FDA sets out rules for approved drugs after concerns over middlemen

FDA – the US Food and Drug Administration – is holding a hearing with the panel on Wednesday, which will determine if some approved medicines that are passed through companies that are also FDA…

FDA sets out rules for approved drugs after concerns over middlemen

FDA – the US Food and Drug Administration – is holding a hearing with the panel on Wednesday, which will determine if some approved medicines that are passed through companies that are also FDA users should go back to being approved products. The development comes after the FDA was scathing about the way drugs companies partner with middlemen. It released a report that outlined six cases where middlemen received experimental drugs for a fraction of their manufacturer’s list price. Following the release of the report, the FDA sent a letter to Pfizer, J&J and other drugmakers asking how they planned to change their practices. The FDA made clear that it didn’t want to shut down drug companies; it just wanted them to follow the regulations they had made. The steps they were outlining were quite specific. You can read them here. The FDA also sent a letter to Moderna, asking for additional information that they don’t have the capacity to provide. You can read that here. Moderna is a biotech company that designs customized mRNA drugs. The mRNA drugs are synthetic, so they are designed to closely match a patient’s genetic makeup. The company has about 25 mRNA drugs in clinical trials. Of those, one is for childhood leukaemia. While the two companies aren’t approved to manufacture drugs in the US, they still do have rights to the medicines, making it easier for the FDA to screen. Among Moderna’s uses, the company has applied to use the drugs for oncology patients. We will be following this story for updates.

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