“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
NEW ORLEANS (AP) — Louisiana filed several lawsuits accusing pharmaceutical giant CVS of abusing customer information and using its dominant market position to drive up drug costs and unfairly undermine independent pharmacies, the state’s attorney general said Tuesday.
Attorney General Liz Murrill began investigating CVS after the company sent out mass text messages to thousands of residents on June 11 to lobby against legislation that took aim at its business structure. The texts warned that medication costs could go up and all CVS pharmacies in the state would close.
The lawsuits, which were filed Monday in central Louisiana’s St. Landry Parish, seek “injunctive relief, civil penalties and restitution,” Murrill said.
CVS “abused customers’ sensitive information to push a political message,” Republican Gov. Jeff Landry said Tuesday at a press conference.
He noted CVS had lobbied his wife over text via the same messaging chain normally used to notify her about picking up a prescription drug or other healthcare-related matters.
One lawsuit argues that the text message lobbying constituted “unfair or deceptive acts” in violation of state trade law. Two Louisiana-based law firms have filed a separate class action lawsuit against CVS over the text messages.
CVS has denied any wrongdoing.
“Our communication with CVS customers, patients and members of the community was consistent with the law,” CVS said in an emailed statement. “We believe it was important for people to know about a potential disruption to where they get their medicine.”
Two other lawsuits allege that CVS artificially inflates prices for consumers and independent pharmacies.
CVS serves as a pharmacy benefit manager — essentially an intermediary that buys medication from manufacturers and distributes drugs to pharmacies.
CVS and the mail-order pharmacy Express Scripts dominate the market by processing about eight out of every 10 prescription drug claims, according to the Federal Trade Commission, which warned in a 2024 report that this allows for “inflating drug costs and squeezing Main Street pharmacies.”
Because CVS also owns a vast network of retail pharmacies — including 119 in Louisiana — it sets the terms for how prescription drugs are sold to customers there.
The proposed law that sparked the text messages from CVS had sought to ban pharmacy benefit managers like CVS from owning drug stores. The law failed to pass, but Landry has stated he will seek to revive it.
In the state’s litigation, Murrill alleges that CVS business structure and practices allow the company to “manipulate prices, restrict competition and channel profits internally.”
One lawsuit accuses CVS of “systematically under-reimbursing independent Louisiana pharmacies to the point of economic hardship, while routing patients to CVS-owned facilities.” The lawsuit alleges that CVS imposes “unethical, unscrupulous, and exorbitantly high fees on independent pharmacies.”
CVS said that it should not have to pay higher rates for “less efficient pharmacies” and that this would lead to “higher costs for consumers.”
“Importantly, CVS Pharmacy remains the lowest cost pharmacy and a critical partner in lowering prescription drug costs for Louisianans,” the company said.
Another lawsuit argues that CVS uses its market control to exclude lower-cost drugs for “high-rebate, high-price brand drugs” and other practices that “distort the drug market” and “drive up costs for the state’s public health programs and its citizens.”
CVS said that its business structure allows for “better access, affordability, and advocacy for those we serve.” The company said that removing CVS pharmacies from Louisiana would increase costs to the state by more than $4.6 million.
Landry said he would seek new legislation targeting CVS if existing laws were insufficient to win in court.
With the rapid emergence and prevalence ofgenerative AI, job security remains a top concern for most professionals, aside from security and privacy. As the technology becomes more advanced, it’s becoming more apparent that it could take over some jobs.
As it now seems, medicine could be onAI‘s chopping block. This is after Microsoft recently claimed that its new powerful AI-powered tool can diagnose diseases up to four times more accurately than a human doctor (via WIRED).
This article is fairly wordy. There is a hyperlink below where you can pull it up and read it. However, the chart below is pretty telling
Key Points
Question How does the risk of overdose change with the number of days with concurrent opioid and benzodiazepine use?
Findings In this cohort study of US Medicare data, the overdose risk associated with concurrent benzodiazepine use changed over time. Concurrent benzodiazepine use was associated with a 5-fold increase in the risk of opioid-related overdose during the initial 90 days and an increase of 1.87 times on days 91 to 180.
Meaning Policy interventions should focus on preventing concurrent opioid and benzodiazepine use in the first place instead of reducing the length of concurrent use. Patients using both medications should be closely monitored, particularly during the first days of concurrent use.
Association Between Concurrent Prescription Opioid and Benzodiazepine Use and Risk of Opioid-Related Overdose
This is a very long blog post, so I asked a AI prgm to summarize it.
Certainly. Here is a concise summary of the main points from the attached file and reporting highlights:
Summary of “Threat in Your Medicine Cabinet: The FDA’s Gamble on America’s Drugs”
Risky Medications and Factory Exemptions: The FDA has granted special exemptions to more than 20 foreign pharmaceutical factories—mostly in India—allowing them to continue exporting drugs to the U.S. despite being banned for serious violations. These violations included contaminated drugs, filthy labs, and falsified records1.
Lack of Transparency and Testing: The FDA did not routinely inform the public or Congress about these exemptions and did not consistently test the exempted drugs for safety. Even within the agency, many officials were unaware of the practice or its scope1.
Patient Impact: At least 150 medications or ingredients from problematic factories were allowed into the U.S. market. Adverse event reports linked to these exempted drugs included about 70 hospitalizations and nine deaths, though the actual number of complaints is likely much higher. Reports described issues such as abnormal taste, odor, or residue, and unexplained health problems1.
