The Week in Review in Prescription Drug Pricing: FDA Move on DTC Ads, HIV Drug Costs Surge for Medicare, CO PDAB Blocked, and more
Welcome to the Week in Review.
New FDA Move Set To Hinder Big Pharma’s DTC Advertisements
The FDA is expected to strengthen transparency and warning requirements for direct-to-consumer (DTC) prescription drug advertisements as part of the administration’s 2026 regulatory agenda – a move that could make ads increasingly difficult and costly to air – even if it falls short of an outright ban. That shift is significant given how effective DTC advertising is: even small increases in ad spending are associated with major jumps in drug sales. At the same time, lawmakers have advanced proposals like the bipartisan, P4ADNow-endorsed No Handouts for Drug Advertisements Act, which would eliminate tax breaks that subsidize this marketing. Together, these efforts signal growing momentum to rein in a practice – unique to the U.S. and New Zealand – that prioritizes industry profits by encouraging the overprescribing of expensive brand-name products, often while downplaying potential side effects. — [POLITICO, OMB, Axios, TIME, Washington Examiner, Sen. Hawley]
Judge Blocks Colorado PDAB and Enbrel Price Relief
A federal judge has temporarily blocked Colorado’s Prescription Drug Affordability Board (PDAB) from implementing a price cap on Enbrel, halting a first-in-the-nation effort to rein in the cost of high-priced prescription drugs through upper payment limits. The policy would have capped the drug at $600 per week, compared to a monthly list price of over $7,000. The ruling comes as the pharmaceutical industry continues to challenge state-level affordability efforts, with Enbrel manufacturer Amgen praising the decision. For Colorado patients who rely on Enbrel, the pause means continued exposure to high and unaffordable prescription drug costs while the case moves forward. The decision underscores the ongoing legal and political barriers facing efforts to lower drug prices – even as states attempt to take action. — [STAT News, CMS, Colorado Sun, Endpoints News]
HIV Drug Costs Set to Surge for Medicare, EPIC Would Make It Worse
The cost of HIV drugs for Medicare is projected to nearly triple over the next decade, rising from $6.4 billion in 2026 to $17.8 billion by 2035, according to a new study. The analysis finds that the high cost of antiretroviral therapy — not other health conditions — is the primary driver of spending for older Americans living with HIV. These findings reinforce concerns previously raised by P4AD: drugmakers continue to raise prices on HIV treatments while pushing policies that would delay cost-saving reforms. Tools like Medicare drug price negotiation would significantly reduce costs, but many HIV drugs could face delayed eligibility under pharma-backed proposals like the EPIC Act — which would extend the timeline before negotiation could begin. As more people with HIV age into Medicare, the stakes are clear: without protecting and strengthening Medicare negotiation, patients and taxpayers will be left to absorb the rising cost of lifesaving medications. — [JAMA, P4AD]
Bipartisan Push for Broader Insulin Price Caps
Sens. Collins (R-ME) and Shaheen (D-NH) highlighted their bipartisan INSULIN Act this week, which would expand Medicare’s $35 monthly insulin cap to private and employer insurance. While out-of-pocket caps don’t address the root cause of high list prices and instead shift costs away from patients to the government, growing GOP support signals meaningful bipartisan momentum. The proposal was recently folded into a broader drug pricing bill and could see action in an upcoming markup. — [Johns Hopkins, Sen. Shaheen, P4AD]
ICYMI: The FDA approved a new sickle cell disease gene therapy, Casgevy, for children over 2, providing a lifeline for families dealing with this debilitating disease, but it comes with an enormous price tag — Casgevy has a list price of over $2.2 million. Gene therapies are often customized and transformative, but the cost barrier in the United States severely limits patient access, particularly when the same drugs often launch at significantly lower prices in countries like Spain and Brazil.
Patient Advocate Spotlight: Doug Lusty
Condition: Crohn’s disease
Drugs: Stelara ($2,641.09 per injection every eight weeks)
Background: Retired state auditor living in Kaysville, Utah
Read more about Doug in his new Deseret News profile:
“‘Between my wife and I, we were on five of the first 10 medications to get negotiated for Medicare,’ he said. He added that the negotiated prices can still be expensive, but not as expensive as before.”
