In 2025 President Donald Trump vowed that for every new regulation implemented, his administration would undo 10 that were already in place. In practice it has been taking more than 100 deregulatory actions for every regulatory one. While some creative math has gone into the claims about the resulting cost savings, it is unequivocally true that Trump has been dismantling the federal government at a pace that far surpasses anything the nation has seen before.

“After four years of stifling overregulation and astonishing government weaponization, 2025 marked the first chapter of the latest American comeback story under President Trump,” Mark Paoletta, general counsel performing the delegated duties of the OIRA Administrator, wrote in the introduction. “Now, the President is writing the next chapter. America is in a new Golden Age.”

Some agencies have few proposed or final rules to report. The Substance Abuse and Mental Health Services Administration only has three, all of which pertain to mandatory workplace drug-testing procedures. The Bureau of Prisons is working on two, a proposed revision to the Prison Rape Elimination Act and another to the First Step Act. The Office of National Drug Control Policy has just one rule in progress, a short item about improving transparency in grantmaking decisions. The Food and Drug Administration has 65.

This rule might result in fewer pharmaceutical ads on TV. It might also result in ads that are a lot longer.

One that the Agenda has labeled “economically significant,” is the proposal to crack down on direct-to-consumer pharmaceutical ads. The extremely American phenomenon of pharma companies using TV commercials to hawk medications to potential patients owes to a 1997 regulatory loophole that allowed potential side effects to be listed somewhere else, rather than during the ad. This meant that companies could fit all the legally required information into a 30-second commercial. The FDA now intends to close that loophole by requiring a “brief summary,” via a final rule that according to the Agenda is slated to arrive in December. This rule might result in fewer pharmaceutical ads on TV. It might also result in ads that are a lot longer.

“FDA anticipates that this rule, if finalized, will result in regulatory costs,” the agency stated in the Agenda. “Industry will face costs of either: 1) purchasing additional advertising time to include required product safety information, 2) dedicating additional advertising time within current advertising time slots toward the newly required information, or 3) the opportunity cost of choosing not to advertise if the cost of inclusion of all newly required safety information induces a decrease or cessation of product advertising.”

The agency pointed out that in 2023 the combined DTC ad spending for the top 10 pharma companies was around $13.8 billion, and that regulation would likely affect international investment and commerce.

“The benefits of this rule are in providing patients more complete safety information during all advertisements covered by the rule, thus improving consumer understanding when they participate in healthcare decision making,” the agency stated. “Risks: TBD.”

Among the Agenda’s updates on other FDA rules, the agency has once again punted its deadline for deciding whether to ban electrical stimulation devices (ESD), which purport to change self-harming or aggressive behavior by delivering shocks through electrodes affixed to the patient’s skin. Autism and intellectual disability advocates have for years testified that ESD are used for torture and punishment, and called on the FDA to remove them from the market. In 2024 the agency committed to reaching a verdict by May 2026. Having not done that, it has now suggested a deadline of November. The devices are still sanctioned at a “behavior modification program” in Massachusetts.

“FDA intends to review the comments received and assess any new data or information in connection with making a determination as to whether the use of ESDs for [self-injurious or aggressive behavior] presents an unreasonable and substantial risk of illness or injury and that the risks associated with ESDs for these intended uses cannot be corrected or eliminated by labeling,” the agency stated. “If FDA makes this determination again, the Agency will issue a final rule to ban these devices.” 

The FDA is also considering a regulation that would support “administrative detention of tobacco products … believed to be adulterated or misbranded,” which refers to the agency’s ability to freeze a retailer’s sale of any nicotine vapes to which it hasn’t granted marketing authorization, while the Department of Justice is looped in to explore legal action including permanent seizure of the products. The FDA claims that this would benefit public health through “the illnesses, injuries, or deaths prevented because the Agency administratively detained a tobacco product it has reason to believe is adulterated or misbranded.”

The majority of nicotine vapes that people actually use in the United States—responsible for the rather important public health benefit of reducing the combustible tobacco use that costs almost half a million lives each year—are not FDA-authorized.

“The ability for FDA to issue administration detention orders against new, unauthorized tobacco products, including ENDS, may encourage manufacturers to submit premarket applications requesting authorization for their products to be lawfully marketed, rather than continue to flood the market with additional unauthorized products,” the agency stated.

Image via United States Representative Rosa DeLauro

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TrumpRx doesn’t sell any medications directly. It offers coupons, or in some cases links to manufacturer websites where discounted prices are available. But all of this requires paying cash, and so the site is of little use to most people with either public or private health insurance.

When the site launched in February, after several months of buildup, it featured discounts for 42 name-brand medications and one authorized generic (meaning the medication itself is identical to the name-brand version, but the labeling is generic). These represented the “most-favored-nation” (MFN) pricing that Trump falsely claimed to have negotiated to historic lows. In many cases, the site was just offering discounts that were already available from manufacturers. Trump’s claim that no other country offers lower prices on the name-brand pharmaceuticals in his MFN deals has also been widely debunked.

