The TRT Turnaround: How New Research Led the FDA to Reverse Testosterone Warnings

A Decade of Data: How the TRAVERSE Trial Reshaped the FDA's Testosterone Guidelines

 From Caution to Clarity: The FDA's Evolving Stance on Testosterone Warnings (2015 vs. 2025)

In the realm of public opinion, even that of healthcare professionals, there has been a great deal of misconceptions involving the safety and efficacy of testosterone when used as a medication in the past several decades.  This is mostly based on faulty research and clinical trials that were poorly designed and easily disproven. Medical guidance and governance of testosterone replacement therapy (TRT) has been significantly shaped by regulation from the U.S. Food and Drug Administration (FDA) which has finally taken a more educated approach and is now saying what many of us have known all along. In 2015, the FDA issued a stringent label warning for testosterone products, largely driven by concerns about heart health and potential cardiovascular risks. This warning was concerning to many patients and providers as it suggested a possible link between TRT and CV events. Well, let’s fast forward to February 2025, and the FDA has made a significant reversal, removing the most severe cardiovascular warnings while introducing new considerations to testosterone. This shift reflects a decade of evolving scientific understanding, particularly the findings of a pivotal clinical trial and no longer looks at antiquated trials to base their decisions.

The 2015 Warning: TRT and its Unwarranted Cardiovascular Concerns

Before 2015, anecdotal reports and some observational studies suggested a possible link between TRT and an increased risk of serious cardiovascular events, such as heart attack and stroke. Some of these studies drew their conclusions from elderly patients with preexisting heart conditions who started testosterone after having cardiovascular events. When there were additional cardiovascular events, they chalked it up to testosterone as the culprit despite a past history of heart problems. While these studies often had limitations in their design (e.g., retrospective analysis, small sample sizes, or not adequately accounting for confounding factors as discussed above), the FDA took a proactive, cautious stance.

So with poorly formulated data and concerns,  the FDA mandated a class-wide labeling change for all approved testosterone products in March of 2015. This included adding  a prominent "Boxed Warning", often referred to as a "black box warning" on all testosterone medications to highlight the “potential” for increased risk of heart attack and stroke in men taking prescription testosterone. This warning was broadly applied and put on all TRT formulations, such as patches, pellets, gels/creams or injectable testosterone, emphasizing the need for patient and provider caution and urging healthcare professionals to only prescribe testosterone for men with a confirmed medical condition associated with low testosterone, rather than for age-related decline alone. This action significantly impacted the prescribing practices for providers, making many doctors hesitant to initiate TRT due to the perceived elevated risk to the patients and the potential for litigation or malpractice for the clinician.

The FDA’s February 2025 Reversal: A Data-Driven Update

Fortunately the recent FDA update this past February of 2025 marks a substantial change in policy, primarily driven by the results of a study called the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) clinical trial (Yes, we know it’s long!). This was a large-scale, randomized, placebo-controlled study conducted that involved over 5,200 men who were diagnosed with hypogonadism and had a history or who were considered high risk of cardiovascular disease, and was designed specifically to evaluate the cardiovascular safety of testosterone therapy over a mean follow-up of close to three years (33 months to be exact).

Interestingly and to no surprise to those of us in the industry, the TRAVERSE trial’s key finding was that testosterone therapy was non-inferior to placebo regarding the incidence of major adverse cardiac events (MACE), meaning it did not significantly increase the risk of heart attack, stroke, or cardiovascular death in men on TRT. This solid evidence provided the scientific backing needed for the FDA to be forced to reconsider their earlier, more severe warnings and reevaluate their processes for determining when such warnings are justified and needed.

As a result, the FDA has now taken a few important steps in regard to testosterone and TRT.

