The FDA is positioned to fare better than many other regulatory agencies, some of which will be virtually shuttered until Congress reaches a deal to fund the government.
FDA programs funded through user fees will continue to operate, including those at the Center for Tobacco Products, according to guidance obtained by The Hill. That means the agency’s Oct. 31 target to propose highly anticipated regulations for electronic cigarettes remains unchanged.
Product approvals, and formal communications involving drug and device safety will also go on unabated, according to the FDA.
The agency will continue all activities needed to protect public health and safety, including high-risk recalls, civil and criminal investigations and scrutiny of certain imports.
The loss of the remaining 45 percent of the agency’s workforce will bring other programs to a halt. That includes most laboratory research, some compliance and enforcement activities and routine establishment inspections, according to the FDA.
Some federal inspectors will remain on the job.
“These excepted inspectors will prioritize their work based on public health need and will be deployed to respond to recalls, outbreaks or other situations requiring immediate attention,” the FDA said.
October 01, 2013, 09:42 pm