The FDA could become much smaller if a proposal by President Trump to separate the regulation of food and medicines comes into effect.
The current dual role makes no sense, according to a White House document that wants around 5,000 FDA staffers transferred to the U.S. Department of Agriculture so that all food regulation occurs under one roof. The current structure at the FDA is a relic of the early 1900s that “introduces greater risk, inefficiency, and inconsistency into the important work of ensuring food safety, which affects everyone in America.”
The plans would also see around $1.3 billion in budget transferred from the FDA—which would be rebadged as the “Federal Drug Agency”—to a new “Federal Food Safety Agency,” which would also be funded with around $1 billion in USDA money. The new FDA would then be able to “focus on its core responsibilities of drugs, devices, biologics, and tobacco,” the White House said.
The document gives one example of how the current system is flawed: the regulation of pizza. If it’s a cheese pizza, the FDA has the authority, but pepperoni falls under the USDA’s Food Safety and Inspection Services (FSIS). Have chicken as a topping? The FDA regulates their feed, but the FSIS inspects them at slaughter.
“In the long term, the Administration expects this proposal would result in improvements in food safety outcomes, policy and program consistency, and more efficient use of taxpayer resources,” it said.
The proposals are part of a sweeping reorganization plan that Trump wants to put in place to tackle “fragmented” decision-making at federal agencies, and the FDA changes come alongside plans to merge the Departments of Education and Labor into a single agency, as well as dozens of other initiatives covering housing, fisheries, environmental programs, humanitarian assistance and international development.
There’s still a long way to go before the plans could be enacted, as Congress would have to agree to the changes, but there does seem to be support for some degree of government reform. For instance, the General Accountability Office (GAO) has been highlighting the problems of food safety regulation for a long time, and earlier this year it published a report saying that—as of January—the FDA had still not set out a clear path for the implementation of food safety strategies in the 2016-2025 program.
It’s worth noting that the White House announcement came just ahead of an FDA “tweetorial” on the subject of food safety, with Commissioner Scott Gottlieb saying: “FDA takes our responsibility for assuring safety of the food supply seriously, and food safety is one of my highest priorities.”
FierceBiotech reached out to the FDA for comment on the proposals but hadn’t heard back by the time this article was published.
By Phil Taylor
Source: Fierce Biotech
Monday, the French pharma giant officially moved into its new global home base in Paris, dubbed La Maison Sanofi. The 9,000-square-meter (about 96,875-square-foot) facility comprises two historic buildings and will host around 500 employees, the company explained in a release.
On the first day of the new year, former Sandoz chief Richard Francis will take the reins from Schultz, who is hanging up his CEO hat to retire on Dec. 31, Teva said Monday. The news comes a little more than two weeks after Teva publicly said it was looking for Schultz’s replacement.
General Electric Co. set the terms for the spinoff of its healthcare division, putting an initial value of roughly $31 billion on the soon-to-be-public company. The Boston conglomerate plans to split into three separate public companies by early 2024. Following the healthcare spinoff, it plans to separate its aerospace business from its power and renewable-energy units.