The site now has two categories of discounts: “Presidential deals,” which now lists 72 name-brand medications, and “Standard prices,” which lists 602 generic medications and the discounts available through one or more of the three partner companies.

“Consumers will now have one source to ensure that they’re getting the lowest possible cost on their prescription,” Trump said during a May 18 press event. “With these additions TrumpRx will feature the best and lowest prices on prescriptions used by tens of millions of Americans already. And in some cases the discounted generics available through TrumpRx may be offered at an even lower cash price than the out-of-pocket insurance cost. Which has always been the lowest, but we’re going to be lower.”

The site does not feature any controlled substances or other medications with Food and Drug Administration-mandated risk evaluation and mitigation strategies. 

Trump claimed that the site has already saved consumers more than $400 million.

“[MFN deals are] one-off agreements made for publicity purposes. They don’t change anything about the way drugs are priced,” Aaron Kesselheim, a professor of medicine at Harvard Medical School whose research focuses on drug prices, told KFF Health News earlier in May. “The agreements are opaque and unenforceable.”

Trump claimed at the press event that the site has already saved consumers more than $400 million. He also claimed that per the Council of Economic Advisers, the MFN pricing will save consumers more than $500 billion over the next decade.

“It’s truly the hottest thing in medicine,” he continued. “This has been the greatest breakthrough in lowering health care costs in modern history.”

Cost Plus Drugs was cofounded by billionaire Marc Cuban, who stated at the May 18 press event that his company is behind 559 of the new generic additions.

Cuban, who in the 2024 presidential election endorsed Democratic candidate Kamala Harris, was criticized on social media for his involvement in the TrumpRx expansion. In a now-deleted tweet, he called anyone who “thinks I’m going to put politics ahead of helping Americans reduce their” health care costs “a fucking idiot.”

Image via the White House

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In late 2025, the federal government reauthorized the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act. One of its provisions required Department of Health and Human Services Secretary Robert F. Kennedy Jr. (R) to work with the Drug Enforcement Administration to publish guidance on use of in-home drug disposal systems. The FDA issued a Request for Information (RFI) in the Federal Register on March 6, and the public can submit comment electronically or by mail until April 6.

“Having unused opioids laying around at home can be a significant risk to those struggling with opioids and can be a gateway for opioid-naïve family members,” stated FDA Commissioner Dr. Marty Makary. “We need to develop creative ways to address opioid misuse and abuse.”

This is ungenerous to his agency’s previous efforts, as both the FDA and DEA have already developed inordinately creative ways of rounding up leftover medications.

Currently, the government’s first-line option for disposal of unwanted or expired medications is for patients to drop them off with law enforcement at a Prescription Drug Take Back Day, a recurring event that the DEA promotes in the tone that car dealerships use to promote Memorial Day weekend sales. In areas where no such event is scheduled in the near future, people are encouraged to find the drug dropboxes stationed at various pharmacies or at their local sheriff’s office. Or, they can use special prepaid envelopes to legally mail the drugs directly to a disposal facility. You get a certificate once they’ve been incinerated. 

If none of those options are feasible, you’re supposed to check the FDA’s flush list, a nonintuitive selection of the medications—mostly opioid analgesics—that the agency claims pose the greatest overdose risk to children and pets. The list includes buprenorphine, methadone, a benzodiazepine rectal gel and a transdermal Ritalin patch.

“Medicines on the flush list are those (1) sought-after for their misuse and/or abuse potential and (2) that can result in death from one dose if inappropriately taken,” the list states. “If children, adults or pets in your home accidentally or intentionally ingest, touch, misuse or abuse a medicine on the flush list, they can suffer serious consequences including death.”

At the end of the list the agency explains that the risk of overdose from accidental exposure “far outweighs” any potential harms of flushing, and that the selected drugs “present negligible risk to the environment, although additional data would be helpful for confirming this.”  

Most medications are not on the flush list, and according to the FDA are fine to add to your regular household trash as long as you make sure they’re unsalvageable. You do this not by dissolving or crushing them, but by leaving them completely intact and mixing them with cat litter, dirt or used coffee grounds. 

“This makes the medicine less appealing to children and pets,” the FDA has stated previously, “and unrecognizable to someone who might intentionally go through the trash looking for drugs.”

Though creative, at the cat-litter stage we start to lose the plot a bit more. Of all the conceivable demographics that might be deterred from eating pills because there’s dirt on them, at the bottom of the list would be babies, dogs and whatever drug-using bogeyman the FDA imagines is waiting to go through your trash, opening random Ziplocs full of cat litter to see if there are pharmaceuticals inside.

