It took years for Elle Moxley to get a diagnosis that explained her crippling gastrointestinal pain and digestion problems, fatigue and hot, red rashes. But even after learning in 2016 that she had Crohn’s disease, a chronic inflammation of the digestive tract, it took more than four years of trying different medications before she got her disease under control with a biologic drug called Remicade.

So Moxley, 33, was dismayed to receive a notice from her insurer in January that Remicade would no longer be covered as a preferred drug on her plan. A different drug, Inflectra, which the Food and Drug Administration says has no meaningful clinical differences from Remicade, is now preferred. It is a “biosimilar” drug.

“I felt very powerless,” said Moxley, who recently started a job as a public relations coordinator for Kansas City Public Schools in Missouri. “I have this decision being made for me and my doctor that’s not in my best interest, and it might knock me out of remission.”

After Moxley’s first Inflectra infusion in July, she developed a painful rash. It went away after a few days, but she said she continues to feel extremely fatigued and experiences gastrointestinal pain, constipation, diarrhea, and nausea.

Many medical professionals look to biosimilar drugs as a way to increase competition and give consumers cheaper options, much as generic drugs do, and they point to the more robust use of these products in Europe to cut costs. Yet uptake of biosimilar drugs has generally been slow in the U.S. since the first such medicine was approved in 2015. That’s in part because of concerns raised by patients like Moxley and their doctors, but also because brand-name biologics have successfully kept biosimilars from entering the market, through a combination of legal actions to extend the life of their patents and incentives that make it more attractive to offer the brand-name biologic on a formulary than a biosimilar.“It distorts the market and makes it so that patients can’t get access,” said Jinoos Yazdany, a professor of medicine and chief of the rheumatology division at Zuckerberg San Francisco General Hospital.

The FDA has approved 30 biosimilars since 2015, but only about 60% have made it to market, according to an analysis by NORC, a research organization at the University of Chicago.

Remicade manufacturer Johnson & Johnson, and Pfizer, which makes the Remicade biosimilar Inflectra, have been embroiled in a long-running lawsuit over Pfizer’s claims that Johnson & Johnson tried to choke off competition through exclusionary contracts with insurers and other anti-competitive actions. In July, the companies settled the case on undisclosed terms.

In a statement, Pfizer said it would continue to sell Inflectra in the U.S. but noted ongoing challenges: “Pfizer has begun to see progress in the overall biosimilars marketplace in the U.S. However, changes in policy at a government level and acceptance of biosimilars among key stakeholders are critical to deliver more meaningful uptake so patients and the healthcare system at-large can benefit from the cost savings these medicines may deliver.”

Johnson & Johnson said it is committed to making Remicade available to patients who choose it, which “compels us to compete responsibly on both price and value.”

Biologic medicines like Remicade, which are generally grown from living organisms such as animal cells or bacteria, are more complex and expensive to manufacture than drugs made from chemicals. In recent years, biologic drugs have become a mainstay of treatment for autoimmune conditions like Crohn’s disease and rheumatoid arthritis, as well as certain cancers, diabetes, and other conditions.

Other drug makers can’t exactly reproduce these biologic drugs by following chemical recipes as they do for generic versions of conventional drugs.

Instead, biosimilar versions of biologic drugs are generally made from the same types of materials as the original biologics and must be “highly similar” to them to be approved by the FDA. They can have no clinically meaningful differences from the biologic drug, and must be just as safe, pure, and potent. More than a decade after Congress created an approval pathway for biosimilars, they are widely accepted as safe and effective alternatives to brand biologics.

Medical experts hope that as biosimilars become more widely used they will increasingly provide a brake on drug spending.

Between 2015 and 2019, drug spending overall grew 6.1%, while spending on biologics grew more than twice as much — 14.6% — according to a report by IQVIA, a health care analytics company. In 2019, biologics accounted for 43% of drug spending in the U.S.

Biosimilars provide a roughly 30% discount over brand biologics in the U.S. but have the potential to reduce spending by more than $100 billion in the next five years, the IQVIA analysis found.

In a survey of 602 physicians who prescribe biologic medications, more than three-quarters said they believed biosimilars are just as safe and effective as their biologic counterparts, according to NORC.

