by tyler | May 15, 2023 | CNN, health
The Covid-19 pandemic hit a major milestone this month as public health emergency declarations were ended by both the United States government and the World Health Organization. Emergency declarations for mpox also recently ended.
This doesn’t mean Covid-19 and mpox are no longer of concern, but it does mark the end of the availability of certain logistical capabilities to manage them.
Still, other critical health challenges were identified as health emergencies years before the start of the Covid-19 pandemic and continue to be so: the opioid crisis in the US and the global spread of poliovirus.
Some public health concerns can be serious health threats without a formal emergency declaration, said Dr. Tom Frieden, former director of the US Centers for Disease Control and Prevention.
It largely boils down to the logistics of government operations.
“When there’s an unusual situation that requires multiple parts of an agency or multiple parts of the government or multiple parts of society to come together and coordinate, collaborate and work efficiently, then an emergency declaration can be a useful tool,” said Frieden, president and CEO of Resolve to Save Lives, an organization focused on global epidemic prevention and cardiovascular health.
“Sometimes, an emergency is declared to make the point that it’s a big problem, to get people’s attention. Sometimes, an emergency is declared to get things done because that’s the only way you can bring certain governmental capacities to bear.”
According to WHO, a public health emergency of international concern is “an extraordinary event” that poses public health risk through the international spread of disease.
It creates an agreement between countries to abide by WHO’s recommendations for managing the emergency, often requiring a “coordinated international response.” Each country, in turn, declares its own public health emergency – declarations that carry legal weight. Countries use them to marshal resources and waive rules in order to ease a crisis.
In the US, the secretary of the Department of Health and Human Services can declare a public health emergency for diseases or disorders that pose a threat, including “significant outbreaks” of an infectious disease, bioterrorist attacks or otherwise.
This triggers the availability of a set of resources and actions for the federal government, such as additional funds and data and reporting requirements.
Emergency declarations typically last up to 90 days, with formal renewal required as necessary every three months after that.
The opioid crisis was determined to be a public health emergency in October 2017, during the Trump administration, driven by the rising rates of opioid-related deaths and opioid use disorder.
The declaration has been renewed for more than five years, most recently at the end of March.
According to the CDC, the opioid epidemic started in 1999 with a rise in prescription opioid overdose deaths. Deaths started to increase precipitously as synthetic opioids – particularly fentanyl – started to take over in 2013.
In 2021, overdose deaths reached record levels in the US, and about three-quarters – more than 80,000 deaths – involved opioids.
Within the first year of the opioid emergency declaration, HHS used expanded authorities to field a survey about treatment for opioid use disorder among providers and to expedite research on the topic.
Public health emergencies are also declared to help with recovery after natural disasters, most recently for severe storms that hit Mississippi in March.
However, the Government Accountability Office considers both federal management of the public health emergency system and efforts to combat drug misuse to be “high-risk” areas that are vulnerable or in need of broad reform.
In a recent report, the federal watchdog group said that it has found “persistent deficiencies in HHS’s leadership role preparing for and responding to public health emergencies” and no demonstrated progress in federal agencies’ actions to address drug misuse.
WHO has considered poliovirus a public health emergency of international concern since 2014.
A committee formed to address the emergency reviewed the most recent data on cases and spread this month and voted unanimously that ongoing risks merited an extension of the emergency declaration, which the director-general formalized Friday.
The committee was “encouraged by reported progress” but says that risks remain high for factors including weak vaccination rates that could have been affected by the Covid-19 pandemic.
WHO identified seven counties with potential risk for international spread. And the US is among a group of 37 countries with recently detected cases.
In July, a polio case identified in New York became the first in the US in nearly a decade. The identified case, along with several positive wastewater tests in nearby communities, met WHO criteria to consider the US a country with circulating poliovirus.
Experts warned that it could just be the “tip of the iceberg,” with hundreds of cases spreading silently.