“Doug retired after 32 years with the state government due to health and meeting his medical needs — not just prescriptions — on a fixed income is challenging.”
“Both of them have at times in recent years skipped medication doses because of the cost. And they’re not alone.”
“Doug Lusty said the bright spot has been that some of the medication costs for them have gone down, thanks in large part to the ability Medicare now has to negotiate the prices on some of the more expensive drugs the program covers.”
Medicare’s GLP-1 Bridge Program Expands Access — But Has Limits
The administration’s GLP-1 “Bridge” program went into effect this week, offering eligible patients on Medicare access to weight loss drugs for $50 per month — marking the first time these treatments are covered for obesity alone. While CMS has not released an official estimate of how many people will qualify, KFF found that roughly 3.8 million beneficiaries would have met the program’s criteria based on 2023 data. For millions of older Americans, this represents a significant step forward, putting highly effective treatments within reach for the first time. At the same time, the program is temporary, does not count toward Medicare’s out-of-pocket cap, and was initially intended to transition into the broader BALANCE model, which remains delayed. GLP-1 drugs continue to cost far more in the U.S. than abroad, highlighting the need for longer-term solutions — but for now, the Bridge program offers meaningful, if limited, relief to some older patients who need it.— [AP, The Hill, USA Today, NBC News, ABC News, Barrons, STAT News]
GLOBE & GUARD Advance, But Questions Remain
CMS has sent the final GLOBE CMMI model rule to the Office of Management and Budget (OMB) for review, the last step before its public release, while its companion model, GUARD, has been under review since June 15th. This move signals that both models are moving from concept to implementation. However, key details remain about how they will function in practice. Reports that drugmakers may be able to avoid participation by entering into voluntary most-favored-nation (MFN) agreements raise uncertainty about whether these models will function as meaningful policy initiatives that will lower costs for patients, or primarily serve as leverage to drive MFN deals. P4ADNow has submitted comments on both of the proposed GLOBE and GUARD models, and we’ll continue to monitor their progression as details emerge. — [OMB, Inside Health Policy]
PBMs and Pharma Continue Pointing Fingers
Pharmacy Benefit Managers are ramping up lobbying spending following the recent passage of bipartisan PBM drug pricing reforms. Drugmakers have spent millions pushing the narrative that middlemen are the primary driver of high drug prices. That messaging push has gained traction, and PBMs are responding with increased advocacy of their own. While PBMs’ opaque and profit-driven practices play a significant role in patients’ access and costs, drug prices are ultimately set by manufacturers. The result is a system where powerful industry players continue to shift blame, while patients face the consequences of high and rising prices. Meaningful reform will require addressing the full system — starting with the pricing power of drugmakers — to deliver lower costs for patients. — [The Hill, P4AD, Congress]
Patient Advocate Spotlight: Josh Swatosh
Condition: Blind, Epilepsy, Cerebral Palsy, Severe Asthma, and Sleep Apnea
Background: 46 year-old patient advocate from Austin, Texas
In His Words: “It’s really been a pain when having to change medications fairly regularly… we should all have more affordable prescription drug prices, as I feel it is not right that drug companies are bringing in massive profits when it does not cost them near what they want you to think it does to manufacture these medications.”
