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Democrats Demand Trump Administration Halt Plan To Collect Federal Workers’ Health Data

Democratic lawmakers are demanding that the Trump administration halt plans to collect sensitive medical records for millions of federal workers and retirees, as well as their family members.

The Office of Personnel Management has asked 65 insurance companies to provide monthly reports with detailed medical and pharmaceutical claims data of more than 8 million people enrolled in federal health plans, KFF Health News reported earlier this month. The request, which could dramatically expand the personally identifiable medical information OPM can access, alarmed health ethicists, insurance company executives, and privacy advocates.

Now, OPM Director Scott Kupor has two letters on his desk — one from 16 U.S. senators and another led by Rep. Robert Garcia, the top Democrat on the House Oversight Committee — asking him to drop the agency’s proposal.

“The collection of broad, personally identifiable data regarding medical care and treatment raises concerns that OPM could target certain federal employees seeking vital health care services that the Administration disagrees with on political grounds,” the Democratic House members wrote to Kupor April 17, citing KFF Health News.

The letters from congressional Democrats alone are unlikely to reverse OPM’s plans. Republicans — who control Congress and, ultimately, any oversight activities — have not weighed in on OPM’s notice.

OPM did not immediately respond to a request for comment on the letters. The agency, which said in its notice that it will use the data for oversight and to manage the federal health plans, has not publicly addressed written concerns about its proposal.

The notice, posted and sent to insurers in December, states that insurers are legally permitted to disclose “protected health information” to OPM and does not provide instructions to redact identifying information, such as names or diagnoses, from the claims.

That data could be used to implement cost-saving measures, health policy experts told KFF Health News earlier this month. But it would also give the Trump administration — which has laid off or fired tens of thousands of federal workers — access to a vast trove of personal information.

In the letters, Democratic lawmakers lay out a number of concerns about potential consequences of OPM’s obtaining detailed medical claims for millions of federal workers.

The letter from Senate Democrats — led by Adam Schiff of California and Mark Warner of Virginia — argues that OPM is not equipped to safeguard such sensitive data and that the administration could share the records across government agencies, as it has done with personal information on millions of Medicaid enrollees.

They also assert that the agency does not have a legal right to the data and that insurers’ sharing the information with OPM would “violate the core principles of the Health Insurance Portability and Accountability Act.” HIPAA requires certain organizations that maintain identifiable health information — such as hospitals and insurers — to protect it from being disclosed without patient consent. The proposal, the senators warn, threatens patients’ relationships with their clinicians, especially “sensitive disclosures regarding mental health, chronic illness, or other deeply personal conditions.”

“For these reasons, we strongly urge you to cease any further consideration of this proposal,” states the letter, which was sent to Kupor on April 19.

The American Federation of Government Employees, the largest union for federal employees, responded with alarm to KFF Health News’ reporting. The union noted in a statement from its national president, Everett Kelley, that OPM’s proposal “comes in the context of coordinated attacks on federal employees and repeated stretching of the legal boundaries for sharing sensitive personal data across government agencies.

“The question of what this administration intends to do with eight million Americans’ most private health information is not academic,” the AFGE statement read. “It is urgent.”

In an emailed statement, Kelley applauded the congressional letters.

“We are pleased that Democratic lawmakers on the Hill are just as outraged as we are over this administration’s blatant attempt to breach the privacy of millions of Americans across the country,” Kelley wrote. “We share their concerns regarding potential misuse of the information to continue illegally targeting workers and their demand for OPM to withdraw this proposal.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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ICMR to roll out multi-state study to expand palliative care access

The proposed study aims to develop and test scalable palliative care models across district hospitals, community health centres, primary health centres and home-based settings, covering patients across age groups and illnesses.

from Top Health News | Latest Healthcare Sector & Healthcare Industry news, Information and Updates: ET HealthWorld : ETHealthworld.com https://ift.tt/nRpUXWw

Bain Capital sole contender for Vitabiotics buy

The group’s Indian arm, Meyer Vitabiotics, accounts for around 20% of the total Rs 3,000 crore (£253 million) in annual sales. Within Meyer’s portfolio, Calcimax holds a strong presence across paediatrics, diabetes, cardiac care, and women’s health segments, particularly in pregnancy and menopause.

from Top Health News | Latest Healthcare Sector & Healthcare Industry news, Information and Updates: ET HealthWorld : ETHealthworld.com https://ift.tt/wPlTGkg

Nuevas reglas federales de Medicaid exigen un mes de trabajo. Algunos estados piden más

Millones de personas que soliciten Medicaid en los próximos años tendrán que demostrar que han estado trabajando, estudiando o haciendo voluntariado durante al menos un mes antes de poder obtener o conservar este seguro de salud federal que gerencian los estados.

Pero legisladores republicanos en algunos estados creen que las nuevas reglas —parte del One Big Beautiful Bill Act del Partido Republicano, firmada en julio pasado por el presidente Donald Trump— no van lo suficientemente lejos.

Indiana encabeza ese impulso, con una nueva ley que exige a los solicitantes demostrar que han estado trabajando o participando en una actividad similar por tres meses consecutivos para recibir beneficios.

