RFK Jr. says he plans to act on legal challenge to ultra-processed foods

HHS Secretary Robert F. Kennedy Jr. in an interview with CBS' "60 Minutes" said he intends to act on a plan issued by former FDA chief David Kessler to overhaul ultra-processed foods.

"We will act on David Kessler's petition," Kennedy said. "And the questions that he's asking are questions that FDA should've been asking a long, long time ago."

In August, Kessler submitted a citizen's petition urging FDA to act against processed refined carbohydrates, which includes sweeteners like high-fructose corn syrup and starches extracted from foods like corn and soy.

In the petition, Kessler argued that FDA should declare these refined carbohydrates as no longer "generally recognized as safe" based on the "likelihood that they are contributing to metabolic harm." Such a change would require the food industry to submit research proving the ingredients are safe, and if they can't do that to FDA's satisfaction, they could be required to reformulate their products or pull them from the shelves.

It's unclear when Kennedy will release his formal response to Kessler's petition or what that letter will say. In the interview, Kennedy added that he's "not saying that we're going to regulate ultra-processed food. Our job is to make sure that everybody understands what they're getting, to have an informed public."

"There is no way for any American to know if a product is safe if it is ultra-processed," Kennedy added.

"The secretary and I, you know, we disagree on a number of issues, I mean, in the strongest possible terms," Kessler said in his own "60 Minutes" interview, specifically citing vaccines. "But if he's willing to take action on these ultra-processed foods, I will be the first to applaud that."

(Todd, STAT+ [subscription required], 2/15)

Trump administration revokes finding that climate change is a danger to public health

The Trump administration on Thursday revoked a scientific finding that climate change is a danger to public health, despite repeated studies that say it's a documented and quantifiable harm.

The finding, published by the Environmental Protection Agency in 2009 under the Obama administration, has been the legal basis of nearly all regulations fighting global warming.

Thousands of scientific studies have looked at how climate change has affected human health in the past five years and have shown the phenomenon is increasingly dangerous to people. Many studies concluded that in the United States, thousands of people have died and even more have gotten sick as a result of climate change in the past few decades.

For example, one study published in JAMA found that yearly heat-related death counts and rates have more than doubled in the past 25 years from 1,069 in 1999 to 2,325 in 2023. Another study published in 2021 in Nature Climate Change looked at 732 locations in 43 countries, including 210 locations in the United States, and found that more than a third of heat deaths are a result of human-caused climate change.

In an event at the White House last week, President Donald Trump said that climate change "has nothing to do with public health. This is all a scam, a giant scam."

"Health risks are increasing because human-cause climate change is already upon us," said Jonathan Patz, a physician who directs the Center for Health, Energy, and Environmental Research at the University of Wisconsin-Madison. "Take the 2021 heat dome for example, that killed (more than) 600 people in the Northwest. The new climate attribution studies show that event was made 150-fold more likely due to climate change."

(Borenstein, Associated Press, 2/12)

HRSA is seeking feedback on a variety of topics, including the potential burdens imposed by a rebate model, potential cash flow impacts, and potential alternatives to a rebate model that would improve safeguards around the 340B program.

Aimee Kuhlman, VP of advocacy and grassroots at the American Hospital Association, said that AHA "welcome HRSA's attempt to gather detailed information about the impact of a rebate model. We look forward to working with the agency to answer the many specific questions it has posed to 340B hospitals and other stakeholders."

(Early, Modern Healthcare, 2/13)

AbbVie sues HHS over price controls for Botox

AbbVie is suing HHS, challenging CMS' decision to include Botox among last month's list of 15 drugs for upcoming price cuts under the Inflation Reduction Act (IRA), arguing that the formulation of Botox makes it ineligible for price controls under the IRA.

When the IRA was signed into law in 2022, it stated that only certain products would be eligible to make the list of drugs that would go through negotiations, specifically excluding "low-spend drugs," meaning those with Medicare spending of less than $200 million, certain orphan rare disease drugs, and plasma-derived products.

In a complaint filed in a Washington D.C. District Court, AbbVie argued that Botox is a plasma-derived product, as the drug is partially made from human serum albumin, which is sourced from donated human blood plasma.

Because of this, AbbVie argued in the complaint that Botox is vulnerable to supply-chain interruptions based on plasma donor supply, and that this factor was "implicitly acknowledged" by Congress when it specifically excluded plasma-derived products from price controls under the IRA.

AbbVie also argued that CMS' actions amounted to a due process violation and an illegal "taking" under the Fifth Amendment.

(Stempel, Reuters, 2/12; Becker, Fierce Pharma, 2/12; Jeffries, Becker's Hospital Review, 2/12)

RFK Jr. makes changes to leadership team

In an email to staff obtained by POLITICO, HHS Secretary Robert F. Kennedy Jr. last week announced that Director of Medicare Chris Klomp would be placed in charge of overseeing all HHS operations and that Kyle Diamantas, deputy commissioner for human foods at FDA, would be a senior FDA counselor as would Grace Graham, FDA's deputy commissioner for policy, legislation, and international affairs.

In addition to serving as director of Medicare, Klomp has been serving as deputy administrator of CMS under CMS Administrator Mehmet Oz. Klomp will retain his roles at CMS and would also serve as chief counselor for the department, the email said.

Meanwhile, Diamantas is a former partner in the Miami law office Jones Day, and Graham previously served as chief health counsel to Rep. Cathy McMorris Rodgers (R-Wash.) when Rodgers led the House Energy and Commerce Committee. He also previously served as an aide to then-Sens. Lamar Alexander (R-Tenn.) and Mike Enzi (R-Wyo.).

Kennedy also said in the email that John Brooks, deputy administrator and chief policy and regulatory officer at CMS, will become a senior counselor there. Kennedy said that the new senior counselors will help coordinate between Kennedy and HHS agencies on any policy decisions and would also retain their prior roles.

(Zeller/Röhn, POLITICO, 2/12)