from the U.S. Food and Drug Administration (FDA) until early 2022 – and the agency rejected the application, seven current and former employees told Reuters.

The rejection has not been previously reported. In explaining the decision to Neuralink, the agency outlined dozens of issues the company must address before human testing, a critical milestone on the path to final product approval, the staffers said. The agency’s major safety concerns involved the device’s lithium battery; the potential for the implant’s tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue, the employees said.

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Source: https://www.cnbc.com/2023/03/02/us-regulators-rejected-elon-musks-bid-to-test-brain-chips-in-humans-citing-safety-risks.html

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The FDA’s interactions with Biogen were “atypical” and did not follow the agency’s documentation protocol, according to a staff report on the findings of an 18-month investigation conducted by two House of Representatives committees into the drug’s regulatory review, approval, pricing, and marketing.

The FDA approved Aduhelm in June 2021 under an accelerated approval pathway over the objections of its panel of outside advisers, who did not believe data definitively proved the drug’s benefit to patients.

It was authorized based on evidence that it could reduce brain plaques, a likely contributor to Alzheimer’s, rather than proof that it slowed progression of the lethal mind-wasting disease.

The Medicare program restricted its coverage, which has led to severely limited use of the Biogen drug.

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