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蘑菇影院 Health News' 'What the Health?': Abortion Access Changing Again in Florida and Arizona
蘑菇影院 Health News' 'What the Health?'

Abortion Access Changing Again in Florida and Arizona

Episode 345

The Host

Julie Rovner
蘑菇影院 Health News
Julie Rovner is chief Washington correspondent and host of 蘑菇影院 Health News鈥 weekly health policy news podcast, 鈥淲hat the Health?鈥 A noted expert on health policy issues, Julie is the author of the critically praised reference book 鈥淗ealth Care Politics and Policy A to Z,鈥 now in its third edition.

The national abortion landscape was shaken again this week as Florida鈥檚 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鈥檚 panelists are Julie Rovner of 蘑菇影院 Health News, Sarah Karlin-Smith of the Pink Sheet, Alice Miranda Ollstein of Politico, and Rachana Pradhan of 蘑菇影院 Health News.

Panelists

Sarah Karlin-Smith
Pink Sheet
Alice Miranda Ollstein
Politico
Rachana Pradhan
蘑菇影院 Health News

Among the takeaways from this week鈥檚 episode:

  • Florida鈥檚 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鈥檚 near-total abortion ban nonetheless leaves the state鈥檚 patients and providers with plenty of uncertainty 鈥 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鈥檚 decision that laboratory-developed tests must be subject to the same regulatory scrutiny as medical devices comes as the tests have become more prevalent 鈥 and as concerns have grown amid high-profile examples of problems occurring because they evaded federal review. (See: Theranos.) There鈥檚 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 鈥渏unk鈥 patents that make it tougher for generics to come to market, and another court ruling delivers bad news for the pharmaceutical industry鈥檚 fight against Medicare drug negotiations.

Plus, for 鈥渆xtra credit鈥 the panelists suggest health policy stories they read this week that they think you should read, too:

Julie Rovner: ProPublica鈥檚 鈥,鈥 by Patrick Rucker, The Capitol Forum, and David Armstrong, ProPublica.

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

Sarah Karlin-Smith: The Atlantic鈥檚 鈥,鈥 by Katherine J. Wu.

Rachana Pradhan: The Wall Street Journal鈥檚 鈥,鈥 by Clare Ansberry.

Also mentioned on this week鈥檚 podcast:

  • Time鈥檚 鈥,鈥 by Eric Cortellessa.
  • NPR鈥檚 鈥,鈥 by Selena Simmons-Duffin.
  • NPR鈥檚 鈥,鈥 by Julie Rovner.
  • CNN鈥檚 鈥,鈥 by Nathaniel Meyersohn.

[Editor鈥檚 note: This transcript was generated using both transcription software and a human鈥檚 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鈥檚 not a political ad, but it is a call-to-action. I鈥檓 Mila Atmos, and I鈥檓 passionate about unlocking the power of everyday citizens. On our podcast 鈥淔uture Hindsight,鈥 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 鈥淲hat the Health?鈥 I鈥檓 Julie Rovner, chief Washington correspondent for 蘑菇影院 Health News, and I鈥檓 joined by some of the best and smartest health reporters in Washington. We鈥檙e 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 蘑菇影院 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鈥檚 six-week abortion ban took effect. Alice, what does this mean for people seeking abortions in Florida, and what鈥檚 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鈥檚 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鈥檙e 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鈥檝e 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鈥檚 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鈥檒l be tough for a lot of folks to navigate.

Rovner: While we think of that, well there鈥檚 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鈥檛 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鈥檚 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鈥檚 kind of a muddle, isn鈥檛 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鈥檛 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鈥檚 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鈥檝e seen in so many states, that leads to patients and providers just being very scared, and not knowing what鈥檚 legal and what鈥檚 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鈥檚 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鈥檙e 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 鈥渘ews鈥 he made was to suggest that he鈥檇 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鈥檓 sure that he鈥檚 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鈥檒l say something, I鈥檓 sure he will get competing advice as to whether it鈥檚 a good idea to say something at all, so we鈥檒l have to see.