Childhood vaccination rates in the US dropped during the Covid-19 pandemic. A CDC report found that about 93% of kindergarteners enrolled in the 2021-22 school year got the required vaccines, including measles, mumps and rubella (MMR); diphtheria, tetanus and acellular pertussis (DTaP); and polio. Coverage fell for the second year in a row amid the pandemic, from about 94% the previous year and below the federal target of 95%.
While no longer under a formal emergency declaration, Covid-19 continues to be part of the “landscape of health threats,” Frieden said.
But the efficiency and coordination that the formal declaration helps facilitate should always be the goal.
“I think there are really important lessons from Covid, including the need to have a much more resilient public health system so that we can find problems quickly and implement effective solutions quickly,” Frieden said.
by tyler | May 15, 2023 | CNN, health
Don’t use sugar substitutes if you are trying to lose weight, according to a new guideline from the World Health Organization.
The global health body said a systematic review of the available evidence had suggested that use of non-sugar sweeteners, or NSS, “does not confer any long-term benefit in reducing body fat in adults or children.”
The review also indicated that there might be “potential undesirable effects” from the long-term use of sugar substitutes such as an increased risk of type 2 diabetes and cardiovascular diseases.
“Replacing free sugars with NSS does not help with weight control in the long term. People need to consider other ways to reduce free sugars intake, such as consuming food with naturally occurring sugars, like fruit, or unsweetened food and beverages,” Francesco Branca, WHO director for nutrition and food safety, said in a news release.
“NSS are not essential dietary factors and have no nutritional value. People should reduce the sweetness of the diet altogether, starting early in life, to improve their health.”
The recommendation included low or no calorie synthetic sweeteners and natural extracts, which may or may not be chemically modified, such as acesulfame K, aspartame, advantame, cyclamates, neotame, saccharin, sucralose, stevia and stevia derivatives, WHO said.
The organization said its recommendation applies to all people except those with pre-existing diabetes.
A total of 283 studies were included in the review. WHO said that the recommendation was “conditional” because the identified link between sweeteners and disease outcomes might be confounded by complicated patterns of sweetener use and the characteristics of the study participants.
“This signals that policy decisions based on this recommendation may require substantive discussion in specific country contexts, linked for example to the extent of consumption in different age groups,” the news release said.
Non-sugar sweeteners are widely used as an ingredient in pre-packaged foods and beverages and are also sometimes added to food and drinks directly by consumers.
WHO issued guidelines on sugar intake in 2015, recommending that adults and children reduce their daily intake of free sugars to less than 10% of their total energy intake. Following that recommendation, interest in sugar alternatives had intensified, the review said.
by tyler | May 12, 2023 | CNN, health
Most parents wouldn’t be thrilled with the idea of their kids getting hooked up to an IV bag filled with trillions of viruses.
But for Melanie Hennick, whose son, Connor, has Duchenne muscular dystrophy, it was an opportunity she hoped would change his life.
“We knew this wasn’t a cure,” Hennick said. “But it was a chance.”
Connor is one of just dozens of kids to have received SRP-9001, an experimental gene therapy that aims to slow or stop the progression of Duchenne muscular dystrophy, or DMD. Current treatments for the disease – which primarily affects boys because of the way it’s inherited – include steroids and, later, heart drugs. But none stop it.
SRP-9001 uses viruses to ferry a copy of a gene to muscles to help make up for one that’s causing the disease. Hennick and many other parents like her are advocating for the treatment’s accelerated approval today in a meeting of outside advisers to the US Food and Drug Administration.
The advisers will vote on whether to recommend the treatment, and then the FDA will decide whether to follow their advice. The FDA’s decision, expected by the end of the month, will have implications not just for families like Connor’s but for how the agency regulates treatments like this one more broadly: It would be the first of its kind of medicine – one-time treatments delivering a gene to try to fix a disease – to get accelerated approval, a faster track through the regulatory process. Its approval would set a precedent for other drugs like this based on so-called surrogate endpoints, a measure of what the drug does in the body, before further clinical evidence is available.