Ongoing Problems: Despite the FDA’s assurances that additional quality checks and third-party oversight were required for exempted drugs, inspectors and former officials expressed concerns about trusting companies that had previously provided unreliable or deceptive test results. The FDA rarely conducted its own routine testing of these drugs1.
Root Causes: The FDA’s decisions were driven by a desire to avoid drug shortages, especially for critical generics. However, this led to reliance on factories with poor track records, and the agency continued to approve new generics from these companies even after repeated violations1.
Regulatory and Cultural Challenges: The practice of granting exemptions was largely managed by a small group within the FDA, with little oversight from top leadership or Congress. The agency failed to maintain a comprehensive list of exemptions and did not proactively investigate patterns of harm in adverse event reports1.
Industry Response: Companies like Sun Pharma and Intas have stated they are investing in improvements and quality programs, but ongoing inspections continue to reveal problems. The FDA has removed exemptions when shortages are resolved, but bans are only lifted after companies demonstrate remediation1.
Key Takeaway: The FDA has repeatedly allowed drugs from banned foreign factories to enter the U.S. market to prevent shortages, often without adequate transparency, public notification, or independent safety testing—raising serious concerns about the quality and safety of America’s drug supply1.
Threat in Your Medicine Cabinet: The FDA’s Gamble on America’s Drugs
Risky Medications: The FDA has given more than 20 foreign factories a special pass to continue sending drugs to the U.S. even though they were made at plants that the agency had banned.
Troubled Factories: The medications came mostly from plants in India where inspectors found contaminated drugs, filthy labs and falsified records.
FDA Secrecy: The agency did not proactively inform the public when drugs were exempted from import bans, and it did not routinely test the medications to ensure they were safe.
On a sweltering morning in western India in 2022, three U.S. inspectors showed up unannounced at a massive pharmaceutical plant surrounded by barricades and barbed wire and demanded to be let inside.
For two weeks, they scrutinized humming production lines and laboratories spread across the dense industrial campus, peering over the shoulders of workers at the tablet presses, mixers and filling machines that produce dozens of generic drugs for Americans.
Much of the factory was supposed to be as sterile as an operating room. But the inspectors discovered what appeared to be metal shavings on drugmaking equipment, and records showing vials of medication that were “blackish” from contamination had been sent to the United States. Quality testing in some cases had been put off for more than six months, according to their report, and raw materials tainted with unknown “extraneous matter” were used anyway, mixed into batches of drugs.
Sun Pharma’s transgressions were so egregious that the Food and Drug Administration imposed one of the government’s harshest penalties: banning the factory from exporting drugs to the United States.
But the agency, worried about medication shortages, immediately undercut its mission to ensure the safety of America’s drug supply.
A secretive group inside the FDA gave the global manufacturer a special pass to continue shipping more than a dozen drugs to the United States even though they were made at the same substandard factory that the agency had officially sanctioned. Pills and injectable medications that otherwise would have been banned went to unsuspecting patients across the country, including those with cancer and epilepsy.
The FDA didn’t routinely test the medications for quality problems or use its vast repository of drug-related complaints to proactively track whether they were harming the people who relied on them.
And the agency kept the exemptions largely hidden from the public and from Congress. Even others inside the FDA were unaware of the details.
In the hands of consumers, according to the FDA’s longtime head of drug safety, the information would have caused “some kind of frenzy.”
“We felt we didn’t have to make it a public thing,” said Janet Woodcock, who spent nearly four decades at the agency.
The exemptions for Sun weren’t a one-time concession. A ProPublica investigation found that over a dozen years, the same small cadre at the FDA granted similar exemptions to more than 20 other factories that had violated critical standards in drugmaking, nearly all in India. All told, the group allowed into the United States at least 150 medications or their ingredients from factories with mold, foul water, dirty labs or fraudulent testing protocols.
Some of the drugs were recalled — just before or just after they were exempted — because of contaminants or other defects that could cause health problems, government records show. And a ProPublica analysis identified more than 600 complaints in the FDA’s files about exempted drugs at three of those factories alone, each flagging concerns in the months or years after they were excluded from import bans in 2022 and 2023.
The “adverse event” reports about drugs from the Sun plant and two others run by Indian drugmaker Intas Pharmaceuticals described medication with an abnormal taste, odor or residue or patients who had experienced sudden or unexplained health problems.
The reports cite about 70 hospitalizations and nine deaths. And those numbers are conservative. ProPublica limited its count to reports that linked problems to a single drug. However, the total number of complaints to the FDA that mention exempted drugs is in the thousands.
“Abdominal pain … stomach was acting very crazy,” one report said about a woman using a seizure drug from Sun Pharma. The FDA received the complaint in 2023, nine months after it excluded the medication from the import ban.
“Feeling really hot, breaking out with hives, hard to breathe, had confusion, glucose level was high, heart rate went up and head, arms and hands got numb,” noted another report about a patient taking a sedative from Intas. The complaint was sent to the FDA in June 2023, the same month the agency exempted the medication.
The outcomes described in the complaints may have no connection to the drug or could be unexpected side effects. In some cases, the FDA received complaints about the same drugs made by other manufacturers.
Still, the seriousness of the reports involving exempted drugs did not galvanize the agency to investigate, leaving the public and the government with no way of knowing whether people were being harmed and, if so, how many.
Those unknowns have done little to slow the exemptions. In 2022, FDA inspectors described a “cascade of failure” at one of the Intas plants, finding workers had destroyed testing records, in one case pouring acid on some that had been stuffed in a trash bag. At the second Intas factory, inspectors said in their report that records were “routinely manipulated” to cover up the presence of particulate matter — which could include glass, fiber or other contaminants — in the company’s drugs.
