But while the drug has helped keep him alive, its side effects have gradually narrowed the confines of his life, said Crosslin, 76, who lives in Ocala, Florida: “My appetite has been minimal. I’m very weak. I walk my dogs and get around a bit, but I haven’t been able to golf since last July.”

He wonders whether he’d do better on a lower dose, “but I do what my oncologist tells me to do,” Crosslin said. Every day, he takes eight of the 120-milligram pills, sold under Amgen’s brand name Lumakras.

Crosslin’s concern lies at the heart of an FDA effort to make cancer drugs less toxic and more effective. Cancer drug trials are structured to promote high doses, which then become routine patient care. In the face of evidence that thousands of patients become so ill that they skip doses or stop taking the drugs — thereby risking resurgence of their cancers — the FDA has begun requiring companies to pinpoint the right dosage before they reach patients.

The initiative, Project Optimus, launched in 2021 just as Amgen was seeking to market sotorasib. At the time, the FDA’s leading cancer drug regulator, Richard Pazdur, co-authored an editorial in the New England Journal of Medicine that said Amgen’s trials of the $20,000-a-month drug were “hampered by a lack of robust dose exploration.”

The FDA conditionally approved sotorasib but required Amgen to conduct a study comparing the labeled dosage of 960 mg with a dosage of 240 mg. The trial, published in November, showed that the 960-mg dose may have given patients a month more of life, on average, but caused more severe side effects than the lower dose.

Amgen is keeping the 960-mg dosage as it conducts further tests to get final approval for the drug, spokesperson Elissa Snook said, adding that the dose showed superiority . Whether medically justified or not, the heavier dosage allows the company to protect 75% of its revenue from the drug, which brought in nearly $200 million in the United States last year.

And there appears to be nothing the FDA can do about it.

“There’s a gap in FDA’s authority that results in patients getting excess doses of a drug at excess costs,” said Mark Ratain, a University of Chicago oncologist who has pushed for more accurate cancer drug dosing. “We should do something about this.”

Deciding on Dosage

It may be too late for the FDA to change the sotorasib dosage, although in principle it could demand a new regimen before granting final approval, perhaps in 2028. Under Project Optimus, however, the agency is doing something about dosage guidelines for future drugs. It is stressing dose optimization in its meetings with companies, particularly as they prepare to test drugs on patients for the first time, spokesperson Lauren-Jei McCarthy said.

“When you go in front of FDA with a plan to approve your drug now, they are going to address dosing studies,” said Julie Gralow, chief medical officer of the American Society of Clinical Oncology. “A lot of companies are struggling with this.”

That’s largely because the new requirements add six months to a year and millions in drug development costs, said Julie Bullock, a former FDA drug reviewer who advocated for more extensive dosing studies and is now senior vice president at Certara, a drug development consultancy.

In part, Project Optimus represents an effort to manage the faults of the FDA’s accelerated approval process, begun in 1992. While the process gets innovative drugs to patients more quickly, some medicines have proved lackluster or had unacceptable side effects.

That’s especially true of the newer pills to treat cancer, said Donald Harvey, an Emory University pharmacology professor, who has led or contributed to more than 100 early-phase cancer trials.

in the Journal of the American Medical Association showed that 41% of the cancer drugs granted accelerated approval from 2013 to 2017 did not improve overall survival or quality of life after five years.

Many of these drugs flop because they must be given at toxic dosages to have any effect, Harvey said, adding that sotorasib might work better if the company had found an appropriate dosage earlier on.

“Sotorasib is a poster child for incredibly bad development,” Harvey said. The drug was the first to target the KRAS G12C mutation, which drives about 15% of lung cancers and was considered “undruggable” until University of California-San Francisco chemist Kevan Shokat in 2012.

Given the specificity of sotorasib’s target, Harvey said, Amgen could have found a lower dosage. “Instead, they followed the old model and said, ‘We’re going to push the dose up until we see a major side effect.’ They didn’t need to do that. They just needed more experience with a lower dose.”

The 960-mg dose “is really tough on patients,” said Yale University oncologist and assistant professor Michael Grant. “They get a lot of nausea and other GI side effects that are not pleasant. It hurts their quality of life.”

The FDA of sotorasib that in phase 1 studies tumors shrank when exposed to as little as a fifth of the 960-mg daily dose Amgen selected. At all doses tested in that early trial, the drug reached roughly the same concentrations in the blood, which suggested that at higher doses the drug was mostly just intensifying side effects like diarrhea, vomiting, and mouth sores.

For most classes of drugs, companies spend considerable time in phases 1 and 2 of development, homing in on the right dosage. “No one would think of dosing a statin or antibiotic at the highest tolerable dose,” Ratain said.

Things are different in cancer drug creation, whose approach originated with chemotherapy, which damages as many cancer cells as possible, wrecking plenty of healthy tissue in the bargain. Typically, a company’s first series of cancer drug trials involve escalating doses in small groups of patients until something like a quarter of them get seriously ill. That “maximum tolerated dose” is then employed in more advanced clinical trials, and goes on the drug’s label. Once a drug is approved, a doctor can “go off-label” and alter the dosage, but most are leery of doing so.

Patients can find the experience rougher than advertised. During clinical trials, the side effects of the cancer drug osimertinib (Tagrisso) were listed as tolerable and manageable, said Jill Feldman, a lung cancer patient and advocate. “That killed me. After two months on that drug, I had lost 15 pounds, had sores in my mouth and down my throat, stomach stuff. It was horrible.”

Some practitioners, at least, have responded to the FDA’s cues on sotorasib. In the Kaiser Permanente health system, lung cancer specialists start with a lower dose of the drug, spokesperson Stephen Shivinsky said.

