The US regulator who oversaw the approval of the highly-addictive opioid OxyContin got a six-figure gig at the drug’s manufacturer a year later, a new book claims.
Curtis Wright, once a director at the US Food and Drug Administration who oversaw evaluation for pain medication, got a position with a first-year compensation package of $400,000 at Purdue Pharma a year after he led the approval of OxyContin, according to the book “Empire of Pain: The Secret History of the Sackler Dynasty” by Patrick Radden Keefe.
Purdue Pharma’s sale of OxyContin, a formulation of the narcotic oxycodone that was said to slow down the release of the strong painkiller when taken as prescribed, has been associated with the rise of the opioid crisis, according to a trillion-dollar lawsuit filed by nearly all US states.
OxyContin was the “most prescribed brand name narcotic medication” for treating moderate to severe pain by 2001, according to a report by the US Government Accountability Office. Deaths from prescription opioid overdose quadrupled between 1999 to 2019, and the Centers for Disease Control and Prevention recorded 247,000 deaths from prescription opioid overdose over the last two decades.
Keefe’s book explores the lives of the billionaire Sackler family who founded Purdue Pharma and profited off of the sale of OxyContin. Forbes estimates the Sackler family’s net worth at $10.8 billion, as of December 2020.
“This author has refused to correct errors in his past reporting and also blatantly violated journalistic ethics by refusing to meet with representatives for the Sackler family during the reporting of his book,” Daniel S. Connolly, an attorney for the Raymond Sackler family, said in a statement to Insider. “Documents being released in Purdue’s bankruptcy now demonstrate that Sackler family members who served on Purdue’s board of directors acted ethically and lawfully.”
The FDA approved OxyContin in December 1995, originally believing the controlled-release formulation of OxyContin would result in “less abuse potential,” according to the agency’s website. The agency amended the label in 2001, giving OxyContin a “black box” warning it adds on drug with the highest possible abuse potential, per the FDA website.
Keefe wrote Wright had confessed in a sworn deposition that he “might” have written the portion of the FDA package insert that said OxyContin was “believed to reduce the abuse liability of the drug.” Keefe added that Wright would instruct Purdue Pharma to mail him documents at his home office, and conducted reviews of clinical study reports regarding the safety of OxyContin with the help of Purdue Pharma employees.
After Wright left the FDA he spent a year at another company before joining Purdue, according to the book.
“That was sufficient as a cooling-off period, apparently, to allay any concerns that Richard Sackler might have had about the appearance of a conflict of interest,” Keefe wrote.
Purdue Pharma did not have additional comment to add. The FDA declined to comment.
The US Food and Drug Administration is planning to ban menthol cigarettes and all flavors of cigars, saying the measure will help people quit smoking and keep young people from starting.
In a statement Thursday, the agency said the move “will help save lives,” though it did not specify when the ban would begin.
Acting FDA Commissioner Janet Woodcock said the ban would help current smokers to quit the habit, keep young people from starting, and decrease health disparities in communities of color, low-income populations, and LGBTQ+ individuals, all of whom are more likely to use the tobacco products.
“We believe these actions will launch us on a trajectory toward ending tobacco-related disease and death in the U.S.,” Woodcock said in the release.
Menthol flavoring covers up the harshness of tobacco products and makes them more appealing to young people, the FDA said.
In a briefing following the announcement, Woodcock said the idea to lower nicotine levels in all cigarettes was “still under consideration.”
“It’s on the table but we have not finished deliberations on that matter,” she said on the call.
Woodcock also said President Joe Biden has been fully supportive of the move to ban menthol cigarettes and all flavors of cigars.
Health and Human Services Secretary Xavier Becerra also hailed the move.
“This science-based decision reflects the Biden Administration’s commitment to improve the health of all Americans and to tackle health disparities in our most marginalized communities. Tobacco-related death and disease must become a part of America’s past. These public health measures will save lives,” Becerra said in a statement.
Altria, the parent company of Philip Morris, which makes several kinds of menthol cigarettes, told Insider in a statement: “We share the common goal of moving adult smokers from cigarettes to potentially less harmful alternatives, but prohibition does not work. Criminalizing menthol will lead to serious unintended consequences.”
