Legal and public health experts are raising alarms over recent changes made by the US Department of Health and Human Services to vaccination guidelines. They argue that these modifications, which downgrade the status of several vaccines, violate federal law and could significantly jeopardize public health, particularly for children and pregnant individuals.

## Experts Warn HHS Vaccine Policy Changes Violate Law and Endanger Health

Legal and public health experts have issued a strong warning regarding the recent decisions made by the US Department of Health and Human Services (HHS) to downgrade several vaccine recommendations.

A brief filed in the case American Academy of Pediatrics et al.

Kennedy outlines how these changes not only violate established federal laws but also pose a serious risk to public health, especially for vulnerable populations like children and pregnant individuals.

The HHS has notably downgraded the COVID-19 vaccine from a "routine" recommendation for all individuals aged six months and older.

This has raised concerns about the potential increase in preventable diseases, as the agency has also dropped longstanding recommendations for universal hepatitis B vaccinations for newborns and reduced the number of childhood vaccines recommended for routine use from 17 to 11.

Public health experts emphasize that vaccines have historically played a crucial role in preventing serious illnesses and deaths.

The implications of these changes are alarming.

Joshua Sharfstein, a former FDA official and one of the legal scholars involved in the case, stated, "The law simply does not permit HHS to change vaccine recommendations for millions of American families on a dime." He stressed the importance of thorough evidence consideration and public discussion when it comes to vaccine policy, particularly as it affects children's health.

Furthermore, the shift in HHS's vaccine recommendations to a category known as "shared clinical decision-making" has created confusion for both families and healthcare providers.

This designation is usually reserved for situations where the evidence regarding the risks and benefits of vaccination is unclear.

Experts argue that this move undermines the established frameworks that govern vaccine policy, which require extensive public input and evidence gathering.

The recent lawsuit filed by the American Public Health Association (APHA) and several medical organizations challenges these changes, claiming they put Americans "at grave and immediate risk" of harm.

The lawsuit specifically targets Secretary Robert F.

Kennedy Jr for his role in these decisions, noting that he has a history of spreading vaccine misinformation.

Critics argue that such actions not only contravene federal procedures but also threaten the integrity of public health initiatives designed to protect the population.

The legal complaint highlights that the directive issued by Kennedy lacks a solid scientific basis.

According to experts, the COVID-19 vaccines have been shown through peer-reviewed studies to be safe and effective for children and pregnant individuals.

The lawsuit asserts that the new guidance creates significant challenges for healthcare providers, who now find themselves in conflicting positions regarding vaccine recommendations.

Susan Kressly, president of the American Academy of Pediatrics, expressed concern that undermining vaccine recommendations could weaken the nation's vaccination infrastructure even further.

She stated, "These actions are creating confusion around proven vaccines and the science supporting them," thereby endangering children's health and contributing to the spread of preventable diseases.

The lawsuit against HHS is part of a broader effort by public health advocates to restore trust in vaccinations and combat the rising tide of vaccine hesitancy exacerbated by misinformation.

As vaccination rates decline, particularly among children, health officials warn of a potential resurgence of diseases that have been largely controlled through immunization.

In summary, the ongoing legal battles and public health warnings underscore the critical need for transparency, evidence-based policymaking, and adherence to established legal frameworks in the realm of vaccine recommendations.

The health and well-being of millions depend on these decisions, and experts are calling for immediate action to rectify the changes made by HHS.

Experts Warn HHS Vaccine Policy Changes Violate Law and Endanger Health

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Hims & Hers experienced a significant stock decline of up to 27% following the FDA's announcement of plans to restrict compounded GLP-1 drugs. The company faces additional legal challenges from Novo Nordisk, which could further impact its operations.

## Hims & Hers Stock Plummets After FDA Targets Compounded GLP-1s

Hims & Hers (HIMS) stock fell dramatically on Monday, losing as much as 27% after the Food and Drug Administration (FDA) announced its intention to take "decisive steps" against the sale of compounded GLP-1 drugs, which include products sold by the company.

The FDA's announcement, made on Friday, highlighted concerns about non-FDA-approved compounded drugs being marketed as alternatives to approved medications.