Smaller Doses — And Revenue

Amgen was clearly aware of the advantages of the 240-mg dosage before it sought FDA approval: It on that dosage before the agency gave breakthrough approval for the drug at 960 mg. The company the patent filing to investors or the FDA. McCarthy said the FDA was prohibited by law from discussing the particulars of its sotorasib regulation plans.

Switching to a 240-mg dosage could register a huge hit to Amgen’s revenue. The company markets the drug at more than $20,000 for a month of 960-mg daily doses. Each patient who could get by with a quarter of that would trim the company’s revenue by roughly $180,000 a year.

Amgen declined to comment on the patent issue or to make an official available to discuss the dosage and pricing issues.

Crosslin, who depends on Social Security for his income, couldn’t afford the $3,000 a month that Medicare required him to pay for sotorasib, but he has received assistance from Amgen and a charity that covers costs for patients below a certain income.

While the drug has worked well for Crosslin and other patients, its overall modest impact on lung cancer suggests that $5,000, rather than $20,000, might be a more appropriate price, Ratain said.

In the company’s phase 3 clinical trial for advanced lung cancer patients, sotorasib kept patients alive for about a month longer than docetaxel, the current, highly toxic standard of care. Docetaxel is a generic drug for which Medicare pays about $1 per injection. The trial was so unconvincing that the FDA sent Amgen back to do another.

Ratain, of Amgen’s , told Centers for Medicare & Medicaid Services officials at a recent meeting that they should pay for sotorasib on a basis of 240 mg per day. But CMS would do that only “if there is a change in the drug’s FDA-approved dosage,” spokesperson Aaron Smith said.

Drug companies generally don’t want to spend money on trials like the one the FDA ordered on sotorasib. In 2018, Ratain and other researchers used their institutions’ funding to conduct a dosing trial on the prostate cancer drug abiraterone, marketed under the brand name Zytiga by Johnson & Johnson. They found that taking one 250-mg pill with food was just as effective as taking four on an empty stomach, as the label called for.

Although , the evidence generated in that trial was strong enough for the standards-setting National Comprehensive Cancer Network to change its recommendations.

Post-marketing studies like that one are hard to conduct, Emory’s Harvey said. Patients are reluctant to join a trial in which they may have to take a lower dosage, since most people tend to believe “the more the better,” he said.

“It’s better for everyone to find the right dose before a drug is out on the market,” Harvey said. “Better for the patient, and better for the company, which can sell more of a good drug if the patients aren’t getting sick and no longer taking it.”

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At issue is not just whether people are using enough sunscreen, but what ingredients are in it.

The Food and Drug Administration’s ability to approve the chemical filters in sunscreens that are sold in countries such as Japan, South Korea, and France is hamstrung by a 1938 U.S. law that has required sunscreens to be tested on animals and classified as drugs, rather than as cosmetics as they are in much of the world. So Americans are not likely to get those better sunscreens — which that can cause skin cancer and lead to wrinkles — in time for this summer, or even the next.

Sunscreen makers say that requirement is unfair because companies including and , which make the newer sunscreen chemicals, submitted on sunscreen chemicals to the some 20 years ago.

Steven Goldberg, a retired vice president of BASF, said companies are wary of the FDA process because of the cost and their fear that additional animal testing could ignite a in the European Union, which of cosmetics, including sunscreen. The companies are asking Congress to change the testing requirements before they take steps to enter the U.S. marketplace.

In a rare example of bipartisanship last summer, Sen. Mike Lee (R-Utah) (D-N.Y.) for urging the FDA to speed up approvals of new, more effective sunscreen ingredients. Now a bipartisan bill is pending in the House that would to allow non-animal testing.

“It goes back to sunscreens being classified as over-the-counter drugs,” said Carl D’Ruiz, a senior manager at DSM-Firmenich, a Switzerland-based maker of sunscreen chemicals. “It’s really about giving the U.S. consumer something that the rest of the world has. People aren’t dying from using sunscreen. They’re dying from melanoma.”

Every hour, at least two people in the United States. Skin cancer is the in America, and 6.1 million adults are treated each year for basal cell and squamous cell carcinomas, according to the . The nation’s second-most-common cancer, breast cancer, is diagnosed about , though it is far more deadly.

Dermatologists Offer Tips on Keeping Skin Safe and Healthy

– Stay in the shade during peak sunlight hours, 10 a.m. to 4 p.m. daylight time.– Wear hats and sunglasses.– Use UV-blocking sun umbrellas and clothing.– Reapply sunscreen every two hours.You can order overseas versions of sunscreens from online pharmacies such as  in France. Keep in mind that the same brands may have different ingredients if sold in U.S. stores. But importing your sunscreen may not be affordable or practical. “The best sunscreen is the one that you will use over and over again,” said , a New York City dermatologist.

Though skin cancer treatment success rates are excellent, 1 in 5 Americans will develop skin cancer by age 70. The disease costs the health care system , according to CDC researchers. One study found that the annual cost of treating skin cancer in the United States from 2002 to 2011, while the average annual cost for all other cancers increased by just 25%. And unlike many other cancers, most forms of skin cancer can largely be prevented — by using sunscreens and taking other precautions.

But a heavy dose of misinformation has permeated the sunscreen debate, and some people question the safety of sunscreens sold in the United States, which they deride as “chemical” sunscreens. These sunscreen opponents prefer “physical” or “mineral” sunscreens, such as zinc oxide, even though all sunscreen ingredients are chemicals.

“It’s an artificial categorization,” said E. Dennis Bashaw, a retired FDA official who ran the agency’s clinical pharmacology division that studies sunscreens.