Mientras tanto, residentes en muchos otros estados tendrán que demostrar que trabajaron solo un mes, la opción menos complicada bajo esta nueva ley tributaria y de gasto interno de Trump. La ley instruye a los estados a decidir si exigirán uno, dos o tres meses de historial laboral.

Al igual que en Indiana, legisladores republicanos de Idaho aprobaron un requisito de tres meses, y el gobernador firmó la ley el 10 de abril.

Estas medidas, junto con acciones similares en Arizona, Missouri y Kentucky, buscan limitar la flexibilidad para implementar la ley federal a nivel estatal.

“Normalmente, no se vería a legisladores estatales interviniendo en estas decisiones”, dijo Lucy Dagneau, funcionaria senior del área de defensa de la Sociedad Americana del Cáncer.

La Oficina de Presupuesto del Congreso, una entidad no partidista, estimó que 18,5 millones de adultos estarán sujetos a las nuevas reglas, que se aplicarán en 42 estados y el Distrito de Columbia.

En Indiana, las reglas laborales afectarán aproximadamente al 33% de la población estatal inscrita en Medicaid. En general, las reglas no se aplicarían a niños, personas de 65 años o más, ni a personas con discapacidades o problemas graves de salud.

Por lo general, los administradores estatales —no los legisladores— detallan cómo planean cumplir nuevas normas federales, y con frecuencia esperan orientación de reguladores federales. Pero funcionarios de los Centros de Servicios de Medicare y Medicaid (CMS) aún no han dicho a los estados cómo cumplir muchos aspectos de la amplia ley presupuestaria, lo que ha llevado a legisladores estatales a intervenir.

El gobernador republicano Mike Braun firmó la ley de Indiana el 4 de marzo, convirtiendo a su estado en el primero en fijar el requisito laboral de Medicaid en tres meses, el período más largo permitido por la ley federal.

El senador estatal republicano Chris Garten presentó un proyecto de ley en enero, con el argumento de que era necesario para “alinear” la ley estatal con las nuevas reglas federales de Medicaid. También presentó la medida como una forma de combatir el “despilfarro, fraude y abuso” en programas públicos.

Cuando personas no elegibles se inscriben, eso perjudica “al verdadero residente vulnerable de Indiana que realmente necesita la ayuda”, dijo Garten durante una audiencia de comité en enero.

El senador estatal demócrata Fady Qaddoura expresó escepticismo durante la audiencia y cuestionó la necesidad de la legislación. Qaddoura pidió al secretario de la Administración de Servicios Sociales y Familiares de Indiana, Mitch Roob, una estimación del número de personas no elegibles inscritas en Medicaid en el estado.

“Creo que muy pocas”, respondió Roob. “Nunca será ninguna”.

Después de escuchar esa respuesta, Qaddoura dijo que no hay evidencia de un problema generalizado en Indiana. Acusó a los republicanos de usar el despilfarro, fraude y abuso como justificación para negar beneficios de salud y ayuda alimentaria a residentes vulnerables del estado.

Más tarde, Garten calificó la acusación de Qaddoura como una “distorsión fundamental” del proyecto de ley.

Los republicanos han dicho que imponer estos límites protege la continuidad del programa Medicaid.

“Creemos en una red de seguridad para nuestros más vulnerables, no en un comodín para adultos aptos para trabajar que deciden no hacerlo”, dijo Garten. “Al ajustar estas medidas, garantizamos que nuestra red de seguridad siga siendo sostenible”.

Se espera que la inscripción en el Medicaid del estado baje debido a la legislación de Garten, según un análisis de la Agencia de Servicios Legislativos de Indiana, una entidad no partidista.

Medicaid ayuda a mantener sanas a las personas para que puedan seguir trabajando, dijo Adam Mueller, director ejecutivo del Indiana Justice Project, una organización legal no partidista enfocada en salud, vivienda e inseguridad alimentaria.

Mueller teme que las personas tengan dificultades para demostrar su historial de trabajo, especialmente quienes tienen empleos no tradicionales.

“Si el objetivo es que la gente participe, con un mes bastaría”, dijo Mueller.

En última instancia, teme que la ley perjudique a los residentes de Indiana que más necesitan ayuda. “Van a tropezar con los obstáculos burocráticos”.

Un análisis del Center on Budget and Policy Priorities predijo que las reglas laborales impondrán nuevas barreras para obtener cobertura y que la forma en que los estados decidan aplicarlas “afectará significativamente la cantidad de personas que pierdan cobertura”. Las decisiones estatales determinarán “qué tan intensa es la carga”, concluyó este centro de estudios de tendencia progresista, y elegir un período de revisión más corto “permitirá que más personas se inscriban”.

Legisladores en varios estados consideraron límites. Y el mismo grupo conservador de cabildeo, la Foundation for Government Accountability (FGA), testificó a favor de estas medidas en Arizona, Indiana y Missouri.

En Missouri, el cabildero de FGA James Harris dijo que la medida busca “sacar a la gente de la dependencia y devolverle esa dignidad y orgullo del trabajo”.