1. Boxed Warning related to an increased risk of adverse cardiovascular outcomes have been removed!  These vague and unfounded warnings are no longer required and have been taken off of all testosterone product labels and packaging. This is the most impactful change, as it alleviates a significant concern for both prescribers and patients alike.
2. They also ADDED the results of the TRAVERSE trial to all testosterone product labels. This is useful in providing direct evidence of cardiovascular safety in a high-risk population especially for those whose beliefs were centered around previous warnings.
3. Retained the "Limitation of Use" language. For those patients interested in TRT for age-related hypogonadism, they are basically telling that while the cardiovascular risk warning is gone, testosterone is still approved only for men with low testosterone due to specific medical conditions, not solely for age related decline, though its difficult to determine the cause of Low T in many patients so its important that a licensed and experienced healthcare provider help make this diagnosis.
4. They added new warnings about increased blood pressure. While the TRAVERSE trial did not show increased MACE, they noted other post-market ambulatory blood pressure monitoring (ABPM) studies had consistently demonstrated that testosterone use, across various formulations, can possibly lead to increases in blood pressure in some men. The FDA is now requiring product-specific information on blood pressure changes and a new warning for products that previously lacked it. This makes it important for all patients to monitor their BP and discuss any changes with their doctor. Many studies suggest an opposite effect on blood pressure for men who are prescribed TRT, with it actually LOWERING BP in some men, so proper diagnosis and monitoring will be necessary.
5. Noted a higher incidence of pulmonary embolism and atrial fibrillation. In the testosterone group of the TRAVERSE trial, they saw a potential for a fib or pulmonary embolisms for some candidates, suggesting continued vigilance for these specific risks for patients in high risk groups.

Implications of the Shift on TRT and Testosterone for Patients and Providers

This dramatic change in just a decade, from 2015 to 2025 marks a win for science and a move towards more nuanced and evidence-based labeling system for testosterone products for the pharmacies that make them, providers that prescribe them and the patients who use them. By removing the broad cardiovascular black box warning on labels, it is expected to increase physician comfort in prescribing TRT for appropriately diagnosed hypogonadal men and allowing for meaningful treatment to be offered to patients where it was once not a consideration. However, there is always a potential risk as the new emphasis on blood pressure monitoring underscores the ongoing need for careful patient selection by physicians who offer HRT for men.  Thorough baseline assessments, reviewing past medical history and diligent follow-up for the men who being testosterone therapy, proper protocols and optimal patients’ safety and care can be prioritized. The FDA's evolving stance on testosterone reflects the dynamic nature of pharmaceutical and medical science, where new research and clinical studies constantly refine our understanding of drug safety and efficacy.

Dr. Timothy Wray Mackey, a distinguished physician at NovaGenix, brings extensive expertise in internal medicine and a specialized focus on hormone replacement therapy. A licensed DO with years of experience in both men and women's hormone replacement therapy, including a background in the U.S. Army, Dr. Mackey provides personalized care to patients seeking solutions for low testosterone, bioidentical hormone replacement, and various wellness needs. He is certified in anti-aging medicine and bio-identical hormone replacement therapy, ensuring a comprehensive and evidence-based approach to optimizing patient health and well-being.

Low T, High Hurdles: Why Doctors Don't Always Prescribe Testosterone

Why Won't My Doctor Prescribe Testosterone? Legal Considerations for Patients on TRT

As men get older, many will begin experiencing symptoms related to low T. Symptoms like feeling tired all the time, having a decreased sex drive, losing muscle mass, and even experiencing mood changes are just a few of the more common symptoms associated with age related testosterone decline. With so much media attention, clinical research and information regarding TRT that people now have access to, the thought of boosting testosterone levels seems like a straightforward solution for many men. Yet, we continuously hear from a significant number of patients that come to us that their doctors are hesitant or unwilling to test for or prescribe testosterone replacement therapy (TRT). This obviously is a source of frustration and confusion, leading many to come to us and seek answers regarding how to best move forward with optimizing their testosterone levels. At NovaGenix Health and Wellness, we believe in empowering our patients with knowledge. So, let's look into and discuss some of the complex reasons why doctors might be reluctant to prescribe testosterone and what you need to know about TRT before starting therapy.

The FDA's Stance and Evolving Research

One of the biggest reasons for physician caution stems from the evolving understanding and regulatory oversight of testosterone therapy by governing organizations, like state health boards and the FDA or even DEA. Going back a long ways, there was a perception, or MISCONCEPTION, fueled by some earlier research and studies and even media reports, that there was a potential link between TRT and increased cardiovascular risks, like heart attacks and strokes. It was so widely believed that in 2015, the FDA even issued a warning to pharmacies requiring a label change on all testosterone products to reflect these possible risks.