Still, such concerns were partly after it published a study that said some sunscreen ingredients had been found in trace amounts in human bloodstreams. When the , and then again , that older sunscreen ingredients needed to be studied more to see if they were safe, sunscreen opponents saw an opening, said , president of Alpha Research & Development, which imports chemicals used in cosmetics.

“That’s why we have extreme groups and people who aren’t well informed thinking that something penetrating the skin is the end of the world,” Shaath said. “Anything you put on your skin or eat is absorbed.”

Adamson, the Austin dermatologist, said some sunscreen ingredients have been used for 30 years without any population-level evidence that they have harmed anyone. “The issue for me isn’t the safety of the sunscreens we have,” he said. “It’s that some of the chemical sunscreens aren’t as broad spectrum as they could be, meaning they do not block UVA as well. This could be alleviated by the FDA allowing new ingredients.”

falls between X-rays and visible light on the electromagnetic spectrum. Most of the UV rays that people come in contact with are UVA rays that can penetrate the middle layer of the skin and that cause up to 90% of skin aging, along with a smaller amount of UVB rays that are .

The sun protection factor, or SPF, rating on American sunscreen bottles denotes only a sunscreen’s ability to block UVB rays. Although American sunscreens labeled “broad spectrum” should, in theory, block UVA light, to meet the European Union’s higher UVA-blocking standards.

“It looks like a number of these newer chemicals have a better safety profile in addition to better UVA protection,” said , deputy director of Environmental Working Group, a nonprofit that researches the ingredients in consumer products. “We have asked the FDA to consider allowing market access.”

The FDA defends its review process and its call for tests of the sunscreens sold in American stores as a way to ensure the safety of products that many people use daily, rather than just a few times a year at the beach.

“Many Americans today rely on sunscreens as a key part of their skin cancer prevention strategy, which makes satisfactory evidence of both safety and effectiveness of these products critical for public health,” Cherie Duvall-Jones, an FDA spokesperson, wrote in an email.

D’Ruiz’s company, DSM-Firmenich, is the only one currently seeking to have a new over-the-counter sunscreen ingredient approved in the United States. The company has spent the past 20 years trying to gain , a process D’Ruiz said has cost $18 million and has advanced fitfully, despite attempts by Congress in 2014 and 2020 to speed along applications for new UV filters.

Bemotrizinol is the bedrock ingredient in nearly all European and Asian sunscreens, including those by the South Korean brand and , a Japanese brand.

D’Ruiz said bemotrizinol could secure FDA approval by the end of 2025. If it does, he said, bemotrizinol would be the most vetted and safest sunscreen ingredient on the market, outperforming even the safety profiles of zinc oxide and titanium dioxide.

As Congress and the FDA debate, many Americans have taken to importing their own sunscreens from Asia or Europe, despite the .

“The sunscreen issue has gotten people to see that you can be unsafe if you’re too slow,” said , a professor of economics at George Mason University. “The FDA is just incredibly slow. They’ve been looking at this now literally for 40 years. Congress has ordered them to do it, and they still haven’t done it.”

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The national abortion landscape was shaken again this week as Florida’s six-week abortion ban took effect. That leaves North Carolina and Virginia as the lone Southern states where abortion remains widely available. Clinics in those states already were overflowing with patients from across the region.

Meanwhile, in a wide-ranging interview with Time magazine, former President Donald Trump took credit for appointing the Supreme Court justices who overturned Roe v. Wade, but he steadfastly refused to say what he might do on the abortion issue if he is returned to office.

This week’s panelists are Julie Rovner of Ģ��ӰԺ Health News, Sarah Karlin-Smith of the Pink Sheet, Alice Miranda Ollstein of Politico, and Rachana Pradhan of Ģ��ӰԺ Health News.

Panelists

Among the takeaways from this week’s episode:

• Florida’s new, six-week abortion ban is a big deal for the entire South, as the state had been an abortion haven for patients as other states cut access to the procedure. Some clinics in North Carolina and southern Virginia are considering expansions to their waiting and recovery rooms to accommodate patients who now must travel there for care. This also means, though, that those traveling patients could make waits even longer for local patients, including many who rely on the clinics for non-abortion services.
• Passage of a bill to repeal Arizona’s near-total abortion ban nonetheless leaves the state’s patients and providers with plenty of uncertainty — including whether the ban will temporarily take effect anyway. Plus, voters in Arizona, as well as those in Florida, will have an opportunity in November to weigh in on whether the procedure should be available in their state.
• The FDA’s decision that laboratory-developed tests must be subject to the same regulatory scrutiny as medical devices comes as the tests have become more prevalent — and as concerns have grown amid high-profile examples of problems occurring because they evaded federal review. (See: Theranos.) There’s a reasonable chance the FDA will be sued over whether it has the authority to make these changes without congressional action.
• Also, the Biden administration has quietly decided to shelve a potential ban on menthol cigarettes. The issue raised tensions over its links between health and criminal justice, and it ultimately appears to have run into electoral-year headwinds that prompted the administration to put it aside rather than risk alienating Black voters.
• In drug news, the Federal Trade Commission is challenging what it sees as “junk” patents that make it tougher for generics to come to market, and another court ruling delivers bad news for the pharmaceutical industry’s fight against Medicare drug negotiations.

Plus, for “extra credit” the panelists suggest health policy stories they read this week that they think you should read, too:

Julie Rovner: ProPublica’s “,” by Patrick Rucker, The Capitol Forum, and David Armstrong, ProPublica.

Alice Miranda Ollstein: The Associated Press’ “,” by Ryan J. Foley, Carla K. Johnson, and Shelby Lum.

