“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
I have been waiting for this to happen! This is the last part of various entities that have “touched” opioids in some manner that have not been sued for “contributing” to our fabricated opioid crisis.
By suing Express Scripts, they are indirectly suing Cigna – the insurance company that owns Express Scripts. In suing Optum, they are indirectly United Healthcare because Optum is part of that huge healthcare organization.
Are they not suing Caremark this time, because CVS Health owns that PBM, and they have already sued/fined CVS Health for billions?
Could all this activity going after any entity that is involved with the manufacturing, prescribing, dispensing, wholesaling, and paying for opioids? Because the 1999 Tobacco Settlement Agreement annual payments to states will start to be reduced in 2025 and years going forward. It has been claimed that abt 3% of all the billions paid out to the states since 1999 has been used for the stated purpose of the agreement. The vast majority of the dollars paid out have been put in the state’s coffers to be used as the state’s bureaucrats wished.
Arkansas is suing pharmacy benefit managers Express Scripts and Optum, accusing them of fueling the state’s opioid crisis
Arkansas on Monday sued two pharmacy benefit managers that oversee coverage for insurers, employers and other large clients, accusing them of fueling the opioid crisis in the state.
Attorney General Tim Griffin filed the lawsuit against Express Scripts Inc. and Optum Inc., and their subsidiaries, in state court.
Pharmacy benefit managers run prescription drug coverage for big clients that include health insurers and employers that provide coverage. They help decide which drugs make a plan’s formulary, or list of covered medications. They also can determine where patients go to fill their prescriptions.
Griffin’s lawsuit said the companies benefitted from the opioid crisis “by negotiating favorable deals with opioid manufacturers and by not taking sufficient action to curb excessive opioid prescriptions.”
“For at least the last two decades, defendants had a central role in facilitating the oversupply of opioids,” the lawsuit said. “Defendants ignored the necessary safeguards in order to ensure increased opioid prescriptions and sales.”
In a statement, Optum said it has taken steps to fight the opioid epidemic and would defend itself against Arkansas’ suit.
“Optum did not cause the opioid crisis or make it worse, and we will defend ourselves in this litigation,” the company said in a statement. “Optum takes the opioid epidemic seriously and has taken a comprehensive approach to fight this issue, including the Opioid Risk Management Program available to all Optum Rx clients, to address opioid abuse and promote patient health.”
Express Scripts did not immediately respond to a request for comment.
According to the lawsuit, opioids were the most commonly prescribed class of controlled substances in Arkansas in 2022, and Arkansas had the second-highest opioid prescribing rate in the nation that year.
State and local governments have filed thousands of lawsuits over the toll of the opioid crisis. The claims have included asserting that drugmakers, wholesalers, pharmacy chains and other businesses engaged in deceptive marketing and failed to stop the flow of the powerful prescription painkillers to the black market.
Many of the major cases have been settled, with proposed and finalized agreements to provide more than $50 billion –- with most of it to be used to fight the opioid crisis. A federal judge who is overseeing federal lawsuits over opioids is lining up cases involving pharmacy benefit managers for trials, possibly a precursor to settlements.
In recent years, opioid overdoses have been linked to about 80,000 deaths annually in the U.S. The majority of those lately have involved fentanyl and other potent drugs produced illicitly in labs and often used to lace other illegal drugs.
A court-appointed panel on Friday recommended how to divvy up a pool of $2.13 billion in legal fees from nationwide drug industry settlements over the U.S. opioid crisis, with top firms set to receive hundreds of millions of dollars.
The panel gave national firm Motley Rice the largest share, with 18.6% of the funds, or $396 million. Other firms with large shares include New York-based Simmons Hanly Conroy, with 11.4%, or $244 million; California-based Robbins Geller Rudman & Dowd, with 8.2%, or $174 million; and California-based Lieff Cabraser Heimann & Bernstein, with 5.65%, or $120 million.
The $2.13 billion fee pool comes out of settlements totaling more than $46 billion that drugmakers, distributors and pharmacies have reached to resolve lawsuit by local and Native American tribal governments accusing them of fueling an epidemic of opioid addiction.
The money was set aside as a so-called common benefit fund, to compensate law firms for work they did that benefited all of the plaintiffs in the litigation.
U.S. District Judge Dan Polster, who has overseen the sprawling opioid litigation since 2017, also ruled Friday that firms have until June 21 to appeal the panel’s recommendations before they become final.