But they were less comfortable with switching patients from a brand-name biologic to a biosimilar. While about half said they were very likely to prescribe a biosimilar to a patient just starting biologic therapy, only 31% said they were very likely to prescribe a biosimilar to a patient already doing well on a brand biologic.

It can be challenging to find a treatment regimen that works for patients with complicated chronic conditions, and physicians and patients often don’t want to rock the boat once that is achieved.

In Moxley’s case, for example, before her condition stabilized on Remicade, she tried a conventional pill called Lialda, the biologic drug Humira, and a lower dose of Remicade.

Some doctors and patients raise concerns that switching between these drugs might cause patients to develop antibodies that cause the drugs to lose effectiveness. They want to see more research about the effects of such switches.

“We haven’t seen enough studies about patients going from the biologic to the biosimilar and bouncing back and forth,” said Marcus Snow, a physician and chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We don’t want our patients to be guinea pigs.”

But studies show a one-time switch from Remicade to a biosimilar like Inflectra does not cause side effects or the development of antibodies, said Ross Maltz, a pediatric gastroenterologist at Nationwide Children’s Hospital in Columbus, Ohio, and former member of the Crohn’s & Colitis Foundation’s National Scientific Advisory Committee. Studies may be conducted by researchers with extensive ties to the industry and funded by drug makers.

Situations like Moxley’s are unusual, said Kristine Grow, senior vice president of communications at AHIP, an insurer trade group.

“For patients who have been taking a brand-name biologic for some time, health insurance providers do not typically encourage them to switch to a biosimilar because of a formulary change, and most plans exclude these patients from any changes in cost sharing due to formulary changes,” she said. 

Drug makers can seek approval from the FDA of their biosimilar as interchangeable with a biologic drug, allowing pharmacists, subject to state law, to switch a physician’s prescription from the brand drug, as they often do with generic drugs.

However, the FDA has approved only one biosimilar —  Semglee, a form of insulin — as interchangeable with a biologic, a medicine called Lantus.

Like Moxley, many other patients using biologics get copay assistance from drug companies, but the money often isn’t enough to cover the full cost. In her old job as a radio reporter, Moxley said  she hit the $7,000 maximum annual out-of-pocket spending limit for her plan in May.

In her new job, Moxley has an individual plan with a $4,000 maximum out-of-pocket limit, which she expects to blow past once again within months.

But she received good news recently: Her new plan will cover Remicade.

“I’m still concerned that I will have developed antibodies since my last dose,” she said. “But it feels like a step in the direction of good health again.

By Sarah Jane Tribble and Emily Featherston, KHN, Nov 16, 2021.

In early July, as the covid-19 pandemic slammed rural America, the president of a small Kansas hospital sat down on a Friday afternoon and wrote the president of the United States to plead for help.

“I do not intend to add to your burden,” said Brian Williams, a retired Army lieutenant colonel and Desert Storm combat veteran. He said his hospital, Labette Health, was “like a war zone,” inundated with unvaccinated patients. A department head had threatened to resign, saying he could not “watch one more body be carried out.”

But Williams wasn’t seeking pandemic relief.

Instead, he asked President Joe Biden to confront pharmaceutical manufacturers Eli Lilly and Co., Novo Nordisk and others for refusing to honor a federal drug discount program for hospitals and clinics. The program gives Williams millions to pay staff members, ensure remote clinics remain open and provide charity care for patients unable to pay, he said.

“During a global pandemic, I think health care workers deserve a little bit more respect than to have resources taken away,” Williams said in an interview with KHN and InvestigateTV. “Every one of those [drug] companies, I looked them up, and they were not suffering tremendous [financial] losses, as hospitals were.”

Eli Lilly’s stock price increased nearly 40% and the company’s value rose by $59 billion in the first seven months of 2021. In the same period, Labette Health lost $1.2 million in revenue just from the missed savings on prescriptions, Williams said.

Lilly and other manufacturers, though, are holding their ground. They refuse to offer discounts to thousands of hospital-contracted pharmacies, saying the program has grown beyond its intended use and lacks federal checks and balances against duplicate discounts and other abuses. In lawsuits, they contend the billions in discounted sales they provide are rarely passed on to patients and instead are swallowed up by middlemen like contract pharmacies and third-party administrators.

Congress created the so-called 340B program in 1992 to provide extra funding for hospitals and clinics, especially those serving the poor and elderly. The purpose, lawmakers wrote, is to “stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.”