New polling from Axios-Ipsos shows that health care costs — particularly prescription drug prices — will be a defining issue in the 2026 midterms, with a majority of voters saying a candidate’s position on affordability will influence their vote. Another survey found that over the past year more than half of voters took steps to attempt to mitigate high health costs, including avoiding doctors’ visits or taking on debt to afford treatment. U.S. health spending hit a record $5.7 trillion in 2025, with one of the biggest factors driving the uptick being demand for high-cost medications, particularly for people on Medicare and private insurance. Average annual growth for prescription drugs was 11.1 percent in 2025 compared to 7.9 percent in 2024. — [Axios, POLITICO, POLITICO]
Insulin Cap Gains GOP Support
Republican support is growing for legislation that would cap insulin costs for privately insured patients. Medicare’s $35 cap on insulin costs is already delivering hundreds of dollars in savings each month for seniors, proving the program’s success and popularity that should be extended to the commercial market. The move reflects mounting pressure to address drug affordability ahead of the midterms. As Senator Josh Hawley (R-MO) stated, “I don’t know why it should divide Republicans… who is in favor of allowing these pharma companies to rip off people with high insulin prices when there is no supply issue or production issue?” While out-of-pocket caps don’t tackle the root cause of high list prices and only shift costs away from patients, their growing bipartisan support signals continued momentum for policies that directly make prescriptions more affordable. — [Congress, POLITICO]
Sickle Cell Cures Advance – But Costs Remain A Barrier
A young man from Louisiana became the first person in the Gulf Coast region to be cured of sickle cell disease after undergoing FDA-approved CRISPR/Cas9 gene editing technology. This breakthrough follows the treatment of a 12 year old boy in Washington, D.C. These advances mark real progress for a debilitating and lifelong condition that disproportionately affects Black and Latino communities. These therapies represent extraordinary scientific progress — but with price tags exceeding $2 million, access remains a significant barrier both for patients and payers. Alternative models like the first of its kind partnership between a Maryland non-profit and the Brazilian government do offer a potential solution, making these promising cures increasingly within reach for patients.— [Guardian, NYT, The Grio, NIH, Biopharma Dive, Fierce Pharma]
ICYMI
Following Germany’s plans to lower drug prices to control rising healthcare costs, the U.S. launched an investigation into what it calls “underpayment for innovative pharmaceutical products,” raising the prospect of new additional tariffs on EU drug imports past the 15% set to begin at the end of July. It’s critical to remember that lowering prices for U.S. patients shouldn’t come at the expense of patients in other countries, and this approach doesn’t even guarantee lower prices at home. — [Bloomberg, POLITICO, STAT News, EU]
Patient Advocate Spotlight: Helen Bell
Condition: Psoriatic Arthritis and Crohn’s disease
Drugs: Methotrexate, Entyvio, and Rinvoq
In Her Words: “My medications have provided me with periods of remission and overall stability. The financial logistics of maintaining this access, however, have become a more stressful burden than my illnesses themselves.
“My Entyvio would have been a massive financial burden on our household, as it falls under Part B as an infusion. I was only able to proceed with this medication because my gastroenterologist’s treatment coordinator navigated a patient assistance program application successfully. Before landing on my current medication combination, six biologic medications failed me. All of these have been expensive enough that I had to avail myself of the manufacturers’ copay assistance programs, at times forcing me to delay new treatments as I coordinated these programs.
“Having insurance does not guarantee access to affordable care, and lifesaving medications are not guaranteed to be affordable for many. My story is tragically far too common in our broken healthcare system.”
Yesterday, the Senate HELP Committee advanced two bipartisan and P4ADNow-supported bills: The Biosimilar Red Tape Elimination Act (S. 1954), which would reduce unnecessary regulatory hurdles that slow the adoption of lower-cost biosimilars, and The Medication Affordability and Patent Integrity Act (S. 2658), which would strengthen oversight of the patent system and close loopholes that delay competition. P4ADNow has been in support of these bills for years, and we see opportunities for both to pass in a number of potential packages later this year. Additionally, The Ensuring Timely Access to Generics Act of 2025 (S. 3014), which targets sham citizen petitions that block generic entry, was amended to include the INSULIN Act and did not receive a vote. This is another P4ADNow-supported bill, and we anticipate it will be included in a forthcoming July markup. — [IP Watchdog, POLITICO
New Study Reaffirms the Broad Success of OOP Cost Caps
After out-of-pocket expenses were capped for patients on Medicare, their ability to both access and use costly medications increased. That’s according to a new study this week examining changes in prescription fills from 2022 to 2025 — before and after Medicare’s annual out-of-pocket spending caps were introduced. In the researcher’s words, “the policy substantially improved patient access.” After the implementation of the cap, patients had a pronounced increase in fill rates for high-cost drugs, such as treatments for cancer and pulmonary fibrosis. These results mirror what we’ve been hearing from members in our community, and it further reinforces the case for expanding similar caps past Medicare and to the commercial market in conjunction with mechanisms that tackle list price. — [JAMA]
ICYMI
P4AD CEO Merith Basey joined Laura Packard of Care Talk last week to discuss the recent Supreme Court decision to reject six of the largest pharmaceutical industry lawsuits against Medicare negotiation. You can watch the full episode below! — [Care Talk]
Patient Advocate Spotlight: Cheryl Jones
Condition: Thyroid Cancer
Drugs: Armour Thyroid (Over $100 per bottle), and other medications
Background: Patient advocate from Del City, Oklahoma
In Her Words: “For those of us on limited incomes and living off of Social Security benefits, such high costs hurt us badly. We are supposed to be living in our golden years, not dealing with fear and anxiety of where our next meal will come from. It ultimately comes down to the decision of buying prescription drugs or food to eat.