The fees stem from settlements with drugmakers Johnson & Johnson, AbbVie and Teva Pharmaceutical Industries; distributors Cencora, McKesson and Cardinal Health; and pharmacies CVS, Walgreens Boots Alliance and Walmart.
They do not include a settlement of up to $6 billion with bankrupt OxyContin maker Purdue Pharma, which is funded by that company’s Sackler family owners in exchange for a shield from future lawsuits. The U.S. Supreme Court is currently weighing whether that settlement is legal.
Opioid settlements, including both the nationwide deals and separate agreements negotiated by individual states, now total well over $50 billion. However, many state and local governments have yet to develop detailed plans for how they will spend the money to remedy the harms caused by opioids.
More than 800,000 people died of opioid overdoses from 1999 through 2023, according to data from the U.S. Centers for Disease Control and Prevention. Plaintiffs in the lawsuits say that drugmakers downplayed the drugs’ risks, and distributors and pharmacies ignored red flags that they were being diverted into illegal channels.
The World Health Organization and drugmaker Eli Lilly and Co. are warning people to be wary of fake versions of popular weight-loss and diabetes medicines.
WHO said Thursday that it has fielded several reports of fake semaglutide — the active ingredient in Novo Nordisk’s Wegovy and Ozempic — in all geographic regions of the world since 2022.
Lilly said in an open letter that it was “deeply concerned” about growing online sales and social media posts involving phony or compounded versions of tirzepatide, the active ingredient behind its drugs Mounjaro and Zepbound.
The Indianapolis-based company said it was the only lawful supplier of those drugs, and it does not provide tirzepatide to compounding pharmacies, wellness centers or online retailers.
Lilly said fake versions of its drugs frequently advertised or sold online are never safe to use.
Novo Nordisk has issued similar warnings in the past about its medications.
WHO said patients can protect themselves by using prescriptions from licensed physicians to buy the medications. The agency said patients also should avoid buying the drugs from unfamiliar sources.
Lilly said any products marketed as tirzepatide and not Mounjaro or Zepbound were not made by the drugmaker and are not approved by the U.S. Food and Drug Administration.
Drug shortages are the highest in a decade, with 2023 topping the charts, according to United States Pharmacopeia’s first annual Drug Shortage Report (USP).
“The number of drug shortages has increased over a decade, with 125 active drug shortages monitored by FDA at the end of 2023. … This high number of shortages is a direct result of persistent market vulnerabilities,” the report authors wrote. “According to our analysis, over a quarter of drugs in shortage were new drug shortages (34 products) in 2023.”
USP is a nonprofit organization that sets quality standards for medication, dietary supplements, and food ingredients worldwide.
The report, published in early June, notes that the average drug shortage lasts more than three years and affects multiple types of drugs. Almost 25 percent of those drugs have been on shortage lists for over five years, and six drugs, including epinephrine injections, have been in short supply for a decade. Injectable generic medications have been hit hardest, comprising more than 53 percent of new drug shortages.
These drug shortages indicate vulnerability in the market and affect patient care.
“Unexpected shocks can break the system and disrupt the supply of quality medicines,” Anthony Lakavage, senior vice president for Global External Affairs at USP, said in a news release. “This worrisome trajectory leads to more frequent drug shortages, prolonged scarcity, and more people at risk of not getting the medicines they need, when they need them.”
What’s Causing the Shortage?
The report states that fundamental supply and demand are likely to blame for the drug shortages but adds that the problem in the United States is exacerbated by manufacturing complexity (e.g., sterile injectables). For instance, drug classes like antibiotics need dedicated facilities, and some active ingredients require complicated chemical synthesis.
Some of the other reasons for the shortages include:
Race to the bottom: Most of the drugs in short supply cost less than $5 to make. Many of these cheap drugs are solid oral and sterile injectable medicines. The authors found that 66 percent of solid oral medications in shortage cost less than $3, and nearly one-third of the injectables in shortage cost less than $2. From 2022 to 2023, the number of discontinued drugs increased by 40 percent. Almost half of these are solid oral medications that cost less than $4. The report suggests tightening margins have pushed some manufacturers to pull out of the market.
Geographic concentration: The United States produces 44 percent of injectable medication, while India produces 56 percent of solid oral medication. These concentrations of production increase supply-chain vulnerability. A well-known example of injectable drugs is semaglutide weight-loss drugs, which were in short supply during the fall and winter of 2023. These medications often require complex chemical synthesis and take more time to manufacture. They also often require more steps in the manufacturing process.