The argument for leaving tablets fully intact is that crushing them would release dangerous drug dust into the air—creating an exposure risk that is not real, but which the feds take very seriously nonetheless—and perhaps be easier for bystanders to accidentally ingest. There are an infinite number of more effective ways to make pills unrecognizable to drug users and inaccessible to babies and dogs.

Similarly, the FDA also warns that “once the expiration date has passed there is no guarantee that the medicine will be safe and effective … don’t use expired medicines—it’s not worth the risk!” The agency is aware that the expiration date printed on the label refers to when the prescription expires (meaning your pharmacy won’t fill it after that date) not the medication itself, but still we talk about shelf-stable opioids like something that could give you food poisoning.

“It remains challenging to validate data on in-home disposal systems because there are no industry-wide agreed upon tests to evaluate in-home disposal systems for their intended purpose of disposing of opioid analgesics,” the FDA stated in its March 6 notice. 

Because in-home disposal products are not regulated, manufacturers are not required to report adverse events and thus there hasn’t been a ton of data for the FDA to review. In looking through more anecdotal records, however, the agency “reports of patients who thought the disposal system was a separate medication that should be ingested,” or “bags not sealing appropriately and foaming out before the bag could be resealed.” 

Companies that make the in-home disposal products currently on the market have a different interpretation. DisposeRx, which posted a March 10 endorsement of the FDA’s action, was already describing its drug-deactivating gel packets as “FDA-recognized.” Deterra, which makes a similar product, states that FDA guidelines “include at-home medication disposal products as a safe, convenient” option.

Despite the flush list, the DEA considers incineration the only method of rendering drugs “nonretrievable.” But since 2022 this standard has not applied to the safe-disposal options the FDA requires pharmaceutical manufacturers to offer.

Open burning of household waste is prohibited. But when explaining why you can’t just burn the unwanted drugs yourself, multiple government agencies including the Environmental Protection Agency also consider it relevant to note that open burns wouldn’t be able to achieve the combustion temperatures necessary to fully, nonretrievably incinerate the drugs.

Using a drug disposal product could itself introduce risk of child exposure, because it involves removing the medication from the child-resistant packaging it already comes in. It might rely on a chemical reaction that takes place over the course of several hours, or more. It also just attracts more attention. The FDA also notes that wider adoption of these products “would likely result in an increased number of used systems with potentially available opioid analgesics in household trash,” from which they could be retrieved if the disposal product didn’t work. 

The prepaid envelopes were the first safe-disposal system that the FDA required manufacturers to offer pharmacies and providers, who can in turn give them to patients. It refers to them as an “underutilized” option, one that essentially checks all the boxes. The envelopes don’t require removing the drugs from their child-safe packaging—you can just put the bottle itself in there—and are straightforward products people are already familiar with. Their use is already regulated by the United States Postal Service. They can even constitute “nonretrievable” disposal because once mailed, federal law ensures they go straight to the incinerator with no tampering along the way.

So we’ve so far established that opioids can be safely flushed; that the prepaid envelopes are the ideal solution; that only incineration can render drugs “non-retrievable”; and that at-home disposal kits introduce multiple opportunities for the diversion and exposure the feds are so worried about. The only reason to reinvent the wheel—or toilet, incinerator, etc.,—is to further the “gateway theory” that Makary was referencing.

The tail end of someone else’s post-surgery prescription is not an ongoing supply source. What the FDA is really getting at is the myth that opioids are so toxic, so likely to get teenagers “immediately addicted,” that regular fire isn’t enough to stop people from using them and so we need to invent increasingly complex yet clumsy ways of containing them.

Image (cropped) via Drug Enforcement Administration

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Though not a strict requirement, two well-controlled studies demonstrating safety and efficacy has long been the FDA’s default position. The agency did not announce the new policy on its website, but in a February 18 New England Journal of Medicine article by Commissioner Dr. Marty Makary and Chief Medical and Scientific Officer Dr. Vinay Prasad, who also directs the FDA’s Center for Biologics Evaluation and Research.

“The FDA’s historical reliance on two clinical trials rather than one was intended to provide credible causal evidence that a therapy could improve clinical outcomes with acceptable safety in a world where biologic understanding was more limited than it is today,” the authors wrote. “Two trials should be seen as just one of many interlocking facets of clinical credibility, and in 2026 there are powerful alternative ways to feel assured that our products help people live longer or better than requiring manufacturers to test them yet again.”

Makary and Prasad argued that the approval process will not become less rigorous since the two-trial standard was never foolproof to begin with, and greater scrutiny will now be placed on each trial that is submitted. They also noted that many drugs are already approved based on a single trial, and that the FDA retains the authority to request a second trial.

The new standard is intended to “substantially” cut costs for sponsors, with the paper citing estimates that the cost of a pivotal study can range from $30 million to $150 million.