We should all have access to affordable prescription drugs in this country. Instead, the pharmaceutical companies keep raising their drug costs while insurance companies refuse to pay for varying degrees of a medication’s cost.”
WASHINGTON, D.C. — Just now, the Senate HELP Committee advanced two bipartisan bills, all supported by P4ADNow, that will help to increase competition and lower prescription drug prices.
The Biosimilar Red Tape Elimination Act (S. 1954), which would reduce unnecessary regulatory hurdles that slow the adoption of lower-cost biosimilars
The Medication Affordability and Patent Integrity Act (S. 2658), which would strengthen oversight of the patent system and close loopholes that delay competition
In response, P4ADNow CEO Merith Basey released the following statement:
“We applaud the Senate HELP Committee for standing with patients and cracking down on tactics deployed by the pharmaceutical industry that block cheaper biosimilars and generics from coming to market. At a time when nine in ten Americans are demanding Congress do more to lower prescription drug prices, there is both an urgent need and an opportunity to pass these bills as soon as possible. Patients cannot wait.”
P4ADNow has been in support of both these bills for years and our community has pushed hard to get them to this point — including sending nearly 1,500 letters to lawmakers on the Senate HELP Committee in the past four days alone. We see a real path forward for these bills to pass in a number of potential packages later this year.
The Ensuring Timely Access to Generics Act of 2025 (S. 3014), which targets sham citizen petitions that block generic entry, was amended and did not receive a vote today. This is another P4ADNow-supported bill, and we anticipate it will be included in a forthcoming July markup.
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Patients For Affordable Drugs Now is the only national, patient advocacy organization focused exclusively on policies to lower drug prices. We empower and mobilize patients and allies, hold accountable those in power, and fight to shape and achieve system-changing policies that make prescription drugs affordable for all people in the United States. P4ADNow is bipartisan and does not accept funding from organizations that profit from the development or distribution of prescription drugs. To learn more, visit: PatientsForAffordableDrugsNOW.org
Welcome to the Week in Review.
Senate HELP Markup on Affordability Bills Next Week
The Senate HELP Committee is set to markup several bipartisan bills on Wednesday aimed at increasing competition and lowering drug prices. Among them are three P4ADNow-endorsed bills, including the Biosimilar Red Tape Elimination Act (S. 1954), which would reduce unnecessary regulatory hurdles that slow the adoption of lower-cost biosimilars, the Medication Affordability and Patent Integrity Act (S. 2658), which would strengthen oversight of the patent system and close loopholes that delay competition, and the Ensuring Timely Access to Generics Act of 2025 (S. 3014), which targets sham tactics that block generic entry. Patients in our community are actively urging lawmakers to support these measures, which would bring more affordable alternatives to market. We will be closely monitoring the markup and will share any updates as it moves forward. — [Congress, Congress, Congress]
Polling Shows Strong Demand for Lower Drug Prices — and Action from Congress
New polling shows overwhelming bipartisan support for lowering drug prices, with 91% of battleground voters backing policies to align U.S. prices with those in other countries and 9 in 10 saying it’s important for Congress to act. A majority (65%) support Congress passing legislation to codify a most-favored-nation approach. The findings reinforce what patients have been saying for years: Americans are tired of paying significantly more than people in other countries and want meaningful action to drive down prices. With U.S. brand-name drugs costing on average 4 times more than in other wealthy nations, a well-designed MFN policy has the potential to deliver lower prices for patients, but voluntary time-bound deals alone won’t get there. The current MFN agreements lack transparency and enforcement mechanisms. — [PRA, POLITICO]
New Op-Ed from P4AD’s Merith Basey: “Big Pharma lost in court. Congress shouldn’t bail them out.”
