How New FDA Drug Approvals and Policies Will Impact Pharmacy Benefits
Key takeaways for PBMs, employers, and healthcare leaders on the 2025 FDA changes:
- How new FDA drug approvals will impact pharmacy benefits in 2025
- The push for diversity in clinical trials: What it means for drug efficacy
- The rise of cell and gene therapy: Cost and coverage challenges
- How political shifts could reshape FDA drug pricing policies
Why staying informed on FDA regulations is crucial for PBMs and employers
How new FDA approvals, drug pricing policies, and regulatory shifts will affect healthcare
The U.S. Food and Drug Administration (FDA) plays a big role in making sure the medications people take are safe, effective, and available when needed.
Every year, the agency approves new drugs, updates regulations, and makes decisions that can affect the entire healthcare system. Whether it’s a new painkiller that helps people avoid opioids or changes in how weight-loss medications are managed, these updates matter—especially for those working in pharmacy benefits.
As 2025 kicks off, several FDA decisions are shaping the way medications will be prescribed, priced, and covered by insurance. For pharmacy benefit managers (PBMs), employers, and patients, keeping up with these changes is crucial.
Will certain medications become more affordable? Will new drug approvals lead to better treatment options? And how will shifts in government policies affect pharmacy benefits overall?
In this article, we’ll break down the most important FDA updates, what they mean for pharmacy benefits, and how they could impact healthcare costs and access to medications. Let’s dive in!
Recent FDA drug approvals in 2025 and their impact on pharmacy benefits
The FDA has been busy approving new medications that could change the way patients manage pain, weight loss, and other health concerns.
Two of the biggest updates involve a new non-opioid painkiller and major developments in weight-loss medications—both of which could have a big impact on pharmacy benefits and healthcare costs.
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FDA approves a new painkiller without the risk of addiction
One of the most talked-about drug approvals is Journavx, a non-opioid painkiller developed by Vertex Pharmaceuticals. The FDA recently gave it the green light, making it one of the first new types of pain medications in over 20 years.
Unlike traditional pain medications that often rely on opioids, Journavx helps manage acute pain without the risk of addiction—a major win for patients and healthcare providers looking for safer pain relief options.
Why this matters:
For years, opioid addiction has been a huge problem in the U.S., and many doctors have been hesitant to prescribe pain medications that carry the risk of dependency.
With Journavx now on the market, patients dealing with post-surgical or injury-related pain may have a much safer alternative.
Impact on Pharmacy Benefits:
Pharmacy Benefit Managers (PBMs) and insurers will now have the opportunity to include this new painkiller in their formularies as a safer option.
If it proves effective and affordable, it could shift prescribing patterns away from opioids, reducing the risks and costs associated with addiction treatment.
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Big changes for weight-loss medications
If you’ve heard about Wegovy and Ozempic, you know they’ve been making waves as game-changing weight-loss medications.
These GLP-1 drugs have helped many people manage obesity and diabetes, but there’s been a big challenge—demand has been so high that they’ve been on the FDA’s shortage list for a while.
That’s about to change. Novo Nordisk, the company behind these medications, expects the FDA to remove them from the shortage list soon.
This means compounding pharmacies will no longer be allowed to sell knockoff versions, which could help regulate the market and ensure patients get the real, FDA-approved medications.
Why this matters:
GLP-1 drugs like Wegovy and Ozempic have completely changed the conversation around weight management. Instead of just focusing on diet and exercise alone, people now have a medically backed way to lose weight and improve metabolic health.
Impact on Pharmacy Benefits:
With the FDA’s update, PBMs will need to reassess cost management strategies and decide how to structure coverage for these medications. As demand continues to grow, ensuring affordable access while managing costs will be a top priority for insurers and PBMs.
A smart solution:
Programs like MediFit have been making these medications more affordable and accessible to employees through pharmacy benefit solutions.
Since GLP-1 drugs are expensive, PBMs that offer cost-effective access programs may have an advantage in helping companies control pharmacy spending while still supporting their employees’ health.
Read more about Novo Nordisk’s update here.
Both of these FDA updates are major milestones that could shape the way healthcare providers prescribe medications and how PBMs structure pharmacy benefits in 2025.
With new pain treatments and expanded access to weight-loss drugs, patients could see safer, more effective options—but managing costs and coverage will be key.
2025 FDA regulatory changes: What they mean for drug coverage and formularies
Beyond new drug approvals, the FDA and other regulatory bodies are making key changes that could impact how medications are developed and covered in the future.
Two major updates involve diversity in clinical trials and the potential reclassification of cannabis-derived medications—both of which could influence access to new treatments and formulary decisions.
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FDA’s push for diversity in clinical trials: A step toward more inclusive drug development
Historically, clinical trials have lacked diversity, which can lead to medications being developed based on limited population samples. Recognizing this issue, Robert F. Kennedy Jr. has committed to finalizing regulations that require more diverse participation in clinical trials.¹
The goal is to ensure that new treatments are tested on a broader range of people, making medications safer and more effective for all demographics.
Why this matters:
Medical conditions don’t affect everyone the same way, and without diverse clinical trial participants, it’s harder to predict how different populations will respond to new drugs.
A more inclusive approach means medications will be better tailored to various racial, ethnic, and gender groups, improving health outcomes for a wider audience.
Impact on Pharmacy Benefits:
For PBMs and insurers, increased diversity in clinical trials means more reliable drug efficacy data across different populations. This could lead to more personalized medication coverage decisions and potentially impact which drugs are prioritized on formularies.