“Youth smoking rates, including menthol cigarettes, are at historical lows, and science and evidence does not support such a ban. We will review FDA’s announcement and continue to engage in this multi-year process with a focus on the science and evidence,” the statement said.
British American Tobacco did not immediately respond to Insider’s request for comment on the matter. Shares of both tobacco companies fell Thursday, according to Markets Insider data.
Of those numbers, about 230,000 African Americans would quit smoking and another 237,000 African American deaths would be averted, the studies showed.
“For far too long, certain populations, including African Americans, have been targeted, and disproportionately impacted by tobacco use,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “Despite the tremendous progress we’ve made in getting people to stop smoking over the past 55 years, that progress hasn’t been experienced by everyone equally.”
The president on Thursday ordered the Food and Drug Administration (FDA) to ban menthol cigarettes, a plan first reported on Wednesday by the Washington Post. Since it’s a regulatory change, Congress has no say in the matter.
As a candidate, Biden sheepishly claimed to have evolved from the days when he was boasting of legislation that he said did “everything but hang people for jaywalking.” As the Democratic nominee, Biden promised to work on decriminalizing marijuana and removing it from the DEA’s list of Schedule I controlled substances.
Biden’s now been in the White House for more than three months, and Vice President Kamala Harris says the administration is simply too busy to fulfill its promise..
But apparently Biden isn’t too busy to use his power to ban menthol cigarettes.
This demonstrates either Biden’s promise was hollow, or that he’s too stuck in his drug warrior ways to see how it’s a certainty that criminalizing a popular product in the Black community is going to be an abject disaster of human carnage.
The madness of prohibition
Albert Einstein almost certainly didn’t say, “Insanity is doing the same thing over and over again and expecting different results.” But it’s still a good line.
Biden enacting a prohibition that instantly creates a black market and room for more unnecessary and potentially dangerous encounters with police, should be seen as the plainly dumb move that it is.
The “unintended consequences” cannot be called “unforeseen.” We can see them plain as day.
We’ve done prohibition before, several times. To expect a different result – the eradication of the banned product without unneeded violence and imprisonment – meets Einstein’s apocryphal definition of insanity.
The American Civil Liberties Union (ACLU) is under no illusions about what the menthol ban means.
In a letter to Health and Human Services (HHS) Secretary Xavier Becerra and members of Congress, the ACLU noted that about 80% of Black smokers prefer menthol cigarettes, and warned the ban “will trigger criminal penalties, which will disproportionately impact people of color,” lead to “constitutional policing,” and “prioritize criminalization over public health and harm reduction.”
While acknowledging that it would be best if no one smoked, the ACLU also seemed to question the necessity of the menthol ban, citing government data showing “cigarette use is down to 2.3% from 13% in 2002” and that among underage African-Americans it’s down to 1.1%.
There is simply no ethical or scientific reason for Biden to impose a move as severe as a total ban on menthol cigarettes.
Prohibition isn’t just ineffective, it’s wrong. And its architects and adherents almost always regret it eventually.
Biden once prided himself on being more of a Drug War and Law and Order hardass than Ronald Reagan. If his mea culpas from the 2020 primary were sincere, he’d be keeping his promises to wind down the war on marijuana, not starting the war on menthols.
When menthol cigarette crackdowns inevitably come to Black communities, Biden shouldn’t be allowed to claim he couldn’t have possibly foreseen the unintended consequences.
The president should know better about prohibition, but he doesn’t.
The US will resume using Johnson & Johnson’s COVID-19 vaccine, more than a week after regulators paused the rollout to investigate reports of rare but serious side effects.
The Food and Drug Administration is adding a warning to the vaccine about the risk of unusual blood clots in women under 50. Still, the shots remain a valuable tool to stop the pandemic, and US health authorities said the benefits of the vaccines in preventing COVID-19 outweigh the risks.
Janet Woodcock, acting administrator of the Food and Drug Administration, told reporters on Friday that regulators had “full confidence that this vaccine’s known and potential benefits outweigh its known and potential risks.”
Rochelle Walensky, director of the US Centers for Disease Control and Prevention, said health care providers could resume use of the vaccine immediately.
“This vaccine was shown to be safe and effective for the vast majority of people,” she said.