Sarah Karlin-Smith: The Atlantic’s “,” by Katherine J. Wu.

Rachana Pradhan: The Wall Street Journal’s “,” by Clare Ansberry.

Also mentioned on this week’s podcast:

• Time’s “,” by Eric Cortellessa.
• NPR’s “,” by Selena Simmons-Duffin.
• NPR’s “,” by Julie Rovner.
• CNN’s “,” by Nathaniel Meyersohn.

[Editor’s note: This transcript was generated using both transcription software and a human’s light touch. It has been edited for style and clarity.]

Mila Atmos: The future of America is in your hands. This is not a movie trailer, and it’s not a political ad, but it is a call-to-action. I’m Mila Atmos, and I’m passionate about unlocking the power of everyday citizens. On our podcast “Future Hindsight,” we take big ideas about civic life and democracy, and turn them into action items for you and me. Every Thursday, we talk to bold activists and civic innovators to help you understand your power and your power to change the status quo. Find us at or wherever you listen to podcasts.

Julie Rovner: Hello, and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent for Ģ��ӰԺ Health News, and I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, May 2, at 10 a.m. As always, news happens fast and things might have changed by the time you hear this. So here we go.

We are joined today via video conference by Alice Miranda Ollstein of Politico.

Alice Miranda Ollstein: Hello.

Rovner: Sarah Karlin-Smith of the Pink Sheet.

Sarah Karlin-Smith: Hi, everybody.

Rovner: And my Ģ��ӰԺ Health News colleague Rachana Pradhan.

Rachana Pradhan: Hello.

Rovner: No interview this week, but more than enough news to make up for it, so we will dig right in. We will start, again, with abortion. On Wednesday, Florida’s six-week abortion ban took effect. Alice, what does this mean for people seeking abortions in Florida, and what’s the spillover to other states?

Ollstein: Yeah, this is a really huge deal not only because Florida is so populous, but because Florida, somewhat ironically given its leadership, has been a real abortion haven since Roe vs. Wade was overturned. A lot of its surrounding states had near-total bans go into effect right away. Florida has had a 15-week ban for a while, but that has still allowed for a lot of abortions to take place, and so a lot of people have been coming to Florida from Alabama, Louisiana, those surrounding states for abortions. Now, Florida’s six-week ban is taking effect and that means that a lot of the patients that had been going there will now need to go elsewhere, and a lot of Floridians will have to travel out of state.

And so there are concerns about whether the closest clinics they can get to, in North Carolina and southern Virginia, will have the capacity to handle that patient overload. I talked to some clinics that are trying to staff up. They’re even thinking about physical changes to their clinics, like building bigger waiting rooms and recovery rooms. This is going to cause a real crunch, in terms of health care provision. That is set to not only affect abortion, but with these clinics overwhelmed, that takes up appointments for people seeking other services as well. My colleagues and I have been talking to people in the sending states, like Alabama, who worry that the low-income patients they serve who were barely able to make it to Florida will not be able to make it even further. Then, we’ve talked to providers in the receiving states, like Virginia, who are worried that there just are simply not enough appointments to handle the tens of thousands of people who had been getting abortions in Florida up to this point.

Rovner: Of course, what ends up happening is that, if people have to wait longer, it pushes those abortions into later types of abortions, which are more complicated and more dangerous and more expensive.

Ollstein: Yes. While the rate of complication is low, the later in pregnancy you go, it does get higher. That’s another consideration as well.

I will flag, though, that restrictions on abortion pills in North Carolina, which is now one of the states set to receive a lot of people, those did get a little bit loosened by a court ruling this week so people will not have to have a mandatory in-person follow-up appointment for abortion pills like they used to have to have. That could help some patients who are traveling in from out of state, but a lot of restrictions remain, and it’ll be tough for a lot of folks to navigate.

Rovner: While we think of that, well there’s at least, you can get abortions up to six weeks, my friend Selena Simmons-Duffin over at NPR had a really good explainer about why six weeks isn’t really six weeks, because of the way that we , that six weeks is really two weeks. It really is a very, very small window in which people will be able to get abortions in Florida. It’s not quite a full ban, but it is quite close to it.

Well, speaking of full bans, after several false starts, the Arizona Senate Wednesday voted to repeal the 1864 abortion ban that its Supreme Court ruled could take effect. The Democratic governor is expected to sign it. Where does that leave abortion law in the very swing state of Arizona? It’s kind of a muddle, isn’t it?

Ollstein: It is. The basics are that a 15-week ban is already in place and will continue to be in place once this repeal takes effect. What we don’t know is whether the total ban from before Arizona was even a state will take effect temporarily, because of the weird timing of the court’s implementation of that old ban, and the new repeal bill that just passed that the governor is expected to sign very soon. The total ban could go into effect, at least for a little bit over the summer. Planned Parenthood is positioning the court to not let that happen, to stay the implementation until the repeal bill can take effect. All of this is very much in flux. Of course, as we’ve seen in so many states, that leads to patients and providers just being very scared, and not knowing what’s legal and what’s not, and folks being unable to access care that may, in fact, be legal because of that. Of course, this is all in the context of Arizona, as well as Florida, being poised to vote directly on abortion access this fall. If the total ban does go into effect temporarily, it’s sure to pour fuel on that fire and really rile people up ahead of that vote.

Rovner: Yeah, I was going to mention that. Well, now that we’re talking about politics. This week, we heard a little bit more about how former President Trump wants to handle the abortion issue, via a long sit-down . I will link to that interview in the show notes. The biggest “news” he made was to suggest that he’d have an announcement soon about his views on the abortion pill. But he said that would come in the next two weeks, the interview was of course more than two weeks ago. They did a follow-up two weeks later and he still said it was coming. In the follow-up interview, he said it would be next week, which this has already passed. Do we really expect Trump to say something about this, or was that just him deflecting, as we know he is wont to do?