The FDA barred both plants in 2023 from shipping drugs to the U.S. Then the agency simultaneously granted more than 50 exemptions to those banned factories — the broadest use of exclusions in ProPublica’s analysis.
Intas, whose U.S. subsidiary is Accord Healthcare, said in a statement that the company has invested millions of dollars in upgrades and new hires and launched a companywide program focused on quality. Exempted drugs were sent to the United States in a “phased manner,” the company said, with third-party oversight and safety testing. Intas also said that some exempted drugs were never shipped to the United States because the FDA found other suppliers. The company would not provide details.
“Intas is well on its way towards full remediation of all manufacturing sites,” the company said.
Sun did not respond to multiple requests for comment. When the FDA imposed the ban, the company said it would “undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the company’s remedial action. Sun Pharma remains committed to being … compliant and in supplying high-quality products to its customers and patients globally.”
Both companies’ factories are still under import bans.
“We’re supposed to have the best medicine in the world,” said Joe DeMayo, a kidney transplant patient in Philadelphia who took an immunosuppression medication made by Intas until December 2023, unaware that a month earlier the FDA had excused the drug from an import ban. “Why are we buying from people who aren’t making it right?”
Game of Chance
How the United States wound up here — playing a game of chance with risky drugs made thousands of miles away — is the story of an agency that has relentlessly pressed to keep the supply of low-cost generics flowing even as its own inspectors warned that some of those drugs posed a potentially lethal threat to the American public.
The vast majority of the prescriptions filled in the country are for generic drugs, from penicillin to blood thinners to emergency contraception, and many of those come from overseas, including India and China. For years, the FDA has vouched for the quality of generics, assuring the public in press releases, speeches and social media campaigns that they are just as safe and effective as brand-name drugs.
That guarantee came under serious question in 2019 when journalist Katherine Eban published a breakthrough book, “Bottle of Lies,” that exposed rampant fraud and manufacturing violations in Indian factories and the FDA’s reluctance to aggressively investigate.
ProPublica identified another alarming level of entrenched failure: Even when the agency did investigate and single out factories that were among the worst in India, it still gave them access to American consumers. All the while, patients took their medicine without question, trusting an agency that has long been considered the gold standard in drug regulation.
While specialized business publications have sometimes reported on exemptions when they happen, they’ve offered little context and few specifics.
The FDA in many ways put itself in this untenable position, forced to decide between not having enough drugs or accepting potentially dangerous ones, interviews and government records show.
For years, the agency gave companies with a history of manufacturing breakdowns approval to produce an increasingly larger share of generic drugs, allowing them to become a dominant force in American medicine with the power to disrupt lives if production lines were shuttered.
“It’s our own fault,” said former FDA inspector Peter Baker, who reported a litany of failures during inspections in India and China from 2012 to 2018. “We allowed all these players into the market who never should have been there in the first place. They grew to be monsters and now we can’t go back.”
The decisions to weaken penalties and allow banned factories to continue sending drugs to the United States were approved by Woodcock, one of the agency’s most powerful administrators. For more than two decades, she led the Center for Drug Evaluation and Research, the arm of the FDA that serves as the country’s gatekeeper for new and generic drugs.
In a series of interviews with ProPublica, Woodcock said she supported the use of exemptions “as a practical approach.”
“We had to kind of deal with the hand we were dealt,” she said.
Woodcock said she didn’t see a need to inform the public because the agency believed the drugs were safe. She said she mentioned the practice periodically in closed-door meetings with congressional staffers, but she did not provide specifics about those conversations.
After Woodcock left her post in 2020 to help lead the agency’s response to the COVID-19 pandemic, the exemptions — including those for Sun and Intas — continued under her successor, Patrizia Cavazzoni. Cavazzoni, who left the agency earlier this year and rejoined Pfizer, declined to comment.
Former FDA Commissioner Robert Califf, who led the agency when Sun and Intas received exemptions, told ProPublica that tough calls had to be made and the practice did not worry him.
The FDA did not respond to questions about who made those decisions or how the drugs were evaluated, and it declined requests for interviews with officials who currently oversee drug regulation. In an email, the agency said the exemptions are “thoroughly evaluated through a multi-disciplinary approach.”
Years after the FDA started granting exemptions, some current and former officials say they wrestle with a lingering fear that bad drugs are circulating in the United States.
“It’s not even a hypothetical,” said one senior FDA employee familiar with the exemptions, who, like others, spoke on the condition of anonymity because they were not authorized to speak publicly. “It’s not a question of if — it’s a question of how much.”
Although the FDA has been giving companies a way around import bans since at least 2013, the internal process was so secretive that many current and former FDA officials said they have no idea how many exemptions have been granted or for what drugs. In an email, the agency said it did not maintain a comprehensive list.
Even two high-level FDA staff members who worked on drug shortage challenges for the agency said in interviews they had never heard of the exemptions.
Congress required the FDA in 2012 to provide specific information every year about how and when the agency relaxed its rules for errant drugmakers to prevent shortages. But the FDA did not mention exemptions to import bans until 2024 — and only then in a single footnote of its 25-page report to Congress.
ProPublica uncovered the frequent use of exemptions by searching for the “import alert” list published on the FDA’s website that names factories banned from the U.S. marketplace. Because the agency publishes only a current list and doesn’t make the old ones public, the news organization used internet archives and FDA documents maintained by the data analytics company Redica Systems, ultimately compiling import alerts dating back more than a decade. The lists identify the drugs exempted from bans but provide few other details.