Now included in the materials the FDA provides for those getting J&J’s shot is a warning that most of the cases of blood clots have happened in women ages 18-49. “Some have been fatal,” it says. The warning also notes that a causal link between the blood clots and the vaccine is “plausible.”
J&J now faces a daunting task in carving out a meaningful role for its vaccine in the US immunization campaign, the resumption coming at a time when the supply of COVID-19 vaccine doses is expected to soon outstrip demand.
J&J’s vaccine is more accessible than other coronavirus vaccines, because it’s given as a single shot. Vaccines from Moderna and Pfizer-BioNTech require two doses given several weeks apart.
In a statement, Paul Stoffels, chief scientific officer at J&J, said the company was confident its vaccine would be of use, despite the setback. “We will collaborate with health authorities around the world to educate health care professionals and the public to ensure this very rare event can be identified early and treated effectively,” he said.
Getting to a better understanding of a rare but serious blood clot issue
The CDC and FDA recommended the pause for J&J’s shot after unusual blood clots appeared in six people of the 6.8 million who had received J&J’s vaccine at that time.
Public confidence in the vaccine has dropped significantly in the week and a half since this pause began. Just 19% of Americans would now be willing to get the shot, according to data presented to the advisory group Friday.
Manufacturing challenges surrounding the vaccine have also brought scrutiny to J&J’s shots. Emergent Biosolutions, a Baltimore-based contractor used by J&J, has run afoul of US regulators, with a recent FDA report describing the plant in poor condition, including peeling paint and workers doing jobs they are not trained to do.
The Emergent plant has not produced any doses of J&J’s vaccine that have been administered. Regulators have held up any shipments from the plant until it can address the agency’s concerns. All the J&J supply used in the US so far has come from other factories in Europe.
US federal agencies may need two weeks or more to know whether Johnson & Johnson’s coronavirus vaccine is linked to rare blood clots, two senior White House health officials told Politico on Saturday.
US regulators recommended a pause in the distribution of J&J’s shot last Tuesday due to six reports of clotting among women who’d recently received the vaccine.
The particular blood clot in question, central venous sinus thrombosis (CVST), forms in the brain – so it can lead to headaches or stroke. In an average year, the condition occurs in about five people out of every million.
The Centers for Disease Control and Prevention’s vaccine advisory panel is scheduled to convene Friday to discuss whether to lift the vaccine pause. But two health officials told Politico that the CDC still might not have enough data by then to determine if J&J’s vaccine indeed causes rare clots.
US regulators may ultimately consider placing age- or gender-based restrictions on the shot, which has been authorized for people ages 18 and older. Alternatively, regulators could simply deliver stronger warnings about possible blood clots in unusual cases.
Many political leaders and medical experts worry that if regulators take too long to evaluate the potential blood clot link, an increasing share of Americans will lose trust in J&J’s vaccine.
“The longer the pause is, the longer it’s going to take for us to convince people that this particular vaccine is safe again,” Arkansas Gov. Asa Hutchinson told Politico.
Peter Gulick, an associate professor of medicine at Michigan State University, said the J&J pause could delay the prospect of herd immunity – the threshold beyond which the virus won’t be able to pass easily from person to person.
“The fear is that, hearing all this, the anti-vaxxers and even the ones on the fence are falling off the fence now into the arena of ‘I don’t think I want to get any vaccine until things are known a little more,'” Gulick told Insider. “We may have taken two steps backwards as far as our wanting to get herd immunity.”
Searching for blood clots in a ‘muddied water’ of data
“It’s important from the perspective of the public: When we say rare, what does that mean?” Dr. Beth Bell, a professor of global health at the University of Washington, said during the meeting. “I want to be able to feel comfortable with my family members and myself getting this vaccine.”
US regulators are now encouraging doctors to report any post-vaccination CVST cases over the last few weeks. Regulators are also working with Johnson & Johnson to find out more about the six reported cases – in particular, whether the women had underlying health problems or were taking any medications that could have predisposed them to clotting.
So far, regulators have noticed a few patterns: The women were between the ages of 18 and 48. They also had a rare combination of CVST and low levels of platelets – colorless blood cells that help clots form.
