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RFK Jr. Wants to Get Rid of 'Entire Departments’ at FDA – Here’s Why That’s Nuts
Robert F. Kennedy Jr. suggested the second Trump administration could eliminate entire departments within FDA for "corruption." In Pedersen's POV, our senior editor explains why that idea is not only nuts but dangerous.
Robert F. Kennedy Jr. (RFK Jr.), who could play a significant public health role in the next Trump administration, has voiced a desire to “clear out” what he calls corruption at FDA and the CDC. Yet there’s little, if any, credible evidence to support his claims of widespread corruption within these agencies.
While government bodies are not without flaws, making such serious accusations without proof is reckless and undermines public trust in the very institutions meant to protect public health.
In a recent interview with NBC News’ Vaughn Hillyard , Kennedy was asked if he would clear out top-level federal workers at FDA and the CDC. Although his response primarily focused on FDA’s Center for Food Safety and Applied Nutrition, his words should raise alarms for the medical device industry.
“In some categories of workers there are entire departments like the nutrition departments at FDA that have to go. They are not doing their job; they're not protecting our kids,” he said. “Why do we have Fruit Loops in this country with 18 or 19 ingredients, while in Canada it has only two or three?”
While his example centers on food and nutrition, it’s not hard to imagine that he might also set his sights on FDA’s Center for Devices and Radiological Health (CDRH), which regulates medical devices.
One silver lining in Kennedy’s comments is his acknowledgment that dismantling an entire agency would require an act of Congress. “To eliminate the agencies, as long as it requires congressional approval, I wouldn't be doing that,” Kennedy said. “I can get the corruption out of the agencies; that's what I've been doing for 40 years. I have a PhD in corporate corruption, and once Americans are getting good science and are allowed to make their own choices, they're going to get a lot healthier.”
Yet this is the same individual who has spread misleading and false claims about vaccine safety. The idea of Kennedy potentially being appointed to a position like U.S. Secretary of Health and Human Services is alarming. His record speaks more to sensationalism than evidence-based policy.
The real danger lies in the possibility of significant turnover or disruption at FDA if Kennedy’s plan to clear out “entire departments” moves forward. This would create a ripple effect across the medical device industry, impacting regulatory standards, global market access, investor confidence, and more.
At best, the result could be a regulatory backlog and uncertainty similar to what the industry faced during the height of the COVID-19 pandemic, when FDA had to prioritize COVID-19 testing and other products, causing delays for other medical devices in the approval pipeline.
Such instability would deter investors from supporting an industry already fraught with challenges. This would be especially damaging for medtech startups and smaller companies striving to bring new, potentially life-saving technologies to market. Meanwhile, larger public medtech companies could face volatility in stock prices as markets react to uncertainty about regulatory timelines and consumer trust.
Eliminating key departments or triggering department-wide turnover at FDA would undoubtedly introduce significant risk and complexity into the medical device industry. It could also erode confidence across stakeholders—patients, providers, and investors—and could lead to a reduction in innovation and a slowdown in the adoption of new technologies, ultimately threatening the industry’s growth and the safety of medical devices on the market.
AdvaMed Reacts to Second Trump Term
Trump’s in. Here’s how one medtech association is reacting to the news, and how it intends to work with the president-elect.
By Katie Hobbins , Managing Editor
The votes are in. The decision has been made. Donald Trump is now the United States president-elect. But how will his controversial comments on the healthcare complex affect how medical technology associations work with the incoming administration?
First, a look back on some of Trump’s statements related to healthcare policy that could impact the medtech industry.
The president-elect has repeatedly shared his views on the Affordable Care Act (ACA) and Medicare during this election cycle, for example writing on X , “Everybody agrees that ObamaCare doesn’t work. Premiums & deductibles are far too high – really bad healthcare! Even the Dems [sic] want to replace it, but with Medicare for all, which would cause 180 million to lose their beloved private health insurance.”
Additionally, during the Sept. 10, presidential debate, he said he had “concepts of a plan” for healthcare under his upcoming term, and said, “If we can come up with a plan that’s going to cost our people, our population, less money and be better healthcare than ObamaCare then I would absolutely do it. But until then I’d run it as good as it can be run.”
Of note, Trump attempted to partially repeal the ACA during his first presidential term by passing the American Health Care Act. This would have repealed the individual and employer mandate, amended Medicaid eligibility, and weakened protections for individuals with pre-existing conditions.
Related: FDA Recall Roundup: September 2024
During the campaign, according to Pharmaceutical Technology , he said he intended to repeal President Joe Biden’s Artificial Intelligence Executive Order, which he said hinders innovation. Also under the president-elect, a new chair of the US Federal Trade Commission will be assigned.
During the last legs of the campaign, Trump promised to let Robert F. Kennedy Jr. — who has touted debunked claims that vaccines cause autism, wrote a book accusing former National Institute of Health official Anthony Fauci of ?conspiring with tech mogul Bill Gates and drug makers to sell COVID-19 vaccines, according to Politico , and launched a movement to “make America healthy again ” which would involve replacing officials and promoting alternative medicine? — “go wild” on healthcare in his administration and saying he would be able to “do what he wants” with women’s healthcare. Kennedy could play a major role in moving the GOP away from debates over legislation and regulation and towards one that more aligns with the government’s role in medicine.
Kennedy also said that Trump had promised him control over public health agencies, including the CDC and FDA.
Related: FDA Recall Roundup: August 2024
These statements are in no way an exhaustive list of Trump’s ongoing health-related discourse, but rather highlight some of the major potential changes specifically affecting medtech that could come to fruition starting on inauguration day.
So, how does this translate to medtech associations actually having to work with, and under, the incoming administration?