El representante estatal de Missouri Darin Chappell propuso exigir un período de revisión de tres meses, similar a la medida en Indiana. Pero la versión más reciente del proyecto que patrocinó exigiría a los solicitantes demostrar que trabajaron solo un mes antes de inscribirse.

Chappell, republicano, dijo que su iniciativa fomentaría una “mentalidad de trabajo”.

Anna Meyer, dueña de una pequeña panadería en Columbia, Missouri, dijo que la insinuación es que ella y otras personas en Medicaid son perezosas. “He trabajado desde los 15 años”, dijo. “Ahora tengo 43”.

Meyer, quien expresó su oposición, dijo que anteriormente tuvo problemas para enviar información a la agencia estatal de Medicaid. Teme que estos nuevos requisitos la pongan a ella y a otras personas en riesgo de perder cobertura, incluso si cumplen la regla laboral.

Tiene fibromialgia, una condición crónica que aumenta la sensibilidad general al dolor. También tiene alergias alimentarias. Medicaid ayuda a pagar medicamentos y visitas al doctor que la mantienen saludable y le permiten seguir trabajando.

“Trabajo muy duro”, dijo Meyer.

En St. Louis, Jessica Norton, obstetra y ginecóloga, atiende a muchas pacientes de Medicaid en una clínica de Affinia Healthcare. Dijo que tienen dificultades para mantener su seguro, aunque Missouri extiende un año completo de cobertura de Medicaid a mujeres elegibles después de dar a luz.

A algunas de sus pacientes se las expulsó de la cobertura sin explicaciones al momento en que iban a la cita médica seis semanas después del parto. Teme que la burocracia de los nuevos requisitos laborales haga más difícil conservar el seguro, aunque se supone que mujeres embarazadas y madres recientes están exentas.

Norton criticó a los legisladores por el mensaje que esta política envía a pacientes vulnerables. Están diciendo: “Ah, en realidad, la atención médica es un privilegio, y hay que ganárselo”.

Casi dos tercios de los adultos de 19 a 64 años inscritos en Medicaid ya trabajan, según KFF. La razón por la que muchos de los adultos restantes en Medicaid no trabajan es que están jubilados, cuidan a otra persona o están demasiado enfermos, según la misma organización.

Algunos estados no solo están estableciendo los requisitos más estrictos, sino que también bloquean la flexibilidad opcional incluida en las reglas federales.

Por ejemplo, los estados pueden adoptar exenciones adicionales a las reglas laborales, como permitir que las personas aleguen una “dificultad de corto plazo”, diseñada para mantener la cobertura de Medicaid a personas con condiciones médicas que les impiden trabajar.

Legisladores de Missouri buscan una enmienda constitucional para impedir que su estado ofrezca esas exenciones opcionales. Pero defensores de pacientes advierten que estos límites perjudicarían a residentes vulnerables del estado cuando más necesitan cobertura, en particular pacientes rurales con cáncer.

Con frecuencia, estos pacientes deben viajar a Kansas City o St. Louis, para recibir tratamiento, lo que interrumpe su capacidad para trabajar, testificó Emily Kalmer, cabildera del brazo de defensa pública de la Sociedad Americana del Cáncer, durante la audiencia de enero. Reconociendo esto, la ley federal ofrece ciertas exenciones para este tipo de situaciones.

Pero esta exención por dificultad de corto plazo quedaría fuera de la mesa en Missouri.

El tiempo es “muy importante en la vida de un paciente con cáncer o de un sobreviviente de cáncer”, dijo Kalmer.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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An Arm and a Leg: The Accidental Architect of America’s Drug Patent Problem

Depending on whom you ask, Alfred Engelberg could be a hero or a villain in the story of American pharmaceuticals. The patent lawyer helped write legislation that led to a dramatic increase in the number of generic drugs on the market. He also contributed to a patent system that gives pharmaceutical companies monopolies on their most lucrative drugs, blocking generic competition and keeping prices high along the way. 

An Arm and a Leg host Dan Weissmann traces Engelberg’s story back more than 50 years, from a scrappy childhood on the Atlantic City boardwalk to watching President Ronald Reagan sign his bill into law at the White House Rose Garden. Today, Engelberg advocates for policy changes he believes will enable more generic drugs to reach the market faster. 

Dan Weissmann @danweissmann @danweissmann.bsky.social Host and producer of "An Arm and a Leg." Previously, Dan was a staff reporter for Marketplace and Chicago's WBEZ. His work also appears on "All Things Considered," Marketplace, the BBC, 99% Invisible, and "Reveal," from the Center for Investigative Reporting.

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Emily Pisacreta Producer Claire Davenport Producer Adam Raymonda Audio wizard Ellen Weiss Editor Click to open the Transcript Transcript: Why drugs cost so much, 101: Medicine monopolies

Note: “An Arm and a Leg” uses speech-recognition software to generate transcripts, which may contain errors. Please use the transcript as a tool but check the corresponding audio before quoting the podcast.

Dan: Hey there–

We are kicking off a new series here — We’re calling it An Arm and a Leg 101.

We’ve spent years of reporting on two huge questions: Why does health care cost so freaking much? And what can we maybe do about it?

We’ve been chasing answers one story, one question at a time.