This crackdown specifically targets GLP-1 active pharmaceutical ingredients (APIs), which have gained popularity for their weight-loss benefits.

In addition to regulatory pressures, Hims & Hers is facing a lawsuit filed by Novo Nordisk, the manufacturer of the widely used GLP-1 medication Ozempic.

The legal action seeks to prevent Hims & Hers from continuing to sell its compounded versions of these weight-loss drugs.

The FDA's statement emphasized the importance of consumer protection, indicating that companies cannot claim that non-FDA-approved compounded products are equivalent to or generic versions of FDA-approved drugs.

It also stated that such companies must not assert that their compounded drugs use the same active ingredients or are clinically proven to yield similar results as approved medications.

The ramifications of these developments have already impacted Hims & Hers' stock performance, which has seen a steep decline of approximately 50% this year.

The stock, which reached a high of $68 per share in late February 2025, was trading below $17 on Monday morning following the announcement.

Hims & Hers markets cheaper compounded versions of GLP-1 drugs directly to consumers, which differ slightly from their FDA-approved counterparts but contain the same active ingredients.

In response to the lawsuit from Novo Nordisk, Hims & Hers characterized the legal action as an attempt by "Big Pharma" to limit consumer choices through the judicial system.

As the landscape for compounded medications continues to evolve, Hims & Hers will need to navigate these regulatory challenges carefully.

The company's ability to adapt to the FDA's restrictions and the outcomes of the ongoing litigation will be critical in determining its future market position and stock performance.

The FDA's commitment to cracking down on misleading advertising practices in the direct-to-consumer market further complicates the situation for Hims & Hers.

The agency has expressed its intention to combat deceptive marketing, which may have implications for how the company promotes its products in the coming months.

With the stock market reacting sharply to these developments, investors will be closely monitoring Hims & Hers' navigation through this turbulent regulatory environment.

The combination of legal challenges and potential changes in the market landscape could significantly influence the company's future trajectory and profitability.

In conclusion, the recent FDA announcement and the impending lawsuit from Novo Nordisk represent significant hurdles for Hims & Hers, leading to a drastic drop in its stock price and raising questions about its business strategy going forward.

As the situation unfolds, stakeholders will be keenly observing how these factors play out in the competitive landscape of weight-loss medications.

Hims & Hers Stock Plummets After FDA Targets Compounded GLP-1s

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Dr Robert M. Califf, former FDA Commissioner, has expressed concerns regarding the current leadership of the Department of Health and Human Services (HHS), suggesting that it emphasizes policy-based evidence rather than evidence-based policy. This shift may undermine public health initiatives and the integrity of vaccine recommendations.

## Former FDA Chief Critiques HHS for Policy-Based Evidence Approach

Califf, the former Commissioner of the US Food and Drug Administration (FDA), has raised alarms about the current direction of the Department of Health and Human Services (HHS).

He argues that HHS leadership is increasingly focused on "policy-based evidence" rather than adhering to the principles of "evidence-based policy." This shift, he contends, could have serious implications for public health and vaccine policy in the United States.

Califf's concerns were articulated in the context of recent statements by the new chair of the CDC's Advisory Panel on Vaccination Practices, Dr Kirk Milhoan.

Milhoan suggested that the polio vaccine might no longer be necessary, prompting criticism from public health experts.

This incident exemplifies a broader trend where individual observations and experiences are prioritized over rigorous scientific data.

Califf emphasizes that such an approach can compromise the ethical foundation of public health and medicine.

The notion of prioritizing "individual autonomy" over public health is problematic, according to Califf.

He argues that effective medical practice must balance individual experiences with robust, population-level data to make informed decisions about health interventions.

For instance, while individual clinicians may observe immediate side effects of vaccinations, such as arm soreness or fever, the broader benefits—such as the prevention of disease outbreaks—can only be assessed through large-scale studies.

Historically, the FDA and CDC operated under a system that emphasized scientific rigor and transparency in policy-making.

This involved public debates, independent evaluations, and a commitment to evidence-based practices that informed vaccine recommendations.

However, Califf warns that the current administration seems to favor a model where evidence is selectively used to support predetermined policies, rather than allowing scientific inquiry to guide decisions.

The implications of this policy shift are far-reaching.