Companies that want their drugs covered by Medicaid or Medicare Part B are required to offer 340B discounts, typically 25% to 50% off what they might otherwise pay. Hospitals and clinics buy the drugs at the discount and then are reimbursed by an insurance company, Medicare or Medicaid at the higher negotiated rate. The difference is kept by the hospital or clinic to use as it sees fit.

The law does not require patients to benefit directly, a nuance that has fueled great conflict about how the program works and should be regulated.

The 340B program’s reach exploded after federal regulators ruled in 2010 that hospitals and clinics could contract with an unlimited number of retail pharmacies such as Walgreens and CVS, which are paid a fee to dispense the discounted drugs. The growth, coupled with long-held questions about regulatory authority, puts the program at a tipping point, with patients stuck in the middle, industry experts say.

The number of pharmacies contracted to work with 340B hospitals to dispense the discounted drugs has soared. It’s reached more than 31,000 nationwide this year from just over 1,700 in 2010, according to an analysis of federal data by InvestigateTV and KHN.

One eye-popping statistic: The drugs purchased under 340B climbed to $38 billion in 2020 from $5.3 billion in 2010, according to the Health Resources and Services Administration, or HRSA, which oversees the program.

Interests on both sides of the program — hospitals and drugmakers — say they are at the mercy of a program designed with the best of intentions, now run amok, hijacked by for-profit companies and wealthy hospitals trying to profit from its largesse.

Adam J. Fein, chief executive of the industry research organization Drug Channels Institute, estimates that nearly half the nation’s retail, mail and specialty pharmacies now profit from 340B: The program, he said, is “essentially taking over the pharmacy industry.”

Legal fights about the program have landed before the U.S. Supreme Court, which is slated to hear arguments this month in American Hospital Association v. Becerra. The hospital industry is challenging a 2018 rule by the Trump administration to cut reimbursement on certain 340B drugs by 28.5%. As Biden’s HHS secretary, Xavier Becerra has upheld the rule.

Most important, the administration says, is to make sure providers use the savings to benefit patients. In an interview with KHN and InvestigateTV, Rear Adm. Krista Pedley, director of the Office of Special Health Initiatives, which oversees the program within Becerra’s agency, said, “We need legislative changes to help make that happen and require that.”

‘Deeply Troubling’

When Sen. Joe Manchin (D-W.Va.) asked during a June appropriations hearing about pharmaceutical companies denying the discounts, Becerra said the drugmakers are violating the law.

“I hope what you’ll do is give us more authority” to regulate the program, Becerra said.

Manchin responded: “I really think we could do that in a bipartisan way, because I’ll tell ya, we’re all being affected.”

As California’s attorney general, Becerra led a coalition of national lawmakers calling for the federal government to hold the manufacturers accountable for their “deeply troubling” actions to undermine the program. At HHS, Becerra put the companies on notice.

Drugmakers — Lilly, AstraZeneca, Novo Nordisk, Sanofi, Novartis and United Therapeutics — took the matter to court, filing several lawsuits. This month, a federal judge ruled that the companies are not required to provide the discounts. A judge in Lilly’s case criticized the “unilateral” action by drugmakers but ruled that the U.S. government’s effort to force them to honor the discounts was invalid.

Notably, U.S. District Court Judge Sarah Evans Barker in Indianapolis wrote that manufacturers believe they are “at the mercy of a system run amok” and that the program “can no longer be held together and implemented fairly” solely through the agency’s guidance and inconsistent messaging.

Becerra requested $17 million annually for 340B program oversight, a $7 million bump. The money would establish a dispute review panel and increase the audits the agency does on manufacturers as well as the providers.

Williams — at his small hospital in rural Parsons, Kansas — said the nearly $4.3 million the hospital gains each year from 340B has allowed him to add a full-time position for case management, increase staffing hours, develop after-school programs and open clinics in impoverished towns that lacked health care.

The hospital has about 20 pharmacies under active contracts, according to the federal database. Williams said it includes locally owned shops like Bowen Pharmacy as well as corporate giants like Walgreens and Walmart, sites that are convenient for patients. A pharmacy added in 2019 is in Frisco, Texas — a mail-order facility that ships specialty drugs directly to patients’ homes.

Patients, Williams said, directly benefit from the federal program: “I’d love to have the CEO of Eli Lilly come here and I’ll take him around and I’ll show him a town of 1,200 where 40% of the population live below the poverty level.”