Rovner: Well, speaking of Trump deflecting, he seemed to be pretty disciplined about the rest of the abortion questions 鈥 and there were a lot of abortion questions in that interview 鈥 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鈥檚 menstrual periods. Lest you think that鈥檚 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, 鈥渉elped to identify patients who had undergone failed abortions.鈥 Yet, none of these things ever seem to stick to Trump. Is any of this going to matter in the long run? He鈥檚 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鈥檚 also not been consistent in saying it鈥檚 totally up to states, whatever states want to do is fine. He鈥檚 repeatedly criticized Florida鈥檚 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鈥檛 a pure 鈥渨hatever states do is fine鈥 stance, this is 鈥渨hatever states do, unless it鈥檚 something really unpopular, in which case I oppose it.鈥 That is a tough line to walk. The Biden administration and the Biden campaign have really seized on this and are trying to say, 鈥淥K, if you are going to have a leave-it-to-states stance, then we鈥檙e going to try to hang on you every single thing states do, whether it鈥檚 the legislature, or a court, or whatever, and say you own all of this.鈥 That鈥檚 what鈥檚 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鈥檛 discriminate against and must provide accommodations for, under rules implementing the Pregnant Workers Fairness Act. The new rules don鈥檛 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鈥檙e going to see more of these. We鈥檙e 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鈥檚 a regulatory battle and a legal one now, too, like in the immediate aftermath of the Dobbs [v. Jackson Women鈥檚 Health Organization] decision, when there were employers, I think about it more practically. Which is that there were employers that were saying, 鈥淲e would cover expenses.鈥 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鈥檚 a whole other … Getting an abortion, or even things related to pregnancy, are incredibly private things, so I don鈥檛 know how many women would be willing to stand up and say, 鈥淗ey, I need this accommodation and you have to give it to me under federal regulations.鈥 In a way, I think it鈥檚 notable both that the EEOC put out those regulations and that there鈥檚 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, 鈥淗ey, I need three days off so I can drive halfway across the country to get an abortion because I can鈥檛 get one here.鈥 I see that might be an awkward conversation.

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

Rovner: That鈥檚 true. It doesn鈥檛 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鈥檝e been talking about since February, well the CEO of Change鈥檚 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 鈥淗acking For Dummies.鈥 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鈥檛 come in guns blazing. He definitely came in thinking that, 鈥淥h, I鈥檓 going to get kicked around, and I鈥檓 just going to have to smile and take it.鈥 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鈥檙e still hearing from providers who still can鈥檛 get their claims processed, and from people who can鈥檛 get their medications because pharmacies can鈥檛 process the claims. There鈥檚 a lot of dispute about how long it鈥檚 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鈥檚 like 40% of all claims, it鈥檚 actually a minimum part of United鈥檚 health claims. United doesn鈥檛 use Change for most of its claims, which surprised me. Which is maybe why United isn鈥檛 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, 鈥淗ey, I took your complaints right to the CEO?鈥

Karlin-Smith: I think there鈥檚 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鈥檚 going to bring a light onto how big they鈥檝e become, the amount of vertical integration in our health system, and the risks from that.

Rovner: We went through this in the 鈥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鈥檝e seen that vertical integration has just created big, behemoth companies like United. I don鈥檛 know whether Congress will get into all of that, but at least it brought it up into their faces.

There鈥檚 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鈥檚 medical device regulations and they鈥檒l 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鈥檙e supposed to do, you鈥檙e getting the right results and so forth. Initially, over the years, the prevalence of these tests has grown, and what they鈥檙e 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鈥檙e actually basically exempting all already-on-the-market products. There鈥檚 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鈥檚 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鈥檙e 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鈥檙e going to make these medical devices, where there鈥檚 already a huge problem with FDA either exempting things that shouldn鈥檛 really be exempt, or just not being able to look at everything they should be looking at.

Karlin-Smith: Right. They鈥檙e 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鈥檚 the most risk of something problematic happening to people鈥檚 health and safety if something goes wrong. It鈥檚 also an admission, to some extent, of something that鈥檚 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鈥檛 feel like they have the manpower and, just, money to deal with FDA. I think that鈥檚 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鈥檓 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鈥檛 know that they鈥檝e 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鈥檒l 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鈥檚 not going to decide about the potential menthol ban that we鈥檝e been talking about on and off. There was a statement from HHS [Department of Health and Human Services] last week that just said, 鈥淲e need to look at this more.鈥 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鈥檚 not good for health. Why would the administration not want to ban menthol?

