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Anna Edney ,
Bloomberg News |
Obesity treatments, life-saving antibiotics and other drugs deemed to offer societal benefit despite their risks may get speedier U.S. approvals under plans being discussed to better balance innovation and safety.
Food and Drug Administration Commissioner Margaret Hamburg told scientific advisers the agency is considering letting makers of such treatments conduct faster clinical trials with a smaller group of patients than now required. A “special medical use” label could be used, allowing doctors to administer the drugs to patients in most dire need, she said.
“This is an issue of having the right science and data to assess risks and benefits but also a broader societal discussion about risks and benefits that individuals and communities are willing to take on and under what circumstances,” Hamburg said in a recording of a meeting released by her agency.