In a new op-ed in The Hill, P4AD CEO Merith Basey argues that after the Supreme Court rejected challenges from six major drugmakers seeking to overturn Medicare drug price negotiation, the industry will only increase their focus on Capitol Hill. The piece highlights the real-world impact of Medicare negotiation, including the story of Judy Aiken, a retired nurse from Maine whose monthly cost for Enbrel fell by 67 percent under the program. It also warns that industry-backed legislation, including the EPIC Act, would delay negotiation for many medicines and keep prices higher for patients. You can read the full op-ed at the link here. — [The Hill]
Insulin Cap Expansion Gains Bipartisan Momentum
Legislation to expand Medicare’s $35 monthly insulin cap to the commercial market is gaining traction, with four new bipartisan co-sponsors bringing the total to 22. The bill would extend the cap to employer and marketplace plans, and create a pilot program to provide low-cost insulin to uninsured patients. The push builds on the success of the Medicare cap, which has significantly reduced out-of-pocket costs for seniors, like Bob Parant, who have struggled with the high cost of their insulin for decades. Polling shows expanding the cap to people beyond Medicare is popular, and patients living with diabetes know relief from high insulin prices is well overdue. — [The Hill, P4AD, KFF]
Patient Advocate Spotlight
Name: Andrea Bertram
Condition: Multiple Sclerosis (MS) and Type 2 Diabetes
Drugs: Ocrevus ($63,000 / year) and Mounjaro
Background: Patient Advocate from Johnstown, Pennsylvania
In Her Words: “As the disease progressed, I became medically disabled and a victim of the outrageously high medical costs this condition carries. Unfortunately, every day is a new battle and a new test to maintain self-autonomy of my body and my brain.
“For three years now I have taken Ocrevus, a drug that carries a list price of over $21,700 per vial. I receive this medication every six months at the cost of $63,000 every year, which is thankfully covered by a grant from the manufacturer and previously covered by an income-dependent foundation grant. And this outrageously high price is even an improvement from my previous drug, Copaxone, which used to cost me $7,700 every month.
“I only live on an income of $30,000, and the high costs of both my medications have forced me to shuffle bills around to pay for my medication or just rack up debt on a credit card. Living life like this is not easy or fair. Patients deserve better treatment and more affordable drug prices.”
Patients For Affordable Drugs Now released a new video featuring patient advocates and staff highlighting the bipartisan ETHIC Act ahead of this week’s House Judiciary hearing on patent law and prescription drug access. Introduced by Sens. Peter Welch, Josh Hawley, and Amy Klobuchar, the bipartisan ETHIC Act would make it easier for generic manufacturers to challenge duplicative patents — lowering barriers to entry and helping drive down costs for patients as well as taxpayers. The bill is gaining traction as lawmakers increasingly focus on how patent thickets delay competition. To date, P4ADNow has mobilized nearly 16,000 patient advocates to contact Congress in support of ETHIC and submitted written testimony to a House Judiciary Subcommittee hearing on ETHIC Thursday. AARP and the ERISA Industry Committee also joined P4ADNow in a joint letter to Congressional leadership urging action. — [P4AD, Testimony, Joint Letter]
SCOTUS Protects Generic Competition
The Supreme Court unanimously ruled in favor of generic drugmaker Hikma Pharmaceuticals, preserving a critical pathway that allows lower-cost alternatives to come to market. The case focused on “skinny labeling,” which lets generics launch for unpatented uses, without waiting for every patent on a drug to expire. Had the court ruled the other way, generic manufacturers could have faced increased legal risk when following the rules established by Congress and the FDA — meaning delayed competition, and higher drug prices for patients and taxpayers. Competition is one of the most effective mechanisms for lowering prescription drug prices. — [SCOTUS, Fierce Pharma, IP Watchdog, POLITICO, STAT News, Endpoints News]
New TrumpRx Drugs Don’t Fix Existing Problems
Despite the Trump administration billing the 160 new medications coming to TrumpRx as new deals, these — like last month’s announcement of 600 generic drugs — are instead simply links to existing cash-discount programs already available to patients. While TrumpRx may help some patients navigate existing options, it does not address the underlying drivers of high costs — including the structural conditions that allow drug companies to price-gouge Americans for their essential medicines. — [Washington Times]
ICYMI: The FDA released new draft guidance allowing developers to leverage existing scientific and manufacturing knowledge (from past studies, similar therapies, or their own previous work) to streamline the development of cell and gene therapies. The move is part of a broader effort to reduce regulatory friction and speed approvals of these complex treatments. While faster development can improve access, it does not necessarily translate to lower prices, particularly with therapies that already launch at extremely high costs, such as a treatment for sickle cell disease that costs $2.2 million per patient. — [Endpoints News, Axios]
Patient Advocate Spotlight
Name: Mary Schmidt
Condition: Pityriasis Rubra Pilaris (PRP) Drugs: Prescribed Otezla ($3,000 / month) but is unable to afford the cost Background: Patient Advocate from Devine, Texas
In Her Words: “When I was first prescribed Otezla, it worked very well. In an attempt to continue the medication, I applied to the drugmaker’s assistance program because I knew it was very expensive. I attempted to prove to them that I was on a limited income. I even had to apply for Extra Help via Texas’s Health and Human Services which sent me a letter saying I could get $1,600 of additional coverage, but that would still be way too expensive.