“Approval of a gene therapy for Duchenne muscular dystrophy will be huge,” said Jeffrey Chamberlain, a professor at the University of Washington School of Medicine who helped pioneer gene therapy approaches for the disease. “This, I think, will spur further research and further development of gene therapies for other diseases.”
DMD patients don’t have a lot of time to wait. Kids with Duchenne typically lose the ability to walk before they’re teenagers and often don’t live well into their 30s, Chamberlain said. He’s not directly involved with SRP-9001, which is being developed by Sarepta Therapeutics, and is on the scientific advisory board for another company working on DMD gene therapies, Solid Biosciences.
“Gene therapy appears to be a really good approach to try to treat this disease, because it’s a genetic disease,” Chamberlain said. “The cause of the disease is a mutation in a single gene.”
That gene is responsible for the production of dystrophin, a protein key to the structure of muscle cells.
“It’s kind of like the two-by-fours that make up your house,” Chamberlain said. “It’s really important for just holding everything together.”
SRP-9001, invented at Nationwide Children’s Hospital in Columbus, Ohio, before being licensed for development by Sarepta, delivers a miniaturized version of the dystrophin gene to cells, aiming to help them make a version of the muscle-preserving protein.
In a key clinical trial, the therapy appeared to do that. But it didn’t meet another main goal: showing a benefit on a measure of muscle function, complicating SRP-9001’s path through the FDA.
Sarepta blamed the outcome on an imbalance in how the trial separated patients into the placebo and treatment groups. But key FDA reviewers appear unconvinced.
“The clinical studies conducted to date do not provide unambiguous evidence that SRP-9001 is likely beneficial for ambulatory patients with DMD,” agency reviewers wrote in briefing documents released ahead of Friday’s meeting, referring to patients who can still walk – the group who will initially be eligible for the treatment if it gets approved.
Family after family who participated in Sarepta’s trials, like the Hennicks, disagree with the reviewers. They say they believe that the treatment has helped keep their kids walking and running in ways they never would have without it.
“It’s really miraculous,” said Nate Plasman, whose son Andrew got SRP-9001 as part of the trial in January 2019, at age 4.
Andrew was away from school for more than two months when he got the experimental therapy, Plasman said, and when he returned, “his teachers at the preschool were blown away,” he recalled. “They’re like, ‘Who is this kid?’ He’s running. He’s jumping. He’s pedaling the tricycle. He’s getting up and down off the ground” – all things he couldn’t do as well before the therapy.
Marit Sivertson, mom to 9-year-old Brecken, agrees.
“We’ve seen the incredible changes with our son,” she said. “He’s not just walking around. He’s running; he’s swimming; he’s diving. He’s truly living the life that every 9-year-old boy ought to be living.”
Sivertson and Plasman are also speaking at today’s meeting. Their goal isn’t to secure the therapy for their own kids; because it’s designed as a one-time treatment, they wouldn’t take it again. They say they’re speaking on behalf of children who are still waiting.
That wait is especially painful for Daniel and Lindsey Flessner, who have two sons with DMD. Their 5-year-old son, Mason, is in the SRP-9001 clinical trial. Their 2-year-old, Dawson, is still too young.
“With every trip, every fall, every time he stands up by walking up his legs using his hands to help stabilize him, it just keeps chipping away at us,” Flessner said. “It’s very painful as the parents watching your children struggling knowing all you can do is wait, when waiting is what you don’t have time for.”
In addition to questions about how well the treatment works, the FDA reviewers raised concerns about safety, particularly “related to the possibility of administering an ineffective gene therapy.”
The reviewers focused on opportunity cost: Because of the viruses used to deliver the gene, patients can develop an immune response that could render future doses ineffective.
Chamberlain said work is underway to find ways to be able to administer more doses, if needed, but it’s currently a one-and-done treatment.
For now, he thinks this approach is the best hope for DMD patients.
“It’s not perfect,” he acknowledged. “It’s not a complete cure, but from what I can gauge from the clinical results that have been released by Sarepta and some of the other companies, I think the micro-dystrophin gene therapy is working better than any other drug that’s been tried for Duchenne muscular dystrophy.”