“Some of our patients come there on a bicycle or in a wheelchair,” Williams said. “I can go 30 minutes in any direction and find pretty tough people living in pretty … pretty austere circumstances.”

One Hospital, 300 Pharmacies

Vanderbilt University Medical Center, based in Nashville, has added three regional hospitals, clinics and providers in recent years — growth that has fueled its rise in contract pharmacies from zero in 2010 to 300 this year. The pharmacies, which reach across Tennessee and all the way to California, “in each instance serve VUMC patients,” Vanderbilt spokesperson John Howser said.

Financial filings do not disclose how much Vanderbilt gains annually from the 340B program, and Howser declined to disclose the amount. The medical system’s operating revenue grew $649 million, or 13%, to $5.5 billion in fiscal year 2021 compared with 2020, according to its latest financial disclosure. Its operating profit rose 25% to $177 million in 2021 compared with 2020.

According to an amicus brief filed in March for the American Hospital Association v. Becerra case, Vanderbilt spends more than $500 million annually on community benefits, such as charity care. Revenue from the 340B program supports low-income programs including medication assistance, home infusion medications and a pharmacy program at a health clinic run by students.

In the brief, Vanderbilt states the government’s cut in Medicare reimbursement has cost the system $12.4 million in 340B savings and will “impact VUMC’s ability to continue to fund community benefit programs at historic levels.”

Large regional health systems have been particularly active in expanding their contract pharmacy networks. The top three — University of Michigan Hospitals and Health Centers, Cambridge Public Health Commission in Massachusetts and Henry Ford Hospital in Detroit — had zero contracts with outside pharmacies in 2010, and each now has more than 500.

InvestigateTV and KHN contacted the 10 providers with the most contract pharmacies and asked why they saw such growth, how much revenue 340B generates and how the money was used.

While some said the money went for charity care and community programs, others did not respond.

Why not require hospitals to report precisely how they use the savings to benefit patients?

It would be “burdensome,” said Maureen Testoni, chief executive of 340B Health, which represents health systems.

She said her organization does not support mandating new reporting for nonprofit hospitals, which are required to submit annual cost reports and tax filings. The advocacy group has funded research that shows the savings from discounts go to patients. Hospitals enrolled in the program are much more likely to provide free care and specialty services, such as transportation, that are “typically not the ones you can use to pad your pockets,” she said.

Testoni said program growth is good because it means more care can be provided in outpatient settings and by safety-net providers for low-income populations. The bigger sales numbers, she said, could stem from more prescriptions or from higher drug prices. Detailed information about either metric is not public.

“Are we concerned that somehow pharmaceutical companies are being hurt by this?” Testoni said. “Because I’ve never seen any evidence of that in terms of their revenue going down or them having trouble keeping their doors open.”

‘Essentially Taking Over’

Hospitals aren’t required to prove that the large pharmacy networks serve uninsured or needy patients. The larger networks enrich the hospitals and the pharmacies, said Fein of Drug Channels.

A 2018 Government Accountability Office report found that a hospital or clinic generally pays a flat dispensing fee — typically from $6 to $15 — for each eligible prescription a pharmacy processed. And pharmacies can contract with multiple health care providers: One Walmart central fill facility in Spring, Texas, contracted with 1,842 340B hospitals and clinics, the InvestigateTV and KHN analysis found.

Recent securities filings for Walmart, Walgreens and CVS Health — the biggest players in the contract pharmacy market —- do not provide line-item detail on how many 340B prescriptions are processed or the revenue those transactions generate. Walmart did not respond to requests for comment. CVS declined to comment.

CVS reported in an August financial filing that operating income increased by a third between March and June compared with a year ago and noted that 340B business contributed to that increase but provided no further detail. The company acquired 340B contract pharmacy administrator Wellpartner in 2017.

Walgreens mentioned the program in its 2020 annual financial filing, noting that changes to government pricing and regulations “could also significantly reduce our profitability.” Walgreens spokesperson Rebekah Pajak said that many of the company’s stores are in underserved areas and that it is proud to help fulfill the program’s goals. She declined to disclose the dispensing fees or terms of its contracts with hospitals and clinics.