ProPublica reviewed scores of inspection reports and corporate documents for overseas factories and interviewed more than 200 people, including current and former officials of the FDA, to understand the little-known practice and the ongoing threat posed by the agency’s decisions.
The investigation revealed not only how many drugs received exemptions from import bans, but also how long the FDA allowed those exemptions to stay in place — in some cases for years.
The agency has removed exemptions when there is no longer a shortage concern. In those cases, the drugs are then banned along with the others at the factory. Both Sun and Intas have had drugs that lost their exemptions.
Two and a half years after the Sun factory was banned, five drugs are still exempted. Intas, whose factories were banned in 2023, currently has 24 drugs on the list. The bans themselves are removed only after companies fix the problems.
Earlier this month, the FDA went back to the Sun Pharma factory for a surprise inspection and found ongoing problems, according to a Sun filing with the Indian stock exchange and Indian media reports. The concerns focused on the way sterile drugs were made, including some of the exempted drugs still being sent to the United States, according to a person familiar with the situation who did not want to be named because they were not authorized to speak publicly.
The FDA said it put protections in place for exempted drugs: Manufacturers are required to conduct additional quality checks before they are sent to the United States. That has included extra drug-safety testing, in some cases at an independent lab, and bringing on third-party consultants to verify the results.
The agency did not provide ProPublica with the names of the third-party consultants hired by Sun and Intas. Intas declined to name its consultants.
“The odds of these drugs actually not being safe or effective is tiny because of the safeguards,” said one former FDA official involved in the exemptions who declined to be named because he still works in the industry and fears professional retribution. “Even though the facility sucks, it’s getting tested more often and it’s having independent eyes on it.”
But current and former FDA inspectors said those safety measures require trusting the vigilance of companies that were banned, at least in part, for providing unreliable or deceptive test results to the government or failing to investigate reports about drugs with contaminants or other quality concerns.
The FDA could have done its own routine testing of the exempted drugs but chose not to. The agency said in an email that it tests the drugs using a “risk-based approach” but would not provide ProPublica with any information about which drugs have been tested and what the results were.
Woodcock said testing was expensive and budgets were tight. She acknowledged that regularly assessing the exempted drugs for quality or safety concerns “would have enhanced our confidence … and made everyone more comfortable.”
The European Union, by contrast, requires drugs made in India and China to be checked for quality on EU soil. And the U.S. Department of Defense is conducting its own testing of more than three dozen generic medications and has already identified potency and other quality issues.
“If you don’t know about the quality of the product, why are you letting it in?” said Murray Lumpkin, the FDA’s former deputy commissioner for international programs, who left the agency in 2014 before most of the exemptions were granted.
Beyond the lack of testing, the FDA didn’t actively look for patterns of harm among the exempted drugs in its adverse event database, Woodcock and others said.
ProPublica’s analysis of that data found thousands of reports both before and after the factories were given a pass to sidestep import bans. The reports described unexpected cases of cardiac arrest, blurred vision, choking, vertigo and kidney injuries, among other issues — and in some instances identified specific concerns about how the drugs were made. One person who took Intas’ clonazepam, a sedative and epilepsy drug, reported getting “brain zaps” and bright blue teeth from the coating of dye on the drug. The FDA received the complaint the same month the agency exempted the drug from the import ban.
Even before the FDA exempted Intas’ antidepressant bupropion, consumers reported that it made them sick, wasn’t always effective and had an abnormal odor, which pharmacists and others say can happen when an inactive ingredient breaks down.
“It was rotten eggs,” Nari Miller, a geologist in California who took the pills in 2022 and had severe stomach pain, told ProPublica. “I opened it and smelled it when I got home and it was awful.”
Intas said it could not respond to specific complaints and that all drugs have side effects. “Intas and Accord pay attention to each and every adverse event report,” the company said, adding, “Accord and Intas are committed to continuing to bring safe and effective medicines to patients.”
In its statement, the FDA said the database is monitored weekly for new reports in general. Woodcock, however, acknowledged the reports about exempted drugs, ideally, “would be under much more scrutiny.”
Too Big to Fail
Decisions made by the FDA decades ago gave rise to the use of exemptions and the risks that now confront the American public.
When new brand-name drugs come to market, they are protected by patents and exclusive sales rights that make them generally expensive. When patents expire, generic drug companies rush in to make their own versions, which are supposed to be equivalent to the brand. Generics are often far cheaper, and insurance companies typically insist that patients use them.
In the 2000s, as the cost of brand-name drugs soared, the FDA began to approve large numbers of generics. The agency, however, gave hundreds of those approvals to foreign manufacturers that had been in trouble before, companies well known to the inspectors working to stamp out safety and quality breakdowns at overseas factories, ProPublica found.
The FDA granted Sun Pharma alone more than 250 approvals for generic drugs since the late 2000s, when the company started amassing violations, records show. The agency’s decisions helped to transform the company from a local provider in India to one of the leading exporters of medications to the United States, with nearly $2 billion in annual U.S. sales.
The approvals kept coming as inspectors continued to raise concerns about manufacturing practices at the company’s factories in India, government records show.
More problems were found at a factory that Sun had acquired in Detroit, where the diabetes drug metformin was contaminated with metal scrapings. The violations were so significant that federal marshals in 2009 raided the plant and seized drugs. The company eventually shuttered the factory.
The rapid expansion of Sun and other foreign drugmakers set off new alarms among inspectors, their supervisors and advisers to Woodcock.