Before the vaccines were authorized, this combination was primarily seen in association with the blood-thinning drug heparin. In rare cases, people taking the medication develop antibodies that bind to a specific platelet, which can make them more susceptible to clots.
“This observation of the low platelet count is part of the mystery and something that has to be worked through to see if that’s connected or not,” Namandjé Bumpus, director of the pharmacology and molecular sciences department at Johns Hopkins Medicine, told Insider.
But medical experts stressed the need for more data before associating the clots with any particular group yet.
“Everything is just like a big muddied water and then you just try to clear things out as much as you can to try to evaluate what is going on,” Gulick said.
Vaccinations may slow for the homeless, prisoners, or rural Americans
Shortly after US regulators announced a pause in J&J’s vaccine, White House COVID-19 coordinator Jeff Zients said the recommendation wouldn’t affect the pace of the US vaccine rollout.
“We have more than enough supply of Pfizer and Moderna vaccines to continue the current pace of about 3 million shots per day,” Zients said at a Tuesday press briefing.
Indeed, many health departments, pharmacies, and vaccine clinics that planned on administering Johnson & Johnson were able to quickly procure other shots so people didn’t lose their appointments.
But some vaccination sites – particularly those in rural areas – were forced to shut down temporarily. A state-run mass vaccination site in Aurora, Illinois, was canceled earlier this week, terminating appointments of 1,000 people. Around the same time, a Johnson & Johnson clinic in Jefferson County, Illinois, put vaccinations on hold.
The J&J pause has also slowed the pace of vaccinations for homeless people, prisoners, and those unable to leave their homes due to illness or old age. J&J’s vaccine is the only single-dose shot authorized in the US, so it’s the easiest to administer. It’s also easier to store than the Pfizer or Moderna vaccines (it can be kept in standard refrigerators rather than freezers).
On top of that, people may gravitate toward J&J’s vaccine if they’re afraid of needles or have difficulty taking time off work to get vaccinated.
“We’re actually seeing that some people opt for the Johnson and Johnson shot just because of their circumstances – it’s one dose, it’s available, and so on,” Johan Bester, director of bioethics at the University of Nevada, Las Vegas School of Medicine, told Insider.
Without the J&J option, medical experts said, US health officials may have a harder time convincing more Americans to get vaccinated – even as new, more contagious variants drive up cases across the country.
Shares of Johnson & Johnson fell Tuesday after the US Food and Drug Administration and the Centers for Disease Control and Prevention jointly recommended a pause in the use of the company’s COVID-19 vaccine as they review reported cases of blood clots in people who had received the shots.
The FDA said the agencies are reviewing data involving cases of a rare and severe type of blood clot in six women after they received the vaccine. The agencies in a joint media call said one case was fatal and one person is in critical condition. At least 6.8 million doses of J&J’s vaccine have been administered in the US.
“We are recommending a pause in the use of this vaccine out of an abundance of caution,” said the FDA and CDC.
J&J shares fell 2.2% and declined by as much as 3.5% during the premarket session. J&J shares put pressure on the Dow Jones Industrial Average which slumped by more than 100 points. Meanwhile, shares of rival vaccine makers jumped after the news. Moderna shares surged 7.5% and Pfizer climbed by 1%.
The CDC said the Advisory Committee on Immunization Practices will meet Wednesday to further review the clotting cases and assess their potential significance and the FDA will review that analysis as it also investigates.
“Until that process is complete, we are recommending this pause,” the agencies said in the statement. “This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot.”
J&J shares have risen by more than 10% over the past 12 months.
Scientists and consumers groups sent a letter to the Food and Drug Administration (FDA) asking it to require that third-party online ordering services provide nutritional information.
The letter, addressed to FDA director Dr. Susan Mayne, asks the agency to extend existing rules on labeling to platforms like DoorDash, Seamless, and Uber Eats. “Guidance should make clear that both chain restaurants and TPPs (third-party platforms) are responsible for complying with the nutrition labeling requirements,” the letter says.
Current FDA labeling regulations apply to restaurants that have 20 or more locations, a spokesperson told Insider.
“FDA recognizes that the dining landscape has changed considerably since the menu labeling requirements were passed into law in 2010, especially with the rise of third-party websites and delivery apps to provide convenient options for ordering to dine at home,” a spokesperson told Insider by email.