Pradhan: It鈥檚 controversial because, I鈥檒l just say, that it鈥檚 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鈥檚 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鈥檙e 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鈥檚 where the tension has been. Although notably, some groups like the NAACP and stuff have been gotten on board with banning menthol. It鈥檚 an interesting thing where we鈥檙e 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鈥檙e predominantly used by the Black population. But then you have people saying, well it鈥檚 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鈥檚 been around for a while. There鈥檚 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鈥檚 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鈥檚 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鈥檚 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鈥檛 enforce the Trump rules. But this is still a live issue in many courts and it鈥檚 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鈥檚 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鈥檓 like, 鈥淥h, we were still kicking this around.鈥 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鈥檚 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鈥檛 be there, and thus making it harder to get generic products on the market. In particular, they鈥檝e been actually going against drugs that have a device component, basically saying these components鈥 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鈥檝e targeted.

The idea would be this should help speed some of the generic entrants. It鈥檚 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鈥檚 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鈥檚 a 鈥

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鈥檚 been interesting because it does seem like FTC鈥檚 had more immediate results, I guess, than you sometimes see in Washington. [Sen.] Bernie Sanders has piggybacked on what they鈥檙e 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 鈥30 Years War,鈥 to do something about drug prices. Before we leave drug prices, we鈥檙e 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鈥檙e 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鈥檛 have to participate.

Another big ruling from this judge was that this program does not constitute First Amendment violations. What鈥檚 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鈥檙e basically being forced under this program to say, 鈥淥h, this is … when CMS [Centers for Medicare & Medicaid Services]鈥 … and then work out a price, that the price they work out is the maximum fair price because that鈥檚 the technical terminology used in the law, that they鈥檙e then somehow making an admission that any other price that they鈥檝e charged has not been fair. The judge basically said, 鈥淲ell, this is a public relations problem, not a constitutional problem. Nobody is telling you you can鈥檛 go out and publicly disagree with CMS about this program and about their prices that you end up having to enter into.鈥

It鈥檚 another blow. They have a lot of different legal arguments they鈥檙e trying out in different cases. As I said, they鈥檝e 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鈥檝e filed in. There was another case that was heard, an appeal was heard yesterday, in PhRMA, the main trade group鈥檚 case, where they鈥檙e trying to push on because of that. There鈥檚 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鈥檛 think anyone really thought that they would be successful and it seems like that is, at least to date, that鈥檚 how it鈥檚 playing out.

Rovner: I鈥檒l repeat, it鈥檚 a good time to be a lawyer for the drug industry, at least you鈥檙e 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鈥檚 basically . It鈥檚 closing down its two dozen clinics and ending its telehealth programs. This feels like another case of that, 鈥淲ow, it looked so easy to make money in health care.鈥 Until you discover that it鈥檚 not.

Pradhan: Right. I think making money in primary care, certainly that鈥檚 not where the people say, 鈥淥h, that鈥檚 a real big cash cow, let鈥檚 go in there.鈥 It鈥檚 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鈥檛 a sustainable business model. To me, that then just brings up the question of 鈥淪hould health care be a business?鈥 and the problems. There鈥檚 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鈥檚 also that distinction that something that鈥檚 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鈥檛 work out. We shall continue.

Anyway, that is the news for this week. Now it鈥檚 time for our extra-credit segment. That鈥檚 when we each recommend a story we read this week we think you should read, too. As always, don鈥檛 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鈥檛 you go first this week?

Pradhan: This story that I鈥檓 going to suggest, [鈥.鈥漖 it鈥檚 in The Wall Street Journal, depressing like most health care things are. It鈥檚 about how millions of children, I think it鈥檚 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, 鈥.鈥 It鈥檚 focused on our initial response in this country to bird flu, and maybe where the focus should and shouldn鈥檛 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 [鈥溾淽 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鈥檚 combative, or maybe they鈥檙e on drugs, or maybe they鈥檙e 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鈥檚 heart stop. The reporting shows it鈥檚 not totally clear if just the drugs themselves are what is killing people, or if it鈥檚 in combination with other drugs they might be on, or it鈥檚 because they鈥檙e 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鈥檚 called 鈥.鈥 It鈥檚 by Patrick Rucker and David Armstrong. It鈥檚 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鈥檚 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鈥檛 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鈥檇 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鈥檙e 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鈥檓 at or on Bluesky.

Rovner: Alice?

Ollstein: on X, and on Bluesky.

Rovner: We will be back in your feed next week. Until then, be healthy.

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