“In a rational system, you would have said, ‘This company is not producing properly, so let’s not approve any more of their drugs,” said William Hubbard, former FDA deputy commissioner for policy, planning and legislation. “The agency in a sense kind of let this happen.”
Ajaz Hussain, the former deputy director of an FDA office that oversaw pharmaceutical science, said that after leaving the agency and becoming a consultant, he made his concerns known in meetings with Woodcock and others.
“They can’t manufacture it. Why do you keep approving it?” Hussain recalled in an interview with ProPublica. “I said, ‘Wake up.’ … But they didn’t listen.”
Hussain in 2012 went to work for Wockhardt, one of the largest pharmaceutical companies in India, but quit eight months later after he said he told his superiors about manufacturing failures in the company’s factories.
Although FDA inspectors had reported lapses after multiple visits to Wockhardt plants between 2004 and 2012, the agency cleared the way for the company to export sedatives, antibiotics, beta blockers, painkillers and other generics to the United States, records show. Wockhardt received exemptions from import bans in 2013. The company did not respond to repeated requests for comment, but at the time, the company said it was going to quickly address the FDA’s concerns.
The FDA could have denied generic drug applications — nothing in the law prohibits the agency from saying no to companies with spotty track records. In an email, the FDA said it considers a company’s history and conducts inspections in some cases before issuing approvals.
Woodcock said the agency knew which factories were poor performers but feared being sued by companies blocked from introducing new drugs based on past behavior. Instead, she said that she tried to convince drugmakers to invest in equipment and practices that would turn out higher-quality drugs.
“We had many meetings about this, and we agonized about all these problems,” she said.
But little changed.
Shortages vs. Quality
In 2008, dozens of Americans were killed by contaminated blood thinner from China. So when Margaret Hamburg was appointed commissioner of the FDA in the aftermath of the crisis, she pressed the agency to crack down on overseas drugmakers.
Her efforts ran headlong into what would become the worst drug shortage in modern history. By 2010, cancer drugs were scarce. So were the drugs on hospital crash carts. In all, more than 200 critical medications were in short supply.
Razor-thin profit margins had limited the number of companies that were willing to make generic drugs. And the FDA’s enforcement overseas had forced some manufacturing lines to temporarily shut down, which exacerbated the problem.
LeRoy Hubley, whose wife and son died after taking a tainted generic blood thinner from China, testified before Congress in 2008. The crisis helped prompt the FDA, under Commissioner Margaret Hamburg, to ramp up inspections of overseas drugmakers.Credit: Brendan Smialowski/Bloomberg News
Congress lambasted the FDA for the shortages and started requiring the agency to prove every year how it was combatting the problem.
At the time, the FDA had a small team focused on shortages that operated on the edges of Woodcock’s 4,000-person Center for Drug Evaluation and Research. With the pressure on, Woodcock elevated the team in 2010 to report directly to her deputy, a move that gave those staff members a commanding voice at the highest levels of the agency, several former staffers told ProPublica.
After 16 years in top leadership roles, Woodcock was formidable enough to force a culture change. Standing 5’2” in FDA conference rooms where she had often been disregarded as the lone woman, Woodcock had fought for her status — sometimes, she said, pushed nearly to tears with frustration. The board-certified internist asserted her authority by wielding data, what she called “brute force” and the soft persuasion of an occasional gift of an orchid, picked from her garden in suburban Maryland.
Woodcock, an avid gardener, retired from the FDA last year.Credit: Jason Andrew for ProPublica
By 2010, Woodcock had marshalled the center into a powerhouse with great independence — in many ways, outside the reach of the political whims of the commissioners who came and went. Those who worked with her over the years said despite her approachable manner, she fiercely guarded her territory.
In the conference room next to Woodcock’s office, the drug shortage staff began to weigh in whenever the FDA’s compliance team moved to penalize wayward drugmakers because of bad inspections, according to several former FDA officials involved in the deliberations.
Sometimes the small group would decide that a factory could no longer ship drugs to the United States and would try to get other manufacturers to make more. And other times, the group determined that exemptions from import bans were the only course.
Discussions could be tense and often lasted for weeks. A former employee on the compliance team told ProPublica that they repeatedly argued to impose a total import ban on a foreign factory because they feared the drugs couldn’t be trusted. They were left feeling uncomfortable about an exemption granted anyway — for a product that they would not use themselves.
Without exemptions, Woodcock told ProPublica, the FDA might have been forced to source the drugs from a “totally unknown manufacturer, say, from China or somewhere.”
Current and former FDA officials said the concessions became a yearslong practice rather than a stopgap measure and that the protections put in place by the agency were not sufficient. They question why Woodcock and her successor didn’t do more to raise alarms with Congress or the public about the decision to rely on inadequate factories for critical drugs.
Woodcock said she thought the exemptions were a symptom of larger issues involving the drug supply that the FDA had no control over — the agency, for example, can’t force companies concerned about slim profit margins to produce generic drugs.
Two former FDA commissioners told ProPublica they knew about the practice but were not included in the decision-making.
Hamburg, who spent six years at the agency under the Obama administration, said the extent of the practice surprised her. “Had I known that it was sort of an open-ended policy, I would have been disturbed,” she said.
One of her successors, Stephen Hahn, appointed during President Donald Trump’s first term, said more people should have been involved in the decisions.
“You’re talking about a drug of questionable quality being brought into the country,” he said.
Woodcock said she did not believe she needed their input. “I didn’t think in the individual circumstances it was necessary to elevate,” she said, “because what could they do?”