Now, we’re pulling together some of what we’ve learned. Digging a little deeper, going a little broader.

Starting with why so many drugs cost so much.

One of the first questions I ever asked — one of our first stories — was: How can insulin be so expensive? Wasn’t it discovered in the early 20th century? Shouldn’t it be a generic drug by now?

You know, cheap? 

And part of the answer I got was: Insulin has been transformed since the early 20th century. A lot.

A medical researcher named Jing Luo told me: Today’s insulins are a long way from what we had a hundred years ago.

Jing Luo: They’ve been really modified at a molecular level. It’s cool stuff. It’s super cool stuff. And you know, there are multiple Nobel prizes in physiology and medicine that have made this happen.

Dan: And all that super-cool stuff, those amazing discoveries, got patented.

Meaning: The patent-holders– the pharma companies — got a monopoly on those amazing discoveries.

The pharma companies claimed patents — and monopolies– on a bunch of other things too. Not all of them amazing.

But each new patent can mean another delay for a generic version coming to market.

Jing Luo: Companies can stack dozens of patents on top of each other to try to thwart generic competition because they can say, look, we’ve got three patents on the active ingredient. We’ve got patents on the medical uses of the active ingredient. We’ve got patents on the non-active excipient associated with this ingredient. We’ve got multiple patents on the devices, and so you who are trying to enter this space will sue you for patent infringement on all of them.

Dan: A patent guarantees you at least a 20-year monopoly. Drugs can generally get an extra five. 

And these extra patents — secondary patents –can keep you protected LONGER. If you don’t file them at the same time as the original: 

To talk about a drug that’s in the news right now. The original patent on the active ingredient in Wegovy and Ozempic actually expired this year.. The extra five years extends it to the early 2030s. 

But dozens of extra patents — secondary patents, filed later — mean that here in the U.S., we might not see cheaper generic versions until 2042. Or later.

And as Jing Luo told me: This strategy isn’t a secret. It’s an industry cornerstone. 

Jing Luo: When you listen to these like CEOs of pharma companies being interviewed at CNBC, you know, they’d be like, well, what about generic competition for this product? And they’ll just keep saying, no, no, no. We’ve got this really robust patent portfolio. We can withstand any challenge. We’re gonna tie this up in courts forever and don’t worry about it.We’re gonna continue this gravy boat for a long, long time. That’s the way they reinsure investors.

Dan: A robust patent portfolio. ?Or what researchers and advocates call a patent thicket.

They say quality matters less than quantity. 

The numbers are wild. 

According to one study, the 10 best-selling drugs for 2021 — drugs for cancer, HIV, arthritis — were protected by a combined total of seven hundred and forty-two patents. With hundreds more “pending.”

When these add-on patents get challenged in court, they actually get tossed out more often than primary patents..

But lawsuits cost money. A robust patent portfolio — a patent thicket — means generic companies would need to be ready to file a LOT of them.

So, we wanted to know: How did all this happen? How did these games get started?

It turns out, there is one guy who can tell you the story from the beginning, for better and for worse. Who helped shape it. Made millions of dollars from it. Saw its flaws. And has spent most of the last 30 years trying to fix them. Hie’s a lawyer named Al Engelberg, and he’s 86 years old.

Alfred Engelberg: I tell people all the time, I live in a world, a pharma world where half the people think I’m dead and the other half wish I was.  

Dan: Al Engelberg’s story is the story  of generic drugs in America. And it’s a wild ride. 

This is An Arm and a Leg — a show about why health care costs so freaking much, and what we can maybe do about it. I’m Dan Weissmann. I’m a reporter, and I like a challenge. So the job we’ve chosen here is to take one of the most enraging, terrifying, depressing parts of American life, and bring you something entertaining, empowering, and useful.

?Al Engelberg’s parents fled Nazi Germany in the late 1930s.

He was born here, less than a year after they arrived. They had nothing.

And  here’s where they made their new life. 

Retro news reel: We are flying over a well-known eastern city. That is remarkable because manufacturing is almost non-existent. A city whose principle business is the entertainment of millions. Atlantic city, often called the vacation capital of the nation

Dan: Al likes to say he learned most of what he knows about practicing law on the Atlantic City boardwalk, by the time he was 16. 

Alfred Engelberg: We grew up very, very fast there. I started working when I was about nine or 10 and, and there were lots of opportunities on the boardwalk. 

Dan: His first “job” was crawling around under the boardwalk, looking for loose change.

Alfred Engelberg: But I went on to work at hotdog stands and at an illegal bingo game for the local mob.

Dan: And in every job, Atlantic City drove home its major lesson: Cheating — hustling — is something you’ve gotta expect. 

At this illegal bingo parlor, Al’s job was walking between tables, doling out bingo cards for a dime apiece. The bosses hired college kids to walk behind kids like Al, to keep him honest.

Alfred Engelberg: I mean, these guys are running an illegal game, but they still need to count, and they still inherently don’t trust anybody. 

Dan: Which was correct. Al says the college kids had their own hustle: They’d have him set aside a dollar or two before turning in his dimes — split that dollar with him fifty-fifty — and tell the bosses Al’s count was fine.