Karyn Schwartz, vice president of policy and research at PhRMA, called the 340B program a “black box” and said drug companies would like more transparency because they “really have no way of knowing” how hospitals and pharmacies use their discounts.

Drugmakers said they continue to participate in the program by sending direct discounts to the hospitals but have eliminated some or all of the discounts passed through contract pharmacies because they didn’t trust the transactions, according to emails the companies sent to KHN and InvestigateTV. Novartis, which announced last year that it would sell drugs at a discount only for pharmacies within 40 miles of a hospital, said there is a “complete absence of transparency” in the contracts between hospitals and pharmacies.

“Contract pharmacy arrangements benefit for-profit pharmacies, third-party administrators, other middlemen and hospitals,” Novartis spokesperson Caryn Marshall wrote in an email.

“Lilly welcomes reforms where patients are identified as 340B eligible at the point-of-sale and share in discounts under the program,” said Tarsis Lopez, Eli Lilly spokesperson.

Getting By on ‘Half a Dose’

Meanwhile, as businesses wage war over profits, patients are stuck. Andrew Kosowski, a 75-year-old retired police officer with diabetes, was shocked last year when he lost access to discounted drugs from 340B.

Kosowski is a patient at UnityPoint Health in Peoria, Illinois, which uses funds from the program to supplement the prescription costs of low-income and Medicare patients. Under 340B, many of his prescriptions were $15 each.

Without the discount, Kosowski’s insulin and other drugs had cost more each month than his Social Security check delivered. “I wasn’t going to spend that kind of money,” he said. He took “half a dose to get me by.”

He recalled how his feet hurt and his mind was affected without his full prescriptions.

PhRMA’s Schwartz declined to speak to Kosowski’s crisis but said the industry participates in 340B and would like to see direct patient benefit. “We hope policymakers step in and really clarify the role that for-profit pharmacies are supposed to be playing in this program and ensure that patients benefit,” Schwartz said.

Kosowski was fortunate to have an ally in Anne Webster, a nurse practitioner at UnityPoint who guided him through months of filling out forms to eventually qualify for financial assistance directly from Novo Nordisk.

The assistance, though, does not cover medications from other companies that he had gotten at the 340B discount price — medications that had helped him better manage his diabetes.

Webster said pharma’s standoff came at the worst possible time: “A Type 2 diabetic is so high-risk for mortality from coronavirus. And they require more insulin if they are ill with the virus.”

Kosowski is not her only patient missing prescriptions.

“I think I prescribed over 2,000 prescriptions in one year to the 340B program for my patients who are underinsured, not insured and are financially challenged,” Webster said.

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A patch containing the active ingredient fentanyl is shown by a pharmacist. The painkiller fentanyl, which can be up to 100 times stronger than heroin, is a growing cause of overdose deaths in the U.S., according to the DEA.

In its first public safety alert in six years, the Drug Enforcement Administration is warning about a dramatic increase in fake prescription drugs being sold on the black market containing a potentially lethal dose of fentanyl.

The DEA said the counterfeit pills — made to look like real opioid medications such as oxycodone, Percocet or Adderall — are sold on the street by dealers or online, including through social media platforms.

“If you have a smartphone and you’re sitting on the sofa at home … your drug dealer is right there in your hands,” DEA spokesperson Anne Edgecomb said in an interview with NPR.

The agency said it has seized more than 9.5 million fake pills so far this year, more than the last two years combined. It said its lab has found that two out of every five fake pills with fentanyl contain a potentially lethal dose of the drug.

“The United States is facing an unprecedented crisis of overdose deaths fueled by illegally manufactured fentanyl and methamphetamine,” DEA Administrator Anne Milgram said. “Counterfeit pills that contain these dangerous and extremely addictive drugs are more lethal and more accessible than ever before.”

The last time the agency issued such a public safety alert was in 2015 when it warned of a sharp increase on the street of fentanyl-laced heroin.

The latest warning comes amid an ongoing epidemic of drug overdoses in the United States. The Centers for Disease Control and Prevention estimates that more than 93,000 Americans died from a drug overdose last year — more than ever before.

“Fentanyl, the synthetic opioid most commonly found in counterfeit pills, is the primary driver of this alarming increase in overdose deaths,” the DEA said.

This alert doesn’t only apply to fake opioid medications. DEA officials said a knockoff version of the stimulant Adderall is being sold on the black market laced with methamphetamines.