Quality concerns: Unrelated but still problematic quality concerns have also slowed production. The report shows that in 2023, the U.S. Food and Drug Administration (FDA) inspected facilities accounting for 40 percent of drug production for having “objectionable conditions.”
“Quality comes at a price,” Vimala Raghavendran, vice president for Informatics Product Development at USP, said in the press release. “The economics of generic drugs often leave manufacturers with razor-thin margins, making it challenging to prioritize investment in modern machinery or to elevate standards of quality. Without sufficient profitability, the cycle of innovation and improvement becomes difficult to sustain.”
The Solution
U.S. Pharmacopeia, which touts itself as an independent, science-based nonprofit focused on building trust in the supply of safe medication, has joined with other national health care organizations in a call to action for the long-term, systemic solutions to the U.S. pharmacy drug shortage.
“As we navigate the complex landscape of drug shortages, it is paramount to shift the market into a stable state,” Mr. Lavakage said.
The coalition called upon policymakers to promote lower-priced drugs and a sustainable, high-quality supply chain. Its suggestions were to:
“Coordinate supply chain resilience and reliability efforts”
“Increase supply chain visibility”
“Establish a vulnerable medicines list”
“Align the market to incentivize a quality and adequate supply chain”
“Bolster manufacturing capacity”
Fund “research to better understand market interactions”
you must click on the RED HYPERLINK BELOW to get the map up and displaying. It shows all the pharmacies that have closed over the last DECADE. Clearly demonstrates the PHARMACY DESERTS that the insurance/PBM is causing.
Mapping U.S. Pharmacy Closures
January 2014 to March 2024
Community pharmacies are accessible locations for health and wellness in the United States.
Pharmacists and pharmacy corporations may close their pharmacy businesses for many different reasons. But when a pharmacy thrives, local communities can access care that helps them get well and stay well.
“The community pharmacy is a foundational piece of our American health system. We must protect pharmacies from closures for the health and wellness of our communities.”
Pharmacy closures are a threat to public health. The map below illustrates pharmacy locations that have closed between January 2014 and March 2024. Pharmacy closure dates and addresses were obtained from dataQ® a product of the National Council for Prescription Drug Programs (NCPDP).
This map progressively displays pharmacy locations that closed between January 2014 and March 2024.
Esri, TomTom, FAO, NOAA, USGS | Esri, US Census Bureau
Use the play ⏵︎ and pause ⏸︎ buttons to start and stop animation at any time. Pharmacy closures will appear progressively over time. Use the + and – buttons to zoom in and out of areas of interest. Click on location points to explore characteristics of closed pharmacies.
Limitations
The map shows locations of pharmacies that closed between January 2014 and March 2024. Because pharmacy closures are voluntarily reported to NCPDP by the store, closures not reported to NCPDP do not appear on this map and reported closure dates may not match dates published by the media. In few cases where pharmacy ownership changed, an active pharmacy may appear as closed on the date previous ownership reported closure to NCPDP. To report a case, email pharmacymaps@pitt.edu.
Conclusion
Community pharmacies serve as essential access points for health care in the United States. Pharmacy closures threaten population and individual access to medications and other health and wellness services.
Could this study be used to rationalize/justify less prescribing of opioids to folks on Medicare? There are 65 million people on Medicare of which 9 million are on Medicare Disability. So about 14% of Medicare folks are disabled. The 137,000 sample was ~ 0.2% of the Medicare population. The article states that ~ 30% of the sample was Medicare folks on disability or ~ 41,100. If the Medicare disabled were fairly represented in the population sample, there would have been ~ 274 folks.
Could the design of this study intentionally have 150 times the percentage of disabled Medicare folks than is typical of the Medicare population as a whole?
I keep reading this article like– U.S. government researchers found 53% of overdose survivors received opioid painkillers – Does this mean that they were prescribed FDA opioids are bought illegal opioids on the street?
About 80% of them had been treated for acute or chronic pain, and nearly half had prescriptions for opioids before the overdose Does this mean that 20% had never been prescribed FDA opioids and little more than HALF had been using STREET OPIOIDS?
The word “prescriptions” was only used THREE TIMES IN THE ENTIRE ARTICLE! The word “PAIN” was only used FOUR TIMES IN THE ENTIRE ARTICLE!
Lost Chances to Treat Overdose Survivors Documented in New Medicare Study
Findings also highlight the difficulty of managing chronic pain
A new study documents lost opportunities to treat drug overdose survivors covered by the Medicare program — and illustrates the difficulty of managing chronic pain.