Pradhan: Well, I’m sure that he’s getting pressure to say something, because as people have noted now quite widely, regardless of individual state laws, there are certainly conservatives that are pushing for him and his future administration to ban the mailing of abortion pills using the Comstock Act from the 1800s, which would basically annihilate access to that form of terminating pregnancies.

Rovner: There are also some who want him to just repeal the FDA approval, right?

Ollstein: Right. Of course, the Biden administration has made it easier for folks to get access to those, to mifepristone, in particular, one of two pills that are used in medication abortion. But yeah, will it be two weeks? I think he obviously knows that this is a potential political liability for him, so whether he’ll say something, I’m sure he will get competing advice as to whether it’s a good idea to say something at all, so we’ll have to see.

Rovner: Well, speaking of Trump deflecting, he seemed to be pretty disciplined about the rest of the abortion questions — and there were a lot of abortion questions in that interview — insisting that, while he takes credit for appointing the justices who made the majority to overturn Roe, everything else is now up to the state. But by refusing to oppose some pretty-out-there suggestions of what states might do, Trump has now opened himself up to apparently accepting some fairly unpopular things, like tracking women’s menstrual periods. Lest you think that’s an overstatement, the Missouri state health director testified at a hearing last week that he kept a spreadsheet to track the periods of women who went to Planned Parenthood, which, according to The Kansas City Star, “helped to identify patients who had undergone failed abortions.” Yet, none of these things ever seem to stick to Trump. Is any of this going to matter in the long run? He’s clearly trying to walk this line between not angering his very anti-abortion base and not seeming to side too much with them, lest he anger a majority of the rest of the people he needs to vote for him.

Ollstein: Well, he’s also not been consistent in saying it’s totally up to states, whatever states want to do is fine. He’s repeatedly criticized Florida’s six-week ban. He refused to say how he would vote on the referendum to override it. He has criticized the Arizona ruling to implement the 1864 ban. This isn’t a pure “whatever states do is fine” stance, this is “whatever states do, unless it’s something really unpopular, in which case I oppose it.” That is a tough line to walk. The Biden administration and the Biden campaign have really seized on this and are trying to say, “OK, if you are going to have a leave-it-to-states stance, then we’re going to try to hang on you every single thing states do, whether it’s the legislature, or a court, or whatever, and say you own all of this.” That’s what’s playing out right now.

Rovner: I highly recommend reading the interview, because the interviewer was very skilled at trying to pin him down. He was pretty skilled at trying to evade being pinned down. Well, meanwhile, Republican attorneys general from 17 states are suing the Equal Employment Opportunity Commission from including abortion in a list of conditions that employers can’t discriminate against and must provide accommodations for, under rules implementing the Pregnant Workers Fairness Act. The new rules don’t require anyone to pay for anything, but they could require employers to provide leave or other accommodations to people seeking pregnancy-related health care. The EEOC has included abortion as pregnancy-related health care. This is yet another case that we could see making its way to the Supreme Court. Ironically, the Pregnant Workers Fairness Act was a very bipartisan bill, so there are a lot of anti-abortion groups that are extremely angry that this has been included in the regulation. This is one of those abortion-adjacent issues that tends to drag abortion in, even when it was never expected to be there. And we’re going to see more of these. We’re going to get back into the spending bills, as Congress tries to muddle its way through another session.

Pradhan: I think, when I think about this, even though there’s a regulatory battle and a legal one now, too, like in the immediate aftermath of the Dobbs [v. Jackson Women’s Health Organization] decision, when there were employers, I think about it more practically. Which is that there were employers that were saying, “We would cover expenses.” Or they would pay for people to travel out of state if that was something that they needed. I wonder how many people would actually do it, even if it exists, because that’s a whole other … Getting an abortion, or even things related to pregnancy, are incredibly private things, so I don’t know how many women would be willing to stand up and say, “Hey, I need this accommodation and you have to give it to me under federal regulations.” In a way, I think it’s notable both that the EEOC put out those regulations and that there’s litigation over it, but I wonder if it, practically speaking, just how much of an impact it would really have, just because of those privacy and practical hurdles associated with divulging information in that regard.

Rovner: As we were just talking about, somebody in Alabama, the closest place they can go to get an abortion is in North Carolina or Virginia, and go, “Hey, I need three days off so I can drive halfway across the country to get an abortion because I can’t get one here.” I see that might be an awkward conversation.

Pradhan: Just like any sensitive medical- or health-related needs, it’s not like people are rushing to tell their employers necessarily that it’s something that they’re dealing with.

Rovner: That’s true. It doesn’t have anything to do with privacy. Most people are not anxious to advertise any health-related issues that they are having. Speaking of people and their sensitive medical information, that Change Healthcare hack that we’ve been talking about since February, well the CEO of Change’s owner, UnitedHealth Group, was on Capitol Hill on Wednesday, taking incoming from both the Senate Finance Committee in the morning, and the House Energy and Commerce Committee in the afternoon. Among the other things that Andrew Witty told lawmakers was that the portal that was hacked did not have multifactor authentication and he confirmed that United paid $22 million in bitcoin to the hackers, although as we discussed last week, they might not have paid the hackers who actually had possession of the information. Nobody actually seemed to follow up on that, which I found curious. My favorite moment in the Senate hearing was when North Carolina Republican Thom Tillis offered CEO Witty a copy of the book “Hacking For Dummies.” Is anything going to result from these hearings? Other than what it seemed a lot of lawmakers getting to express their frustration in person.