The alert issued Monday doesn’t apply to legally prescribed and dispensed legitimate pharmaceutical medications, the DEA said.

By Maia Anderson, Becker’s Hospital Review, Sep 17, 2021.

Pfizer has recalled all lots of its smoking cessation drug Chantix because of the presence of the carcinogen N-nitroso-varenicline at levels above FDA-approved limits. 

The FDA said Sept. 16 that long-term ingestion of N-nitroso-varenicline may increase the risk of cancer, but there is no immediate risk to taking the drug. Chantix is intended for short-term use. 

The agency added that the health benefits of stopping smoking outweigh the risk of cancer from taking Chantix, and patients currently on the drug should consult with their provider about alternate treatment options. 

Pfizer said it hasn’t received any adverse events notifications for Chantix related to the recall. 

The FDA said distributors with supplies of Chantix should stop distributing the drug and quarantine it. 

Pfizer halted global distribution of Chantix in June after finding the elevated N-nitroso-varenicline levels and recalled nine lots of the drug. In July, the FDA said it would allow drugmakers to sell generic versions of the drug even if they contain low levels of nitrosamines, as the health benefits of quitting smoking outweigh the risk of taking the drug. In August, Pfizer recalled four more lots of the drug.

The FDA has tapped drugmakers Apotex and Par Pharmaceuticals to help address the shortage of Chantix.

Article link: https://www.beckershospitalreview.com/pharmacy/pfizer-recalls-all-lots-of-chantix.html

By Maia Anderson, Becker’s Hospital Review, Jun 21, 2021.

Medical device and drug recalls, whether voluntary or mandated by the FDA, ensure patient safety. Here are five reported to the FDA since the end of May:

1. Philips recalls 3.5M CPAP and BiPAP devices, cites potential cancer risk

Philips has recalled roughly 3.5 million ventilation devices after finding a defect that could cause cancer. The ventilators use polyester-based polyurethane sound abatement foam, which has the potential to degrade into particles that could be ingested or inhaled and have toxic and carcinogenic effects.

      2. Viona Pharmaceuticals recalls metformin due to carcinogen

Viona Pharmaceuticals, a generic drugmaker in Cranford, N.J., has recalled two lots of metformin tablets after finding they contain levels of Nitroso dimethylamine, or NDMA, above acceptable daily limits.

       3. Innova Medical Group recalls unauthorized COVID-19 test

Innova Medical Group has recalled at least 77,339 of its COVID-19 antigen tests after the FDA discovered the company was selling the test without its approval and that it carries the risk of false positive and false negative results.

       4. Lepu Medical Technology recalls COVID-19 antigen test

Lepu Medical Technology has recalled its COVID-19 rapid antigen test after finding it’s likely to produce false results. The test wasn’t authorized, cleared or approved for marketing or distribution in the U.S.

       5. Step-Har Medical recalls infusion pump

Step-Har Medical, a biomedical repair company in Fountain Valley, Calif., has recalled the Alaris infusion pump after finding a component of the device may crack or separate, leading to an inaccurate delivery of fluids to patients. The pump is used to deliver medications, nutrients, blood and other therapies into a person’s body in controlled amounts.

By Maia Anderson, Becker’s Hospital Review, May 03, 2021.

Acella Pharmaceuticals is recalling 38 lots of its thyroid drug after routine testing conducted by the drugmaker found the drug to be subpotent.

The recalled lots contain less than 90% of the labeled amount of liothyronine and/or levothyroxine, the ingredients that make up the drug. The drug is designed to treat hypothyroidism, or underactive thyroid. 

Acella has received 43 reports of serious adverse events that may be linked to the recall. 

Patients taking the drug to treat hypothyroidism who receive the subpotent drug could experience symptoms of hypothyroidism, including fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight, the FDA said. 

The FDA said there’s a reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism, including early miscarriage, fetal hyperthyroidism and impairments to fetal neural and skeletal development. 

In elderly patients and those with underlying cardiac disease, toxic cardiac manifestations of hyperthyroidism could occur, including cardiac pain, palpitations or arrhythmia.

Article link: https://www.beckershospitalreview.com/pharmacy/acella-pharmaceuticals-recalls-thyroid-drug-43-serious-adverse-events-reported.html

Purdue Pharma, the company that makes OxyContin, the powerful prescription painkiller that experts say helped touch off an opioid epidemic, will plead guilty to three federal criminal charges as part of a settlement of more than $8bn, according to the US justice department.

