Legal questions swirl around FDA's new expedited drug program, including who should sign off

A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been rocked by recent layoffs and resignations. Agency staffers and outside experts worry the FDA commissioner's voucher program runs afoul of legal, ethical and scientific standards used to review new medicines. FDA staffers tell The Associated Press the effort is taking decisions away from career scientists and placing them in the hands of political appointees. The program awards vouchers to drugs favored by President Donald Trump's administration, promising reviews in as little as one month, not six to 10 months. Health and Human Services says the voucher program prioritizes “gold standard scientific review."