“Though many third-party online ordering websites likely would not meet the definition of a covered establishment under our current requirements, and therefore would not be subject to menu labeling requirements, we encourage third-party websites and delivery apps to provide important nutrition information for the menu items offered on their platform. “
The FDA also says that many restaurants available for online include menus with nutritional information. “We encourage consumers to look directly on the restaurant or other covered establishment’s websites for nutrition information for their favorite menu items.”
This isn’t enough for the letter’s signers, which include the American Heart Association, Consumer Reports, Center for Science in the Public Interest, and others.
“For the menu labeling requirements established under the ACA to have their intended impact, consumers must have easy access to the labeled information,” the letter says. It argues that consumers need access to nutritional information at the point of ordering, and many of the benefits of labeling are lost if access involves extra steps.
DoorDash says restaurants can add nutritional information in the description field of menu items.
“We work hard to enable customers to have access to the most up-to-date and accurate menu information, which is why we provide partners on our platform with the ability to enter and edit menu information directly, including nutritional information. We welcome the opportunity to engage with policymakers and stakeholders on this and other important issues impacting our industry.”
Sabra is recalling about 2,100 cases of its 10 oz Classic Hummus, the Food and Drug Administration announced on Monday.
The product was recalled after a routine FDA screening found Salmonella in one of the tubs of hummus. The FDA said the affected products are unlikely to be found in stores, as the hummus is already halfway through its shelf life.
The recalled tubs were produced on February 10 and have a “Best Before” date of April 26. To date, no food-borne illnesses or consumer complaints have been linked to the product, according to the FDA.
The hummus was distributed across 16 states: Alabama, Arizona, Arkansas, California, Florida, Indiana, Mississippi, Maine, Missouri, Nebraska, North Carolina, New Jersey, Utah, Virginia, Washington and Wisconsin.
Salmonella is known to cause stomach cramps, fever, and diarrhea within 72 hours of eating contaminated food. Most Salmonella cases are mild and do not require medical treatment.
Sabra said that consumers with the contaminated product should return it to the company for a full refund.
Health authorities are urging Americans to avoid Real Water-branded alkaline water after five children in Nevada were hospitalized with liver failure after drinking it.
One family in the state has also sued the beverage brand.
Authorities including the Centers for Disease Control and Prevention (CDC) said Tuesday they had launched an investigation, but could not yet confirm that the water caused the illnesses.
The Food and Drug Administration (FDA) told consumers, restaurants, and retailers not to drink, cook with, sell, or serve the product until more information is known about the cause of the illnesses.
In November 2020, five infants and children from across four households in Clark County, Nevada were hospitalized with acute non-viral hepatitis, which caused acute liver failure, the authorities said. All have since recovered.
Other adults and children from two of the households experienced less severe symptoms, including fever, vomiting, nausea, loss of appetite, and fatigue, the authorities said.
Real Water says that its water is pH 9.0 and is “infused with negative ions.” It claims that this means the water “can help your body to restore balance and reach your full potential.” The brand is owned by Las Vegas-based company Affinity Lifestyles.com.
The patients all drank Real Water’s alkaline water before falling ill, which the FDA said was “the only common link” between the cases.
“Epidemiologic information currently indicates that this alkaline water product may be the cause of the illnesses,” it said.
Additional products could be connected to the “outbreak,” it added.
Real Water told News 3 Las Vegas, an NBC-affiliated station, that it would “work with the FDA to achieve a swift resolution.
“While the potential problem arose in Las Vegas, we are taking proactive steps to stop selling and distributing real water products throughout the United States until the issue is resolved,” it said. It had asked retailers to pull the product from shelves, it said.
Real Water did not immediately respond to Insider’s request for comment.
Family files civil complaint in Clark County
That same day, one of the families filed a civil complaint in Clark County that said three members of the household became ill after drinking the water, The Las Vegas Review-Journal reported.
Christopher Wren was hospitalized for several days in November after his bloodstream showed extremely high levels of an enzyme that indicates liver damage, while his two-year-old son was hospitalized with signs of liver malfunction, the lawsuit said, per the Review-Journal.