Alfred Engelberg: And everybody knowing that the counts were wildly inaccurate anyway ‘cause the little old ladies were, were stealing cards. Everybody in the room had their own thing going, you know, from the customers on.

Dan: After Al made it out of Atlantic City, his unique on-the-job education continued. He studied chemical engineering at Drexel, then took a job as a patent examiner while going to law school at night.

And at that job, he learned: The patent system was ripe for hustling.

Partly because most of his colleagues weren’t necessarily giving the job their all. 

Like him, most patent examiners were working their way through law school. And they were sneaking time to study on the job.

Alfred Engelberg: We used to be able to cut our notes down so they fit in these file drawers with the patents. And we would be reading your notes and if your boss came by, you would just drop a patent on top of the notes.

Dan: You could say it was Atlantic City all over again. Everybody in the job is sneaking something for themselves — in this case, time.

And Al Engelberg could see that, even if his colleagues gave it their all, they were too green to do their job well. 

A patent examiner’s job — deciding whether a proposed invention deserves a monopoly (which at that time was 17 years) — means deciding whether the idea for that invention would be obvious to “a person of ordinary skill in that field.”

Alfred Engelberg: And most of the examiners had never worked in that field and had absolutely no idea. And this is the big leagues. You’re granting somebody a monopoly for 17 years, and it seemed ridiculous on its face.

Dan: Al cut his own path at the patent office. He’d worked his way through engineering school, in manufacturing plants, he saw what people of ordinary skill in that field solve problems every day. So he specialized in examining patents he actually knew something about.

That got him promoted, then it got him recruited by a corporate lawyer.. After the company paid his way through the rest of law school, he jumped to the Justice Department. 

He was ambitious– he wanted experience junior lawyers don’t usually get — like trying cases of his own.

After a few years doing just that, he took a job with a small law firm in New York City in 1968.

Alfred Engelberg: I came to New York to private practice at the age of 30 and I was ready to go. I mean, I was ready to, to tear the world apart and I did.

Dan: Patents were still a specialty. Then, in 1973, he gets a call that leads to his first generic drug case.

Generic drugs were not a hot market at the time.

Alfred Engelberg: ?The generic drug industry in 1970s was essentially, a half a dozen, privately owned family businesses, mostly in the metropolitan New York area. And most of the drugs that they were selling were drugs that were approved before 1962. 

Dan: Yeah. 1962 is when the FDA made it harder to get a new drug approved — you had to go through long clinical trials to show that your drug was safe and effective. 

Even if your drug was a generic version of an existing drug. Those little companies didn’t have the capital to run those trials, so they were stuck selling those old drugs.

Not much of a business. Maybe 20 percent of prescriptions were for generic drugs.

So when Al Engelberg got a call for his first generic drug case, that was the context. And the case itself did not sound promising. For one thing:

Alfred Engelberg: The call wasn’t even from the client. It was from a bank. The client was bankrupt. 

Dan: The client was bankrupt. This bankrupt client, Premo Pharmaceuticals, was getting sued for patent infringement. The bank was willing to put up ten thousand dollars for a defense. Nowhere near enough to actually try a case. Oh, and…

Alfred Engelberg: From what they told me, the information they gave me, we didn’t have a very good defense.

Dan: But Al Engelberg saw an opening. He could see that his opponents have weaknesses too.

Alfred Engelberg: The patent owners were in a very strange position. If they won, they got nothing because we were already bankrupt. Two, they were gonna have to spend the legal fees to win.

Dan: Win against a young lawyer named Al Engelberg who already had a rep as a tough opponent. So they could lose.

Alfred Engelberg: And if they lost, they would lose millions and millions of dollars in business because there wouldn’t be a patent. And they’d have competition from generic drugs.

Dan: And meanwhile, Al Engelberg is also sizing up the judge. He knows the guy doesn’t love patents.

So Al shows up to the first conference and he bluffs. 

Alfred Engelberg: I said to the judge, oh, your Honor, you know, it’s another one of those patents. They’re all invalid. And I said, we don’t need very much discovery. We’re, we’ll be ready to go to trial in a few months. Just set a trial date.

Dan: The other side walks out beside themselves.

And within a couple of weeks they call Al to say: Hey, how about this? You guys just acknowledge our patent is OK, and we’ll give you the money we would’ve spent litigating. Call it 400,000 bucks?

Alfred Engelberg: I called the client and said, how’s $400,000? He said, are you kidding?

Dan: They didn’t just get out of trouble — they got out of bankruptcy, with $400,000 in their pockets. Because Al Engelberg knew how to size up a situation.   

Alfred Engelberg: You don’t learn that in law school. That’s not what they teach.

Dan: Word gets  around about that case, and pretty soon everybody in the generic drug world is calling him.

It’s a small world, but by the end of the 1970s, there may be room for it to start getting bigger. 

People are starting to notice: Drugs are expensive. Maybe there should be more cheap generics. 

Some generic drug companies form an association and start lobbying: Make it easier to get generic drugs to market without having to go through all those trials.

The brand-name drugmakers push back: They say it takes so long to run the trials and get their drugs approved, they don’t get enough time to make money before those patents expire.

