December 7, 2021

Alliance for Stronger FDA Worries about Sequestration Budget Cuts

The Alliance for a Stronger FDA has released a policy update regarding the Food Safety Modernization Act and the possibility of budget cuts implemented through sequestration. Congress returns next week, which gives them only 10 working days to approve a fiscal year 2013 Continuing Resolution to fund  government programs such as the FDA and USDA before appropriations expire on October 1, 2012.

Then they’ll recess until after the election and come back at the end of November for another session. That would give them only four weeks to avoid budget sequestration, which is across-the-board cuts of about 8%. Those cuts were part of the contentious Budget Control Act of 2011 that passed over partisan wrangling about the debt ceiling. If the cuts occur, the FDA will lose $200 million from its current appropriation. And considering that the agency’s program costs are increasing by 15 to 20% each year, these cuts will be devastating.

Steven Grossman, the Deputy Executive Director of the Alliance, wrote, “the Alliance’s foremost concern will be to avoid the budget sequestration that is scheduled for January 2, 2013. If sequestration occurs: food will be less safe, drug and device approvals will be slower, problems with imports and globalization will become more numerous, and FDA modernization will be severely slowed (the opposite of what everyone, critics included, want.)”

He continued, “it is hard to imagine that anyone – including Congress and the President – thinks that the optimum FDA strategy is for the American people to rely on good luck when it comes to products under the agency’s jurisdiction.”

Mr. Grossman states that “a slower, less vigilant FDA is a boon for marginal companies, hucksters, and those attempting to cut corners … and, in contrast, creates a competitive disadvantage for companies that want to produce and market quality products. I was told yesterday that there are still companies being caught trying to import melamine-tainted milk into the United States.”

One of the FSMA rules that has been delayed covers the safety of imported foods. Just this year, there have been three nationwide food poisoning outbreaks linked to imported foods. The first, a Salmonella Bareilly and Salmonella Nchanga outbreak linked to raw scraped Nakaochi tuna imported from India, sickened at least 425 people in 27 states and the District of Columbia. Contaminated tempeh starter culture imported from Indonesia was linked to a Salmonella Paratyphi B outbreak that sickened 88 people in North Carolina and surrounding states. And there is a Salmonella Braenderup outbreak currently ongoing that is linked to mangoes imported from Mexico. That outbreak has sickened at least 105 people in 16 states.


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