It’s unclear how long the effects will last; Sarepta is continuing trials, and a confirmatory study would be required as part of accelerated approval. Sarepta has proposed a trial that it’s already running to satisfy that requirement, with results expected later this year.
For families facing DMD, there’s an opportunity cost to waiting, too. In its briefing documents for the FDA meeting, Sarepta estimated that accelerated approval would speed up broad access to SRP-9001 by at least a year, a time in which about 400 boys could lose the ability to walk, and another 400, whose disease is more advanced, would die.
Melanie Hennick said Connor was admitted to the trial just weeks before he’d have aged out, at 8 years old. She said she believes the therapy is the reason Connor’s doing so well.
“We had the opportunity to see Connor grow as an 8-, 9-, 10-, 11- and 12-year-old with more capacity than we ever dreamed,” she said. “He climbs stairs unaided; he runs around; he plays football; he plays hockey; he plays on a baseball team. … Those are things that we never thought we would be able to see him do, especially at 12.”
by tyler | May 12, 2023 | CNN, health
Astronauts have been adjusting to the challenges of sleeping in space for years — and the lessons learned from their zero gravity slumbers will ensure that one day the first crewed missions to Mars will have gotten enough rest before exploring the red planet.
Rotating crews have spent an average of six months living and working aboard the International Space Station for nearly 23 years, and they struggle with sleep issues just like people on Earth. Some of the challenges are similar to those of shift workers or people with abnormal schedules, but others are more unique to the space environment.
For example, most people don’t have to worry about floating away from their beds due to zero gravity. Don’t worry — astronauts use special restraints to keep them from floating through the space station while asleep.
Two of the biggest challenges for astronauts include their sleep environment and the establishment of a natural sleep cycle.
Astronauts have dark, quiet and private crew quarters on the space station conducive to good sleep — but that won’t always be the case on other space missions, said Dr. Erin Flynn-Evans, director of the Fatigue Countermeasures Laboratory at NASA’s Ames Research Center in Mountain View, California.
Like their historic Apollo predecessors, the Orion capsules that will be used during future Artemis missions to the moon are small vehicles with limited space for crews and sleeping bags for rest periods.
“I think of it like camping,” Flynn-Evans said. “If it’s for a couple days, probably no big deal. But the longer you’re in close quarters with someone, the more disruptive that can be.”
While the space station affords incredible views of Earth, the 16 sunrises an astronaut witnesses a day can wreak havoc on circadian rhythm, the body’s natural clock for sleeping and waking.
On Earth, disruptions to circadian rhythm occur for people who work overnight shifts or experience jet lag while traveling across time zones.
“Light is what resets our circadian rhythm and keeps us organized to that day-night cycle, but in space we have several challenges,” Flynn-Evans said.
The space station orbits around Earth every 90 minutes, creating alternating cycles of darkness and light. Rather than force the astronauts to adapt to such a strange cycle, experts at NASA have added lighting to the interior of the space station that mimics what people experience during a normal day on Earth.
“We have to try to block out the light from windows during the night,” she said, “and we have to really try to maximize the light either through windows or with internal lighting to make sure the crew are getting that synchronizing stimulus so that they’re able to stay awake and asleep at the right time.”
Jet lag begins before astronauts ever arrive at the space station, and their sleep schedules are shifted for days before liftoff based on the time of day and time zone from which they will launch. Once they reach the space station, each astronaut is shifted to Greenwich Mean Time, “a nice middle ground between all of the countries that participate,” Flynn-Evans said.
At the Fatigue Countermeasures Laboratory, Flynn-Evans and her colleagues develop tools to help astronauts overcome sleep challenges. Some of the strategies involve managing when the astronauts are exposed to blue light, the primary synchronizing wavelength for the circadian system, and when to reduce blue light to help them sleep.