“Lowering capital costs for drug developers may remove a persistent argument in justification of lofty and rising drug prices for everyday Americans—the onerous cost of research and development,” the authors wrote. “The FDA expects a surge in drug development in response to our initiative.”

“Who was consulted? Was anyone consulted? What were the data that drove the decision?” Center for Medicine in the Public Interest President Peter Pitts, a former FDA associate commissioner, told Regulatory Focus. “Was there industry input? Was there patient input? Was there input of any kind from anybody other than Drs. Makary and Prasad?”

In May 2025, shortly after his appointment to FDA commissioner, Makary began an “aggressive” internal rollout of artificial intelligence tools that purportedly “allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process.” These include a generative chatbot called Elsa that reads, writes and summarizes scientific documents, and a more recent agentic AI tool ​​used for “more complex tasks” including review validation.

Makary has also established the Commissioner’s National Priority Voucher pilot program, a new expedited approval process that will see certain drugs cleared to go to market after just one to two months of review. The standard has been six months for priority drugs, and 10 months for most drugs. Makary had initially planned to give a voucher to a psychedelic treatment for depression developed by Compass Pathways, but it was cut at the last minute. 

President Donald Trump’s second term has seen sweeping rollbacks of economic and environmental safeguards that have often attracted less media attention—from the Department of the Interior opening federal lands to development under expedited permits to the Federal Communications Commission forcing anti-consumer policies past the public during the 2025 government shutdown. Earlier in February, the EPA revoked its 2009 finding that greenhouse gas emissions are a public health threat, the legal basis of their regulation under the Clean Air Act. 

In December 2025 the White House announced that the administration had so far completed 646 deregulatory actions, and only five regulatory actions. Deregulation is expected to be the de facto theme of Trump’s 2026 State of the Union Address on February 24.

“Deregulation is the unsung hero of this entire economic turnaround,” state Trump’s prepared remarks. “We are cutting costs through deregulation faster than anybody ever thought possible.”

Top image (cropped) and inset graphics via Food and Drug Administration

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“Through the website, patients will be able to access large discounts on many of the most popular and highest-priced medicines in the country,” states a White House fact sheet, “paying prices in line with the lowest paid by other developed nations (known as the most-favored-nation, or MFN, price).”

In May 2025 Trump issued an executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” in which he pledged to tackle “global freeloading” by pharmaceutical manufacturers that inflated United States prices in order to subsidize discounts that they offered to foreign markets. The order did not mention that medications in other countries often cost less because those governments actually regulate their market rather than leaving it up to manufacturers—or more specifically, pharmacy benefit managers—to set the prices.

TrumpRx was subsequently announced in September 2025. Since then, the administration has built up the launch by announcing a series of deals with certain pharmaceutical companies for certain drugs that would be getting discounts. The February 5 launch includes 43 medications from AstraZeneca, Eli Lilly, EMD Serono, Novo Nordisk and Pfizer, which according to the White House were the first five companies to agree to the MFN pricing. More are promised in the coming months.

Four of the medications are only discounted for patients not enrolled in government-funded health programs like Medicaid.

Most TrumpRx discounts work via coupons. Of the 43 listed medications, 31 have coupons on the website that patients can present to their pharmacies. These include nicotine partial agonist Chantix; nicotine replacement therapy Nicotrol; chronic obstructive pulmonary disease inhaler Bevespi; antidepressant Pristiq; and HIV antiretroviral Viracept.

“This is an out-of-pocket price,” the website states on the page for each medication. “If you have insurance, check your co-pay first—it may be even lower.”

Another three medications have coupons but are described as specialty drugs “available only by mail-order,” which isn’t necessarily the case. Their TrumpRx coupons, however, can only be redeemed through one of the mail-order pharmacies listed on the website.

Another four have coupons that patients can only access by agreeing to terms and conditions that state they are not enrolled in Medicaid, Medicare or any other government-funded medical or prescription benefits program; that they won’t seek any reimbursement through private insurance; and that they will not count the costs toward their deductibles.

Manufacturer direct-to-consumer website already offer discounts to patients paying cash.

The rest of the medications don’t have coupons; the discounts can only be accessed through their manufacturers’ direct-to-consumer websites. These websites generally already offer discounts to patients paying cash.

The TrumpRx website revolves around pointing out cost differences between the MFN prices and “original” prices, but the latter are wholesale prices that are always vastly greater than what any patients pay using public or private insurance. 

It’s likely that in many cases, the MFN prices are still higher than the price of insurance copays. Some of the medications are also available as generics that are cheaper than the brand-name versions from the manufacturers participating in TrumpRx.

The White House has also previously claimed that its MFN negotiations with manufacturers would result in savings for state Medicaid programs—which already receive substantial rebates from manufacturers. Some analysts have speculated that these deals may end up increasing costs and decreasing access for Medicaid patients.