Emely Wren also suffered from extreme nausea and fatigue, but the couple’s daughter – who didn’t drink the water – had no symptoms, the Review-Journal reported, citing the lawsuit.
Pfizer’s management knew last year there was “a mold issue” at the Kansas facility now slated to produce the drugmaker’s urgently needed covid-19 vaccine, according to a Food and Drug Administration inspection report.
The McPherson, Kansas, facility, which FDA inspectors wrote is the nation’s largest manufacturer of sterile injectable controlled substances, has a long, troubled history. Nearly a decade’s worth of FDA inspection reports, recalls and reprimands reviewed by KHN show the facility as a repeat offender. FDA investigators have repeatedly noted in reports that the plant has failed to control quality and contamination or fully investigate after production failures.
The 1970s-era manufacturing site has had persistent mold concerns over the years and been the focus of at least four intense FDA inspections since Pfizer took over its operations in late 2015, when it acquired Hospira. At the end of the January 2020 inspection, FDA investigators appeared to be growing frustrated.
Pfizer’s plant managers told investigators they knew they had either bacteria or mold throughout the facility at various times of the year. In a Jan. 17, 2020, establishment inspection report obtained by KHN, one of three FDA experts who visited wrote that Pfizer said it addressed problems and added “more cleaning activities in response to mold” after a 2018 inspection and “yet, there are still unexplained discrepancies.”
After the January 2020 inspection report, Pfizer immediately developed and put in place a corrective action plan, company spokesperson Eamonn Nolan told KHN. Neither Pfizer nor the FDA responded to requests to provide a copy of the plan.
Nolan, in an email last week, said “significant investments have been made” in resources, equipment and the facility. He stated all improvements related to covid manufacturing would be completed before vaccine production begins. He declined to provide details on when production of the vaccine would begin, but said the site is currently operating in a state of good manufacturing, which means it has met a regulatory standard enforced by the FDA.
“We are confident in the McPherson site’s ability to manufacture high-quality COVID-19 vaccine,” he wrote.
Large clinical trials have found Pfizer’s vaccine to be safe and 95% effective against covid.
Balancing safety with supply needs
News that the plant will be a fill-and-finish site for the Pfizer-BioNTech covid vaccine means more watchful eyes focused on the facility. “That alone should be helpful,” said Barbara Unger, a former pharmaceutical industry executive who now does manufacturing audits for companies.
It is unclear whether FDA investigators have returned to check on production practices in McPherson or plan to visit before vaccine production begins. The FDA did not respond to specific questions. FDA spokesperson Abigail Capobianco wrote in an email that the public “can be assured that the agency used all available tools and information to assess compliance.”
Pfizer’s emergency use authorization letter for its mRNA vaccine includes safeguards, such as quarterly reports to the FDA and a quality analysis from the company for each manufactured drug lot at least 48 hours before it is distributed.
The plant’s manufacturing issues can be traced in FDA reports dated from 2011 to last year. Several former FDA staffers and industry experts said the ongoing challenges in McPherson highlight how agency officials must balance aggressively going after a company’s manufacturing practices with the need to keep the supply of medications flowing to patients.
“I do not envy the FDA choices,” Unger said, describing a balancing act. “Which has the more significant public health risk?”
A ‘severe risk of harm’
The site produces a wide array of sterile, generic medications used in hospitals, and its troubles have played a role in some big health system shortages, specifically for injectable opioid analgesics, according to a 2018 FDA statement.
The FDA rejected Pfizer’s biosimilar version of Amgen’s anemia drug Epogen because of concerns about the fill/finish plant in 2017. The same year, John Young, who was a group president at Pfizer, told investors the company had submitted a “corrective and preventative action plan” for the facility.
That is the same language used after the January 2020 inspection, which said there were contamination concerns for the site but not in the medicines. And it was Young, now Pfizer’s chief business officer, who last month told Congress that Pfizer had added production lines at the McPherson site to help meet covid-19 vaccine demands.
The facility’s record of recalls and field alerts include vials of medication that contained glass and cardboard particles and, as one customer complained, a “small insect or speck of dust.”
A 2017 FDA warning letter – which is a strong rebuke for the agency – said the contaminants such as cardboard and glass found in vials posed a “severe risk of harm to patients” and indicated that the facility’s process for manufacturing sterile injectable products was “out of control.”