Here’s what AdvaMed had to say:
“We congratulate President-elect Trump and Vice President-elect [JD] Vance and welcome new members of Congress on both sides of the aisle. We look forward to working with the new administration on issues of importance to medtech and patients in need,” Scott Whitaker, president and CEO of AdvaMed, told MD+DI. "Medtech is the backbone of our health care system and is largely responsible for the incredible innovations that are transforming patient care. Of course, there are even more exciting innovations in our future that will save and improve millions of lives. But in order for medical innovation to thrive, it is essential that the public policy environment support innovation throughout the medtech ecosystem. We look forward to working with the Trump administration and the new Congress to ensure the regulatory and policy environments keep pace with these advances and the patients who need them."
J&J Joins Medtronic & Boston Sci in PFA Race with FDA Approval of Varipulse
The competition in the pulsed-field ablation market is intense but is it oversaturated?
By Omar Ford
It was only a matter of time before Johnson & Johnson MedTech joined Medtronic and Boston Scientific to win approval for pulsed-field ablation technology.
The New Brunswick, NJ-based company said on Thursday that it won FDA approval for the Varipulse platform for the treatment of drug refractory paroxysmal atrial fibrillation (AFib).
FDA approval of Varipulse was supported by data from the admIRE study, a prospective, multi-center, non-randomized trial. Twelve-month outcome data from the pivotal phase of the admIRE study were?published ?in?Circulation.
Among 291 patients across 30 healthcare centers in the U.S., 100% achieved acute procedural success, including 98% with first-pass isolation recorded per vein.2 85% achieved peak primary effectiveness when 73-96 applications were applied per vein (n=85),?showed minimal adverse events (2.9%), and 25% of procedures were performed without fluoroscopy, likely attributable to integration with the Carto 3 System.
Tim Schmid, executive VP and worldwide Chairman of J&J MedTech, spoke about the competitive landscape in the PFA market during an October call with analysts and investors.
“As it relates to the U.S., you're right, we're seeing continued competition, especially in the ablation space, given that we don't currently have a PFA product, Schmid said in a call last month according to a Seeking Alpha transcript. “But having spent a lot of time in EP labs over the last couple of weeks, I can tell you that we are incredibly excited for the availability of Varipulse.”
This is an incredible moment for the PFA market. Dublin-based Medtronic was the first company to kick off the PFA revolution, winning FDA approval for the PulseSelect system late last year . Boston Scientific followed suit garnering approval for the Farapulse system in January .
In a research note earlier this year, Marie Thibault, an analyst with BTIG wrote about a competitive scenario in the PFA market. She noted that despite the number of players the space wasn’t crowded.
“In the third year following the first PFA launches, traditional ablation is expected to be used in roughly half of the ablation cases (42% RF, 10% cryo), while PFA takes the other half (16% Farapulse, 13% Varipulse, 10% PulseSelect, and 7% Sphere-9.),” Thibault wrote. “This matches what we have heard in diligence over the past four years, including an expectation that PFA will quickly become standard of care and that there will be more than one winner in PFA.”
What's at Stake for Medtech as Trump Wins the Presidency?
Where does Donald Trump stand on healthcare issues as he is elected the next president of the United States?
Editor's note: This story has been updated to reflect that Donald Trump has won the U.S. presidential election.
Sifting through pages upon pages of political rhetoric to learn what's at stake for any given industry in the U.S. presidential election is a daunting task. For those in medtech wanting to know where former President Donald Trump has said on the campaign trail regarding healthcare policy, we've drilled it down for you.
Most of the healthcare commentary from this presidential election that could impact the medical device industry has centered around the Affordable Care Act, Medicare, and drug prices (relevant because of drug-delivery devices such as insulin delivery devices and asthma inhalers).
Trump's statements on healthcare/Medicare:
Despite his remarks during the September 10 presidential debate that he only has "concepts of a plan" for healthcare, the former president has repeatedly shared his views on the Affordable Care Act and Medicare during this election cycle via social media and elsewhere. Below are some highlights of these statements.
Wait a minute, which administration really lowered drug prices?
If you're confused by Trump's claim about lowering drug prices (given the Biden-Harris administration has made similar claims), you're not alone.
According to C. Michael White, distinguished professor of pharmacy practice at the University of Connecticut, the Trump and Biden-Harris administrations both have some "very modest wins to tout" when it comes to drug pricing. White teaches and studies the ethics of prescription drug prices and the complexities of drug pricing nationally.
"Delving into the presidential candidates’ successes on a number of drug-pricing policies, you’ll see a continuation of progress across the administrations. Neither the Trump administration nor the Biden-Harris administration, however, has done anything to truly lower drug prices for the majority of Americans," White writes .
In July 2020, the Trump administration enacted a?$35 cap on insulin ?copayments via executive order. In effect, it made participating Medicare Part D programs limit the price of just one of each type of insulin product to $35. For instance, if there were six short-acting insulin products on an insurance plan’s approved drug list, the insurer had to offer one vial form and one pen form at $35.
These price changes did not go into effect during Trump’s presidency. By 2022, only?about 800,000 people ?– or around 11% of the more than?7.4 million people in the U.S. who use insulin ?to regulate their blood sugar – saw their prices reduced, White noted.
In August 2022, the Biden-Harris administration signed the?Inflation Reduction Act ?into law. This maintained the $35 insulin cap with the same stipulations but made the program mandatory for all Medicare Part D and Medicare Part B members. This expanded the number of people who could benefit from cheaper insulin to 3.3 million, White noted.
"This still?doesn’t help a majority of diabetics . If you don’t have Medicare, the $35 reduction does not apply to you," White writes. "Furthermore, pharmaceutical companies are not responsible for lowering insulin costs under these policies, but health plans are on the hook for lowering copayments. Costs could be passed along to beneficiaries in future Medicare premiums."
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