Pradhan: Can I just say how incredible it is to me that a company that their net worth is almost $450 billion, one of the largest companies in the world, apparently does not know how to enforce rules on two-factor authentication, which is something I think that is very routine and commonplace among the modern industrialized workforce.

Rovner: I have it for my Facebook account!

Pradhan: Right. I think everyone, even in our newsroom, knows how to do it or has been told that this is necessary for so many things. I just find it absolutely unbelievable that the CEO of United would go to senators and say this, and think that it would be well-received, which it was not.

Rovner: I will say his body language seemed to be very apologetic. He didn’t come in guns blazing. He definitely came in thinking that, “Oh, I’m going to get kicked around, and I’m just going to have to smile and take it.” But obviously, this is still a really serious thing and a lot of members of Congress, a lot of the senators and the House members, said they’re still hearing from providers who still can’t get their claims processed, and from people who can’t get their medications because pharmacies can’t process the claims. There’s a lot of dispute about how long it’s going to take to get things back up and running. One of the interesting tidbits that I took away is that, as much of health care that goes through Change, it’s like 40% of all claims, it’s actually a minimum part of United’s health claims. United doesn’t use Change for most of its claims, which surprised me. Which is maybe why United isn’t quite as freaked out about this as a lot of others are. Is there anything Congress is going to be able to do here, other than say to their constituents, “Hey, I took your complaints right to the CEO?”

Karlin-Smith: I think there’s two things they may focus on. One is just cybersecurity risks in health care, which is broader than just these incidents. In some ways, it could be much worse, if you think about hospitals and medical equipment being hacked where there could be direct patient impacts in care because of it. The other thing is, United is such a large company and the amount of Americans impacted by this, but also the amount of different parts of health care they have expanded into, is really under scrutiny. I think it’s going to bring a light onto how big they’ve become, the amount of vertical integration in our health system, and the risks from that.

Rovner: We went through this in the ’90s. Vertical integration would make things more efficient, because everybody would have what they called aligned incentives, everybody would be working towards the same goal. Instead, we’ve seen that vertical integration has just created big, behemoth companies like United. I don’t know whether Congress will get into all of that, but at least it brought it up into their faces.

There’s lots of regulatory news this week. I want to start with the FDA, which finalized a rule basically making laboratory-developed tests medical devices that would require FDA review. Sarah, this has been a really controversial topic. What does this rule mean and why has there been such a big fight?

Karlin-Smith: This rule means that diagnostic tests that are developed, manufactured, and then actually get processed, and the results get processed at the lab, will now no longer be exempted from FDA’s medical device regulations and they’ll have to go through the process of medical devices. The idea is to basically have more oversight over them, to ensure that these tests are actually doing what they’re supposed to do, you’re getting the right results and so forth. Initially, over the years, the prevalence of these tests has grown, and what they’re used for, I think, has changed and developed where FDA is more concerned about the safety and the types of health decisions people may be making without proper oversight of the tests. One, I think, really infamous example that maybe can people use to understand this is Theranos was a company that was exempted from a lot of regulations because of being considered an LDT. The initial impact is going to be interesting because they’re actually basically exempting all already-on-the-market products. There’s also going to be some other exemptions, such as for tests that meet an unmet medical need, so I think that will have to be defined. There is a reasonable chance that there’s going to be lawsuits challenging whether FDA can do this on their own or need Congress to write new legislation. There have been battles over the years for Congress to do that. FDA, I think, has finally gotten tired of waiting for them to lead. I think initially, we’re going to see a lot of battles going forth and FDA also just has limited capacity to review some of this stuff.

Rovner: We already know that FDA has limited capacity on the medical device side. I was amused to see, oh, we’re going to make these medical devices, where there’s already a huge problem with FDA either exempting things that shouldn’t really be exempt, or just not being able to look at everything they should be looking at.

Karlin-Smith: Right. They’re going to take what they call a risk-based approach, which is a common terminology used at the FDA, I think, to focus on the things where they think there’s the most risk of something problematic happening to people’s health and safety if something goes wrong. It’s also an admission, to some extent, of something that’s not necessarily their fault, which is they only have so much budget and so many people, and that really comes down to Congress deciding they want to fix it. Now, FDA has user-fee programs and so forth, so perhaps they could convince the industry to pony up more money. But as you alluded to early on, one of the fights over this has been their different segments of companies that make these tests that have different feelings about the regulations. Because you have more traditional, medical device makers that are used to dealing with the FDA that probably feel like they have this leg up, they know how to handle a regulatory agency like FDA and get through. Then you have other companies that are smaller, and do not have that expertise, maybe don’t feel like they have the manpower and, just, money to deal with FDA. I think that’s where you get into some of these business fights that have also kept this on the sidelines for a while.

Pradhan: Well, also I wonder, hospitals also use laboratory developed tests, too, and they develop them. I feel like, and Sarah, correct me if I’m wrong, but I think previously when there was debate over whether FDA was going to do this, I think hospitals were pretty critical of any move of FDA to start regulating these more aggressively, right? Because they said for tests used for cancer detection or other health issues, I think that they were not thrilled at the idea. I don’t know that they’ve had to really deal with FDA in this regard either when it comes to devices.

Karlin-Smith: Yeah. I know one big exemption that people were looking for was whether they were going to exempt academic medical centers, and they did not. We’ll see what happens with that moving forward. But obviously, again, the older ones will have this exemption.