Califf notes that no individual clinician can fully gauge the benefits of vaccines solely through personal experience.

Instead, comprehensive, methodologically sound studies are essential to understand the risk-benefit ratio of vaccination programs.

This is particularly crucial in preventing diseases like polio, which have historically posed significant public health threats.

Furthermore, Califf highlights a disturbing trend in recent dietary guidelines issued by HHS, which have been criticized for lacking scientific rigor and clarity.

The removal of specific alcohol consumption guidelines illustrates a departure from evidence-based recommendations and raises concerns about the potential public health impact of such decisions.

Califf advocates for a restoration of a system where evidence is compiled transparently, allowing public input and scientific discourse to inform policy decisions.

He argues that advisers should be selected based on their expertise rather than their alignment with political positions.

This call for integrity in health policy echoes a growing sentiment among public health professionals who fear that political agendas may increasingly dictate health outcomes.

The challenges of maintaining public trust in health recommendations are compounded by the COVID-19 pandemic, which has exposed vulnerabilities in the FDA's credibility.

Public skepticism regarding vaccine safety and efficacy has been fueled by perceived political interference in regulatory processes.

Califf's stance underscores the need for HHS to prioritize scientific integrity and public health over political considerations, ensuring that health policies are grounded in solid evidence.

In conclusion, as the landscape of public health continues to evolve, the principles of evidence-based policy must remain at the forefront of decision-making.

Dr Califf's critique serves as a reminder of the importance of scientific rigor and transparency in health policy, particularly in a time of heightened public scrutiny and mistrust.

The stakes are high, as the future of public health depends on the integrity of the systems designed to protect it.

Former FDA Chief Critiques HHS for Policy-Based Evidence Approach

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A significant reduction in health alerts from the CDC has raised concerns among healthcare professionals about preparedness and response to health risks. With only six alerts issued in 2025, doctors feel unprepared for emerging health threats like flu and measles.

## CDC Health Alerts Drop Leaves Doctors 'Flying Blind'

The Centers for Disease Control and Prevention (CDC) has significantly reduced its issuance of health alerts, raising serious concerns among doctors and public health authorities.

In 2025, the CDC issued only six alerts from its Health Alert Network (HAN), a drastic decline compared to previous years when the agency typically released many more alerts, often numbering in the dozens.

"We're absolutely flying blind," stated Dr Georges Benjamin, executive director of the American Public Health Association.

He emphasized that the reduced alerts leave medical professionals unaware of a range of health risks that may be entering or re-emerging in their communities.

The decrease in alerts has rendered hospitals, doctors, and health departments less prepared for potential health threats.

Lauren Sauer, associate director at the Global Center for Health Security at the University of Nebraska, highlighted the importance of HANs, explaining that they provide crucial information for clinicians about diseases that could be encountered in emergency departments.

Historically, past alerts have been vital in warning healthcare providers about various significant health threats, including Ebola, bird flu, and the coronavirus pandemic.

"It's our early-warning system," said Benjamin, likening it to a "weatherman of public health" that provides essential situational awareness.

In addition to informing healthcare providers, these alerts prompt hospitals to ensure they have the necessary medications and supplies while also preparing staff for potential health crises.

Furthermore, they help health departments monitor unusual disease clusters, which is vital for public health preparedness.

Notably, the CDC has faced criticism for failing to issue a HAN regarding this season's flu, which is driven by a mutated strain and is projected to be one of the worst in recent years.

Additionally, there has not been a HAN about measles since March 2025, even as outbreaks in states like South Carolina threaten to reverse the country’s measles elimination status.

The agency also neglected to issue alerts for recent whooping cough outbreaks.

"The silence is deafening," Benjamin remarked on the current situation, indicating a growing concern among health professionals about the lack of communication from the CDC.

Critics argue that the reduction in alerts reflects a broader trend of the CDC being "muzzled." This assertion is supported by the agency’s decreased publication of reports in its Morbidity and Mortality Weekly Report, the cancellation of flu vaccination campaigns, and a halt in updating critical health databases.

Dr Debra Houry, who resigned as the CDC's chief medical officer in August, noted that the agency has been compromised by mass firings and is now primarily influenced by political appointees rather than scientists.