Overdose survivors “should be at the front of the line for the full range of medications and counseling and support,” said Brian Hurley, MD, president of the American Society of Addiction Medicine, who was not involved in the research.
Instead, those on Medicare who survived a drug overdose in 2020 were much more likely to later receive opioid painkillers than any medication to treat addiction — and some went on to die of an overdose, according to the study findings in JAMA Internal Medicine
U.S. government researchers found 53% of overdose survivors received opioid painkillers while 4% received treatments such as buprenorphine. Only 6% filled prescriptions for the overdose antidote naloxone. Within a year of their overdose, 17% experienced a second nonfatal overdose and 1% died of an overdose.
The researchers looked at nearly 137,000 Medicare beneficiaries who survived an overdose in 2020, when the emergence of COVID-19 scrambled drug treatment efforts.
The group included about 30% who qualified for Medicare because of a disability rather than their age. About 80% of them had been treated for acute or chronic pain, and nearly half had prescriptions for opioids before the overdose.
In some situations, it might be appropriate to continue to prescribe opioids after an overdose, but “these patients should be closely monitored, provided naloxone,” and have plans in place to reduce overdose risk, said lead author Capt. Christopher Jones, PharmD, DrPH of the Substance Abuse and Mental Health Services Administration.
Gaps in treatment for overdose survivors exist throughout the U.S. healthcare system and predate the pandemic, said Michael Barnett, MD, of the Harvard T.H. Chan School of Public Health, who was not involved in the new study, but found similar results among Medicare patients from 2016-2019.
“The health system is very poor at connecting people to life-saving medication after they overdose,” Barnett said. “It’s a health system problem. And it’s also a problem of stigma and public education that many people may not be interested in or may not trust medications for opioid use disorder.”
In 2020, Medicare expanded coverage to include methadone to address a longstanding treatment gap. Methadone is the oldest, and experts say, the most effective of the three approved medications used to treat opioid addiction. It eases cravings without an intense high, allowing patients to rebuild their lives.
Medicare still does not cover residential addiction treatment, another gap that should be closed, Hurley said.
You may submit comments for Proposed Administrative Order OTC000035 electronically in OTC Monographs@FDA beginning on June 14, 2024. See the Proposed Administrative Order for instructions. The Scientific Review Supporting Proposed Administrative Order OTC000035 can be viewed under the Supporting Documents.
The family of a Texas man is suing after they say he died waiting for life-saving medication. On Dec. 7, 2023, Jerrold Allen, 79, went to H-E-B Pharmacy in San Antonio to pick up a prescription ordered by his doctor, according to a lawsuit filed by his son. But when Allen went to the pharmacy, he was told the prescription was filled and would be sent to him in the mail. “Allen was erroneously informed that H-E-B could not dispense the medication,” the lawsuit said. Four days later, on Dec. 11, Allen suffered a heart attack and died on Dec. 13, the lawsuit said. “H-E-B Pharmacy followed applicable standard of care. Because this matter is in pending litigation, we cannot comment further,” a statement from H-E-B Grocery Company to McClatchy News said. The lawsuit said his death was due to him “not taking the life-saving medication prescribed by his doctor that was to be dispensed by H-E-B Pharmacy.” Allen was a retired major general in the United States Air Force, according to his obituary. “Jerry loved to support young people in their pursuit of success and found great joy in witnessing their achievements,” the obituary said. H-E-B Pharmacy failed to obtain an override and failed to provide an emergency supply of the medication, according to the lawsuit, which also said the pharmacy was negligent in not informing Allen’s doctor about the issue. The lawsuit seeks between $250,000 and $1 million in relief to be decided by a jury.
One factory making CVS-branded pain and fever medications for children used contaminated water. Another made drugs for kids that were too potent. And a third made nasal sprays for babies on the same machines it used to produce pesticides.
The drugs were among those sold by CVS Health Corp., the largest US pharmacy, under its store-brand label before being recalled.
Other chains have seen their share of recalls for their own store-branded medications. But over the past decade CVS’s have been recalled about two times more than those from Walgreens Boots Alliance Inc. and three times more than those from Walmart Inc., a Bloomberg analysis of public records found. Both CVS and Walgreens say they offer more than 2,000 store-brand health and wellness products; Walmart declined to say how many it had for sale, but its website indicates it has many of the same drugs available as CVS and Walgreens do under its Equate store brand.
CVS Has Many More Store-Brand Recalls Than Rivals
Over-the-counter generics with safety concerns in the last decade
Source: Food and Drug Administration data
This potentially dangerous pattern has roots in the quality of the factories from which CVS sources its generic medicines, the findings show.