Rovner: Well, speaking of controversial regulations, the administration has basically decided that it’s not going to decide about the potential menthol ban that we’ve been talking about on and off. There was a statement from HHS [Department of Health and Human Services] last week that just said, “We need to look at this more.” Somebody remind us why this is so controversial. Obviously, health interests say, really, we should ban menthol, it helps a lot of people to continue smoking and it’s not good for health. Why would the administration not want to ban menthol?

Pradhan: It’s controversial because, I’ll just say, that it’s an election year and they are worried about backlash from Black voters not supporting President Biden in his reelection campaign, because they do this.

Karlin-Smith: It’s a health versus criminal justice issue, because the concern is that yes, in theory, if Black people make up the majority of people who use menthol cigarettes, you’re obviously protecting their health by not having it. But the concern has been among how this would be enforced in practice and whether it would lead to overpolicing of Black communities and people being charged or facing some kind of police brutality for what a lot of people would consider a minor crime. That’s where the tension has been. Although notably, some groups like the NAACP and stuff have been gotten on board with banning menthol. It’s an interesting thing where we’re trying to solve a policing or criminal justice problem through a health problem, rather than just solving the policing problem.

Ollstein: Like Sarah said, you have civil rights groups lined up on both sides of this fight. You have some saying that banning menthol cigarettes would be racist because they’re predominantly used by the Black population. But then you have people saying, well it’s racist to continue letting their health be harmed, and pointing out that those flavored cigarettes have been targeted in their marketing towards Black consumers, and that being a racist legacy that’s been around for a while. There’s these accusations on both sides and it seems like the politics of it are scaring the administration away a little bit.

Rovner: Well, just speaking of things that are political and that people smoke, the Drug Enforcement Administration announced its plan to downgrade the classification of marijuana, which until now has been included in the category of most dangerous drugs, like heroin and LSD, to what’s called Schedule III, which includes drugs with medicinal use that can also be abused, like Tylenol with codeine. But apparently, it could be awhile before it takes effect. This may not happen in time for this year’s election, right?

Karlin-Smith: Right. They have to release a proposed rule, you got to do comments, you got to get to the final rule. OMB [Office of Management and Budget] even. It’s supposedly at OMB now. OMB could hold it up for a while if they want to. As anybody who follows health policy in [Washington] D.C. knows, nothing moves fast here when it comes to regulations.

Rovner: Yes. A regulation that we thought was taken care of, but that actually only came out last week would protect LGBTQ+ Americans from discrimination in health care settings. This was a provision of the Affordable Care Act that the Trump administration had reversed. The Biden administration announced in 2021 that it wouldn’t enforce the Trump rules. But this is still a live issue in many courts and it’s significant to have these final regulations back on the books, yes?

Pradhan: It is. I think this is one of the ACA regulations that has ping-ponged the most, ever since the law was passed, because there have been lawsuits. I want to say it took the Obama administration years to even issue the first one, I think knowing how controversial it was. I believe it was the second, I think it was his second term and it was when there was no fear of repercussions for his reelection. Yeah, it’s been a very, very long-fought battle and I imagine this is also not the end of it. But no, it is very significant, the way that they defined the regulations.

Rovner: I confess, I was surprised when they came out because I thought it had already happened. I’m like, “Oh, we were still kicking this around.” So, now they appear to be final.

Well, finally this week, lots of news in health business. First, an update from last week. The Federal Trade Commission is challenging so-called junk patents from some pretty blockbuster drugs, charging that the patents are unfairly blocking generic competition. Sarah, what is this and why does it matter?

Karlin-Smith: FDA has what’s known as an orange book, as a part of a very complicated process set up by the 1984, I believe, Hatch-Waxman Act that was a compromise between the brand and the generic drug industries to get generic drugs to market a bit faster. FTC has been accusing companies of improperly listing patents in the orange book that shouldn’t be there, and thus making it harder to get generic products on the market. In particular, they’ve been actually going against drugs that have a device component, basically saying these components’ patents are not supposed to be in the orange book. They are basically asking the companies to delist the patents. They actually have gotten some concessions so far, from some of the other products they’ve targeted.

The idea would be this should help speed some of the generic entrants. It’s not quite as simple, because you do have lots of patents covering these drugs, so it does make it a little bit easier, but it’s not like it automatically opens the door. But it is unique and interesting that they have focused in on these targets because, typically, what are sometimes known as complex generics, are a lot harder for companies to make and get into the market because of the devices. Because for safety reasons FDA wants the devices to be very similar. If you pick up your product at the pharmacy, you have to be able to just know how to use it, really, without thinking about it, even if it’s a …

Rovner: Obviously, this covers things like inhalers and injectables.

Karlin-Smith: Right. The new weight loss drugs everybody is focused on, inhalers has been a big one as well. Things like an EpiPen, or stuff like that.

I think it’s been interesting because it does seem like FTC’s had more immediate results, I guess, than you sometimes see in Washington. [Sen.] Bernie Sanders has piggybacked on what they’re doing and targeted these companies and products in other ways, and gotten some small pricing cost concessions for consumers as well. But it will take a little bit of time for, even if patents get delisted, for generic drugmakers to actually then go through the whole rigamarole of getting cheaper products to market.

Rovner: Yes. This is part of what I call the “30 Years War,” to do something about drug prices. Before we leave drug prices, we’re still fighting in court about the Medicare drug negotiation, right? There, the drug industry continues to lose. Is that where we are?

Karlin-Smith: Correct. They have their fourth negative ruling this week. Basically, in this case, the judge ruled on two main arguments the industry was trying to push forward. One is that the drug negotiation program would constitute a takings violation under the Fifth Amendment. One of the main reasons the judge in this district in New Jersey said no is because they’re saying basically participation in Medicare and this drug price negotiation program are voluntary, the government is not forcibly taking any of your property, you don’t have to participate.