“We Know What Was Found”
In 2020, the billionaire founder of Sun Pharma joined a pivotal conference call with FDA compliance and investigative staff.
Dilip Shanghvi, whose father had run a wholesale drug business in Kolkata, India, started the company in the 1980s and ultimately turned Sun Pharma into one of the largest suppliers of generic drugs in the United States. On the call, Shanghvi spoke about improvements at Sun’s enormous plant in the Indian city of Halol, according to an FDA official who attended the meeting.
Among other drugs, the plant produced at least 16 sterile injectables for the U.S. market, according to a Sun email to the FDA obtained by ProPublica. Injectables are particularly dangerous if contaminated because the medication is injected directly into the body, unlike a pill that goes through the filtering of the digestive tract.
In 2018 and 2019, inspectors had reported a series of violations at the factory, and Sun had received more than 700 complaints about what appeared to be crystals or spider webs forming in one of its injectable medications, records show.
The company also had to recall more than 135,000 vials of vecuronium bromide, a muscle relaxer used during surgery, after reports that the medication contained glass particles. Sun said the defect could cause life-threatening blood clots.
On the call with the FDA, according to the agency official, Shanghvi assured the government that the Halol plant was turning out high-quality products.
Yet, when the three investigators went back to the factory that scorching morning in 2022 for the surprise inspection, it was clear within days that the FDA would have to take swift action.
Splitting up to check different parts of the plant, the inspectors quizzed workers about cleaning procedures and looked at disassembled equipment to see if it was contaminated with residue from old drugs. At one point, they spotted water leaking near areas where sterile drugs were made, an alarming observation because water can introduce contaminants capable of causing infections or even death.
Digging through company records and test results, they found more evidence of quality problems, including how managers hadn’t properly investigated a series of complaints about foreign material, specks, spots and stains in tablets.
Several FDA employees familiar with the inspection report — 23 pages of detailed violations — said they had no idea why the agency went on to exclude so many of Sun’s drugs from the subsequent import ban.
“We know what was found,” said the FDA official who attended the meeting with Shanghvi. “How could you trust [those] drugs?”
Sun did not respond to questions about the recalls or its regulatory history with the FDA. In its 2023-24 annual report, the company said, “We have a relentless focus on 24×7 compliance to ensure continuity of supplies to our customers and patients worldwide.”
The specific findings of the FDA’s latest inspection of the Sun plant conducted this month have not yet been made public, and the company did not respond to a request for comment.
To some current and former FDA officials and other experts, plugging a supply shortage with drugs that may be contaminated or ineffective is no solution at all.
“That might be helping a shortage but might be creating a new problem,” said Lumpkin, the former deputy commissioner.
Last summer, a pair of FDA investigators arrived at another manufacturing plant in India that had a bustling production line. After more than a week at the Viatris factory, they left with a familiar list of safety and quality violations. We Spent a Year Investigating How the FDA Let Risky Drugs Into the U.S. Market
The inspectors found that equipment wasn’t clean and managers failed to thoroughly investigate unexplained discrepancies in test results.
In a statement to ProPublica, Viatris said it immediately worked to resolve the FDA’s concerns. “Patient safety remains our primary and unwavering focus,” the company said.
Just before Christmas, the FDA banned the facility from exporting drugs.
Then the agency gave the factory a pass, and four of its drugs are still bound for the United States.
It has been a rough stretch for large pharmacy chains.
CVS, Walgreens and Rite Aid are all in the midst of mass closures, and Rite Aid recently filed for bankruptcy for the second time in as many years.
Mass closures extend beyond the retail pharmacy space, however, as other companies such as Forever 21, Joann, Macy’s, Denny’s, Bahama Breeze and more have announced locations would shutter this year.
Here’s the latest on pharmacy chains CVS, Walgreens and Rite Aid, including how many stores each company is planning to close.
On May 15, Rite Aid said it “successfully entered into a series of sale agreements and pharmacy services transition agreements,” which would include transitioning pharmacy assets from locations across the U.S. to CVS Pharmacy, Walgreens, Albertsons, Kroger, Giant Eagle and other operators. Rite Aid and Bartell Drugs stores in some states will also be operated by CVS Pharmacy as part of the sale agreements, which were approved on May 21 in the U.S. Bankruptcy Court of New Jersey, according to Rite Aid’s bankruptcy docket.
During the transition of prescription files, Rite Aid said its stores will remain open and customers can continue to access their pharmacy services, including prescription refills and immunizations. Before the bankruptcy filing, Rite Aid operated 1,240 stores across 15 states.
“A key priority for Rite Aid is to ensure that as many of our loyal customers as possible continue to receive the pharmacy services and care they require without interruption,” Matt Schroeder, CEO of Rite Aid, said in a statement. “These agreements ensure our pharmacy customers will experience a smooth transition while preserving jobs for some of our valued team members.”
Rite Aid has buyers for customer files at 810 of its stores, but did not find a buyer for files at 200 other locations, according to Reuters. While the deadline to enter bids for Rite Aid’s pharmacy assets (May 13) has passed, the deadline to enter bids for the chain’s remaining assets, including the Thrifty Ice Cream business, is June 13, with an auction date set for June 20.
If you are choosing or forced to use a chain pharmacy where the Pharmacy department/staff looks like chaos is SOP, or your prescriptions never seems to be ready. You can complain to the state’s pharmacy board, but most state pharmacy boards are stacked with non practicing corporate Pharmacists. The primary function of the pharmacy board is to protect public safety. When most pharmacy boards are stacked with non-practicing corporate Pharmacists, who do you think their concerns are focused? Their employer and their pay checks, or how long you have to wait to get your Rxs filled or how many pts get the wrong medication in their bottle? Just remember, you only have one life and getting the wrong medications, could adversely affect that!
