March 17, 2022
Congress Needs to Fix the FDA's 'Accelerated' Drug-Approval Process – Bloomberg
The agency needs the authority to demand prompt clinical trials to demonstrate that medicines actually work.
The FDA needs to see that all drugs help patients.
Congress is targeting a strategy that drug companies have increasingly used to speed up the approval of their medicines. Legislation in the House of Representatives would put more guardrails on the Food and Drug Administration’s so-called accelerated approval pathway.
The bill, from Representative Frank Pallone, a New Jersey Democrat, offers needed fixes for a system that can allow questionably effective — and often breathtakingly expensive — drugs to linger on the market for years.