In 1983, Democratic Representative Henry Waxman steps in to broker a compromise, with Republican Senator Orrin Hatch.

And Mr. Engelberg goes to Washington. To run strategy for the generic drugmakers. 

Alfred Engelberg: In a lot of ways , that’s where my Atlantic City training really helped me at the end of the day

Dan: There were a lot of people, with a lot of interests. A lot of angles. ?He starts commuting from New York to Washington DC a couple times a week — for months and months, more than a year.

And Al Engelberg says: This time, it wasn’t just about winning a case.

Alfred Engelberg: I was in the back of a cab the way I remember, with the senior partner of the law firm. And he says to me, why are you breaking your ass going to Washington two or three times? Why don’t you send an associate? You know, it’s just like, it’s just another case. And I said. I said, are you kidding? I said, you know, how many lawyers ever get to do what I’m doing right now? To be at the table influencing what may be a major law that’s gonna have major consequences is, is like something I never thought my whole life I’d be doing.

Dan: A kid from Atlantic City was exactly the right person to try to balance all the angles, negotiate a compromise. It took more than a year. It almost didn’t happen. But then it did. Congress passed the bill, and President Ronald Reagan got in front of cameras to sign it.

Ronald Reagan: Let me turn my attention to the real reason we’re here this afternoon, signing into law the Drug Price Competition and Patent Term Restoration Act of 1984. 

Dan: better known as Hatch-Waxman.

Hatch Waxman had three basic components:

One: Brand drugmakers got a few extra years on their patents.

Two: Generic drugmakers got a pathway to get FDA approval.

And three –The new law laid out rules for a generic drugmaker when they wanted to CHALLENGE an existing patent. 

Negotiating that third part was the part where Al Engelberg’s education on the Atlantic City boardwalk, and the U.S. patent office, and the generic drug industry came together: The result would make him millions and millions of dollars — and blow a giant hole into the grand bargain he had worked so hard to bring about.

That’s coming right up.

This episode of An arm and a Leg is produced in partnership with KFF Health News. That’s a nonprofit newsroom covering health issues in America. The folks at KFF Health News are amazing journalists — their work wins all kinds of awards, every year. We are honored to work with them.

So. The brand-name drug makers and the generic drug makers struck a deal. That deal was good for them. Both sides got something big out of it. The public was supposed to get something out of it too.

And, to be fair, we did: Remember, back then, maybe one out of five prescriptions was for a generic drug. Now it’s nine out of ten.

But we pay more than ever for drugs. Mostly for branded, patent-protected drugs. And the biggest, most-important, most profitable drugs get locked behind patent thickets.

How did that happen? 

Well, to understand that, it helps to know what Al Engelberg got out of the whole bargain.

Al had been there at the bargaining table, on behalf of the generics. 

One day, during those negotiations, he was in the office with Henry Waxman’s lead counsel, a guy named Bill Corr, when Corr got a call from someone on the other side.

Corr starts pointing at the phone, pointing to Al — indicating: This guy is talking about you.

When Corr gets off the phone he says: That guy’s not sure about this deal where bad patents could be challenged. He’s suspicious about where you might take this. Like, are you just gonna set up a bounty-hunting operation, to get patents declared invalid?

And Corr said, Al, would you do that? 

Alfred Engelberg: And I said, you know, Bill, until this moment, I’ve never given it any thought, but it’s a hell of a good idea. Maybe I’ll look at it. 

Dan: And he did. Starting almost as soon as Hatch-Waxman became law.

Alfred Engelberg: And we sat in the rose garden, September 23rd, 1984, watched Reagan sign the bill. And in December of that year, I sat down at my kitchen table with a yellow pad and I laid out a strategy.

Dan: If you were gonna set up a bounty-hunting operation, how would you do it?

Al Engelberg knew a lot of patents were garbage. Knew it from his time in the patent office, knew it from practicing law. And he knew how much money a successful patent challenge could be worth.

The way Hatch-Waxman worked: If a generic drug company challenged a patent and won, they would get six months before any OTHER generic drugmakers could get a crack at the market.

So their only competition would be the brand. If a pill cost two cents to make, and the brand was selling for a dollar a pill — that’s 98 cents of profit for every pill.

You’re the only competitor? You could charge 75 cents a pill and get 73 cents of profit. On a hit drug, you could make millions and millions — just in those six months. 

Al’s idea was this: Partner up with a generic drugmaker. Go find cases– drugs with weak patents. Win ’em. 

And split those millions in potential profits fifty-fifty. 

Al pitched a generic drugmaker — they were ready to go — and brought the deal to his law firm. .

Alfred Engelberg: As it turned out, my partners weren’t interested in having me do this. They tried to talk me out of it.

Dan: But they couldn’t. So he left. Went out on his own. All on his own.

Alfred Engelberg: I never hired a single soul, not even a secretary. And I couldn’t type. I still can’t type.

Dan: But he hunted and pecked his way through brief after brief. He bought an early portable computer — it weighed thirty pounds — and lugged it around in the back of his car. For ten years.

Alfred Engelberg: It was stupid. I almost killed myself. But, it worked out okay.