“Purdue Pharma actively thwarted the United States’ efforts to ensure compliance and prevent diversion,” Tim McDermott, assistant administrator with the Drug Enforcement Administration (DEA), said in a statement. “The devastating ripple effect of Purdue’s actions left lives lost and others addicted.”

The company will plead guilty to a criminal complaint being filed on Wednesday in federal court in New Jersey to three counts, including conspiracy to defraud the United States and violating federal anti-kickback laws.

The deal does not release any of the company’s executives or owners – members of the wealthy Sackler family – from criminal liability. A criminal investigation is ongoing.

The settlement will be the highest-profile display yet of the federal government seeking to hold a major drugmaker responsible for an opioid addiction and overdose crisis linked to more than 470,000 deaths in the country since 2000.

As part of the resolution, Purdue will admit that it impeded the DEA by falsifying an effective drug diversion program by reporting misleading information to the agency in order to boost the company’s manufacturing quotas. A justice department official said Purdue had been misrepresenting “robust controls”, but instead had been “disregarding red flags their own systems were sending up”.

Purdue also admitted to using a speakers program to violate federal anti-kickback laws by paying doctors, inducing them to write more prescriptions for the company’s opioids and for using electronic health records software to influence the prescription of pain medication.

As part of the plea deal, Purdue will make a direct payment to the government of $225m, which is part of a larger $2bn criminal forfeiture. In addition to that forfeiture, Purdue also faces a $3.54bn criminal fine, though that money probably will not be fully collected because it will be taken through a bankruptcy, which includes a large number of other creditors.

Purdue will also agree to $2.8bn in damages to resolve its civil liability.

Since the company doesn’t have $8bn in cash available to pay the fines, it agreed to transform into a public benefit company, meaning it would be governed by a trust that has to balance the trust’s interests against those of the American public and public health, the officials said.

The Sacklers would not be involved in the new company and part of the money from the settlement would go to aid in treatment and drug programs to combat the opioid epidemic. That arrangement mirrors a key element of the company’s proposal to settle about 3,000 lawsuits filed by state, local and Native American tribal governments.

The company also admits it violated federal law and “knowingly and intentionally conspired and agreed with others to aid and abet” the dispensing of medication from doctors “without a legitimate medical purpose and outside the usual course of professional practice”, according to a copy of the plea agreement obtained by the AP.

The company is also required to cooperate with the ongoing federal investigation and potential other prosecutions.

Before the deal was announced, the plea deal faced resistance from state attorneys general, Democratic members of Congress and advocates who wrote the attorney general, William Barr, asking him not to make the bargain with the company and the family. They said it does not hold them properly accountable and they raised concerns about some of the details.

“Millions of American families impacted by the opioid epidemic are looking to you and your department for justice.,” 38 Democratic members of Congress wrote, adding the only real consequence “is that a handful of billionaires are made slightly less rich”

About half the states oppose that settlement, and also wrote to Barr in disapproval. The deputy attorney general, Jeffrey Rosen, in announcing the settlement, defended the deal allowing the new company to continue to sell highly addictive drugs.

Purdue – but not the family – declared bankruptcy as a way to work out that plan, which could be worth $10bn over time.

The Sackler family – was once listed among the nation’s wealthiest by Forbes magazine – has already pledged to hand over the company itself plus at least $3bn to resolve thousands of suits against the Stamford, Connecticut-based drugmaker. A 2019 court filing said they had made up to $13bn over the years from the drug, though a lawyer said they brought in far less after taxes and reinvestment.

Until recently, the Purdue name could be found on museum galleries and educational programs around the world because of gifts from family members. Under pressure from activists, institutions from the Louvre in Paris to Tufts University in Massachusetts have dissociated themselves.

It is not the first time Purdue has admitted wrongdoing: in 2007, the company and three executives pleaded guilty to federal criminal charges, paying more than $630m in a settlement at the time. The nation’s opioid crisis only worsened after that.

Purdue, in its new form, will be permitted to continue producing OxyContin and other painkillers, including drugs to combat the opioid overdose crisis.

Article link: https://www.theguardian.com/us-news/2020/oct/21/oxycontin-purdue-pharma-pleads-guilty-8bn-settlement