While more recent, robust research, including large-scale randomized trials, has provided reassuring evidence suggesting that testosterone treatment, when prescribed appropriately, does not necessarily increase the risk of cardiovascular events in the short- to medium-term, the earlier warnings have left a lasting impression on the medical community. In Fact, just this past February of 2025, the FDA has REMOVED the boxed warning about testosterone and any increased risk of cardiovascular events. These findings were prompted by the TRAVERSE trial which showed that there were no elevated risks or major cardiovascular events (MACE) in males who use TRT to treat hypogonadism. Doctors, understandably, prioritize their patient safety, are fearful of potential litigation and action against their medical license will often adopt a conservative approach when faced with even a hint of potential risk. Due to their past belief that there were risks, many are unwilling to change their stance as they don’t see a need to risk THEIR practice, despite overwhelming evidence that testosterone therapy is both safe and beneficial when prescribed appropriately.

The Challenge of Diagnosis: Is it Truly Low T?

Another major hurdle for patients getting an Rx for TRT is the accurate diagnosis of hypogonadism (clinically low testosterone). Lots of the signs and symptoms associated with low testosterone – fatigue, low energy, mood changes, decreased libido, etc… – are also common signs of aging or may be caused by a myriad of other underlying health conditions such as sleep apnea, thyroid disorders, diabetes, alcohol, tobacco or drug use. Sometimes it could even be caused by stress or may be psychological in nature like with depression. Figuring out the cause of the suboptimal hormones or low T can be tricky and often many doctors don’t feel comfortable looking into the root cause.

Doctors are trained to rule out these other possibilities first but don’t really train in medical school on the nuances of hormone replacement therapy and when it’s appropriate to consider HRT for a patient’s treatment. Usually, the first part of this process involves proper blood testing. Getting blood work with both free and total testosterone levels is important. Other tests can check for things like LH, FSH, SHBG, estradiol and TSH for thyroid functioning. Medical guidelines usually recommend at least two early morning tests (when the levels are the highest) to get the best reading. Often doctors will prefer to get blood taken between 8 AM and 10 AM for serum testosterone measurements on separate days to confirm persistently low levels. Furthermore, understanding the difference between total testosterone, bound testosterone, and free testosterone is vital, as a patient might have a seemingly "normal" total testosterone but still suffer from a deficiency in free, bioavailable testosterone. We have seen patients will clinically high total testosterone levels but due to SHBG levels being higher than normal, their free and bio-available levels were low, which lead to them being symptomatic.

Some of the more cautious primary care physicians also worry about the potential for over-prescription and misuse of TRT for non-medical reasons, like improving athletic performance, muscle building or enhancement or general anti-aging purposes, when a clinical need just isn't present. This concern emphasizes the importance of a thorough diagnostic process from a specialist in the field of testosterone therapy.  We often have to turn away patients who tell us that they just want to “do a cycle of testosterone for a few months to get bigger…” as that is not what TRT is used for and any reputable clinic or physician will not prescribe testosterone under those circumstances.

Every Patients is Unique and Monitoring Can Be Challenging

No two patients are alike. Each patient presents with different labs, signs, symptoms, possible side effects and goals and challenges with monitoring. Even when a diagnosis of hypogonadism is confirmed, doctors recognize that not everyone responds to TRT in the same way. The same dose may cause levels to rise significantly higher for one person than the next as well as cause changes in blood pressure, hematocrit or estrogen level increases. Because individual responses can vary significantly, with some patients experiencing profound benefits and others seeing little to no changes or improvement in their symptoms, some doctors prefer to not deal with those challenges. This variability makes it tough for doctors to predict how a patient will react to therapy, adding an element of uncertainty thus making the amount of work required on their end as a clinician not worth it in their eyes.

Furthermore, ongoing monitoring is essential once TRT is initiated. This includes regular checks of testosterone levels to ensure they are within the therapeutic range, as well as monitoring for potential side effects such as an increase in red blood cell count (which can thicken the blood and increase clot risk), prostate stimulation, and worsening of sleep apnea. Some doctors may be hesitant to take on the responsibility of this intensive monitoring, especially if they are not specialists in endocrinology or men's health.