As a result, I had to go on Methotrexate — a drug that has the potential to do more harm than good for me. I had to have my blood drawn regularly and would bruise badly because of my condition. Next, I was put on Skyrizi and was accepted into their assistance program for a year — but it then came time to renew, and I haven’t been able to get back into the program again.
This has been an ongoing issue, and I’ve done everything possible on my part. In the meantime, I’m forced to call my dermatologist and ask if they have a sample, simply to get my next dose. Otezla and Skyrizi cost thousands of dollars that I do not have. Medication for profit is really sad and life-threatening to patients like me.”
WASHINGTON, D.C. — Today, Patients For Affordable Drugs Now released a new video featuring patient advocates and P4ADNow staff highlighting the bipartisan ETHIC Act and how the legislation would help curb one of Big Pharma’s most common tactics for blocking lower-cost competition to keep drug prices high.
The ETHIC Act would address patent thickets — a practice in which brand-name drugmakers accumulate dozens, and sometimes hundreds, of overlapping patents on a single medicine. These patent thickets can be used to block generic and biosimilar competition through costly litigation, entrenching monopolies and forcing patients to pay higher prices for brand-name medications for longer.
Introduced by Sens. Peter Welch, Josh Hawley, and Amy Klobuchar, the bipartisan ETHIC Act would require generic manufacturers to challenge only one patent per patent family rather than litigating against dozens of duplicative patents. The reform would preserve legitimate patent protections while helping prevent abuse of the system to delay competition.
Patent-protected brand-name drugs only make up about 10% of prescriptions, but account for three-quarters of drug spending in the U.S. On average, there are 74 patents per top-selling drug, and when challenged, more than two-thirds of secondary patents are invalidated.
Kris Garcia, Patient Advocate: “Americans pay the highest drug prices in the world.”
Lisa Ann Trainor:“A big reason why is because branded drug companies game the patent system to block patients from accessing lower-cost generics and biosimilars.”
Sarah Wisniewski, Patient Advocate: “One of the ways they do this is by amassing dozens, often hundreds, of patents on a single drug. Then their lawyers use these patents to sue competitors when they try to launch lower-cost generics.”
Alejandra Borbolla Diaz:“Often, brand-name drug companies aren’t even necessarily trying to win the lawsuit. They just want to tie their competitors up in court so they can’t launch their products.”
Merith Basey:“The ETHIC Act is a bipartisan bill introduced by three Senators: Peter Welch, Josh Hawley, and Amy Klobuchar. If passed, this bill would help stop big pharma from bombarding competitors with frivolous patent lawsuits that delay them from launching generics and biosimilars.”
Emma Sands:“So, the ETHIC ACT. It’ll rein in these patent games, which will lead to more competition, which will lead to lower drug prices.”
Kris Garcia:“That’s good for patients. Really good for patients. That’s why we’re fighting to pass the ETHIC Act. Get involved at www.patientsforaffordabledrugsnow.org.”
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Patients For Affordable Drugs Now is the only national, patient advocacy organization focused exclusively on policies to lower drug prices. We empower and mobilize patients and allies, hold accountable those in power, and fight to shape and achieve system-changing policies that make prescription drugs affordable for all people in the United States. P4ADNow is bipartisan and does not accept funding from organizations that profit from the development or distribution of prescription drugs. To learn more, visit: PatientsForAffordableDrugsNOW.org