Astronauts have regimented schedules, but the arrival of resupply missions or new crews sometimes interrupt those. Flynn-Evans and other researchers develop approaches to shifting sleep safely for the astronauts, such as determining when to take naps or stay up later to accommodate schedule changes.
The same tips that help astronauts sleep also apply on Earth, including following a regular schedule with waking and falling asleep at the same time as much as possible and limiting exposure to blue light before going to bed, which is emitted by LED TVs, smartphones, computers and tablets.
Although scientists have sleep data from years of spaceflight, conducting simulated missions on Earth allow for more control.
“We do fake space missions all the time,” Flynn-Evans said. “We have what we call an analog space environment at Johnson Space Center called the Human Exploration Research Analog or HERA, and that’s basically a small habitat.”
The habitat mimics the size of a lunar base or small spacecraft and can house crews of four people for long periods of time. Flynn-Evans was involved in a study in which crews spent 45 days in the habitat and were restricted to five hours of sleep on weeknights and eight hours on weekends. The participants were tested for alertness and performance.
Findings from the experiment showed that if crew members only got five hours of sleep one night, they needed more opportunities to catch up on sleep on subsequent nights to prevent the ill effects of sleep deprivation. The current requirement is that crew members get 8½ hours of sleep per night on missions to avoid long-term sleep loss, fatigue-induced errors and health complications, according to NASA.
In June, NASA will begin the first experiment in a new 3D-printed Martian habitat at Johnson Space Center called the Crew Health and Performance Exploration Analog, or CHAPEA.
Over the course of one year, a four-person crew will live and work inside a 1,700-square-foot (158-square-meter) space to simulate living on Mars. The focus for the first experiment is nutrition, but Flynn-Evans and her fellow researchers will also monitor how well the crew sleeps.
Habitats such as HERA and CHAPEA allow scientists to simulate surprises that may happen on a real mission to the moon or Mars, such as limited resources, failing equipment, communication issues and other stressors of small habitats.
An unexpectedly rich source of sleep data has proven to be studying the Earth-bound scientists and engineers who work on Mars missions such as the Perseverance rover.
A day on Mars lasts about 39 minutes longer than one on Earth, but it’s just enough that the members of Mars mission control have to adjust their schedules constantly to stay on Perseverance’s timetable.
“If you’re shifting 39 minutes a day, that means that you’re basically going to bed 39 minutes later every day,” Flynn-Evans said. “It doesn’t seem that bad on a single night. But after five days, it’s like you’ve crossed like six time zones. It’s a real stressor on the body.”
Many unknowns still exist about being on “Mars time,” such as how the time shift affects the human body’s metabolism.
Understanding how people on Earth adapt to live on Mars time is one way of preparing for future missions to the red planet. Flynn-Evans and her team are working closely with those planning the Artemis lunar missions to optimize the astronauts’ schedules and ensure that the lighting is sufficient and the noise is dampened inside Orion when they need to sleep.
Researchers also want to study how much caffeine astronauts require for alertness to make sure crews don’t run out of coffee in a spacecraft with limited storage.
“Sleep is intimately tied with performance, alertness, interpersonal communication and relationships,” Flynn-Evans said, “so we want to make sure that the crews are set up for success and getting that sleep they need.”
by tyler | May 12, 2023 | CNN, health
US Food and Drug Administration on Thursday paved the way for more gay and bisexual men to donate blood by finalizing new risk-based recommendations for blood donation. Going forward, prospective donors will be asked the same set of questions regardless of their sex or sexual orientation.
Before the FDA began taking a second look at its guidance several years ago, gay and bisexual men had faced a lifetime ban on blood donation, a move that many said was discriminatory. The most recent policy recommended that men who have sex with men wait three months after sexual contact with other men before they could donate blood.
The policy changes eliminate deferrals and screening questions specific to men who have sex with men (MSM) and women who have sex with MSM. It brings the United States in line with other countries such as the UK and Canada, which have also implemented risk-based rules.