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Potential reclassification of cannabis-derived medications: What it could mean for pharmacy benefits
Another regulatory discussion gaining attention is the potential reclassification of cannabis from a Schedule I to a Schedule III substance.²
If this happens, it would mean that certain medications containing delta-9 THC could become eligible for FDA approval and wider medical use.
Why this matters:
Right now, cannabis-derived treatments face strict federal restrictions, limiting research and access.
A Schedule III classification would place cannabis-derived medications in the same category as drugs like ketamine or anabolic steroids—still controlled, but recognized for their medical use.
If cannabis-derived medications become FDA-approved, PBMs may need to evaluate their inclusion in formularies and consider how these treatments compare to existing options. For now, this remains a developing topic, and stakeholders will be watching closely to see what regulatory changes unfold.
Looking Ahead: How regulatory updates will shape pharmacy benefits in 2025
These regulatory updates could shape the future of pharmacy benefits by influencing drug approvals, formulary decisions, and patient access.
More diversity in clinical trials could mean more effective treatments for a wider range of patients, while reclassification of cannabis-derived medications could open the door for new treatment options.
As these discussions continue, PBMs and insurers will need to stay informed to make the best decisions for patient care and cost management.
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How political changes in 2025 could reshape FDA policies and drug pricing
Government leadership plays a major role in shaping healthcare policies, and new political appointments can lead to significant changes in how the FDA operates.
One of the biggest developments in 2025 is the nomination of Robert F. Kennedy Jr. to lead the U.S. Department of Health and Human Services (HHS)³, which oversees the FDA.
His leadership could bring shifts in drug approvals, healthcare regulations, and pharmacy benefit policies—potentially impacting how medications are priced and covered
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How new FDA leadership could impact drug pricing and approvals
Robert F. Kennedy Jr. has been known for his outspoken views on healthcare and medical regulations. While his specific plans for the FDA aren’t fully outlined yet, changes in leadership often bring shifts in regulatory priorities.
This could mean:
✔️ A stronger push for transparency in drug pricing
✔️ New approaches to medication approvals and safety regulations
✔️ Potential changes to policies affecting PBMs and drug reimbursements
Why this matters for PBMs and employers
The FDA’s decisions don’t just affect pharmaceutical companies—they impact PBMs, insurers, and ultimately, patients.
If new policies make it easier (or harder) for certain drugs to be approved or priced differently, it could reshape formularies, medication availability, and overall pharmacy costs.
Impact on Pharmacy Benefits and Drug Accessibility
PBMs will need to stay on top of any regulatory shifts that could influence which drugs get approved, how they’re covered, and what pricing strategies need to be adjusted.
With potential new guidelines on drug affordability and access, these policy changes could directly affect how pharmacy benefits are structured in the near future.
Final Thoughts: How PBMs and employers can prepare for regulatory changes
Politics and healthcare are closely connected, and new leadership at HHS could mean big shifts for the FDA. Whether it leads to faster drug approvals, stricter pricing regulations, or new transparency rules, stakeholders in pharmacy benefits need to keep a close watch.
The key is to stay informed, adapt to policy changes, and make sure patients continue to have access to the medications they need—without unnecessary cost burdens.
The rise of cell and gene therapy approvals: How FDA innovations will shape pharmacy benefits
The pharmaceutical industry is rapidly evolving, and one of the biggest areas of growth is cell and gene therapy.
According to the FDA, the agency is expected to approve 10 to 20 new cell and gene therapy products every year by 2025.⁴
These treatments offer groundbreaking ways to target diseases at a genetic level, providing potential cures for conditions that were previously difficult to treat.
Why cell and gene therapy approvals matter for healthcare and PBMs
Unlike traditional medications, cell and gene therapies work by modifying a patient’s own cells or DNA to treat diseases like:
✔️ Certain types of cancer
✔️ Rare genetic disorders
✔️ Blood and immune system conditions
While these treatments are exciting for patients, they also come with high costs and complex administration requirements, which means PBMs and insurers will need to determine how to balance affordability with access
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The impact on pharmacy benefits and drug pricing
- High-cost treatments could require specialty pharmacy management strategies
- Gene therapy approvals could shift the focus from lifelong medication management to one-time, potentially curative treatments
- More personalized medicine could change how PBMs approach formularies and cost-containment
Looking ahead: How PBMs and insurers should prepare for fda-approved gene therapies
As more cell and gene therapies enter the market, pharmacy benefits managers and insurers will need to stay ahead of pricing models, access strategies, and long-term patient outcomes.
With the potential to revolutionize treatment for many conditions, these innovative therapies will play a major role in shaping pharmacy benefits in 2025 and beyond.
Conclusion: How FDA changes in 2025 will reshape pharmacy benefits
The latest FDA updates are set to bring significant changes to the pharmaceutical landscape in 2025. From new non-opioid pain medications and advancements in weight-loss treatments to regulatory shifts in clinical trials and a rise in cell and gene therapy approvals, these developments will have a direct impact on pharmacy benefits and drug accessibility.
For PBMs, insurers, and healthcare providers, staying ahead of these changes is crucial. New drug approvals mean new opportunities, but they also come with challenges—such as cost management, formulary decisions, and regulatory compliance.
As political shifts continue to influence FDA policies, industry stakeholders must remain proactive in adapting to new guidelines and pricing structures.
What’s next? How PBMs and employers can stay ahead of regulatory changes
As 2025 unfolds, keeping up with these FDA changes will be key to ensuring patients have access to safe, effective, and affordable medications.
By staying informed and adapting pharmacy benefit strategies accordingly, stakeholders can make the most of these advancements while optimizing costs and improving patient care.
The world of pharmacy benefits is evolving—and those who stay ahead of the changes will be best positioned for success.