FDA records show that multiple batches of vancomycin hydrochloride, a drug injected into hospital patients who have an infection that penicillin won’t treat, were recalled in 2016 and 2017.
John Avellanet, an FDA compliance expert and principal at Cerulean Associates, reviewed the 2020 inspection reports. He said he fears the fixes have been little but “window dressing.”
“They may have solved it in one instance, like the cardboard particles. But for some reason, they were never able to solve the contamination,” Avellanet said. “Whatever they are doing for quality control testing doesn’t appear to be working, because if it was working they wouldn’t continue to have these contamination problems.”
Pandemic has taken a toll on regulation
Pfizer shut down McPherson’s manufacturing in December 2017 even though the FDA had visited two months earlier and improved the facility’s inspection rating. McPherson’s management suspended production and rejected batches of finished products after finding mold on equipment in a filling area, according to an FDA inspection report. The facility returned to production weeks later.
When the FDA came back to inspect in late summer 2018, it found that procedures to prevent microbiological contamination of drugs were lacking. It also noted a lack of employee training, employees not following procedures, obstructed surfaces and in-house testing that did not guarantee drugs met standards.
In 2019, when CEO Albert Bourla took the helm at Pfizer, he told analysts it would be another hard year for U.S. hospitals to get their hands on sterile injectables because of ongoing work at the McPherson plant.
Since then, the coronavirus pandemic has taken a toll on the FDA’s ability to inspect plants, according to a recent report from the U.S. Government Accountability Office. The agency halted non-urgent foreign and domestic inspections in March 2020 out of concerns for staff safety and has since resumed select visits to domestic plants.
John Fuson, a partner at the law firm Crowell & Moring and former associate chief counsel at the FDA, said the agency has sent surveys to manufacturers to help it prioritize inspections. While not speaking directly about the Pfizer plant, Fuson said the FDA lacks the resources to do all the inspections “we might like it to do.”
It is unclear what oversight Pfizer’s McPherson facility has had in the past year. In 2020, the pharmaceutical company Gilead Sciences signed a multiyear agreement with Pfizer to produce its covid treatment remdesivir in the Kansas plant. Gilead spokesperson Arran Attridge wrote in an email that Gilead “evaluates our manufacturing partners’ facilities” to make sure they follow regulations.
FDA inspectors visited the McPherson plant annually before the pandemic, according to public FDA records. The plant was given ratings of VAI, or voluntary action indicated, or OAI, official action indicated, depending on the inspection. John Godshalk, a former FDA investigator who worked on vaccines, said a VAI is one of the most common inspection ratings given. That means the FDA is “trusting the company to fix” the observations made during the inspections, he said.
The FDA assigned Pfizer’s McPherson facility a VAI rating in January 2020 – and company executives were so pleased they reported in their third-quarter financial filing that the agency had “upgraded” the plant.
Before January 2020, the McPherson plant appears to have been operating with the more severe OAI rating since its 2018 inspection, according to FDA reports. Former FDA investigator Godshalk said an OAI puts the company on notice. It’s “what you don’t want as a company,” he said.
Pfizer employs about 1,500 people at the McPherson plant, plus contractors. Kasi Morales, executive director of McPherson Industrial Development Co., said the facility is the largest employer in the industrial town about an hour north of Wichita, Kansas, and not far from Interstate 70, a major east-west thoroughfare across the country.
The 2020 inspection report that led to McPherson’s “upgraded” rating listed repeat observations that involved quality control procedures not being fully followed and “contamination” with mold and bacteria on surfaces because of humidity and cleaning practices.
No contamination was found in the medications themselves during the inspection, but investigators described seeing operators “leaning over and talking over sterilized items being unwrapped.”
Notably, the 2020 inspection report states early on that Pfizer had made “significant management changes” since the previous inspection in 2018. That latest inspection spanned three weeks from December 2019 to January 2020 and inspectors wrote “management was cooperative and no refusals were encountered.”
Christopher Smith, vice president of quality operations for Pfizer’s U.S. and European Union sterile injectables, was at the McPherson facility periodically during the visit. In the end, he “expressed discontent” with several of the 2020 observations made by investigators and “repeatedly sought clarifications.”