Dan: Yeah. Turns out Al was really good at finding the problems with drug patents.

In one of his first cases, Al Engelberg personally made more than 70 million dollars. Others settled: A few million here, a few million there– it adds up.

And then…

Alfred Engelberg: It got to be the mid nineties, and I was working on a case called Buspar. 

Dan: The Buspar case ended up a big winner for Al Engelberg and his generic drug partners. 

But it had consequences that went way beyond a single case. And led to big losses for the public.. Here’s how it went.  

Alfred Engelberg: Buspar was an anti-anxiety drug. And by all accounts not a very good one.

Dan: But Bristol Meyers Squibb invested in big advertising and marketing campaigns.

Speaker 5: I feel anxious. I can’t concentrate. 

Speaker 6: I’m so irritable. If you. You suffer from excessive worry. It can feel like a mountain of anxiety. 

Speaker 5: I’ll never get it all done. I’m overwhelmed. 

Speaker 6: But a prescription medication called buspar can help.

Dan: And all that marketing did its job. By the mid-1990s, Buspar was making more than 200 million dollars a year for Bristol.

Alfred Engelberg: The only problem for them was that the drug was not new. 

Dan: The active ingredient was well-known in medical literature as a tranquilizer. Nobody had bothered to market it.

So Bristol Myers Squibb filed a patent on it, claiming it had discovered a new use for this well-known tranquilizer: Treating anxiety.

Al Engelberg says when he read the patent application, he could barely believe it: What do tranquilizers do if not… treat anxiety?

It’s like saying: There’s this stuff called sugar. We’re gonna take out a patent on using it as a sweetener.

This looked like a case for a guy from Atlantic City. 

Alfred Engelberg: I did something that lawyers don’t. That’s just the way I was built. 

I filed a motion with the court and basically said, we don’t need any evidence.

You just have to read the patent. If you believe it’s true, the patent’s invalid. Just, you know, all you need is a dictionary basically.

Dan: Al says Bristol was eager to settle. 

Alfred Engelberg: We get into a settlement discussion and we keep saying, no, no, no, no.

Dan: Al’s partners had done the math: They figured they stood to make a hundred million dollars or more once they won. So when the other side offered 25 million, no was the easy answer.

Alfred Engelberg: We said, why are we gonna take this? You know, it’s crazy. There’s a reward here we know what it is. We’re gonna get it eventually.

Dan: Al sits down with a lawyer from the other side, a guy he knows, explains how he sees the math.

And soon the other side comes through with a much bigger offer: 72 million dollars – almost three times as much. 

Alfred Engelberg: And I’m sitting there like, what are you crazy? But then think about it from their point of view. 

Dan: Paying 72 million dollars is nothing, compared to what Bristol stands to gain if this lawsuit goes away. 

With their monopoly, Bristol Meyer Squibb is making more than 200 million dollars a year on Buspar. And unless somebody else lines up to do what Al Engelberg had done, expect to keep that monopoly for years.

Charging whatever they want. Two dollars a pill, three dollars a pill. Which Al Engelberg says is exactly what happened.

In fact, they kept that monopoly for like five years. 

Alfred Engelberg: As it turned out, nobody came behind us. And so, they had that monopoly until 2000. So they got five years of 2 billion, in gross profits. 

Dan: They made out.

Alfred Engelberg:  For the cost of $75 million. And you know, the public got screwed ’cause they are continuing to pay, you know, $2 a pill or $3 a pill for a drug that eventually ends up being available for 20 or 30 cents. Um, so that’s, that’s how it works.

Dan: That’s how it works. The branded company and the generic company both make out great. Cheaper generic versions of a drug get delayed. 

That amazing payday for Al Engelberg and his partners at the generic drug company turned into a model a template for the kind of deal that every generic drug company would want in on.

It got a nickname: Pay for delay.

Alfred Engelberg: That spread through the industry like wildfire, those numbers, you know, you don’t make those numbers half a cent at a time on, on pills,

Dan: Lawsuits were way more profitable.

But Al Engelberg wasn’t filing them.

A year or so after the Buspar case settled, sparking the Pay for Delay gold rush, he retired. He had plenty of money and nothing to prove.

And in retirement, he started evaluating what he’d accomplished, for better and for worse.

For better, generic drugs had more than doubled their share of the market since Hatch-Waxman took effect.

For worse, he could see two places where — despite all of his Atlantic City training — he had missed a couple of angles in negotiating Hatch-Waxman. 

One was: this whole pay-for-delay scheme. Turned out, in balancing incentives for brands and generic makers, he’d left open this perverse incentive that left the public out. 

And the second was a loophole  that Hatch-Waxman had left open.: 

It created a process where players like Al and his generic partners could challenge patents on drugs like Buspar, that they thought didn’t deserve protected monopolies. It removed some friction for those attacks. 

The drug companies developed a way to add more friction:  stacking extra patents — secondary patents — on every drug.

Developing patent thickets.

Even if a secondary patent is trivial  — and lots of them do get tossed out — challenging it means a court fight. And that costs money.

