FDA GLP-1 labeling, influence of RFK Jr., GSK

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Good morning! Today we’re talking a lot about RFK Jr. and also President-elect Donald Trump. Additionally, we note that GLP-1 medications may increase a person’s risk of aspiration during surgery. Have a nice week!

From hospitals to biopharmaceuticals, change is coming

It’s hard to say exactly what changes in Washington will mean for the healthcare industry starting next year. But we have some pretty good clues.

Possibilities include: Newly empowered Republicans could tweak Medicare’s drug price negotiation program in a way that could be more to the liking of biopharmaceutical companies. Other changes may not be as welcomed by the industry: If President-elect Donald Trump’s deputy, Robert F. Kennedy Jr., has his way, expect even more anti-pharma rhetoric and possible instability at the Food and Drug Administration Set administration.

Is drug advertising on TV also at stake? There are reasons to believe that this will not be the case.

Read more from STAT’s Rachel Cohrs Zhang, Bob Herman and Tara Bannow.

Aspiration hazard during surgery added to GLP-1 drug labels

By STAT’s Elaine Chen: Earlier this month, the FDA updated GLP-1 drug labels to warn about the risk of patients inhaling food into the lungs, also known as aspiration, while undergoing sedation or anesthesia for medical procedures .

Typically, patients fast before operations to prevent this risk. But GLP-1 drugs delay gastric emptying, and there have been rare reports of patients who still had food in their stomach and experienced aspiration despite following standard fasting guidelines, the FDA update said.

Drugs whose labels have been updated include Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro.

However, the agency said there is not yet enough data to make recommendations on how to mitigate this risk, such as whether fasting guidelines should be changed or whether patients should temporarily stop taking the medications.

Doctors have debated how big the risk is and how to deal with it. The American Society of Anesthesiologists has suggested that patients stop treatments before procedures, while the American Gastroenterological Association has said there is not enough evidence to issue a formal guideline and suggested that doctors should assess each patient individually.

Will supervision of dietary supplements become even more relaxed?

Robert F. Kennedy Jr.’s potential influence on the Trump administration’s health care agenda could also extend to dietary supplements. Kennedy is known for his anti-vaccination stance and his support of alternative therapies. He openly criticized the FDA and called for an end to regulatory oversight of many health products, including dietary supplements and nutraceuticals.

This shift could allow the supplement industry, known for promoting untested and sometimes harmful products, to operate with less scrutiny, two nutrition experts say in a new First Opinion essay.

“The supplement industry is rich and ruthless,” they write. “Not only do they market their products with a variety of misleading claims, but they also flood statehouses with disinformation and wage an all-out attack on scientific research and researchers like us.”

Read more.

Brian Skorney and Daphne Zohar comment on Trump

In case you missed it, biotech analyst Brian Skorney and industry veteran Daphne Zohar joined “The Readout Loud,” STAT’s delightful podcast, to discuss how the Trump administration is affecting the FDA, biotech industry and the stock market. We offer a transcript of some of the insightful things they had to say.

Skorney, for example, singled out former biotech executive and political candidate Vivek Ramaswamy as a person close to Trump’s heart on health care: “He’s a super smart guy, understands the regulatory side of things, understands drug development,” Skorney said. “I find [Vivek] Hopefully I would be a cooler person making recommendations here.”

Zohar argued that certain “Wild West” scenarios — like losing FDA oversight or banning childhood vaccines — are “really very unlikely.” However, she believes issues of women’s health and gender-inclusive care are at risk.

Read more.

MAHA presents nominations for healthcare positions

Speaking of RFK Jr., he has launched a website called “Nominees for the People” to collect candidates for health-related government positions in the Trump administration, STAT’s Isabella Cueto reports. His “Make America Healthy Again” initiative favors candidates who hold anti-establishment, wellness-oriented views that are often critical of mainstream medicine.

High-profile nominees include Casey Means, a functional medicine doctor specializing in nutrition who is reportedly being considered for a job at the FDA. Also on the list is Simone Gold, who founded America’s Frontline Doctors, the right-wing doctors group that campaigned against Covid vaccines and protocols and promoted ivermectin and hydroxychloroquine as treatments. She is also known for illegally entering the US Capitol on January 6, 2021, after Trump’s re-election failed nearly four years ago.

Read more.

More reading

• What medtech CEOs are saying this week about Trump’s possible tariffs, FierceBiotech
• Autolus Therapeutics Receives FDA Approval for Cancer Treatment, MarketWatch
• Pharmaceutical giant GSK is leaving BIO in the latest setback for lobby group STAT
• Pfizer is making a $1 billion commitment to China to boost innovation, targeting the Chinese market, BioSpace