Physician Specialty and Training Differences

The medical training landscape also plays a big role. While many primary care physicians can initiate the diagnostic process via writing a prescription for labs and blood work, many feel more comfortable referring patients with complex hormonal issues to certain specialists like a urologist or an endocrinologist for the cases of men with suspected hypogonadism, andropause, relative androgen deficiency or age-related Low T. These specialists have advanced training in hormone systems, the HPG axis, HRT and are often more familiar with the nuances of testosterone therapy, including different formulations of medications, dosing and potential interactions with other medications. However, even among these specialists, opinions and approaches can vary greatly based on their experience, interpretation of the latest research and clinical guidelines. Finding a doctor who is experienced in TRT is important to maximize the benefits of treatment.

Comprehensive and Personalized Care

A good physician will understand these complexities and the frustration that can arise when seeking help for low testosterone. Our approach has always been rooted in comprehensive, personalized care for our patients who all have unique treatment needs. It’s vital to start with a thorough evaluation, including detailed symptom analysis, comprehensive lab testing (looking at both total and free testosterone, among other vital markers), and a review of your past medical history to accurately test, diagnose and treat the patient with Low T.

Find a clinic and doctor that believes in educating their patients about both the risks and benefits of TRT, exploring all potential causes of their symptoms, and developing a treatment plan that is tailored to their individual needs and health goals.  It’s important to work with a health care professional who stays abreast of the latest research and guidelines to ensure they provide the safest and most effective care for their patients.

If you suspect you may be experiencing symptoms of low testosterone, don't let past experiences with reluctant doctors deter you. There is always options to be proactive about your health. Schedule a consultation with NovaGenix Health and Wellness if you’d like to know more. We are dedicated to providing clear answers, thorough diagnostics, and effective solutions to help you regain your vitality and well-being and finding experienced doctors who prescribe testosterone.

TRT Costs on the Rise? How Global Tariffs Could Impact Your Wallet

 What Will Tariffs Mean for Testosterone? Preparing for the Potential Impact on HRT

Long gone are the days of local mom and pop pharmacies serving the entire town in the US. We now live in an increasingly globalized world, and the ripple effects that international trade policies can have may be felt in unexpected corners, even when it comes to the personal health and wellness industries, whether you’re a supplier, provider or patient. For men and women undergoing Testosterone Replacement Therapy (TRT) or Hormone Replacement Therapy (HRT) or those just considering it, recent talks in the news media about President Donald J. Trump and his recent tariffs might seem distant from their daily medical regimen, however, trade tariffs on pharmaceutical ingredients, particularly active pharmaceutical ingredients (APIs) and excipients, may eventually have quite a serious impact on the both the accessibility and affordability of testosterone and other hormone replacement therapy medications.

In the United States, our reliance on international pharmaceutical partners and suppliers is undeniable. A huge portion of the world's APIs, the core chemical compounds that give medications their therapeutic effect, are manufactured in countries like China and India. Essentially, API’s are the "drug" part of the drug. All medications, whether prescription or over-the-counter (OTC), contain one or more APIs. Medications like Acetaminophen, Ibuprofen, Amoxicillin, Atorvastatin, Levothyroxine, Metformin, Gabapentin and Testosterone are just a few examples of API’s made in countries like India and China with Inda being the largest manufacturer producing over 35% of the global supply. It's estimated that the US imports 80% of all medications. Unfortunately, our reliance in America on international sourcing means that any barriers to trade, like tariffs, imposed by pharmaceutical companies or the importing nations where they operate could instantly translate into increased costs of goods and potentially cause disruptions down the road in the supply chain, similar to what we saw in 2020 with COVID. Hopefully there won’t be a shortage of toilet paper however medications like testosterone may be impacted.

Let's look more into what this could potentially mean for medications like testosterone, both in its generic form and as a raw material/ingredient for compounded medications, which play a major role in personalized hormone therapy. Compounding pharmacies are a major supplier of medications to HRT patient and the industry is valued at over 10 billion annually, so there is a huge financial stake in their ability to operate, manufacture and dispense medication to the patients and providers that depend on them.

The Direct Hit: The Increased Cost of Raw Materials to Pharmacies

The biggest, most immediate and clearly the most obvious consequence of any tariffs placed on raw pharmaceutical ingredients and API’s would be an increase in the cost of raw materials. If sugar, milk and flour prices go up, one would expect the cost of a cake to increase as well. It’s the same thing with medications. Compounded pharmacies, which specialize in creating customized medications tailored to individual patient needs, are particularly vulnerable here. Compounding pharmacies frequently import the APIs they use as well as the excipients they add to create the finished pharmaceutical product from a diverse range of global suppliers like Europe, China and India. If these nations or companies get tariffs levied on them or the components used in making these drugs, then the cost of acquiring them will inevitably rise as will the overall cost in obtaining them either for cash pay or even through insurance. It’s estimated that around 10-20 major U.S. firms are actively producing API’s either for their own finished products or as contractors.