Big Take
CVS Drug Recalls Tied to Tainted Factories
There’s little incentive for large drug purchasers like pharmacies and hospitals to choose suppliers based on quality, said Kevin Schulman, a professor of medicine at Stanford University. Rather, they often choose the lowest-cost manufacturing contracts, which Schulman’s research has found leads to lower-quality medicines. “The best way to make a low-price product is to skimp on quality and that’s what we’re seeing over and over and over again,” he said.
When choosing suppliers, CVS prioritizes “good manufacturing and ethical sourcing practices and the ability to meet our strict standards and testing practices,” said Amy Thibault, a spokesperson for the company.
CVS-branded medication recalls represent fewer than 1% of US Food and Drug Administration drug recalls over the past decade, she added. The FDA’s drug recall database includes both prescription and non-prescription treatments. CVS’s store brands “are designed to maximize quality and safety, work as intended, comply with regulations and satisfy customers,” she said.
CVS brand allergy medicine that was recalled in January.Source: National Library of Medicine; 731 Illustration
Many consumers believe that drugstore brands are a cheaper, nearly interchangeable substitute for name-brand ones. Last November, Joan Collins, a 78-year-old from Nassau County, New York, purchased CVS eye drops to relieve irritation. Soon after using them, her eyes turned red and swollen and she developed headaches and started seeing double, according to a legal complaint she filed against the pharmacy chain in January. Collins was diagnosed with a severe eye infection, which a doctor attributed to the CVS eye drops. Collins ended up in the hospital for a week.
The eye drops Collins bought shouldn’t have been on CVS shelves at all. A month earlier, FDA inspectors had found peeling paint, barefoot workers and fabricated test results that gave the appearance of product safety at the facility in India where they were made. Samples taken at the factory also found bacteria in crucial parts of the production facility. While the FDA had warned consumers not to use certain CVS eye drops on Oct. 27, the drugstore chain still had them for sale two weeks later, when Collins bought them.
Even months later, Collins hadn’t completely regained her eyesight, according to the complaint.
CVS responded to Collins’ claims in court documents, saying that it sold the drops but denying “that the product at issue in this action had quality oversight issues or was unsanitary or defective in any respect.” The retailer also said that it isn’t responsible for the manufacturing process or quality control of the factories that make its generic drugs. The case is still pending in New York state court.
The use of contract manufacturers is increasingly attractive in the pharmaceutical industry because outsourcing is cheaper than building a production plant, said Michael de la Torre, chief executive officer at Redica Systems, a pharmaceutical data analytics firm. Larger drugmakers typically visit a supplier that’s either making an active ingredient or producing a finished product. This can help them see glaring problems like sanitation issues and evaluate manufacturing practices firsthand.
Drugmakers that outsource production to other companies are “legally responsible for approving or rejecting drugs manufactured by the contract facility, including for final release,” said Amanda Hils, a spokesperson for the FDA.
There is a loophole, however, for store-brand drugs. The agency considers pharmacy chains like CVS “private-label distributors.” In the case of the generics they hire others to make, it’s the manufacturers themselves that are responsible for the quality of the drugs, according to FDA guidance.
That setup has created a concerning gap in the oversight of everyday medicines that many Americans take to save a few bucks.
Over the last decade, CVS hired at least 15 manufacturers that were cited for manufacturing problems, more than twice as many as its largest rival, Walgreens. This led to 133 recalls of CVS store-brand drugs — an average of more than one a month — in that time frame for both pediatric and adult medications, according to a Bloomberg News review of FDA data. Walgreens had 70 recalls over the same period and Walmart had 51. CVS and Walgreens each have around 9,000 stores; Walmart has about half as many, though that doesn’t necessarily correlate to how many store-brand products they sell.
In one instance involving CVS store brands, FDA inspectors visited a contract manufacturer called Unipharma LLC in Tamarac, Florida, in 2019, and determined it had been ignoring test results that showed water used in its drugmaking was contaminated with a bacteria that can be deadly to children with weakened immune systems. The company, now defunct, recalled all of its non-prescription products, including cherry-flavored children’s pain and fever medicine, mixed berry children’s allergy relief and pineapple-flavored children’s cough syrup — all made so CVS could sell them under its own name. The drugs were distributed nationwide.
