The Drug and Device Law Blog is deliberately apolitical. Our purpose is to support the defense of prescription medical product liability litigation, and we recognize that the political views of our intended audience undoubtedly vary widely.
But one of the foundational grounds of our defense efforts is that the FDA, in its approval and subsequent regulation of prescription medical products, does so through skilled experts impartially evaluating well-conducted research and sufficiently supported facts. The agency’s adherence to the scientific method and scientific principles is essential to our clients as they develop, and seek regulatory approval for, new prescription medical products, as well as changes to existing labeling, designs, and manufacturing processes. In litigation, the FDA’s adherence to the scientific method and scientific principles is the underpinning of our clients’ two most powerful defenses – preemption and Rule 702/expert admissibility. If the FDA (and other federal agencies such as the CDC, NIH, and ACIP) ever abandoned, or were perceived to have abandoned, the scientific method in its decision-making, both regulatory and litigation chaos quite likely would result.
That’s why we are disturbed by indications that anti-vaccine crusader and all-around science denier Robert Kennedy, Jr. might be given authority over the FDA – and allowed to “go wild” over “health care” and “medicines.” Here is a video link to a recent Trump speech, and here is our transcript limited to the relevant statements:
Robert F. Kennedy cares more about human beings and health and the environment than anybody, and he’s gonna be absolute, having him is such a great honor, I’ve been friends of his for a long time, and uh I’m gonna let him go wild on health, I’m gonna let him go wild on the food, I’m gonna let him go wild on medicines . . . .
Video link at 0:06-0:34 (emphasis added).
To us, and to others, this development is cause for significant concern. And don’t just take our word for it. Here’s an excerpt from Science magazine:
The former presidential candidate, who dropped out in August and then joined Trump’s campaign, told supporters that “President Trump has promised me … control of the public health agencies.” He ticked off “HHS and its subagencies, CDC [Centers for Disease Control and Prevention], FDA, NIH, and a few others, and then also the USDA [U.S. Department of Agriculture],” according to a video that CNN reported on Tuesday.
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Public health researchers are alarmed, especially given Kennedy’s opposition to vaccines. “I can’t imagine anyone who would be more damaging to vaccines and the use of vaccines than RFK,” University of Minnesota epidemiologist Michael Osterholm told CNN.
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Kennedy also has plans to overhaul the agencies within HHS. At FDA, for example, which he faults for failing to approve controversial treatments such as ivermectin for COVID-19 and psychedelic compounds for mental health conditions, he’s said staffers should “pack your bags.” At NIH, he wants to shift funding from infectious disease research to chronic diseases. . . .
Numerous critics of Kennedy have weighed in with concerns. Children’s Hospital of Philadelphia vaccine expert Paul Offit told CNN Kennedy is a “science denialist.” Even Jerome Adams, who was surgeon general during Trump’s presidency, said at a meeting this week that if Kennedy discourages people from getting vaccines, “I am worried about the impact that could have on our nation’s health,” economy, and security.
Science, “Researchers ‘in a state of panic’ after Robert F. Kennedy Jr. says Trump will hand him health agencies” (embedded links in original article).
An equally recent New York Times article makes similar points:
Mr. Kennedy has in recent years promoted unproven theories about the dangers of pharmaceutical treatments, including childhood vaccinations. His potential role in running America’s public health bureaucracy has animated his supporters, but alarmed medical professionals.
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[RFK Jr.] said he would “reorient” the N.I.H. “so that instead of developing drugs” or “serving as an incubator for pharmaceutical products,” the organization would instead “be figuring out what’s causing these autism rates and autoimmune diseases and neurodevelopmental diseases.”
“R.F.K. Jr. Said Trump Promised Him Control of Public Health Agencies,. . . .” (Oct. 30, 2024). Much more commentary is available online to anyone who is interested.
Why the cause for concern, and for vaccines in particular? Robert Kennedy Jr. has repeatedly compared vaccination to what the Nazis perpetrated in the Holocaust:
Kennedy had referenced [Anne] Frank, a child who died in a Nazi concentration camp, while speaking in front of the Lincoln Memorial on Sunday at an anti-vaccine rally. “Even in Hitler’s Germany, you could cross the Alps to Switzerland. You could hide in an attic like Anne Frank did,” said Kennedy, a longtime opponent of vaccines who has spread unsupported claims about shots shown to protect against covid-19.
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It was not the first time Kennedy has invoked the Holocaust in reference to vaccines. In 2015, he said of vaccinations: “They get the shot, that night they have a fever of a hundred and three, they go to sleep, and three months later their brain is gone. This is a holocaust, what this is doing to our country.”
Washington Post, “Robert F. Kennedy Jr. apologizes for saying the unvaccinated have less freedom than Anne Frank did.” Nor does RFK Jr. have any background in science or in drug regulation (beyond his own admitted illegal use).
Throughout its history – before and after COVID-19 − this blog has been a steadfast supporter of vaccination, in particular, and the scientific method generally. We believe that “the elimination of communicable diseases through vaccination” is “one of the greatest achievements of public health in the 20th century.” Bruesewitz v. Wyeth LLC, 562 U.S. 223, 226 (2011).
We don’t like how our clients, as “Big Pharma,” are constantly villainized for political purposes. Nor do we like alliances between politicians and the plaintiffs’ bar – including, but not limited to, RFK, Jr.’s own affiliations with p-side mass tort firms − that perpetuate the “tort tax” surcharge that mass tort litigation adds to the cost (and thus the prices) of our clients’ lifesaving products. Drug (and device) development simply isn’t cheap:
It can take billions of dollars for a manufacturer to get a new drug from the laboratory onto the pharmacy shelf. In a study from the London School of Economics, the median cost was determined to be $985 million. Differences can often occur with more expensive therapeutic classes. For example, cancer and immunomodulator drugs have had a median development cost of up to $2.7 billion.
“FDA Drug Approval Process” (drugs.com last updated 8/14/2024).
But for all the villainization, and all the coerced MDL settlements, the plaintiffs’ bar has never seriously tried to destroy the FDA, CDC, NIH, etc. as scientifically based organizations. That this possibility is being floated is something we find profoundly disturbing. The precedent such a development would set, and the damage it would do, could well be irreparable. If the scientific guardrails that have governed American public health policy for a century are breached – and the public servants who have administered them “pack their bags” and leave – restoration of the status quo ante would be extremely difficult, if not impossible.