Image (cropped) via TrumpRx.gov

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Through a deal struck by the Clinton Health Access Initiative, Unitaid and Wits RHI with a pharmaceutical manufacturer in India, and a separate deal between the Gates Foundation and a second manufacturer in India, generic versions of lenacapavir are expected to enter the global market in 2027. Funders announced the news September 24.

Lenacapavir entered the domestic market in June under brand name Yeztugo, following its approval by the Food and Drug Administration. As an injectable that only has to be administered twice a year, it’s by far the longest-acting PrEP medication. It’s been widely heralded as a unprecedented breakthrough for HIV prevention—or rather, it could be, if people at risk could access it.

“While an HIV vaccine remains elusive, lenacapavir is the next best thing,” World Health Organization Director-General Dr. Tedros Adhanom Ghebreyesus said in July.

In one study that included 5,338 at-risk participants assigned female at birth, lenacapavir was 100-percent effective in preventing HIV acquisition after one year—none of the 2,134 people who received lenacapavir contracted HIV. In another comparably sized study of primarily male participants, the medication was 96-percent effective after one year.

For now, the cost in the US remains over $14,000 per dose.

On September 18, the Centers for Disease Control and Prevention issued new HIV prevention guidance, stating in an open letter that “on the basis of a high certainty of evidence for its efficacy and safety” the agency “strongly recommends lenacapavir.”

While the CDC recommendation doesn’t have a direct bearing on medication access the way FDA approval does, its value is that it may persuade insurers to cover it. For now, its cost in the US remains over $14,000 per dose.

In late August, Reuters reported that CVS would not add Yeztugo to its drug coverage lists. Pharmacy benefit manager CVS Caremark controls the drug-pricing in more than one-quarter of the US pharmaceutical market.

“We’re in the process now of attaining insurance coverage for lenacapavir,” Daniel O’Day, chairman and CEO of Gilead Sciences, said at a September press conference. “It’s going as planned. We expect within six months of launch to have around 75 percent of insurers covering lenacapavir and about 90 percent in 12 months. And that plan is very actively underway right now for Americans.”

At that press conference, the Trump administration unveiled an agreement with Gilead to cover the cost of Yeztugo for 2 million people internationally over the next three years. This is focused only on preventing mother-to-child transmission; however, State Department senior official Jeremy P. Lewin said that “there’s no formal restriction” as to how countries allocate the doses.

Gilead had already voluntarily licensed the medication to generics manufacturers by the time lenacapavir received FDA approval, which appears to be the first such arrangement of its kind.

No PrEP medication is FDA-approved for HIV risk associated with injection drug use; only with sexual contact.

Three other PrEP medications have previously been approved by the FDA, and appear in the CDC’s clinical guidance. Truvada, which was already an established HIV treatment medication, received FDA approval for PrEP in 2012. Descovy followed in 2016, and Apretude, the first injectable form, was approved in 2021. While Truvada and Descovy are pills meant to be taken once a day, Apretude requires only one injection every two months. 

None of the four medications are FDA-approved for the prevention of HIV transmission associated with injection drug use (IDU); only with sexual contact. However, the CDC guidance states that Truvada is “recommended to prevent HIV among all people with sex or injection drug use risk factors,” and medical experts widely agree that PrEP medications are effective and advisable for people at risk from sharing needles—many of whom are also at risk from sexual contact.

A statistic widely circulated by the CDC and other state and federal health agencies is that oral PrEP pills are shown to reduce risk of HIV transmission associated with IDU by at least 74 percent. However, despite the established link between sharing needles and HIV transmission, few studies have been conducted on the efficacy of PrEP medications in this context and most of the existing data represent patients who weren’t necessarily adhering to the treatment regimen as prescribed—which suggests that these medications have even greater potential, if at-risk drug users have access to treatment options that fit them. For many people, a clinic appointment twice a year would be more sustainable than a medication that has to be taken every day to be fully effective.

Though transmission has been steadily declining, approximately 31,800 people in the US were diagnosed with HIV in 2022, the most recent year for which the CDC has comprehensive data.

“[A]dherence to available PrEP regimens is suboptimal,” the agency wrote in its September 18 clinical recommendation, published in the Morbidity and Mortality Weekly Report. Lenacapavir “provides the potential to improve PrEP adherence and thus enhance HIV prevention in the United States. Additional research is needed to understand [its] effectiveness in persons who inject drugs.”

Image via United States Department of Health and Human Services

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On September 9, President Donald Trump signed a memorandum ordering the Food and Drug Administration (FDA) to increase enforcement of restrictions on DTC drug advertising, with an emphasis on TV ads. The FDA announced a crackdown on “deceptive” DTC ads that same day.

“For far too long these ads have distorted the doctor-patient relationship and have created artificial demand for induction regardless of their clinical appropriateness,” FDA Commissioner Marty Makary stated on social media. “In recent years the FDA has increasingly been lax in its enforcement approach … Well, it’s a new day.”

