The Food and Drug Administration on Friday cleared the way for Florida’s first-in-the-nation plan to import lower-priced prescription drugs from Canada, a long-sought approach to accessing cheaper medications that follows decades of frustration with U.S. drug prices.
Republican Gov. Ron DeSantis signed the plan into law in 2019, but it required federal review and approval by the FDA, which controls prescription drug imports.
Democratic President Joe Biden has backed such programs as a way to lower prices, signing an executive order in 2021 that directed the FDA to work with states on imports.
The policy change represented a seismic shift after decades of lobbying by the pharmaceutical industry, which said imports would expose U.S. patients to risks of counterfeit or adulterated drugs. The FDA also previously warned of the difficulties of assuring the safety of drugs originating from outside the U.S.
But the politics have shifted in recent years, with both parties — including former President Donald Trump — doubling down on the import approach.
The FDA said Florida’s program will be authorized for two years. Under federal requirements, state officials must test the drugs to make sure they’re authentic and relabel them so that they comply with U.S. standards.
Florida’s health department must also provide a quarterly report to the FDA on the types of drugs imported, cost savings and any potential safety and quality issues.
“These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs,” FDA Commissioner Dr. Robert Califf said in a statement.
Many people already buy at least some of their medicines from pharmacies in Canada or Mexico, although technically it’s illegal to import them.
Work on allowing state imports began under Trump, a relentless critic of industry pricing.
Under the current regulations, states can import certain medicines through pharmacies and wholesalers. DeSantis has previously estimated taxpayers could save up to $150 million annually under the program.
The state’s proposal includes a number of drug classes, including medications for asthma; chronic obstructive pulmonary disease, or COPD; diabetes; HIV and AIDS; and mental illness.
The medications would be only for certain people, including foster children, inmates, certain elderly patients and — eventually — Medicaid recipients.
Like most developed nations, Canada sets limits on the prices drugmakers can charge if they wish to enter the market. Health officials there previously have suggested their country’s prescription drug market is too small to have any real impact on U.S. prices.
The U.S. has long had the highest prescription drug prices in the world, with essentially no government limits on what companies can charge. Only in 2022 did Congress pass a law allowing the federal government to negotiate prices for a small number of medications used by seniors in the Medicare program. The first such negotiations are set to take place later this year.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
These monkeys — called “rhesus macaques” — were originally brought to Florida by the manager of a glass-bottom boat operation, who released six on an island in the Silver River to attract tourists.
However, the monkeys swam away from the island into the surrounding forest, breeding and increasing their numbers over the years.
While the population of monkeys in the Silver Springs State Park has reached as high as 400 at some points, trapping and removal efforts have kept them from getting out of hand. As of 2015, the FWC reported that there were around 190 inside the park.
Nowadays, these monkeys can be found throughout the state, though the FWC says that these sightings likely stem from the group of monkeys at Silver Springs.
Aside from environmental concerns, these monkeys pose a threat to public health, as rhesus macaques in Florida have tested positive for herpes B.
The CDC states that this viral infection is extremely rare, but it can lead to severe brain damage or even death. The virus can be transmitted by these monkeys through bites, scratches or contact with bodily fluids.
In addition, these monkeys may become aggressive when fed by people, so the FWC passed a rule in 2017 prohibiting locals from feeding any wild monkeys in the state.
According to the FWC’s rhesus monkey tracker, the following counties have had credible sightings of these monkeys outside of the core population:
The FWC provides these tips for rhesus macaque encounters:
Never approach or offer food to wild monkeysIf a monkey is encountered, keep children close and pets leashedDispose of uneaten food and garbage in closed trash containersIf bitten or scratched by a wild monkey, immediately wash the wound and seek medical attention. Call the National B Virus Resource Center for emergency information at (404) 413-6550.If you observe a wild monkey that poses a threat to people, call the FWC’s Wildlife Alert Hotline at (888) 404-3922Any rhesus macaque observations seen outside of the core population near Silver Springs should be reported by calling the Exotic Species Hotline at (888) 483-4681 or by clicking here
More U.S. hospitals are requiring masks and limiting visitors as health officials face an expected but still nasty post-holiday spike in flu, COVID-19 and other illnesses.
While many experts say this season likely won’t prove to be as deadly as some other recent winters, it still could mean hundreds of thousands of hospitalizations and many thousands of deaths across the country.
New York City last week instituted a mask mandate for the city’s 11 public hospitals. Similar measures were ordered last week at some hospitals in Los Angeles and Massachusetts. Some hospitals reinstated masking rules for employees months ago, in anticipation of a seasonal rush of sick people.
Flu and COVID-19 infections have been increasing for weeks, with high levels of flu-like illness reported in 31 states just before Christmas. Updated national numbers are to be released Friday, but health officials predict infections will grow in many states well into January.
“What we’re seeing right now, in the first week of January, is really an acceleration — of flu cases, in particular,” said Dr. Mandy Cohen, director of the Centers for Disease Control and Prevention.
There is some good news. Flu and COVID-19 cases may peak by the end of the month and then drop, Cohen said. Though the flu has been skyrocketing, this year’s cases are being caused by a strain that usually doesn’t cause as many deaths and hospitalizations as some other versions. What’s more, signs suggest current flu vaccines are well-matched to the strain.
“I don’t think it’s going to be overwhelming,” said Dr. William Schaffner, Vanderbilt University infectious diseases expert. He deemed the current season “moderately severe.”
The CDC is pointing the public to an agency website where people can look up their county, which can help them make decisions about whether to wear masks or take other precautions. Cohen urged people to get vaccinated and to seek treatment for flu and COVID-19.
Vaccinations are down this year, officials say. About 44% of U.S. adults had gotten flu shots by Dec. 23, according to the most recently available CDC vaccination survey data. Only about 19% of U.S. adults were reported to have received an updated COVID-19 shot as of early December.
COVID-19 cases are causing more severe disease than the flu but have been rising less dramatically. Health officials are keeping an eye on JN.1, a new version of the ever-evolving coronavirus. The omicron variant was first detected in the U.S. in September and just before Christmas accounted for an estimated 44% of COVID-19 cases.
The JN.1 variant may spread easier or be better at evading our immune systems, but there is no evidence that it causes more severe disease than other recent variants, health officials say. Current evidence indicates vaccines and antiviral medications work against it.
The CDC also has reported disappointing vaccination rates against another seasonal bug, respiratory syncytial virus, or RSV. That is a common cause of mild cold-like symptoms, but it can be dangerous for infants and older people. RSV cases rose in the fall but appear to have plateaued and are even going down in some places, according to the latest data.
At Hillsdale Hospital in southern Michigan, a 65% increase in respiratory illness activity in late December triggered a limitation to visitors in the birthing center. Only a spouse, a support person and grandparents can visit. They all must wear a mask and not show symptoms of sickness.
The restriction is common for the hospital around this time of year, said Dr. Nichole Ellis, a pediatrician who is the hospital’s medical chief of staff. But it’s more difficult this season, she added.
“In the past, we would have one … disease that we were tracking or monitoring at one time,” Ellis said. “But now, babies and children will have multiple diseases at the same time. It’s not that they just have RSV … but they’re getting RSV and COVID at the same time, or influenza and RSV at the same time because all of the diseases are prevalent in our community.”
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Kenya Hunter in Atlanta contributed.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Pennsylvania recorded a steep increase in the deaths of older adults following an abuse or neglect complaint the last few years, as COVID-19 ravaged the nation, complaints grew and agencies struggled to keep caseworkers on staff.
The staggering increase shown in state data — from 120 deaths reported in 2017 to almost 1,400 in 2022, a more than tenfold increase — may have had several contributing factors, and the state and county-level agencies that field and investigate complaints gave varying answers explaining why.
Mostly, Pennsylvania’s Department of Aging and county-level agency officials speculated that it had to do with a growing population of people 65 and older, an increase in complaints and the devastating impact of the COVID-19 pandemic on older adults.
One county said errors in its data entry procedure — now corrected — led to undercounting in the initial years. Another pointed to cases staying open longer.
Some county agencies wouldn’t answer questions about it at all.
The increase came as agencies in Pennsylvania and nationwide struggled to keep caseworkers on staff through the pandemic and manage caseloads.
The Department of Aging said it has no data to suggest that a lack of caseworkers contributed to the increase in deaths, and suggested that the data could be misleading since the deaths may have had nothing to do with the original abuse or neglect complaint.
“The data does not make any correlation between the provision of protective services and how the older adult died,” the agency said.
The department doesn’t track causes of death, and individual county-level agencies aren’t required to provide that information to the state. When caseworkers enter data on a case, they are given a choice of reasons for why a case was closed, including death.
If anything changed in recent years, state efforts to train caseworkers likely improved how data on cases was recorded and entered, former department employees and county officials said.
It’s not clear to what extent better data collection helps explain Pennsylvania’s increase, but evidence suggests that other similar jurisdictions did not see a similarly steep increase.
Officials from the National Adult Protective Services Association said they had not heard discussion of such a steep increase in deaths among the state programs that investigate abuse and neglect complaints of adults.
Although states have different practices for investigating complaints and collecting data, two states with similar-sized populations — Illinois and Michigan — also reported significant increases in deaths.
But those increases — roughly triple during the pandemic — were nowhere near the proportion of Pennsylvania’s.
The broader death rate of older adults did not increase nearly as steeply during the pandemic, going from about 4% of those 65 and older in 2018 to 4.5% in 2021, according to federal statistics.
All told, Pennsylvania’s data shows caseworkers reported closing 120 neglect or abuse cases due to death in 2017.
That number rose steadily every year. It reached 784 in 2020, 1,284 in 2021 and then 1,389 in 2022 — rising by more than 10 times in five years, or more than 1000%.
The number of complaints called into caseworkers rose over that period, too. But it rose by a much smaller proportion — by about half, or 55%, according to state data.
This year, the pace of cases closed due to death slowed a bit, but still remained well above 2020’s pace. Through the first six months of 2023, the number of deaths was 528, on pace for 1,056 over the full year.
The department also doesn’t disclose the details of case investigations or what shortcomings it finds when it inspects the performance of the 52 county-level “area agencies for aging” across Pennsylvania.
Some agencies are county-run while others are nonprofits, and field calls about elder abuse or neglect under state contracts. They employ caseworkers to investigate complaints and coordinate with doctors, service providers and if necessary, law enforcement.
Most calls involve someone who lives alone or with a family member or caregiver. Poverty is often a factor.
The department released the deaths data in response to a request filed by The Associated Press under Pennsylvania’s open records law.
The AP submitted the request after reviewing internal emails — also released through an open records request — showing that state protective services staff had become alarmed at how Philadelphia’s agency had handled the cases of three people in 2021.
The department refused to disclose the fate of the three people — including when a state lawmaker asked about it following AP’s story on it.
In Pennsylvania, state data shows caseworkers took longer to close some cases as the pandemic wore on and often handled more cases than state regulations allow.
The shortage of caseworkers during the COVID-19 pandemic became so extreme that, in 2021, then-Gov. Tom Wolf’s administration took the extraordinary step of marshaling state employees to handle investigations for Philadelphia’s agency.
The agency, the nonprofit Philadelphia Corporation for Aging, reported four cases closed due to death in 2017. By 2020, that number rose to 220. In 2021, it hit 472 before dropping to 295 in 2022.
Bob Burns, the director of Dauphin County’s Area Agency on Aging, said he wasn’t surprised by the increase in deaths, considering the ravages of the COVID-19 pandemic.
The shortage of caseworkers leads to higher caseloads because it might take longer to close out a case, Burns said. But, he said, counties began using experienced caseworkers up front to quickly investigate complaints to determine right away if a person was in a dire situation.
Gov. Josh Shapiro’s secretary for the Department of Aging, Jason Kavulich, told lawmakers in a March hearing that many county-level agencies “are struggling for a variety of reasons, from not having adequate staff to a high number of staff turnover to some serious training issues, that we need to get them up to an acceptable level of understanding.”
Even before the pandemic, the performance of area agencies on aging had drawn criticism.
In 2018, the state’s internal investigation agency, the Office of Inspector General, issued a report that criticized how the state and counties handle abuse and neglect reports. That report pointed to failures to properly investigate complaints under timelines required by state law and inadequate staffing of the Department of Aging office that monitors those agencies.
Look for flu and COVID-19 infections to ramp up in the coming weeks, U.S. health officials say, with increases fueled by holiday gatherings, too many unvaccinated people and a new version of the coronavirus that may be spreading more easily.
High levels of flu-like illnesses were reported last week in 17 states — up from 14 the week before, the Centers for Disease Control and Prevention said Friday.
“Folks are traveling a lot more this season. They want to see their families,” said the CDC’s Dr. Manisha Patel. “And all of that sort of adds to the mix” in the spread of viruses.
Health officials are keeping an eye on a version of the ever-evolving coronavirus, known as JN.1. The omicron variant was first detected in the U.S. in September and now accounts for an estimated 20% of cases. The CDC expects it to reach 50% in the next two weeks, Patel said.
It may spread easier or be better at evading our immune systems, but there is no evidence that the strain causes more severe disease than other recent variants, health officials say. And current evidence indicates vaccines and antiviral medications work against it.
As for flu, early signs suggest current vaccines are well-matched to the strain that is causing the most illnesses, and that strain usually doesn’t cause as many deaths and hospitalizations as some other versions.
But the bad news is vaccinations are down this year, officials say. About 42% of U.S. adults had gotten flu shots by the first week of December, down from about 45% at the same time last year, according to the CDC.
Americans have also been slow to get other vaccinations. Only about 18% have gotten an updated COVID-19 shot that became available in September. At nursing homes, about a third of residents are up to date with COVID-19 vaccines.
And only 17% of adults 60 and older had received new shots against another respiratory virus. RSV, respiratory syncytial virus, is a common cause of mild coldlike symptoms but it can be dangerous for infants and older people.
The CDC last week took the unusual step of sending a health alert to U.S. doctors urging them to immunize their patients against the trio of viruses.
The Carolinas are currently seeing the heaviest traffic for respiratory infections in emergency rooms, according to CDC data posted this week.
It’s not as dire as some past winters, but some patients are still waiting days to get a hospital bed, noted Dr. Scott Curry, an infectious diseases specialist at the Medical University of South Carolina in Charleston.
“We’ve barely been cold in South Carolina, and flu tends to hit us very hard when people actually get some cold weather to deal with,” he said. “We could get worse, very easily, in the next four to eight weeks.”
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
Low-cost airlines Ryanair and Malta Air won a court case Wednesday against the European Union’s decision to approve billions of euros in state aid by the French government to Air France and holding company Air France-KLM during the COVID-19 pandemic.
Ryanair has filed several court challenges against measures introduced by EU countries to help some airlines weather the fallout of coronavirus restrictions.
The bloc’s 27 members must seek approval from the European Commission, the EU’s executive branch, when granting financial support to companies. Many countries across Europe did so to help keep their airlines afloat during the pandemic.
Back in 2020, French authorities notified the European Commission of an aid measure of 7 billion euros ($7.67 billion), which was supposed to benefit Air France solely, to the exclusion of all the other companies in the Air France-KLM group. A year later, France told the European Commission about plans for 4-billion-euro ($4.38 billion) recapitalization of Air France and the holding company.
In both cases, the European Commission didn’t raise objections.
But the European General Court ruled that the Air France-KLM holding and KLM “were capable of benefiting, at least indirectly, from the advantage granted by the state aid at issue” and annulled the European Commission’s decisions.
“Where there are grounds to fear the effects on competition of an accumulation of state aid within the same group, the onus is on the Commission to exercise particular vigilance in examining the links between the companies belonging to that group,” the court said.
The ruling can be appealed.
The European Commission is also the EU’s anti-trust watchdog. As pandemic restrictions in 2020 brought travel to a halt and threatened the existence of airlines, the commission eased its policies, approving billions of euros in support for national flag carriers.
Under a fast-track system set up during what the commission described as “an unprecedented crisis,” Brussels approved around 3 trillion euros in state support across all sectors in member nations. Ryanair believes that 40 billion euros was granted to Europe’s airline sector alone.