As this June issue of The Pharmacist Activist was being finalized, I was made aware of the suicides of two CVS pharmacists that occurred just days apart in mid-June. The pharmacists worked at two stores that are approximately 5 miles apart. One of them had worked for CVS for more than 20 years and was well known to those in his community and also to other local well-connected pharmacists in a community that still has an active county association. The other pharmacist was a relatively recent graduate. I do not know the factors that may have resulted in their tragic decisions. It is my understanding that CVS management has “informed” the other employees in the two stores that they must not respond to questions about or discuss these events.
I called CVS corporate headquarters in Rhode Island to ask if CVS had prepared a statement such as a tribute to the service of these pharmacists. After being placed “on-hold” for about 10 minutes, I was informed that no information was available.
We pray for and extend our sympathy to the families and friends who are coping with the grief from the loss of these loved ones.
Thousands of pharmacies have closed and their prescription files are being transferred to those which remain. In many of these latter pharmacies, increased staffing will be required to handle the increased workload. If sufficient staffing is not provided, the number of errors will increase and pharmacists and other employees will be overwhelmed. Please do not place your patients or yourselves at risk! If you experience continued understaffing in your workplace, IGNORE the metrics and REDUCE your work and time commitment (e.g., the number of prescriptions for which you have responsibility) to the level that YOU consider to be SAFE for your PATIENTS and for YOURSELF. DO NOT come in early or work later to attempt to reduce a backlog that you did not cause and will not be able to resolve. DOCUMENT your experiences and discussions with leaders/managers/owners. CONFIDE in other pharmacists whom you know are experiencing similar challenges and stress for the purpose of supporting and “monitoring” each other. If you, or a family member or friend, feels your stress/anxiety are affecting your mental health (e.g., “I don’t like the person I have become”), SEEK PROFESSIONAL COUNSELING AND REQUEST MEDICAL LEAVE. You are loved, valued, and needed!
Some of what is said in this article reminds me of when Medicare implemented DRG (Diagnostic Related Groups) in the early 80’s. The hospital was paid a specific $$ when a pt was admitted to the hospital, based on the diagnose(s) that the pt was dealing with. If the hospital spent less than allotted for a pt, the hospital got to keep the excess payment. If the hospital ended up spending more on the pt’s care than the DRG provided, the hospital had to “eat” the extra cost. This is the time that I expanded our pharmacy into supplying Home Medical Equipment, because pts were being discharged QUICKER & SICKER.
Notice that everywhere in this article when they mention better pt care and saving money. IMO, the reality is they are saving money and the pt ends up with BETTER CARE… that is a PLUS
CVS Health’s Aetna supports industry actions to simplify prior authorization
Aetna, a CVS Health company, said it is committed to distinctive actions that will make it easier to navigate the healthcare system.
Aetna, a CVS Health company, announced its support of initiatives championed by American’s Health Insurance Plans to improve the experience of doctors and patients. Aetna said it also is committed to leading the market through a comprehensive strategy to make it easier to navigate health care — reducing reviews, simplifying care site transitions and putting technology to work for healthcare professionals and their patients.
“The American healthcare system must work better for people, and we will improve it in distinctive ways that truly matter,” said Aetna president Steve Nelson. “We support the industry’s commitments to streamline, simplify and reduce prior authorization. We will go beyond prior authorization, building a health care experience for people we serve and introducing solutions that improve navigation and advocacy for Aetna members.”
Aetna said it already has one of the shortest lists of treatments and procedures requiring prior authorization in the industry. Of eligible prior authorizations, more than 95% are approved within 24 hours, with some completed in just a few hours.
Aetna noted that one area it can simplify is the prior authorization process. For people with lung, breast or prostate cancer who need prior authorizations for MRI or CT scans, Aetna is bundling multiple authorization requests into one up front approval.
Later this year, the company plans to add additional bundles for cardiology and musculoskeletal conditions. This initial scope has the potential to help thousands of members across Aetna’s commercial and Medicare plans and the medical professionals caring for them.
“We have also introduced our Aetna Clinical Collaboration (ACC) program, which focuses on improving care transitions for patients moving between care settings. In this program, our nurses work with other medical professionals to help members get to the most appropriate care setting when they leave the hospital,” the company said. “Our goal is to reduce 30-day readmission rates and emergency room visits, resulting in improved care outcomes and cost savings.”
Aetna added that what makes this program unique is that Aetna nurses work on-site at healthcare facilities, collaborating directly with a patient’s care team to coordinate a transition from the hospital to their home or other community care program based on the individual’s health needs. “By comprehensively supporting a person’s healthcare touch points — medical, pharmacy, mental well-being and other areas — there is a seamless transition to care at home or in a community setting with a proactive care plan in place,” the company said.
Aetna added that it has successfully launched the ACC program providing support for Medicare Advantage members transitioning out of a hospital setting and reducing hospital readmissions. “We expect to expand this program later this year to other facilities, and to commercial members, people under 65 who get their health benefits from their employer,” the company said.
Recent updates to the Aetna Health app give Aetna members access to features like Smart Compare that helps match members with medical professionals who are suited to the member’s health needs and budget. “In addition, we provide status badges showing prior authorization progress, expanded information about service quantities (such as hospital stays and physical therapy visits) and clearer explanations of coverage decisions. These improvements allow members to better track their care journey and understand their authorization status without repeatedly contacting their providers for updates,” Aetna explained.