The FDA has already issued approximately 100 cease-and-desist letters, and thousands of additional warning letters. These actions are being heavily promoted by the administration, and framed as a corrective to the dwindling number of letters the FDA has been issuing in recent years. However, it doesn’t appear that the agency actually sent companies individualized letters describing specific violations identified in their advertising. The letter authored by Makary and shared by the FDA begins “Dear Pharmaceutical Company,” and includes the line “We are issuing this letter to provide notice to all application holders.” Cease-and-desist letters are not typically issued in this generic fashion.

The FDA has a certain amount of enforcement authority under the Federal Food Drug and Cosmetic Act, which requires that all prescription drug advertising balance information about potential benefits with information about potential risks, so as to not be misleading. But the administration is not banning DTC ads outright—something Health and Human Services Secretary Robert F. Kennedy Jr. has pushed for, but which federal courts have historically viewed as a violation of the First Amendment, and which the FDA has stated it doesn’t have the authority to do.

 

Let’s get President Trump back in the White House and me to DC so we can ban pharmaceutical advertising. pic.twitter.com/Qp7fj9xskU

— Robert F. Kennedy Jr (@RobertKennedyJr) November 3, 2024

TV ads hawking pharmaceuticals to potential patients is essentially an American phenomenon; only New Zealand has comparably permissive regulations.

Up until the 1980s, pharma companies would pitch their products to health care providers, who were the sole source of information for patients. Then companies realized they could bypass the medical professionals, and advertise to the public directly. 

In 1985 the FDA issued guidelines that restricted pharmaceutical ads, including by banning them from naming specific conditions that a drug could treat, unless they also included the complete list of side effects. Newspapers and magazines were able to accommodate this requirement, but the concept of “fine print” doesn’t translate as well to TV and radio. Many companies didn’t bother. 

Then, in 1997, the FDA issued new guidelines. Rather than list all the side effects, ads only needed to include a brief summary. Or, instead of the brief summary, a URL or toll-free number viewers could use to find the information. This became known as the “adequate provision” loophole. The pharmaceutical industry now spends over $5 billion a year on TV advertising, and over $10 billion a year on DTC ads in total.

“The Trump administration is taking action to return to the pre-1997 status quo by engaging in FDA rule-making to close the ‘adequate provision’ loophole to ensure risk disclosure,” HHS stated, ”and stepping up enforcement action of DTC pharmaceutical ads.”

RFK Jr. has suggested the changes might result in ads that swell to four minutes long, in order to include all the side effects and required risk information. The likelihood of this is unclear, but what seems more certain is that pharma companies will file legal challenges to the new restrictions.

“Pharmaceutical ads hooked this country on prescription drugs,” RFK Jr. stated. “We will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising. Only radical transparency will break the cycle of overmedicalization that drives America’s chronic disease epidemic.”

In 2019 during his first presidential term, Trump attempted to force pharma companies to include drug prices in their DTC commercials, if the price would be more than $35 per month. A federal judge blocked it in the final hours before it would have taken effect, ruling that the administration doesn’t have the legal authority to compel private companies to disclose their prices.

Image (cropped) via United States Food and Drug Administration/YouTube

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“Tragically, the new drug application for OxyContin was initially approved without study data supporting its long term use to treat pain in many patient populations for which it has been prescribed,” the FDA stated in a press release. “The updated labeling change reflects … new data on how long-term opioid use can lead to serious side effects.”

The new requirements have been on the horizon since May, when the FDA held a public advisory meeting to discuss the results of two postmarket review studies that catalyzed the decision. The studies defined long-term use as anything over 70 days out of a 90-day period.

Among a number of other updates, the new safety labeling for extended-release/long-acting opioids will bear the following:

“The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy. In postmarketing studies, addiction, abuse, misuse and fatal and non-fatal opioid overdose were observed in patients with long-term opioid use.”

In the nearly two decades since the United States began its crackdown on opioid prescribing, the prevailing narrative around the overdose crisis become one where the blame lies entirely with pharmaceutical companies. Pain patients with opioid prescriptions are not a high-risk population for overdose, and limiting their access to their medications increases harm without making any dent in the overdose crisis or reducing rates of opioid use disorder. Villainizing OxyContin has come at a much higher cost to pain patients than it has to Purdue Pharma or the Sacklers.

Opioids are extremely effective medications for managing pain, and are a lifeline to many chronic pain patients who need them for day-to-day functioning. But the health care industry has long favored the myth that opioid analgesics are only advisable for short-term treatment, not ongoing maintenance. Long-term maintenance on medications for opioid use disorder is viewed the same way, as methadone and buprenorphine are FDA-approved for both OUD and pain. 

What the labeling will not bear going forward is any reference to an “extended treatment period,” which the FDA has instructed pharmaceutical companies to remove in order “to avoid misinterpretation that there are data to support safety and efficacy of opioid analgesics over an indefinitely long duration.”