She articulated that the current communication decline is evident in both the quantity and quality of information being shared with healthcare professionals.

Despite the CDC's lack of response to inquiries about the number of HANs, a spokesperson from the Health and Human Services Department described claims of reduced alertness as "false." Andrew Nixon stated that the CDC continues to inform the public about urgent health incidents and collaborates closely with various federal and local partners to establish response protocols.

In light of the CDC's decreased activity, alternative organizations are stepping up to fill the gap.

Caitlin Rivers, an epidemiologist at Johns Hopkins University, noted that states are forming regional consortiums to enhance public health communication.

She has initiated a newsletter called FOI Clinical to address this need, highlighting a growing demand for more relevant and higher-volume communication in public health.

As the healthcare community navigates this troubling trend, the implications of reduced CDC alerts could lead to serious consequences in public health readiness and response.

The call for improved communication and alert systems is more urgent than ever to ensure that medical professionals can adequately prepare for emerging health threats.

CDC Health Alerts Drop Leaves Doctors 'Flying Blind'

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South Carolina State Senator Margie Bright Matthews has introduced a bill to abolish religious exemptions for the measles vaccine, aiming to improve public health amid a significant outbreak in the state. The proposal has sparked debate, with critics arguing it infringes on religious freedoms.

## SC Senator Proposes Bill to Eliminate Religious Exemptions for Measles Vaccine

South Carolina State Senator Margie Bright Matthews, a Democrat from Colleton, has introduced a bill that seeks to eliminate religious exemptions for the measles, mumps, and rubella (MMR) vaccine for children attending public schools.

The bill's introduction comes at a critical time, as South Carolina is grappling with one of the country’s worst measles outbreaks, reporting a total of 920 cases concentrated in the Upstate and Midlands regions.

The state has witnessed a disturbing trend of declining vaccination rates, which have been exacerbated by the COVID-19 pandemic and increasing skepticism regarding vaccine safety.

Critics of the bill, including South Carolina Attorney General Alan Wilson, have voiced strong opposition, arguing that it undermines religious freedom rights.

Since 2020, we've seen a concerted push to curtail personal liberty in the name of health and safety." He emphasized the importance of individual conscience and parental rights in making health decisions for their children.

The proposed legislation has been referred to the Senate Medical Affairs Committee for further consideration.

The backdrop for Matthews' proposal is a growing national concern over vaccination rates.

Recent studies indicate that childhood vaccination rates have declined due to a rise in non-medical exemptions, which includes religious reasons.

In fact, the share of children claiming exemptions from one or more vaccinations rose to 3.6% in the 2024-2025 school year, the highest national exemption rate recorded.

Many states have seen similar legislative proposals aimed at altering or expanding vaccine exemption policies.

For instance, states like New York and California have recently passed laws eliminating religious exemptions amidst rising public health concerns over measles outbreaks.

Public opinion on vaccination requirements remains largely supportive, with approximately 81% of parents favoring mandatory vaccinations for school entry, according to recent polling.

This suggests that while there is a vocal minority advocating for personal belief exemptions, a significant portion of the population recognizes the importance of vaccinations in safeguarding public health.

### Implications of the Proposed Legislation

If successful, Matthews' bill could lead to increased vaccination rates among school-aged children in South Carolina, thereby reducing the risk of further outbreaks.

The Centers for Disease Control and Prevention (CDC) recommends that at least 95% of the population be vaccinated to achieve herd immunity against measles, which is highly contagious.

The introduction of this bill also reflects a broader national trend where lawmakers are grappling with vaccine policies in the wake of misinformation and political debates surrounding public health interventions.

As the legislation moves forward, it will be essential to monitor its progress and the public's response, particularly in a state where personal liberties and religious freedoms are often prioritized.

In summary, Senator Margie Bright Matthews' proposal to end religious exemptions for the measles vaccine highlights the tension between public health initiatives and individual rights.

As South Carolina continues to face a significant measles outbreak, the bill aims to bolster vaccination rates and protect vulnerable populations from preventable diseases.

The fate of the bill now lies in the hands of the Senate Medical Affairs Committee, where further discussions and potential revisions will shape its future.

