RE: BMJ Blog re Innova12 Jul 2021 09:38
pt 1
Why all the secrecy around Innova lateral flow tests?
July 11, 2021
The basis for the MHRA extending its exceptional use authorisation for Innova lateral flow tests must be published immediately if public trust is to be restored, say Allyson M Pollock and Peter Roderick
Last month, the Medicines and Healthcare products Regulatory Agency (MHRA) announced that it had extended for just over two months its exceptional use authorisation for the NHS rebranded Innova lateral flow tests (LFTs). The authorisation for them to be used by asymptomatic people testing themselves will now run until 28 August. The original six month authorisation expired on 22 June, and so without an extension the government’s covid-19 mass testing programme, Operation Moonshot, could not have continued. The extension came, however, just one week after the US Food and Drug Administration (FDA) said the tests should be put “in the trash.”
Unlike in the UK, no authorisation had been given for their use in the US, and the FDA has expressed its “significant concerns that the performance of the test has not been adequately established, presenting a risk to health,” along with warning that their labelling was “false or misleading.” Innova had earlier recalled the tests in the US in what the FDA described as “the most serious type of recall.”
The MHRA has said that it conducted a review following the FDA’s action, which reached a hardly resounding “satisfactory outcome,” allowing the authorisation to be extended. It is not known, however, what this review consisted of, what evidence the MHRA has as to whether the conditions of the original authorisation have been complied with and which justified the extension, why the extension is only for two months, and what the terms of the extended authorisation are. This is because the MHRA has refused to disclose this information, despite freedom of information requests. The recent publication by the Department of Health and Social Care (DHSC) on the test performance of LFTs is very limited. Why has this completely unacceptable state of affairs arisen?
The MHRA is an agency of the DHSC and has no independent legal status. Bizarrely, the authorisation is given by the secretary of state for health and social care (acting as the MHRA) to themselves (as the DHSC and deemed legal manufacturer) to supply the tests. The DHSC has entered into several contracts with Innova Medical Group for the tests, valued at perhaps as much as £3.2 billion. Innova is owned by Pasaca Capital, a California based, Nevada registered, private equity firm. It is reported to be setting up a manufacturing plant in Wales. Currently, according to their instructions for use, the tests are manufactured for Innova by Xiamen Biotime Biotechnology, based in Fujian, China, and are intended to be used on those “suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.”