It’s true that there’s very little clinical evidence supporting prescription opioid use for chronic pain management. However, very little research has been conducted. The idea that opioid analgesics aren’t suitable for long-term maintenance comes from a body of evidence that mostly shows that short-term use is effective, rather than that long-term use is harmful.

In its longer guidance document accompanying the announcement, the FDA instructs providers to “[r]egularly re-evaluate” opioid prescriptions for any patient who’s been taking them for “more than a few days,” as well as “frequently assess for development of addiction, abuse or misuse.” The agency has also commissioned a new clinical trial to assess the merits of long-term use.

The labeling changes have also provided a slightly ironic opportunity for Big Pharma to further a separate agenda.

Providers are often unwilling to work with patients who need opioids analgesics to manage chronic conditions rather than short-term pain relief after a surgery or accident. In addition to any pre-existing bias, they’re conscious that they might be accused of inappropriate prescribing if they have too many pain patients who have—in the Drug Enforcement Administration’s view at least—been taking opioid analgesics for too long.

Prescriptions for various controlled substances, but mainly opioids, are tracked through state-level databases called prescription drug monitoring programs (PDMP). In many cases, before prescribing an opioid providers are required to screen the patient’s history for any activity that the DEA deems suspicious. Pharmacists are responsible for vetting incoming prescriptions the same way. In some states, local law enforcement can access PDMP data without a warrant.

PDMP algorithms are proprietary and the specific “red flags” that can trigger a DEA investigation are withheld from the public, but it’s widely understood that they include activity such as writing higher-dose prescriptions.

The labeling changes have also provided a slightly ironic opportunity for Big Pharma to further a separate agenda, in which references to “naloxone” are quietly replaced with references to “opioid overdose reversal agents like naloxone and nalmefene.”

Nalmefene, a longer-acting opioid antagonist compared to the better-known naloxone—which continues to reverse overdose from fentanyl and other opioids just fine, regardless of law enforcement misinformation—can put people at increased risk of overdose if they have a physical tolerance to opioids. The nalmefene-inclusive language has been increasingly appearing in every kind of overdose-response document from state legislation to school board policies since Indivior got FDA approval for the first nalmefene-based opioid overdose antidote product in late 2023.

The other pharma company that’s gotten a nalmefene antidote approved since then is Purdue.

Image (cropped) via Georgia Department of Public Health

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Oxycodone, oxymorphone, hydromorphone, methadone. It was the golden age of doctor-shopping. Anything was possible. One general practitioner wanted to wean me off the 10 mg Percocets he’d been prescribing and switch me to fentanyl patches. He said that because fentanyl was a designer drug, there was less risk of me getting addicted.

At first I was just sticking to prescribers inside the Medicaid network, but that would only cover one prescription of each class of drug per month. So I branched out to those who generously allowed me to pay in cash. Sometimes you’d have to give the doctor $100 on your way out, then give another $100 to the receptionist—his wife—but for the most part the out-of-pocket costs were really negligible. A lot of us made a living this way, reselling the drugs to people without prescriptions of their own.

Not all generics are created equal, or at least what people believe.

It wasn’t just opioids. But, as pharmaceuticals go, opioids are cheap. The rectangular white “coffins”—methadone tablets, the kind there was a market for—I was getting prescribed at 60 mg per day for pain. Each tablet cost me about $0.71, and would resale for between $6 and $8.

A prescription for 8 mg generic hydromorphone tablets, three times a day—the circle-shaped kind, not the shield-shaped kind—cost me $1.09 per tablet. Those sold all day long for $8 per tablet, and that was for bulk buys of 100 at a time. If someone was buying singles, they paid $12 per tablet.

Not all generics are created equal, or so people believe. People wanted not just any generic Xanax, but the 2 mg “G3722” manufactured by Greenstone LLC. They wanted the Teva Pharmaceuticals generic Klonopin, not another kind. The 30 mg orange ovals of generic Adderall were the most popular, though the round pink 20 mg tablets were up there too.

Some preferences it’s fair to chalk up to mythology, or individual things people had convinced themselves about the properties of one generic versus another. But, not to attach a moral value to drugs, some pills are obviously better or worse than others. 

One company’s 2 mg buprenorphine tablet might be just a little microdot, the way it ought to be, but Roxane Laboratories made a 2 mg that was huge. All filler. Even if you weren’t going to crush and inject it, it was just this big ball of chalk no one wanted to deal with.

In the first couple of appointments one doctor kept sticking me with generic Adderall tablets that were not 5 mg, not 10 mg, but 7.5 mg. As if anyone had ever heard of such a thing. They had tons of filler, and nobody wanted to buy them in the first place because they were weird. 

A monthly prescription of roxies could pay your rent, and that was just one scrip from just one doctor.

