Former FDAers: OMB Polices Delay Regs, May Spur Backdoor Lobbying

Two former FDA officials say the White House’s unprecedented, stepped-up regulatory review policies are delaying FDA’s ability to issue scientific and technical guidance to industry in a timely manner and increasing the potential for political interference in the regulatory process. Former agency chief Scott Gottlieb questioned whether certain White House policies will advance patient care, and former FDA Principal Deputy Commissioner Joshua Sharfstein called for the White House Office of Management and Budget to be more transparent in its reviews...