Six former FDA commissioners called for the next administration or Congress to make the US food and drug agency a body independent of the Departments of Health and Human Services and Agriculture – insisting such a move could help cut through red tape in fulfilling its public health mission of regulating medical products.
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A set of 19 bills aimed at improving the efficiency and pace at which the FDA and the National Institutes of Health (NIH) do their work is now on its way the full Senate for consideration after the chamber's Health, Education, Labor and Pensions (HELP) Committee agreed during an April 6 markup session on the remaining pieces of legislation.
In a 344-77 vote on 10 July, the US House passed legislation intended to overhaul the US biomedical enterprise, with the aim of accelerating the discovery, development and approval processes for medical products – the 21st Century Cures Act (HR 6).
The US FDA on 20 June said it would permit Teva to sell its single-pill emergency contraceptive Plan B One-Step (1.5 mg levonorgestrel tablet) without a prescription or age restrictions – ending a battle that stretched across three administrations, pitting scientists against policymakers.