Alfred Engelberg: It caused the big drug companies to just get more and more patents. Because why not? You know, there was nothing standing in the way.

Dan: I mean, nobody knows better than Al Engelberg: Patent examiners don’t exactly stand in the way. 

And those patent thickets and pay for delay, they feed on each other. 

Alfred Engelberg: The economics of the business, caused these kinds of settlements to reach epic proportions. So the generic companies would, challenge these secondary patents and, the drug companies would pay them off.

Dan: In 1999 he published an article in a scholarly journal arguing that Hatch-Waxman needed a reboot. Even the six-month head start for a successful challenge could probably go. 

And ever since — for more than twenty-five years — he’s poured millions of dollars into efforts to tighten the rules. Funding research. A public-information campaign from Consumer Reports. Even a center for IP law at his alma mater, NYU.

It hasn’t always gone his way. 

Pay for delay has gotten much bigger since Al Engelberg wrote his first article calling for reform: He wrote in 1999 that about two dozen patent challenges had been filed.

Now he estimates that number at twelve thousand.

Alfred Engelberg: I can’t tell you how many tens of billions of dollars in legal fees that is. It’s one of the fastest growing and and steadiest industries for big law.

Dan: A Hatch-Waxman litigation forum on LinkedIn has more than fourteen thousand members.

And Hatch-Waxman doesn’t cover many of today’s the top-selling drugs– the biggest moneymakers. They belong to a class called “biologics.”

That includes famously-expensive rheumatoid arthritis drugs like Humira and Enbrel — and insulin. 

Biologics weren’t a category forty years ago when Hatch-Waxman got negotiated. Congress passed a new law to deal with them in 2010 — ?the Biologics Price Competition and Innovation Act.

Al Engelberg is not a fan of that law.

Alfred Engelberg: Whatever mistakes were made in Hatch Waxman, they were multiplied by 10 and deliberately in the biologics law

Dan: He says the all but encourages patent thickets. And doesn’t provide a pathway to challenge them.

He says it reminds him of some of his early days practicing law.

Alfred Engelberg: Back in the seventies, we used to have small startup clients in the computer field, and they would get letters from IBM. It says, we are ready to inform you that you may be infringing one or more of the following patents. And there was a 10 page list of patents attached. And the startup would come to us and say, you know, what should we do? And we would say, find another line of work, you know, what are you gonna do?

Dan: But he has not given up. In 2025, he published a book: Breaking the Medicine Monopolies.

It tells the story of his career — and lays out his prescriptions for fixing the problem.

He doesn’t JUST focus on plugging the holes in Hatch-Waxman and the biologics law.

Alfred Engelberg: You know, we don’t actually need a generic drug industry. We need generic drug pricing. 

Dan: He’s got proposals for an increased government role in negotiating and regulating prices — and more than that.

He argues that a 1980 law allows the government to commisssion generic versions of drugs that were developed using public research dollars.

He also says the FDA rules that protect secondary patents on drugs — that allow patent thicketing — are based on a completely wrong interpretation of Hatch-Waxman.

And tells us he’s working up a challenge, with help from AI tools like Claude. 

He’s 86 years old. And he doesn’t seem inclined to stop.

Alfred Engelberg: It so changed my life and I did so well by it, I thought, how can I not take on this problem? Who’s gonna do it if I don’t do it?

Dan: He’s got the time. Money’s no object. And he knows the territory as well as anybody. He helped create it. 

Alfred Engelberg: So it’s, it’s my obligation really. It’s that sort of Jewish guilt. What can I tell you? I’m paying back for the bingo game.

Dan: So we’ve gone back more than fifty years on the question: Why aren’t there more generic drugs? We’ve learned why we’ve got the ones we have, and what stands in the way of getting more.

And that is just in time. Because this spring the U.S. Supreme Court will hear arguments in a case that could restrict the generic drug pipeline even further. It could have major implications.

And understanding what they are requires all of the 101 we’ve covered here. We’ll have that story for you in a few weeks. Til then, take care of yourself. 

This episode of An Arm and a Leg was produced by Emily Pisacreta, with help from Dan Weissmann— and edited by Ellen Weiss. 

Adam Raymonda is our audio wizard.

Our music is by Dave Weiner and Blue Dot Sessions. 

Claire Davenport is our engagement producer.

Sarah Ballema is our Operations Manager. Bea Bosco is our consulting director of operations. 

This series — An Arm and a Leg 101 — is made possible in part by support from Arnold Ventures. 

An Arm and a Leg is produced in partnership with KFF Health News. That’s a national newsroom producing in-depth journalism about health issues in America and a core program at KFF, an independent source of health policy research, polling, and journalism.

 Zach Dyer is senior audio producer at KFF Health News. He’s editorial liaison to this show.

An Arm and a Leg is distributed by KUOW, Seattle’s NPR news station.

And thanks to the Institute for Nonprofit News for serving as our fiscal sponsor.

They allow us to accept tax-exempt donations. You can learn more about INN at INN.org.

Finally, thank you to everybody who supports this show financially.

You can join in any time at arm and a leg show, dot com, slash: support.

“An Arm and a Leg” is a co-production of KFF Health News and Public Road Productions.

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