SC Senator Proposes Bill to Eliminate Religious Exemptions for Measles Vaccine

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Apple's ambitious AI health coach project, known as Project Mulberry, is reportedly being scaled back due to leadership changes and increasing competition. While the company aims to integrate AI-driven wellness features into its Health app, a more fragmented launch may be on the horizon as Apple reassesses its approach.

## Apple's AI Health Coach Project Faces Challenges Amid Leadership Changes

Apple is reportedly scaling back its ambitious plans for an AI-powered health coach, known internally as Project Mulberry.

This initiative, which aimed to integrate comprehensive health features into the Health app, is undergoing significant changes following a leadership shakeup within Apple's health technology division.

Originally, the project was designed to provide users with personalized health insights by analyzing data from their devices, including the iPhone and Apple Watch.

The AI health coach was expected to offer tailored recommendations on fitness, nutrition, sleep, and mental well-being, drawing on expertise from various medical fields.

However, Bloomberg reports that Apple will now break the project down into individual features, rolling them out over time rather than as a single, cohesive product.

The decision to alter the project stems from new leadership under Eddy Cue, who is now overseeing Apple's health technology efforts.

Cue has expressed concerns that the company's plans may not be compelling enough to compete with rivals such as Oura and Peloton, as well as tech giants like Google and OpenAI, which have also entered the health space.

Despite the scaling back of the original vision for Project Mulberry, some initiatives related to the AI health coach may still be released.

Apple is reported to have built a studio in Oakland, California, for producing educational video content that could accompany the Health app.

This content, created in collaboration with experts in various medical fields, is expected to help users understand health trends and improve their wellness.

As part of the overhaul, Apple may also introduce food tracking capabilities, allowing users to log meals and receive nutritional insights.

This feature would position Apple in direct competition with existing platforms like MyFitnessPal and Noom.

Additionally, the AI health coach is set to utilize the iPhone's camera to analyze users' workout techniques, providing real-time feedback akin to a personal trainer.

The rebranding of the Health app to "Health+" suggests a potential subscription model, although it remains unclear if the AI health coach will require a subscription.

This aligns with Apple CEO Tim Cook's vision of making healthcare a significant part of the company's legacy, as Apple seeks to enhance its offerings in the health sector.

While the project's future remains uncertain, the integration of these features reflects a broader trend towards personalized, data-driven solutions in health technology.

Apple’s commitment to expanding its presence in this industry could redefine how users interact with their health data, although challenges related to data privacy and AI accuracy persist.

In conclusion, while Apple’s AI health coach project aims to revolutionize personal wellness and provide users with tailored health insights, recent developments indicate that the company must navigate leadership changes and competitive pressures carefully.

The fragmented rollout of features may ultimately lead to a more gradual introduction of the advanced health services that users had anticipated.

Apple's AI Health Coach Project Faces Challenges Amid Leadership Changes

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A recent KFF Tracking Poll reveals a significant decline in public trust towards the CDC, with less than half of Americans expressing confidence in the agency's vaccine guidance. The poll highlights partisan divides regarding the newly revised childhood vaccination schedule, with many expressing concerns about its impact on children's health.

## Trust in CDC at Low Point Amid Vaccine Schedule Changes

A recent KFF Tracking Poll indicates that public trust in the Centers for Disease Control and Prevention (CDC) has plummeted, particularly following the Trump administration's announcement of changes to the childhood vaccine schedule.

The survey, conducted in January 2025, shows that only 47% of Americans trust the CDC for reliable vaccine information, a stark contrast to the 85% trust reported six years ago.

The trust deficit is particularly pronounced among Democrats, whose confidence has dropped from 88% in September 2023 to just 55% in early 2025, marking a significant 33-point decrease within 16 months.

Meanwhile, trust among Republicans stands at 43%, with independents slightly higher at 46%.

This decline in confidence reflects a broader trend of skepticism toward federal health agencies, with 56% of respondents expressing "little" to "no confidence" in their recommendations for childhood vaccines.

The recent changes to the childhood vaccination schedule have sparked considerable concern among parents and the general public.

Approximately 54% of those aware of the revisions believe they will negatively impact children's health, while only 26% view the changes positively.

Among Democrats, this sentiment is even more pronounced, with 83% expressing concerns about the health implications for children.