Tailoring medicines to an individual’s genetic profile is now possible. One critical aspect is genetic testing that reduces side effects, particularly for patients on psychiatric and cardiovascular drugs.
For millions of Americans, taking medication is a routine and necessary part of maintaining health, but if you’ve watched drug advertisements on TV, you’re familiar with the litany of possible side effects. Many of us have experienced some – perhaps drowsiness from an antihistamine, nausea after one of the new GLP-1 weight-loss shots, or an episode of low blood pressure from a hypertension drug. For some people, a prescribed drug can trigger a severe, even life-threatening, reaction.
These adverse drug reactions (ADRs) are not only dangerous to patients but also place a massive financial burden on healthcare systems: They lead to increased healthcare costs through hospital admissions, longer hospital stays, emergency room visits, and the need for additional treatments to manage the reactions. In the U.S., the costs may be as much as $30.1 billion annually.
However, a groundbreaking new study from British researchers suggests that genetic testing for just three specific genes before a prescription is even written could avoid up to 75% of ADRs. Published in PLOS Medicine, this research highlights how pharmacogenomic (PGx) testing could revolutionize medicine and reduce costs by making drug prescribing safer.
The Genetic Clues Behind Adverse Drug Reactions
Not everyone processes medication in the same way. Our bodies metabolize drugs using enzymes, which are controlled by our genes. Variations in these genes – and, therefore, in the enzymes they express — can make a person metabolize a drug too quickly or too slowly, leading to dangerous side effects.
The study analyzed over 1.3 million ADR reports collected by the Yellow Card scheme, the U.K.’s official system for tracking medication side effects, and the findings were striking:
Nine percent of ADRs were linked to drugs that interact with three key genes — CYP2C19, CYP2D6, and SLCO1B1 – that play a crucial role in how the body processes many commonly prescribed medications. Those ADRs were, therefore, considered to be “mitigatable,” or avoidable, by pre-administration genetic testing.
The study found that certain classes of drugs were disproportionately linked to ADRs that could be prevented with genetic testing:
Psychiatric Medications: Accounting for 47% of all genetically linked ADRs, these include antidepressants and antipsychotics, which can cause severe side effects in people with specific genetic variants.
Cardiovascular Medications: Responsible for 24% of preventable ADRs, these drugs are commonly used for heart conditions and blood pressure management.
A Simple Test with Major Benefits
Genetic testing for CYP2C19, CYP2D6, and SLCO1B1 could allow doctors to personalize prescriptions and adjust drug choices and dosages based on a patient’s genetic makeup. This approach is neither theoretical nor completely new — previous research, including the international PREPARE trial, whose results were reported in 2023, had already shown that some PGx testing can reduce ADRs by approximately 30% when incorporated into routine prescribing.
Who Would Benefit the Most?
The study also highlighted disparities in drug metabolism across different populations. Certain genetic variations are more common in specific ethnic groups: People of African and Asian ancestry appear to be at higher risk for some ADRs. Unfortunately, ethnic data were not available in the Yellow Card reports, but based on known genetic differences, PGx testing could disproportionately benefit these underrepresented groups and help reduce health inequalities.
Why Hasn’t Pharmacogenomic Testing Become Standard Practice?
Despite its clear benefits, PGx testing is not yet widely used in healthcare systems like the U.K.’s National Health Service or in large Health Maintenance Organizations (HMOs) in the U.S. and elsewhere. Some of the barriers include:
Cost and infrastructure: Implementing routine genetic testing requires investment in laboratory capabilities and integration of data into electronic health records.
Awareness and education: Many healthcare providers are not yet trained to interpret PGx test results or apply them to clinical decision-making.
Regulatory and ethical concerns: There are ongoing discussions about how genetic data should be stored and used while protecting patient privacy.
The Takeaway: Safer, Personalized Medicine is Within Reach
The idea of tailoring medicine to an individual’s genetic profile is no longer science fiction — it has become an achievable reality. Pharmacogenomic testing offers a clear path to safer, more effective treatment, particularly for patients on psychiatric and cardiovascular medications.
As healthcare systems evolve, integrating genetic testing into routine prescribing could become one of the most important innovations in modern medicine — saving lives, reducing costs, and making treatment more personalized. We need a crash program to implement it.
What does abortion have to do with pain management. This FL Rep almost died from a Ectopic pregnancy that practitioners in a ED was not wanting to terminate this woman’s ectopic pregnancy. The member of Congress was facing the fears of a practitioners of losing their licenses, because of a very restrictive FL abortion law, which EXEMPTS terminating an ectopic pregnancy.
If the practitioners kept scratching their heads about what to do about Rep. Kat Cammack’s ectopic pregnancy, the possible outcomes for Cammack was for the ectopic pregnancy to rupture and she would bleed to death, have the ectopic pregnancy removed by invasive surgery procedure – most likely making Rep. Kat Cammack sterile and not able to have any more children or give her the medication methotrexate to help her body to safely “remove” the ectopic pregnancy.
Here is a member of Congress that has a first hand experience of how Congress’ attempt to implement laws based on our society’s puritanical thread to protect us from ourselves. Just another example of how bureaucrats and politicians are implementing laws without considering “exceptions to the rules”.
Maybe chronic pain pts in her district should reach out to her and explain to her how some chronic painers that are not able to get their necessary medications and some are dying and/or committing suicides to finally resolve their chronic pain.
Rep. Kat Cammack’s represents Florida’s 3rd congressional district and her offices:
