Science
The FDA knew long ago that red dye No. 3 causes cancer. Why did it take so long to ban it?
The Food and Drug Administration said Wednesday that the much-maligned red dye No. 3 will be banned in the United States because it has been shown to cause cancer in animals.
The decision, lauded by consumer advocacy groups, comes a full 25 years after scientists at the agency determined that rats fed large amounts of the artificial color additive were much more likely to develop malignant thyroid tumors than rats who weren’t given the food coloring. They also had an increased incidence of benign tumors and growths that can be precursors to cancer.
Those findings prompted the FDA to declare in 1990 that red dye No. 3 could not be used in cosmetics or drugs applied to the skin. The reason for the decision was clear: A federal law known as the Delaney clause says no color additive can be considered safe if it has been shown to cause cancer in animals or people.
Yet the dye remained a legal food coloring. It’s in the bright red cherries that dress up a bowl of Del Monte’s fruit cocktail. It makes Nesquik’s strawberry milk a pleasing shade of pink. It also colors beef jerky, fruit rolls, candy, ice cream and scores of other processed products.
Now food makers will have two years to reformulate their products without red dye No. 3. Drug companies have three years to remove it from their medicines.
The FDA does not seem to be bothered by the fact that this cancer-causing chemical will linger in the food supply. The agency’s view is that the biological process through which the dye causes cancer in rats doesn’t occur in people.
“We don’t believe there is a risk to humans,” Jim Jones, the FDA’s deputy commissioner for human foods, told members of Congress last month.
In announcing the ban, the agency added that people consume red dye No. 3 at levels far lower than those shown to cause cancer in two studies of rats. A host of other studies in both animals and humans did not show the dye to be cancerous.
Nonetheless, regulators revoked authorization of red dye No. 3 to satisfy a petition demanding that the Delaney clause be enforced.
Starburst-flavored Fruit by the Foot, which contains red dye No. 3. (Christina House / Los Angeles Times)
“Regardless of the truth behind their argument, it doesn’t matter,” said Jensen N. Jose, regulatory counsel for food chemical safety at the Center for Science in the Public Interest, which spearheaded the effort. “Once it’s established that it causes cancer, FDA must prohibit the chemical by law.”
This wasn’t the first case of the FDA banning a food additive it considers safe to comply with the Delaney clause. The situation shows why the federal law is long overdue for a refresh, food safety experts say.
“A lot of people think we need to reform this,” said Diana Winters, deputy director of the Resnick Center for Food Law and Policy at UCLA Law. “It does lead to some absurd results.”
The Delaney clause is part of a 1958 federal law that expanded the FDA’s regulatory authority over newfangled food additives developed during World War II that were making their way into consumer products, Winters said.
Back then, members of Congress were worried about the cancer risks posed by all sorts of man-made compounds. Even small amounts seemed capable of triggering cancerous growths if people encountered them over and over again.
Arthur Flemming, who served as President Eisenhower’s Cabinet secretary for health and welfare, told Congress at the time there was no way for FDA regulators to know whether any exposure level was low enough to be truly safe. Considering the many cancer risks lurking in the environment, he said, the government should “do everything possible to put persons in a position where they will not unnecessarily be adding residues of carcinogens to their diet.”
Signature Select rainbow cups, which contain red dye No. 3.
(Christina House / Los Angeles Times)
The issue was personal for Rep. James Delaney, a Democrat from New York City whose wife was undergoing cancer treatment at the time. He made sure the new law included a zero-tolerance provision for cancer-causing substances, though it said nothing about additives that might cause other kinds of health problems.
“No additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal,” the Delaney clause states. A 1960 amendment governing color additives extended the rule to dyes.
As the years went by, advances in toxicology allowed scientists to expand the list of known cancerous compounds, and to identify them in ever-smaller amounts. Regulators were no longer as clueless as they’d been in Flemming’s day.
In 1986, the FDA tried to take that progress into account as it evaluated the safety of two color additives — orange dye No. 17 and red dye No. 19 — for use in lipsticks, nail polishes, face powders and other cosmetics. The agency acknowledged that both dyes were capable of inducing cancer in laboratory animals. But it argued that the regulatory decision should be guided not by a literal interpretation of an aging law but by the real-world risks to people.
When those color additives were used as intended, those risks were vanishingly small: A panel of scientists from the U.S. Public Health Service determined the lifetime cancer risk posed by the red dye was 1 in 9 million at worst; for the orange dye, it was 1 in 19 billion. In both cases, the possibility of developing cancer was “so trivial as to be effectively no risk,” the panel concluded.
A federal appeals court agreed that the dyes seemed to be safe. In fact, the risks they posed were millions of times lower than the risks of smoking, the judges wrote.
Moreover, the judges noted, forbidding the use of chemicals that carry a minute risk of cancer might prompt manufacturers to use compounds that are more toxic, albeit in noncancerous ways. Substitutions like these would be “a clear loss for safety,” they wrote.
But none of that matters, the court ruled: If a dye or any other chemical is found to cause cancer in animals, the FDA’s only option under the Delaney clause was to forbid its use.
Nestle Nesquik strawberry milk, containing red dye No. 3. (Christina House / Los Angeles Times)
Regulators found themselves in a more absurd situation in 2018 when they were asked to revoke their authorization of a flavoring additive called myrcene.
When the synthetic compound was force-fed to rats at doses of 1 gram per kilogram of body weight for two years, the animals developed kidney cancer and other forms of renal disease. Female mice fed under the same conditions developed liver cancer as well, the FDA said.
But the amount of artificial myrcene consumed by a typical American is 813,000 times lower — around 1.23 micrograms per kilogram of body weight, the agency said.
Moreover, myrcene is a natural component of mangoes, citrus juices, cardamom, and herbs including basil, parsley and wild thyme. The amount of natural myrcene in the food supply is about 16,5000 times greater than its synthetic counterpart, the agency added.
Still, the FDA declared the additive unsafe “as a matter of law” while assuring the public that no one’s health was actually at risk when synthetic myrcene was on the market. It blamed the Delaney clause for the confusion.
In 2020, a group of food industry scientists said the problem goes well beyond confusion. Revoking approval for artificial myrcene “has contributed to the ongoing erosion of trust in regulatory agencies,” they argued in the journal Regulatory Toxicology and Pharmacology. Such decisions promote an irrational fear of chemicals and cause consumers to lose faith in the safety of the U.S. food supply, they wrote.
Red dye No. 3 was approved for use in U.S. food in 1907, when it was known as erythrosine. It won permanent listing as an authorized color additive for foods, supplements and ingested drugs under the name FD&C Red No. 3 in 1969.
Soon after that decision, an industry group called the Toilet Goods Assn. petitioned the FDA to upgrade the dye’s listing for cosmetics and topical drugs from provisional to permanent. The request triggered additional tests in the 1970s and ‘80s, including two long-term feeding studies in rats.
Beginning before birth and for their entire lives, the animals were put on diets that included the red dye at concentrations of 0.1%, 0.5%, 1% or 4%. Compared to male rats that didn’t consume any dye, male rats that ate the most had a significantly higher incidence of tumors — both malignant and benign — as well as abnormal cell growth in the thyroid. No other group had an increased incidence large enough to be considered statistically significant. Among female rats, the incidence of benign tumors was elevated for those on the 1% diet, though not for rats on the 4% diet, as would be expected if the dye were the cause of cancer in these animals.
After consulting with scientists from the National Toxicology Program and the U.S. Public Health Service, the FDA concluded that red dye No. 3 could cause cancer in animals. In 1990, the agency denied the industry group’s request for permanent listing.
That decision applied only to cosmetics and topical drugs, and had no immediate bearing on food products sold in the U.S. At that point, the dye had been permanently listed as an approved food additive for decades. Nothing in those rat studies indicated to the agency that its designation needed to change.
Over the years, the dye has been tested in mice, rats, gerbils, pigs, beagles and humans. An extensive review conducted by the World Health Organization and the Food and Agriculture Organization of the United Nations found “no concerns” about the dye’s ability to trigger cancer, impair fertility or cause developmental problems in people of all ages when consumed in realistic doses.
“Claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information,” the agency said Wednesday.
Frosted sugar cookies from Favorite Day Bakery, containing red dye No. 3.
(Christina House / Los Angeles Times)
Pitting the Delaney clause’s strict legal requirements against advances in cancer research has been a longstanding challenge for the agency, officials said.
“When we ban something, it will go to court,” Dr. Robert Califf, the FDA’s commissioner, told the Senate Health, Education, Labor and Pensions committee last month. “And if we don’t have the scientific evidence that will stand up in court, we will lose in court.”
The elaborate regulatory process for removing an additive from the food supply can certainly result in litigation, said Emily Broad Leib, director of the Center for Health Law and Policy Innovation at Harvard Law School.
“The Delaney clause probably works a lot better at the outset if you’re trying to add a new substance to food,” she said. “Once things are in food, it takes a really long time to remove it.”
The way some people see it, the problem with the Delaney clause isn’t that it forces the FDA to ban food additives that don’t pose a true cancer threat. It’s that the law doesn’t address all the other ways the foods we eat can be hazardous to our health.
“There’s a lot of things in foods naturally that cause cancer, and the Delaney clause doesn’t cover that,” said Alyson Mitchell, a food scientist at UC Davis. “It also does not speak to anything regarding other illnesses, whether it’s kidney dysfunction or ADHD or mental health issues or endocrine imbalances.”
The General Accounting Office (now known as the U.S. Government Accountability Office) raised this issue back in 1981, when it advised Congress to update the Delaney clause to reflect the latest scientific and medical knowledge. It would make sense for the law to apply “ equally to cancer-causing and non-cancer-causing substances,” the GAO said.
Other items that contain red dye No. 3: Del Monte fruit cocktail, Signature Select Jordan almonds, Betty Crocker Suddenly! pasta salad, and Jack Links beef stick and cheese. (Christina House / Los Angeles Times)
California has banned all uses of red dye No. 3 in the Golden State, and prohibited the use of six other dyes in foods served or sold in schools. Scientists who examined the dyes for the California Office of Environmental Health Hazard Assessment determined that “the behavioral factors are more of a concern” than the cancer risk, said Asa Bradman, an expert on exposure assessment and epidemiology at UC Merced and co-author of the comprehensive state report.
The FDA has studied the behavioral risks of color additives and hasn’t found “a clear and causal link,” an FDA spokesperson told The Times. Studies suggest some children with behavioral challenges like ADHD appear to be sensitive to food dyes, and that genetic variants affecting the body’s ability to break down histamine are a likely cause. In the FDA’s view, that doesn’t mean the dyes themselves are “neurotoxic,” the spokesperson said.
If there was convincing evidence that an artificial dye failed to meet FDA’s safety standards, the agency would take action whether the health threats were covered by the Delaney clause or not, the spokesperson added.
Mitchell, who worked on the California report with Bradman, said that because manufacturers have been phasing out red dye No. 3 for more than a decade, it’s not a significant concern for her. She’s more worried about the hyperactivity risk posed by red dye No. 40 because it’s ubiquitous in processed foods, especially those consumed by children.
“I’m grateful for the Delaney clause because I do think it’s been very helpful in trying to protect our food,” Mitchell said. “But it doesn’t go far enough. So much of this needs to be revisited.”
At a confirmation hearing for Dr. Marty Makary on Thursday, senators focused heavily on the safety of the abortion pill, with Republican lawmakers urging him to restrict access and Democratic lawmakers demanding that he maintain its current availability.
Dr. Makary, President Trump’s nominee to lead the Food and Drug Administration, signaled that he shared Republicans’ concerns about the current policy, issued during the Biden administration, which expanded access by allowing people to obtain the pills without an in-person medical appointment.
Several Democrats pointed to volumes of studies showing that the drugs are safe. Dr. Makary told members of the Senate health committee, which held the hearing, that he would review the pill’s safety and the policy at issue.
He said he would “take a solid, hard look at the data and to meet with the professional career scientists who have reviewed the data at the F.D.A. and to build an expert coalition to review the ongoing data, which is required to be collected.”
The hearing also touched on vaccines, with several lawmakers, including the committee chairman, Senator Bill Cassidy, Republican of Louisiana, questioning why an advisory committee meeting on next year’s flu vaccine had been canceled in recent weeks and asking whether it would be held later. He and others stressed that the flu panel met annually, and some reminded Dr. Makary that Robert F. Kennedy Jr., who oversees the F.D.A. as health secretary, had pledged transparency in agency decision-making.
Senator Patty Murray, Democrat of Washington, called the cancellation “unprecedented and dangerous” after decades of annual meetings.
Dr. Makary repeatedly reminded senators that he was not responsible for scrapping the meeting. He also suggested there was a need for a broader review of the role of vaccine committees that convene experts to advise the F.D.A. He shot back at criticism, saying there is a “huge difference” between “requiring every 12-year-old girl to get an eighth Covid booster” and “rubber stamping” the vaccine chosen by a global health panel that had targeted dominant influenza strains.
He offered no details about any school or entity that requires children to have annual Covid boosters.
He also was questioned about the measles vaccine in light of the current outbreak in Texas, where one child has died and 22 people were hospitalized.
“Vaccines save lives,” Dr. Makary said. “I do believe that any child who dies of a vaccine-preventable illness is a tragedy in the modern era.”
But he did not take the bait lobbed by Senator John Hickenlooper, Democrat of Colorado, who criticized Mr. Kennedy’s endorsement of vitamin A and cod liver oil as remedies for measles. Dr. Makary responded by saying that supplements can improve conditions like malnutrition, which is associated with poor outcomes in measles outbreaks.
Lawmakers also warned about staff cuts and hiring freezes the Trump administration has ordered and how they could affect workers who inspect the safety of the food supply, and urged Dr. Makary to review the layoffs among those staff members whose salaries are backed by industry fees.
They also touched on work related to chemicals like dyes in the food supply, an area Dr. Makary agreed to study, invoking European products with fewer additives as an area for review.
Among other issues raised during the hearing, the vexing problem of illegal vape products from China with unknown ingredients was stressed by Senator Ashley Moody, Republican of Florida.
The vapes tend to have high levels of nicotine, advertise thousands of puffs and come in flavors like strawberry lemonade that are appealing to adolescents.
Ms. Moody said it was concerning that the products were banned within China.
“Whoever comes in as the head of F.D.A., this is one of your problems you have to address immediately,” said Ms. Moody, who was previously Florida’s attorney general.
Blocking the flow of the unauthorized vapes has been a priority for major tobacco companies that have followed F.D.A. rules and marketed vapes in tobacco or menthol flavors in the United States. It’s a priority public health groups also share. Dr. Makary said he would address the problem with the F.D.A.’s law enforcement division and the Justice Department.
Throughout the hearing, several senators returned to the abortion pill and the F.D.A.’s oversight of policy changes during the lengthy history of medication abortion over more than two decades.
Mifepristone — part of the standard two-drug medication regimen now used in nearly two-thirds of abortions — has become a focal point of anti-abortion efforts since the Supreme Court overturned the national right to abortion in 2022.
In a lawsuit filed against the F.D.A. and other efforts, abortion opponents have demanded that the agency either withdraw approval for mifepristone or roll back regulations to prevent abortion pills from being prescribed by telemedicine and mailed to patients.
The Biden administration waived the in-person dispensing requirement in 2021. Senator Maggie Hassan, Democrat of New Hampshire, said that she was concerned that Dr. Makary would “unilaterally overrule the data that currently exists for political purposes and for political reasons.”
Dr. Makary repeated that he had no preconceived notions and would examine the data. “I wish you were hedging a little bit less today,” Ms. Hassan shot back.
Mifepristone, which blocks progesterone, a hormone necessary for pregnancy to develop, has long been regulated by the F.D.A. under an especially strict program that applies to only a small number of drugs.
For years after its approval in 2000, mifepristone could be prescribed only by a doctor and patients were required to attend three in-person doctor visits to obtain and take the medication. In 2016 and 2021, based on updated scientific evidence, the agency made several changes, including that nurse practitioners and some other health care providers could prescribe mifepristone and that patients did not have to pick up the medication in person.
Senator Josh Hawley, Republican of Missouri, argued that the policy change to drop the requirement for in-person appointments was made in anticipation of the Supreme Court decision that overturned Roe v. Wade.
Reproductive health experts and organizations, however, had long argued that the requirement was unnecessary for safety and noted that the F.D.A. had already allowed women to take the medication at home without being supervised by a doctor. The Covid pandemic increased the importance of allowing people to obtain the pill by mail because many patients were not able to visit clinics or abortion providers.
Pressed further by Mr. Hawley, Dr. Makary signaled that he shared the concerns of some abortion opponents and said that he knew doctors who preferred to give the drug in their office: “I think their concern there is that if this drug is in the wrong hands, it could be used for coercion,” he said.
Mr. Cassidy closed the hearing with a direct request: to change the policy back to what it was in the first Trump administration and require an in-person visit.
The F.D.A. has a staff of about 18,000 and a budget of about $7.2 billion. The agency has vast regulatory authority over products that include prescription and over-the-counter drugs, medical devices, tobacco and about 80 percent of the food supply. It also regulates artificial intelligence software used to scan medical images, an area where the agency has been dismissed as too permissive in its approvals.
If confirmed, Dr. Makary would first encounter tensions among staff members, who have been whipsawed by the Trump administration’s aggressive measures to reshape the federal bureaucracy in recent weeks.
The staff endured an initial round of about 700 layoffs, decimating some product-review teams that ensure the safety of medical devices such as surgical robots and systems that deliver insulin to people with diabetes. Those firings were followed by some job reinstatements, though many of those in the tobacco division who review the safety of new products and lost their positions, were not called back.
Asked about the layoffs, Dr. Makary said he supported efforts to increase efficiency and that he would review recent personnel decisions.
Pam Belluck contributed reporting.
Science
Contributor: How federally funded research saved my son's sight — and his life — from a rare cancer
If you want to make this country great, imagine the strength of a nation whose children have been fought for and know they have been fought for.
Last month, my son reached two years in remission from a rare, malignant cancer that almost took his eye and his life. He is alive, well and enjoying 20/20 vision because of a groundbreaking treatment that was pioneered by National Institutes of Health researchers, among others, and funded by the government grants the Trump administration is blocking and threatening to cut. If the president continues on this course, children diagnosed during and after this administration will needlessly fare worse than those who came before.
My son Jack was diagnosed in 2022 with retinoblastoma, a malignant childhood cancer of the central nervous system that originates and grows in the eye. If left untreated, it typically migrates through the optic nerve to the brain, eventually metastasizing and taking the life of the child.
Because the cancer usually attacks children under the age of 3, its victims are often unable to report the symptoms of a mass blocking their vision until it’s too late to treat with procedures that can salvage the eye. That’s when enucleation — removal of the eye — is required.
This is why pediatricians developed standard screening for retinoblastoma starting at birth. This now-routine preventative care has enabled medical professionals to find and treat most cases without a loss of vision or life. Because of these developments and others, retinoblastoma has a very high survival rate in 21st century America.
Jack’s was one of very few documented diagnoses with retinoblastoma after the age of 8. His oncologist suggested his tumor had been hiding in a dark corner of his retina for years, out of his vision and that of physicians; other doctors thought it had “self-arrested” or presented late and grew rapidly. We discovered it only because it burst from the impact of a belly flop at the neighborhood pool, spewing cancer cells in a constellation of poison floating inside his still-intact eyeball, visible to Jack as spots that didn’t go away.
It took weeks for doctors to nail down the diagnosis. When we walked out of that appointment on a day that was so windy I had to hold onto my dress, I put Jack in the car, turned the radio on for him, closed the passenger door and walked about 30 feet away to scream in the parking lot. “My baby!” I wailed through the phone to my mother.
It was an advanced-stage tumor, complicated by the release of cancer cells inside his eye. They could now attach and grow anywhere within — including the optic nerve, with its direct connection to his brain — if we didn’t act quickly. We might have just days before it was too late.
“We could remove his eye,” our oncologist offered at first, “and even that might not be enough.”
Medical researchers from universities and the National Institutes of Health rally near the Health and Human Services Department’s headquarters in Washington.
(John McDonnell / Associated Press)
Then he explained that we could try to save his eye with a highly advanced procedure called intra-arterial chemotherapy, or IAC. It involves threading a catheter through the thigh’s femoral artery, behind the heart through the carotid artery and into the skull. An interventional radiologist, guided by MRI, releases the chemotherapy agent directly into the artery feeding the retina. This allows doctors to deliver more aggressive and targeted medicine to the diseased cells and limit damage to the healthy ones.
Our oncologist explained that IAC is still a very new technology but one with extraordinary promise whose benefits far outweighed the risks for Jack.
My son underwent six rounds of intra-arterial chemotherapy and seven rounds of intravitreal chemotherapy, in which the medicine is injected directly into the eye. He went under anesthesia 13 times in six months, required monthly breathing treatments that made him spit gray foam, and lost most of the brow and all the lashes around the affected eye. His list of drugs included ketamine, propofol, hydromorphone, melphalan, fentanyl, topotecan, pentamidine, albuterol, prednisolone and aldosterone. At one point, he needed epinephrine because he nearly went into cardiac arrest. Toward the end of his treatment, he received cryotherapy to kill the base of the tumor and woke up from surgery in so much pain that he gritted his teeth to the point of cracking one.
At every turn, my family was reminded of our privilege — to live in a country that was scientifically advanced enough to have developed such miracle treatments, to live in a city (Denver) with such good hospitals, to have good health insurance through my husband’s employer. If we had lived without such access to care, in a country lacking our resources or just 15 years earlier, our story would have ended differently. Instead, nine months after his diagnosis, thanks to the advanced research our country has supported socially, academically and financially, my son’s cancer was in remission.
My family recently attended a gathering with other retinoblastoma survivors, from toddlers to adults who had conquered the disease decades earlier. As each survivor entered the conference, it became evident that this was once primarily a disease of blindness: The price of survival was generally a loss of sight and eyes. Some of the older survivors had facial abnormalities from radiation or enucleation. Some had canes or family members to guide them. When we told the group that Jack’s body, vision and dream of becoming a pilot were all still intact, many gasped in awe that the science had advanced so far.
But now the Trump administration’s lack of empathy threatens other children and families facing such horrific diagnoses. Continuing research on intra-arterial chemotherapy and other treatments at the University of Colorado’s Anschutz Medical Campus, where Jack was treated, is paid for by programs in the administration’s crosshairs. “These cuts to NIH funding jeopardize the foundation of our life-saving research,” a university spokeswoman told Chalkbeat Colorado. “Reduced research capacity means fewer scientific discoveries, job losses and delayed advancements on therapies and cures that could improve — and save — lives.”
I wonder whether our hospital will be able to continue offering groundbreaking treatments should Jack face a recurrence. And will the newly diagnosed have the same access to care that we did? What greatness can be celebrated when a mother fears she will lose her child’s access to lifesaving treatment?
My son’s recovery was a direct result of the greatness of our country and its past leaders, who had the foresight to pursue progress and excellence in science and refuse to accept losing children without a fight. Because of it, I believe my son will someday fly planes. And I can only hope the next child who faces a dire disease will get the same chance he did.
Dayna Copeland is a writer and teacher in Colorado.
Florida’s insurance regulator has demanded an unusually intrusive trove of data on millions of prescription drugs filled in the state last year, including the names of patients taking the medications, their dates of birth and doctors they’ve seen.
The Florida Office of Insurance Regulation in January sought this information from pharmacy benefit managers like UnitedHealth’s Optum Rx and CVS Health’s Caremark, companies that oversee prescription drugs for employers and government programs.
It remained unclear why the state was ordering the submission of so much data. In a letter to one benefit manager reviewed by The New York Times, the regulator said the state required the data to review whether the benefit managers, known as P.B.M.s, were compliant with a 2023 state law aimed at lowering drug prices and reining in the managers.
But the demand is sparking concerns about government overreach and patient privacy.
“You don’t need such granular patient information for purposes of oversight,” said Sharona Hoffman, a health law and privacy expert at Case Western Reserve University. She added: “You have to worry: Is the government actually trying to get information about reproductive care or transgender care or mental health care?”
Florida’s six-week abortion ban, enacted by Gov. Ron DeSantis, a Republican, and the state’s Republican-dominated legislature, requires that doctors who prescribe abortion pills dispense them in person, not through the mail. Another Florida law banned transgender transition care for minors and made it harder for adults to seek such care. Last year, a judge struck down key parts of that law, though it is still being enforced while the legal fight makes its way through the courts.
The data requested by the state could, in theory, be used to determine whether physicians are complying with those laws.
It was also unclear whether any of the benefit managers had complied and turned over the information to the state.
Some benefit managers and the employers that hire them to handle prescription drug benefits for their workers have also criticized the state’s demand.
A group of large employers, the American Benefits Council, is asking the Florida regulator to withdraw its order to turn over the information. In a letter to the state, the council’s lawyers wrote that the “demand impermissibly violates the health privacy and security of millions of Floridians,” and that the state had not clearly outlined its authority or reasons for the action.
“We have a duty to employees and their data,” Katy Johnson, the president of the council, said in an interview.
Shiloh Elliott, a spokeswoman for Florida’s insurance regulator, said that objections to the state’s data request “are clearly from those who do not want to be regulated or have any oversight in their industry.” She said the office “will continue to request data in the best interest to protect consumers.”
Rosa Novo, the administrative benefits director for Miami-Dade County Public Schools, which provides health coverage to about 45,000 people, said in an interview that while she appreciated the state’s efforts to address drug prices, it was unclear why it would need this level of detailed information about patients and their medications.
“My doctor is the only one who should know that,” Ms. Novo said.
Federal privacy law allows benefit managers to hand over limited data about individual patients in certain circumstances, such as when regulators are conducting an audit. But, according to experts, Florida’s data request could violate the law because it is so broad and may go beyond what the regulator needs to conduct its review.
Experts said that another concern with Florida’s request is that when sensitive patient data is in multiple hands, it raises the risk of a breach in which the information may be stolen.
Ms. Elliott, the spokeswoman for the regulator, said those concerns “should be addressed to the actual health care insurance companies that have had countless data breaches exposing millions of Americans’ sensitive information.”
Florida’s data order was first reported by Bloomberg.
Like other states, Florida already has access to some of the data it is seeking, such as detailed information about prescriptions that are paid through Medicaid. But that data is generally strictly walled off, accessible only to staff members whose jobs require it.
Benefit managers often field requests from government regulators asking for slices of data to conduct audits or investigations. Such requests typically ask benefit managers to strip out patient names, and other identifying details, or ask for a small sample of patient claims.
By comparison, Florida’s data request was “pretty expansive and unprecedented,” said Joseph Shields, the president of a group of smaller benefit managers, Transparency-Rx.
Florida sought data not only on Florida residents, but also on patients who may have filled a prescription while visiting the state. Its request included patients covered through the federal Medicare program and commercial plans through employers that are regulated under federal law rather than state law, according to the regulator’s letter to one benefit manager reviewed by The Times.
The Prescription Drug Reform Act, the Florida law the regulator used to justify the data request, imposed new reporting requirements on the benefit managers but said nothing about a mandate requiring them to turn over such detailed patient information. Benefit managers have fiercely fought efforts to scrutinize their business practices.
Patricia Mazzei contributed reporting from Florida.
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