Conversely, nearly half of Republicans who are aware of the changes believe they will have a positive impact, highlighting a clear partisan divide on this issue.

The CDC's recent overhaul reduces the number of diseases for which vaccination is recommended from 17 to 11, positioning the US as an outlier among peer nations.

The updated recommendations also shift several vaccines, including COVID-19 and flu, from universal recommendations to a framework of shared clinical decision-making, which requires discussions between parents and healthcare providers.

These policy changes have not only altered the landscape of childhood vaccinations but also affected public perception of the CDC and federal health agencies.

A significant portion of the population, 53%, reported that the changes made them less trusting of these agencies, while only 14% felt their trust had increased.

Health and Human Services Secretary Robert F.

Kennedy Jr has publicly stated that the changes aim to "rebuild trust in public health," yet the current data suggests the opposite effect.

The erosion of trust is further reflected in Kennedy's job approval ratings, with 55% of Americans disapproving of his performance as HHS Secretary and 57% disapproving of his handling of US vaccine policy.

The KFF poll also reveals varying levels of confidence in the safety of specific vaccines.

While 82% of adults express confidence in the safety of polio vaccines and 81% in measles, mumps, and rubella (MMR) vaccines, only 48% feel similarly about COVID-19 vaccines for children.

This disparity underscores the impact of political affiliations on vaccine perceptions, with 79% of Democrats confident in the COVID-19 vaccine's safety compared to just 28% of Republicans.

As public trust in federal health agencies continues to fluctuate, the implications for childhood vaccination rates and public health initiatives may be significant.

The KFF Tracking Poll highlights the urgent need for federal health agencies to address the growing public skepticism and restore confidence in vaccine recommendations.

In summary, the KFF Tracking Poll paints a concerning picture of public trust in the CDC and federal health agencies amidst significant changes to the childhood vaccine schedule.

The partisan divide in perceptions regarding vaccine safety and efficacy further complicates the public health narrative, indicating a challenging road ahead for health officials seeking to rebuild trust among the American populace.

Trust in CDC at Low Point Amid Vaccine Schedule Changes

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On February 5, President Donald Trump unveiled TrumpRx, a new initiative aimed at providing cost-effective medications to Americans. The program, set to launch in 2026, is expected to significantly reduce prices for popular GLP-1 weight loss medications, making them accessible to more individuals.

## President Trump Launches TrumpRx to Make Medicines More Affordable

On February 5, President Donald Trump announced the launch of TrumpRx, a program designed to offer Americans access to cost-effective medications.

The initiative aims to reduce the financial burden of prescription drugs, particularly for those seeking weight loss treatments, which have seen soaring prices in recent years.

The TrumpRx program is set to debut in early 2026 and will focus on popular GLP-1 medications like semaglutide (Wegovy, Ozempic) and tirzepatide (Zepbound).

These drugs, which are primarily used for weight management, currently have list prices exceeding $1,000 per month.

The administration's new plan is expected to lower these costs substantially, with reports indicating that consumers could pay around $350 monthly when purchasing through the TrumpRx platform.

According to the White House, the pricing structure for GLP-1 medications will also extend to Medicare and Medicaid beneficiaries.

For these groups, the anticipated monthly cost for drugs like Ozempic and Wegovy will be approximately $245, with copayments around $50 for eligible recipients.

This approach marks a significant shift towards making essential medications more accessible to older adults and individuals facing financial challenges.

TrumpRx's development comes amid broader discussions about healthcare affordability and accessibility in the United States.

Recent studies have revealed that nearly 12 percent of Americans have utilized GLP-1 medications for weight loss, with older adults showing a keen interest in such treatments.

However, the steep prices have deterred many from seeking these options, highlighting the urgent need for initiatives like TrumpRx.

The administration's efforts to partner with pharmaceutical manufacturers, including Eli Lilly and Novo Nordisk, aim to ensure that these medications are not only affordable but also widely available.

This collaboration suggests that the government is taking steps to address concerns about the rising costs of prescriptions, particularly for those who may not have adequate insurance coverage.

Healthcare experts have expressed cautious optimism about the potential impact of TrumpRx.

If successful, the program could lead to a paradigm shift in how medications are priced and accessed, particularly for chronic conditions that require ongoing treatment.

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