Consumer groups proclaimed an increase in FDA user fees isn’t viable due to opposition from Congress, exacerbating the proposed cuts to FDA’s budget authority coming from taxpayer dollars.

Josh Long, Associate editorial director, Natural Products Insider

May 24, 2017

4 Min Read
Consumer Groups Slam Trumps Plan to Reduce FDA Food Safety Budget

President Donald Trump on Tuesday unveiled a budget for fiscal year 2018 (FY18) that would reduce expenditures for food safety programs at FDA, drawing criticism from consumer groups who doubted Congress would support the White House’s plan.

“It’s incredibly disappointing and irresponsible," said Cristina Stella, a staff attorney with the nonprofit Center for Food Safety, commenting in a brief phone interview on Trump’s budget for FDA. “Food safety…is a core responsibility of FDA, and defunding its food safety efforts sends the exact wrong message to the agency about what it’s priorities should be, and it doesn’t reflect what Congress has prioritized in statutes like the Food Safety Modernization Act."

Trump’s budget includes US$1.3 billion for food safety across FDA programs, a reduction of $83 million from funding appropriated in the FY17 continuing resolution, the U.S. Department of Health and Human Services (HHS) disclosed in a summary of FDA’s budget.

“In FY 2018, FDA will continue its most critical public health and safety activities, including outbreak response, implementation of Food Safety Modernization Act [FSMA] regulations, and ensuring that foods are safe and properly labeled," HHS proclaimed.

Added the agency: “FDA will make targeted reductions to the food safety program, including reducing staff levels through attrition. FDA will continue support for food safety research, cosmetics safety, partnerships with academic institutes, and international capacity building at reduced levels."

Jim O’Hara, director of Health Promotion Policy with the nonprofit Center for Science in the Public Interest (CSPI), described Trump’s budget as a “slap in the face of Americans."

“I mean basic protections and safeguards for our health and safety are being cut left and right," he said in a phone interview.

At the level of funding provided in Trump’s budget, FDA can’t adequately provide food safety protections, respond to outbreaks and offer industry technical assistance on compliance with new preventative controls under FSMA, indicated O’Hara, a former HHS official who served as Deputy Assistant Secretary for Health.

What’s more, he noted the FY18 reduction to FDA’s food safety budget is even greater than reflected in HHS’ budget tables. In recently funding the government for the remainder of FY17, Congress provided a $35 million increase for FDA’s food safety program, O’Hara said. HHS’ FY17 figures, however, only reflect funding under a continuing resolution that ended April 28, 2017.

“In essence, what they’re [Trump administration] also doing is taking away that new money that Congress just appropriated," O’Hara maintained.

Trump’s budget earmarks a total of $5.1 billion for FDA, an increase of $456 million or 10 percent above the funding provided by Congress in the FY17 continuing resolution. While the budget reflects an increase of $1.3 billion in user fees, it curtails FDA’s budget authority by $854 million, HHS disclosed.

“With the proposals in this budget, the burden on American taxpayers will be even lower—a little over one cent per American per day," HHS declared in its summary of FDA’s budget.  

However, consumer groups proclaimed the increase in FDA user fees isn’t viable due to opposition from Congress, exacerbating the proposed cuts to FDA’s budget authority coming from taxpayer dollars. It’s up to Congress—and its appropriations committees—to review Trump’s budget and ultimately decide whether to adopt it in part or in full.

“We are especially concerned because Congress has made clear that these additional user fees will not be adopted," said Troy Zimmerman, president of the Alliance for a Stronger FDA (Alliance), a multi-stakeholder advocacy group, in a press release criticizing Trump’s budget. “Thus, the administration has not proposed a viable pathway for the agency to avoid a 31% cut in FDA’s BA [budget authority] appropriation."

O’Hara of CSPI echoed the Alliance’s observations: “When you look at the actual budget authority number, it’s even worse for FDA because there’s not going to be $1 billion in new user fees."

In presenting FDA’s budget to Congress’ appropriations committees, FDA Commissioner Scott Gottlieb, M.D., acknowledged decreases in the agency’s budget authority, but he said the reductions are “targeted to certain areas where better tools and policies will allow us to do more with less, while preserving core mission activities."

Consumer groups are nonetheless worried that Trump’s budget will force FDA to make hard decisions.

“We are concerned that should the FDA, as a consequence of this proposed budget shift, become significantly underfunded, the agency will have to choose among important public health priorities," said Kristin Stephenson, vice president of the Alliance. “Beyond the needed investment in FDA’s core functions, sufficient funding is necessary to spur innovation and provide critical oversight initiatives for drugs, biologics, and food."

 

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

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