Another big ruling from this judge was that this program does not constitute First Amendment violations. What’s happening here is a regulation of conduct, not speech. One of the more amusing things in the decision to me, that I enjoyed, is the industry has argued that they’re basically being forced under this program to say, “Oh, this is … when CMS [Centers for Medicare & Medicaid Services]” … and then work out a price, that the price they work out is the maximum fair price because that’s the technical terminology used in the law, that they’re then somehow making an admission that any other price that they’ve charged has not been fair. The judge basically said, “Well, this is a public relations problem, not a constitutional problem. Nobody is telling you you can’t go out and publicly disagree with CMS about this program and about their prices that you end up having to enter into.”

It’s another blow. They have a lot of different legal arguments they’re trying out in different cases. As I said, they’ve thrown a lot of spaghetti at the wall. So far, other arguments have failed. Some of the cases are stalled on more technicalities, like the districts they’ve filed in. There was another case that was heard, an appeal was heard yesterday, in PhRMA, the main trade group’s case, where they’re trying to push on because of that. There’s going to be a lot of more action, but so far, looks good for the government.

Pradhan: When this was first rolling out, including when CMS announced the initial 10 drugs that would first be on the list, lawyers that I talked with at the time said that the arguments that the industry was making, it was a reach, to be diplomatic about it. I don’t think anyone really thought that they would be successful and it seems like that is, at least to date, that’s how it’s playing out.

Rovner: I’ll repeat, it’s a good time to be a lawyer for the drug industry, at least you’re very busy.

All right, well, finally this week, we spend so much time talking about how big health care is getting, Walmart this week announced that it’s basically . It’s closing down its two dozen clinics and ending its telehealth programs. This feels like another case of that, “Wow, it looked so easy to make money in health care.” Until you discover that it’s not.

Pradhan: Right. I think making money in primary care, certainly that’s not where the people say, “Oh, that’s a real big cash cow, let’s go in there.” It’s other parts of the health care industry.

Karlin-Smith: One thing that struck me about a quote in a CNN article from Walmart was how they were focusing on they wanted to do this, but they found it wasn’t a sustainable business model. To me, that then just brings up the question of “Should health care be a business?” and the problems. There’s a difference between being able to operate primary care and make enough money to pay your doctors and cover all your costs, and a big company like Walmart that wants to be able to show big returns for their investors and so forth. There’s also that distinction that something that’s not attractive for a business model like that can still be viable in the U.S.

Rovner: This reminds me a lot of ways of the ill-fated Haven Healthcare, which was when Amazon and JPMorgan Chase and Berkshire Hathaway all thought they could get together because they were big, smart companies, could solve health care. They hired Atul Gawande, he was one of the biggest brains in health care, and it didn’t work out. We shall continue.

Anyway, that is the news for this week. Now it’s time for our extra-credit segment. That’s when we each recommend a story we read this week we think you should read, too. As always, don’t worry if you miss it. We will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device.

Rachana, why don’t you go first this week?

Pradhan: This story that I’m going to suggest, [“.”] it’s in The Wall Street Journal, depressing like most health care things are. It’s about how millions of children, I think it’s over 5 million children under the age of 18, are providing care to siblings, grandparents, and parents with chronic medical needs, and how they are becoming caregivers at such young ages. In part, because it is so hard to find and afford in-home care for people. That is my extra credit.

Rovner: Right, good story. Sarah?

Karlin-Smith: I looked at a piece in The Atlantic by Katherine J. Wu, “.” It’s focused on our initial response in this country to bird flu, and maybe where the focus should and shouldn’t be. It has some interesting points about repeat mistakes we seem to be making, in terms of inadequate testing, inadequate focus on the most vulnerable workers, and what we need to do to protect them in this crisis right now.

Rovner: Alice?

Ollstein: I chose [““] an AP investigation, collaborating with Frontline, about the use of sedatives when police are arresting someone. This is supposed to be a way to safely restrain someone who’s combative, or maybe they’re on drugs, or maybe they’re having a mental health episode, and this is supposed to be a nonlethal way to detain someone. It has led to a lot of deaths, nearly 100 over the past several years. These drugs can make someone’s heart stop. The reporting shows it’s not totally clear if just the drugs themselves are what is killing people, or if it’s in combination with other drugs they might be on, or it’s because they’re being held down in a way by the cops that prevent them from breathing properly, or what. But this is a lot of deaths of people who have received these injections and is leading to discussions of whether this is a best practice. Pretty depressing stuff, but important.

Rovner: Yeah. It was something that was supposed to help and has not so much in many cases. My story this week is from ProPublica. It’s called “.” It’s by Patrick Rucker and David Armstrong. It’s about exactly what the headline says. A doctor who spent too much time reviewing potential insurance denials because she wanted to be sure the cases were being decided correctly. It’s obviously not the first story of this kind, but I chose it because it so reminded me of a story that I did in 2007, which was about a , it was Humana in that case, who was pushed to deny care and first testified to Congress about it in 1996. I honestly can’t believe that, 28 years later, we are still arguing about pretty much the exact same types of practices at insurance companies. At some point you would think we would figure out how to solve these things, but apparently not yet.

OK, that is our show. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us, too. Special thanks as always to our technical guru, Francis Ying, and our editor, Emmarie Huetteman. As always, you can email us your comments or questions. We’re at whatthehealth@kff.org, or you can still find me at X .

Rachana, where are you hanging these days?

Pradhan: I am also on X, .

Rovner: Sarah?

Karlin-Smith: I’m at or on Bluesky.

Rovner: Alice?

Ollstein: on X, and on Bluesky.