So, let’s think about the journey that testosterone makes to get to the patient. It starts its journey as a chemical precursor to eventually be turned into a usable medication. Whether it's injectable or transdermal creams, testosterone cypionate, enanthate, or propionate, the foundational API has to be manufactured, almost entirely overseas, and then imported into the United States. Tariffs would add a percentage directly onto the imported cost, a financial burden that would ultimately need to be absorbed or passed on down the line. The importer will increase the cost to the pharmacy, and the pharmacy to the patient.

For some of the larger generic pharmaceutical manufacturers, the impact is similar. While they might be able to operate on a larger scale, their reliance on internationally sourced APIs remains the same. If their costs to import and then manufacture increases because of increased costs like tariffs, then the  wholesale price of generic testosterone products will likely follow a similar increase thus making it unaffordable to many and may even have the unattended effect of leading to the rise of unlicensed and illegal online pharmacies where there is no oversight and there are significant health risks to the patients. Having a choice between Generic, commercial and compounding medication is important for patients.

The TRT Patient's Wallet: Higher Costs for Medications

The increased costs on importing raw materials and manufacturing won't end at the pharmacy counter; it’s going to inevitably trickle all the way down to the patient. Compounded pharmacies will be facing higher overhead costs of goods and would most likely need to adjust their pricing for customized testosterone medications. This likely could make Testosterone replacement therapy, which is often a long-term treatment for most men, less affordable for many patients. For some patients, the difference might be negligible, but for others on fixed incomes or who don’t have any financial relief from their insurance coverage, even a slight increase in costs might pose a very real barrier to ongoing affective treatment. The risk is that many patients might reduce their dose to make their medication last longer, ultimately self-prescribing in an effort to save some money and will most likely reduce the effectiveness of their therapy.

The generic testosterone market is a popular choice for most patients, instead of paying for their “brand name” counterparts made by pharmaceutical industry giants. The industry has grown in popularity due to its competitive pricing, affordability and accessibility, and will most likely also feel a financial squeeze due to potential tariffs. Generic drug manufacturers operate on notoriously thin margins. If tariffs make their import costs too high, they may be forced to raise their prices to stay in business, potentially eroding the cost advantage that makes generics so vital for patients in need of affordable healthcare.  Patients without insurance or on treatments that are not covered under their plans would be most at risk. This could lead to a scenario where patients are faced with more expensive options, or in worst-case scenarios, a lack of available affordable alternatives similar to what we are seeing in the GLP-1 space.

Supply Chain Instability and the Specter of Shortages

Another unforeseen problem associated with tariffs is consumer fear and uncertainty, Global supply chains are complex and when people sense change or get afraid of what may happen in the marketplace, there can be unforeseen negative consequences associated with the element of instability that they can create. Relationships that were years in the making with local importers or international suppliers may become strained or possibly even broken if tariffs make imported goods financially unfeasible. This could potentially force compounded pharmacies and generic manufacturers to scramble last minute for alternative sources without the proper time to vet their services or look into their legitimacy. The challenge in finding new suppliers that meet the stringent quality standards rewired by the FDA and regulatory bodies in the pharmaceutical industry, offer competitive pricing, and have facilities and processes in place to meet sufficient production capacity demands is not so easy. If you want to see for yourself, perform a simple google search for a company that supplies raw testosterone and see what you can find. This process can lead to delays in ordering and receiving the necessary supplies and ingredients, which will result in longer wait times for prescriptions to be manufactured and filled. In the most severe cases, it could possibly trigger outright shortages of certain testosterone formulations or compounded preparations if the supply can’t keep up with demand. Nationwide shortages are certainly possible and something we’ve seen before. Once again, look no further back to 2020 when it was nearly impossible for physicians and clinics to obtain a simple medication like lidocaine for basic in clinic procedures due to a nationwide shortage and backorder. Imagine the individual frustration and potential health implications for those patients whose consistent TRT regimen suddenly stops because of a tariff-induced shortage.