But 30 mg Roxicodone (roxies) tablets, if they were the M-30s everyone wanted, were going for $30 each. A monthly prescription could pay your rent, and that was just one scrip from just one doctor. I knew so many people who, in 2014 when the PDMP really came into full swing, man that was it for them. Their rent wasn’t paid, they had nothing. Had to figure everything out from scratch if they could.

These days, PDMP are how the Drug Enforcement Administration tracks controlled substance prescriptions—mainly opioids, especially if they come with a benzodiazepine and a muscle relaxant—by doctors who catered to such doctor-shoppers as myself. Whereas in 2012 my 11 doctors didn’t know about each other, or at least could pretend they didn’t, now prescribers are generally required to check a state database before they write you a prescription for anything interesting, and pharmacists must do the same before they fill it.

It’s been probably 10 years now since I’ve seen methadone pills on the street. PDMP and the opioid prescription crackdowns cut off tons of chronic pain patients from the pharmaceuticals they were using for an approved medical purpose, and many ended up navigating the much riskier street supply.

Doctor-shoppers like me were blamed for the crackdowns. But when you moralize drug use, there’s never a black-and-white line between the people whose need for pharmaceuticals is legitimate and the people whose need is not. All of us were cut off or suddenly faced with barriers to everything except street supply. When the supply we’d been using was safer.

Image via Wyoming Department of Health

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If Walgreens is sold or otherwise absorbed by a different company before the end of Fiscal Year 2031, it will owe an additional $50 million. The settlement comes a few weeks after Walgreens, which has seen its stock value nosedive by about 80 percent in the past five years, confirmed that by the end of 2025 it would be acquired by private equity group Sycamore Partners. The DOJ stated that the $300 million figure was determined based on the company’s ability to pay.

Its first payment of $20 million is due in May, with the full settlement due within the next six years. The allegations stem from what were originally four separate whistleblower lawsuits filed by former Walgreens employees, who will be collectively awarded about $4.25 million.

In January, the DOJ sued Walgreens for allegedly violating the Controlled Substances Act as well as the False Claims Act. The allegations that pertained to the CSA centered on Walgreens filling prescriptions that it knew were either invalid or not written for a “legitimate medical purpose,” or both. In particular, the lawsuit highlighted “trinity cocktail prescriptions”—the Drug Enforcement Administration’s term for a combination of an opioid, a benzodiazepine and a muscle relaxant, which has become the go-to example of the kind of “red flag” pharmacists are supposed to watch for.

The allegations under the False Claims Act describe Walgreens knowingly submitting false reimbursement claims for those same prescriptions, thereby defrauding half a dozen federal health care programs including Medicare, Medicaid and the in-house network for the Department of Veterans Affairs.

Walgreens had initially responded with a similar—albeit much more restrained—defense strategy as the one used by CVS.

Much of the DOJ’s January announcement of the lawsuit was verbatim what it had stated one month earlier when it announced a similar civil suit against CVS, the only US pharmacy chain larger than Walgreens. Between the two of them, the companies hold about 40 percent of the nation’s prescription drug retail market. 

Walgreens had responded that same day with a similar—albeit much more restrained—defense strategy to the one used by CVS, which was to essentially act as if the DOJ was suing the company’s pharmacists rather than the company itself, and it was only getting involved because it couldn’t allow the DOJ to bully its employees with made-up rules that no one understands. 

The CSA definition of “person,” in terms of the person responsible for improperly dispensing a medication, includes corporations as well as individuals. No individuals were named as defendants in the lawsuit. 

According to the DOJ suits, both companies faced penalties of $80,850 per substantiated violation within the past decade or so, and up to $25,000 per violation for older ones. The CVS case is still ongoing.

Both lawsuits link the respective companies to loss of life, stating that in some cases patients had fatally overdosed shortly after the pharmacies improperly filled their prescription. However, the DOJ allegations against Walgreens were slightly less pointed than those it had brought against CVS, which had included explicitly claiming that “CVS’s actions contributed to the opioid crisis.” The Walgreens lawsuit merely stated that prescription drug diversion contributed to the crisis, and “Walgreens’s corporate management made choices that caused these millions of violations of federal law.”

Over the past two decades, the government’s inordinate focus on opioid analgesics, and pharmaceuticals drugs in general, as factors in the overdose crisis has been catastrophic for chronic pain patients who rely on those prescriptions for day-to-day functioning.

Alongside “trinity” prescriptions, for example, DEA red flags have included higher-dose prescriptions for opioids, which not only discourages providers from seeing patients who need those prescriptions so that they don’t get flagged, but flags the patients for suspicious activity too.

Other red flags like traveling long distances to see a provider or having multiple providers belie the fact more patients are forced to do this as the government makes their medications less accessible. It’s also never been the case that a drug’s therapeutic value can be determined by looking at a prescription.

Image (cropped) via Walgreens Boots Alliance

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