The administration is seeking $4.7 billion for the Food and Drug Administration, which includes new spending to implement laws to improve food safety and the safety of custom-mixed drugs made by large specialty pharmacies. The proposed funding represents an increase over last year’s $4.4 billion budget.
“This is really quite a positive outcome for FDA in this tight budget environment,” said FDA Commissioner Margaret A. Hamburg. “I consider the additional funding for the Agency to be a tribute to the important work FDA performs on behalf of the American people, the hard work and dedication of FDA employees, and our ability to meaningfully demonstrate the value of our work to stakeholders.”
Under the proposal, the Food Safety and Modernization Act would receive $253 million for implementation of the Food Safety Modernization Act to support programs aimed at preventing rather than reacting to food-borne illnesses. Every year, contaminated food sickens about 48 million Americans and kills about 3,000. Most of the money would come from new user fees for imported foods, imposed on the industry.
The budget also adds in $25 million to register and inspect large-scale specialty pharmacies — called compounders — that mix custom-ordered medications for patients, hospitals and doctors. The new enforcement measures were prompted by a fall 2012 fungal meningitis outbreak linked to tainted steroids produced by the now-shuttered, Massachusetts-based New England Compounding Center. The contaminated drugs sickened 751 people, resulting in 64 deaths. The funds would come from trims made to other portions of the agency’s budget dealing with medical products.
In a prepared statement, Sen. Tom Harkin (D-Iowa) — who is chairman of the Committee on Health, Education Labor and Pensions — said he was pleased to see the proposed budget include funding to deal with an ongoing problem of drug shortages. He called increased funding for food safety and the compounding industry “critical missions” for the agency.
“Americans must have confidence that the foods they are consuming and the medications they have obtained either through a hospital, a doctor’s office, or at the pharmacy counter are safe.”