Increased Pressure on Profit Margins and Business Operations

Compounded pharmacies often pride themselves on personalized service and attention to detail for physicians and patients, however they are still a business and their goal is to make money. Its already difficult for them to stay in the black with the costs of testing and maintaining operations so with the potential of rising costs due to tariffs squeezing profit margins they will most likely need to increase their costs in order to survive. While some costs will probably be passed on to patients, pharmacies may also absorb a portion to remain competitive with the large pharmaceutical companies or just out of a commitment to patient affordability. This unexpected reduction in profitability for a business may hinder their ability to invest in the business and obtain needed upgrades in things like new equipment, their ability to expand services and offer new products or even maintain current staffing levels. In a challenging economic climate, tariffs may even force layoffs or require employees to come in to work longer hours without pay. The pressure on smaller, “mom and pop” independent compounding pharmacies is even greater than the larger operations further putting a strain on provider, patients and pharmacists locally within communities across the country.

Is Domestic Production Near?

One of the goals in implementing tariffs is to incentivize domestic manufacturing and cut our reliance on foreign countries when it comes to providing the U.S. population with necessary products and materials like medicine. The idea behind tariffs is that by making imported goods more expensive, it becomes more viable for entrepreneurs, investors and companies to produce and manufacture goods within the tariff-imposing country. In theory, this could lead to a resurgence in US-based API manufacturing for drugs like testosterone with existing companies ramping up production and investing in U.S. based jobs and resources. This sounds like a good thing, but not at the expense of a sustained period of increased goods or even a shortage.

Unfortunately, the reality of pharmaceutical manufacturing is extremely complex and isn’t as easy as constructing a building and starting up manufacturing. Experience, training, people and procedures often take many years to obtain and perfect before a safe and approved final product can be produced and distributed. The construction of new API manufacturing infrastructure and operating plants in the United States requires a massive capital investment, adheres to some of the worlds strictest regulatory requirements, and will take many years to come online which may require increased costs unless there is some government subsidy in place which ultimately increases the deficit and these costs often get passed down to tax payers anyway. A recent article in Reuters claims that there will be a 51 billion dollar increase in pharmaceutical costs. The costs of things like labor, environmental regulations, and regulatory compliance in the US are also significantly higher than in many other countries that few organizations are willing or able to take on this daunting task. Therefore, while tariffs may in theory create a long-term incentive to build USA based manufacturing, they aren’t very likely to provide immediate or even medium-term relief in terms of U.S. domestic testosterone API production. The short-to-medium term impact on the industry would almost certainly be an increase in both costs and potential supply disruptions.

The Broad Implications for Healthcare Access for Men and Women on HRT

At the end of the day, imposing tariffs on pharmaceutical ingredients for medications like testosterone carries broader implications for healthcare access for patients and providers. Despite some people’s misconceptions about testosterone, TRT is not an unnecessary  cosmetic treatment. For many patients, TRT or HRT addresses a legitimate medical condition like hypogonadism for example, that can significantly impact and improve a patient's quality of life, energy levels, mood, bone density, muscle mass, and sexual functioning. If tariffs make these medications and therapies more expensive or difficult to get, it could possibly lead to:

• Undertreatment: Men who need TRT or women who need Bio-Identical Hormone Replacement therapy may forgo receiving treatment due to the higher costs, leading to continued or worsening symptoms.
• Health Deterioration: Interrupted or inconsistent treatment could not only lead to a return of the symptoms that lead the patients to treatment but potentially exacerbate and worsen the underlying health issues related to low testosterone or hormones which caused the patient to seek treatment to begin with.
• Increased Health Disparities: The reality of higher costs in medications would disproportionately affect those individuals with lower incomes or who have limited insurance coverage, widening gaps in existing health disparities.

So essentially, while tariffs are widely used as a policy tool of international trade, their potential impact on the pharmaceutical sector, and specifically on medications like testosterone and the people who depend on them, is far from abstract. They pose a very real and tangible threat of not only increased costs, disruption to global supply chains, and reduced patient access for men and women. For those men who rely on Testosterone therapy, these trade decisions could mean significant difficulties in the very near future in managing their health and well-being. As these policy discussions, negotiation s and decisions evolve, it's vital to carefully and thoroughly consider and evaluate what the potential consequences for these essential medications will be in order to ensure that life-improving therapies remain accessible and affordable for all of the patients who need them.