Trump Effect: Big FDA Changes Afoot?

 

 

President Donald Trump has called FDA “slow and burdensome,” vowing to speed things up and reduce regulations at the agency during his administration. He ruffled feathers when he instituted a media blackout at USDA and took down animal welfare information within his first month in office. His picks to lead both agencies could shift how those agencies handle regulation, including the areas of dietary supplement and food safety.

 

The key to how the deregulation of FDA unfolds will likely be the new FDA Commissioner. Former FDA Commissioner Robert Califf, M.D., resigned on Trump’s inauguration day, and Stephen Ostroff, M.D., has once again taken over as acting commissioner—he served the interim post before Califf was appointed in early 2016.

 

In a January meeting with top pharmaceutical industry executives, Trump said he had “a fantastic person” in mind for the top post. Among the names being talked about for consideration include a few interconnected tech industry leaders—Balaji Srinivasan, Ph.D., a Silicon Valley entrepreneur, and Jim O’Neill, a venture capitalist who works for Silicon Valley billionaire and PayPal founder Peter Thiel, the man helping Trump vet potential FDA leaders.

 

Both tech candidates would bring a disruptive, start-up mindset to the slow-moving agency, but both have experience in health-related work. O’Neill worked in senior roles in the U.S. Department of health and Human Services (HHS)for several years under the George W. Bush Administration and has some experience working with FDA. Srinivasan has studied and taught computational genomics and co-founded a genetic testing company, Counsyl. Both advocate quick paths to market—focus more on safety, less on efficacy—a change aimed more at drug approvals, but could apply to supplements if adopted agency-wide. Still, neither has a medical decree or background in medicine, which would be a departure from the last nine commissioners.

 

“In my experience, an FDA commissioner often comes with an agenda that they plan to pursue,” said Susan Winckler, a former FDA chief of staff who now serves as chief risk management officer for Leavitt Partners—founded by former Health and Human Services (HHS) Secretary Mike Leavitt. “And … the agenda that they get to pursue is very different because something will happen.”

 

For instance, she recalled how former FDA Commissioner Andrew von Eschenbach, M.D., (2006 to 2009) intended to leverage his experience leading the National Cancer Institute (NCI) and focus his FDA term on eliminating deaths from cancer and on fostering innovation while protecting public health. “Dr. von Eschenbach got to spend a lot of time on food safety issues and a lot of time on product safety issues,” said Winckler, who noted the Commissioner hadn’t anticipated having to respond to melamine contamination of pet foods in 2007.

 

One candidate under consideration for the FDA job has a medical background and degree. Scott Gottlieb, M.D., is a former deputy commissioner at FDA (George W. Bush Administration) and was an advisor to the Centers for Medicare and Medicaid Services. He is less likely to be as brashly disruptive to the agency as would the tech candidates, and he is the first choice of most pharma executives, according to an informal survey by Mizuho Securities USA.

 

None of these candidates has much of a history with dietary supplements or has made any strong statements on the industry’s regulation. While at FDA, Gottlieb gave a speech in which he referenced the agency’s efforts to curtail false and misleading claims from supplement marketers, but he stayed focused on what the industry calls “bad actors.”

 

Perhaps more telling is what Trump has said about FDA, an agency he has called “the food police” and made campaign promises to scale back the agency’s authority. A Trump campaign fact sheet (since removed) noted, “The FDA Food Police, which dictate how the federal government expects farmers to produce fruits and vegetables and even dictates the nutritional content of dog food.” Noting the agency regulates minute details of farming, animal care and food production, the fact sheet further stated, “It also greatly increased inspections of food ‘facilities,’ and levies new taxes to pay for this inspection overkill.”

 

Food Safety

This could have an impact on FDA’s food safety progress, namely the implementation of the Food Safety Modernization Act (FSMA). Trump’s pick for USDA Secretary, former Georgia Gov. Sonny Perdue, may also change the course of food safety. He would oversee the Food Safety Inspection Service (FSIS), which handles food safety, and inspections for meat, seafood, poultry and eggs.

 

Early in his term, Perdue, a known cost cutter, reduced the state agriculture department’s consumer protection budget by 29 percent, from US$39.5 million in his first budget to $28.2 million two years later. A couple of years after these cuts, a devastating salmonella outbreak tied to Blakely, Georgia-based Peanut Corp. of America (PCA) resulted in more than 700 people across the country falling ill and nine people dying from the food poisoning.

 

The company’s CEO, Stewart Parnell, was sentenced to 28 years in prison for knowingly shipping contaminated peanut butter products, and investigations revealed a long history of food safety violations. Following the scandal, Perdue signed new food safety legislation and increased the consumer protection budget.

 

It is not clear whether Perdue’s budget cuts directly impacted food safety inspections during the time of the PCA debacle, and the Georgia Bureau of Investigation (GIB) concluded the situation at PCA did not fall under state laws, but was a federal matter.

 

Dan Fabricant, Ph.D., former director of FDA’s Division of Dietary Supplement Programs and current executive director and CEO of the Natural Products Association (NPA), told INSIDER he is not worried about food safety under Perdue’s leadership.

 

“If confirmed, Perdue would be only the third USDA head who actually grew up on a farm,” he noted. “I imagine as a farmer, he may have ideas about how to keep costs down and still ensure food safety.”

 

Fabriciant added that USDA and FDA are tasked with protection and promotion, and he doesn’t see those as mutually exclusive, but as going hand-in-hand. “We will work with the new FDA commissioner and USDA Secretary no matter who gets confirmed.”

 

In fact, beyond the agency chiefs, there are numerous policymakers and regulators receptive to natural products industry causes, Fabricant noted. “The big thing for us is that now we have receptive people in Congress, in the White House and in the cabinet, including the new HHS Secretary Tom Price,” he explained. “They are looking for solutions and are open to a possible role for natural products in helping the country with healthcare costs.”

 

He noted longtime industry wish list items such as health and flexible spending accounts (HSAs/FSAs) and WIC (Women, Infants and Children), which would expand access to dietary supplements for all Americans, are all now more possible than ever.

 

“The administration recognizes we have ‘sick care’ system in this country, and they are looking for ways to keep costs down while keeping people healthy, which ties very nicely with what the natural products industry is working on right now,” he said, noting NPA has launched a grassroots effort to get Congressional support for the Health Savings Act of 2017 (S.403 and H.R.1175) introduced by Sen. Orrin Hatch (R-Utah) and Rep. Erik Paulsen (R-Minnesota).

 

Source: https://www.naturalproductsinsider.com/blogs/insider-law/2017/03/leadership-changes-afoot-at-fda.aspx

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