Sun Pharmaceutical Industries Ltd. recalled generic Allegra allergy medication it made for CVS after an FDA inspection at the company’s drug manufacturing facility.Photographer: Amit Madeheshiya/Bloomberg
More recently, a factory in Xiamen, China, that made burn cream for CVS home first aid kits was banned in October from sending drugs to the US because they were at risk of microbiological contamination. Sun Pharmaceutical Industries Ltd. recalled generic Allegra allergy medication it made for CVS in January after FDA investigators found stagnant liquid inside an air purification unit at the drugmaker’s facility in India that was later found to have yeast and mold colonies, according to an inspection report. Sun Pharmaceutical didn’t respond to requests for comment.
In response to questions from Bloomberg, CVS said it doesn’t visit the factories it hires to make store-brand drugs. CVS relies on a third-party auditor who visits any facility before the company begins working with it, and annually after that. Walgreens either sends its own representative or a third party to visit the factories with which it works. Walmart didn’t respond to questions about its practice.
CVS first started emphasizing store brands in 2014 and then put “considerable focus” on them four years later, Brenda Lord, vice president of store brands and quality assurance at CVS Health, told the National Retail Federation in a 2022 interview. CVS wanted to be a leader as consumers sought less expensive alternatives. “There’s no longer a stigma attached to buying cheaper store brands,” Lord said in the interview with the trade group.
CVS store-brand drugs are marked with a red heart and the words “CVS Health.”Patrick T. Fallon /AFP/Getty Images
The pharmacy chain’s drugs are marked with a red heart and the words “CVS Health” on the box or bottle. CVS doesn’t break out how much it makes from such products, though store-brand items of all kinds — from beauty and food to home and health — accounted for around a quarter of the company’s overall sales, Lord estimated at the time. Since then, the category across retailers has only grown, rising 4.7% to $236 billion in 2023 compared with 2022, according to the Private Label Manufacturers Association.
For retail pharmacies, including CVS, front-of-store sales — meaning anything not sold at the pharmacy counter — have been struggling for years with e-commerce and discount giants attracting more shoppers. To lure people back, drugstores are refreshing the stores and trying to carry more products that align with health and wellness messaging.
FDA officials have raised concerns before about lax oversight of contract manufacturers. In 2017, an official said the agency had sent multiple warning letters to companies for not keeping a close eye on manufacturers for hire. Several cases involved companies that hadn’t checked for particulates in eye drops. “They are just not even looking,” Francis Godwin, who monitored drug quality in the agency’s Office of Compliance, said at a conference that year.
Still, in 2019, CVS, Walgreens and Walmart had store-brand eye drops recalled. They stemmed from an FDA inspection that found workers at an Altaire Pharmaceuticals plant in New York were falsifying data to make their products appear safe. In the incident, CVS had many more types of drops recalled than its competitors. Altaire declined to comment.
US health authorities last year tied at least four deaths and several cases of vision loss to drops made at a factory in India. Those weren’t sold at CVS, but other retailers nationwide.
Brassica Pharma issued a recall of Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, and CVS Health Lubricant Eye Ointment, and Lubricant PM OintmentSource: Food and Drug Administration (FDA); 731 Illustration
FDA officials found more red flags in other factories in India that supplied store-brand eye drops to the pharmacy giants. Agency officials who in January visited Brassica Pharma Private Ltd., which made drops for both Walmart and CVS, found operators touching the inside of tubes that were to be filled with sterile drug products, according to an inspection report obtained via a Freedom of Information Act request. Brassica also faked test results that were meant to detect microbiological contamination at the factory, according to the inspection report. Brassica Pharma didn’t respond to requests for comment.
The FDA generally inspects drug-production factories once every few years and doesn’t regularly test drugs Americans take. With companies under pressure to keep generic drug prices low, there’s little incentive to invest in additional quality control measures. And while recalls may get unsafe medications off of shelves, it doesn’t necessarily get them out of medicine cabinets — consumers aren’t always aware of the defective products.
“This sole emphasis on cost pushes the price down to the point where high-quality manufacturers don’t want to stay in the market,” Schulman said.
There has been a committee of a few pain advocates that have been working for several months on a proposed federal bill to help the chronic pain community regain their QOL with better pain management.
Some of those of us who were on that committee will be on www.waok.com at 8:30 AM EDT on Friday 06/14/2024 for a 30-minute discussion of what is involved in the Protection of American Medicine (AKA the PAM Act)
There will be a “call-in line”, I don’t have the number as of this post yet.
I have been waiting for this to happen! This is the last part of various entities that have “touched” opioids in some manner that have not been sued for “contributing” to our fabricated opioid crisis.
