About 60 patient advocacy organizations and health professional associations call on Congress and the Trump administration to end the stalemate and reopen the federal government , saying that this closure would reduce the ability of the FDA (Food and Drug Administration) to ensure the protection of Americans from harm and have access to the latest therapies.
The FDA is one of the few organizations in the health sector to be shut down by the government, with funding being confused with that of the Department of Agriculture, even though it is part of the Department of Agriculture. Health and Social Services (HHS). . The HHS 2019 budget was approved by Congress last year and is therefore not affected by the closure.
"The current government closure is forcing the FDA to make difficult choices about the essential functions of its greatly reduced resources," the patient and physician groups said in their report. letter President Donald J. Trump and the majority and minority leaders of the US House and Senate. "These are decisions that should never be made – the health and safety of Americans today should never be weighed against the prospect of new vital treatments for patients," the authors wrote. signatories, including the American Society of Clinical Oncology. American Academy of Pediatrics.
When the closure began, about 41% of the 17,397 people employed by the FDA were not working and were not paid (paid leave). From January 18th (the last information available at the agency), 31% were on leave. Thirty-seven per cent of the staff was engaged in fee-based activities for pharmaceuticals and medical devices and was paid, and 9% was unpaid and working at no-charge activities. Twenty-three percent worked part-time and were partially paid.
FDA Commissioner Scott Gottlieb has informed the public of the agency's activities periodically via Twitter. Earlier in January, he said the agency could only had funding to last through the week of February 11th.
Mr. Gottlieb also stated that some workers would be recalled to carry out high-risk food inspections, as well as monitoring and inspections of high-risk products and facilities for medicines, medical devices and pharmaceutical preparations.
Office staff members brought back to work also add monitored devices to detect unwanted events and malfunctions and develop recall activities. Some 260 workers recalled are dedicated to inspecting high-risk apparatus, drugs and biologics facilities, Gottlieb said in a tweet on Jan. 15.
Groups of patients and doctors said that was not enough. "While congratulating Commissioner Gottlieb, the FDA's leadership and" critical staff "for the truly heroic work to maintain many aspects of its mission, we are concerned that this continued closure will not only endanger the health and safety of Canadians. current security of Americans, but jeopardize scientific discoveries and future innovations, "they wrote.
"We are asking the President and Congress to act immediately to bring the FDA back to its full potential.The health of Americans and the future of patients are at stake."