“It’s going to make a donation more inclusive. It ensures that all donors are treated equally. It enables more people the opportunity to donate blood. So anytime more people are able to enter the donor pool safely, that is a good thing. And this really is the start of a new era of blood donor eligibility,” said Susan Forbes, senior vice president of corporate communication and public relations for OneBlood, a system of blood collection centers that serves hospitals in the Southeast.
Forbes said OneBlood is moving quickly to implement the new guidance, which means it will have to update its donor history questionnaire. “So there was a lot of regulatory steps to do it, but we’re doing it as quickly as possible,” Forbes said.
The new questions are designed to reduce the risk of transmission of HIV, or human immunodeficiency virus, through blood donation. The FDA says it made the changes after reviewing data from other countries that have similar rates of HIV and that have implemented risk-based eligibility for blood donations, information on the accuracy of tests to detect HIV, surveillance information from a system that monitors infections passed by transfusions, and information on individual risk factors gleaned from a government-funded study.
Under the new questions, anyone who had a new sexual partner and anal sex, or who had multiple sexual partners and anal sex within the last three months, would be asked to wait at least three months from their most recent sexual contact to donate blood.
Anyone taking medications to treat or prevent HIV, such as PrEP, would also be deferred from donation. The FDA says that although HIV is not transmitted during sex in people whose viral levels are are undetectable, the same does not apply to blood donation. Blood is transfused directly into a vein and involves a larger volume of fluid, making it inherently riskier than sexual contact.
The FDA advises against HIV medication or PrEP to donate blood.
Sarah Kate Ellis, President and CEO of GLAAD, the Gay and Lesbian Alliance Against Defamation, said the new recommendations signal “the beginning of the end of a dark and discriminatory past rooted in fear and homophobia,” but argued that by excluding people taking PrEP, they didn’t go far enough.
“Placing potential blood donors taking PrEP in a separate line from every other donor adds unnecessary stigma. The bias embedded into this policy may, in fact, cost lives. GLAAD urges the FDA to continue to prioritize science over stigma and treat all donors and all blood equally,” Ellis said in a statement posted on their organization’s website.
The FDA says the guidance to industry is a recommendation. Blood banks aren’t required to follow it, so policies may differ slightly from place to place. The FDA does have to approve the language used on donor history questionnaires, however, so most blood banks hew to its recommendations.
“The FDA has worked diligently to evaluate our policies and ensure we had the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products. The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Marks said the agency would continue to closely monitor the safety of the US blood supply after the rules are implemented.
by tyler | May 12, 2023 | CNN, health
In a rare moment of bipartisan agreement, lawmakers were highly critical of the US Food and Drug Administration’s handling of the infant formula shortage Thursday.
The hearing of the US House Oversight and Accountability Subcommittee on Health Care and Financial Services was one of several Congress has held to better understand what contributed to the recent formula shortage and to understand how to prevent more problems down the road.
Rep. Lisa McClain, R-Michigan, said that the FDA has not been fully forthcoming with Congress and the public.
“Why was the FDA unprepared for the crisis?” she asked in her opening statement.
She said that the agency failed to prioritize food safety. “The FDA has not taken the action needed to prevent a similar crisis from happening again.”
Rep. Katie Porter, D-California, said she agreed with McClain that another shortage could happen, “and that is a deadly serious problem.”
“There is a lot of blame to go around,” Porter added. “It’s clear with today’s witness selection that Republicans want to blame the FDA, and I’ll level with you, I think some of that blame is well-placed. We’ve had two subsequent infant formula recalls in 2023 already, and we’re still seeing that the FDA can make further improvements on internal processes, intervene in issues sooner and follow through with more inspections to prevent further contamination.”
Three major manufacturers in the US control over 90% of the formula market, and that consolidation is a “serious concern” that “contributed significantly to shortages,” according to Dr. Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, who testified Thursday.
A shortage that started in 2021 was exacerbated when the country’s largest infant formula maker, Abbott Nutrition, recalled multiple products in mid-February 2022 and had to pause production at its plant in Sturgis, Michigan, after FDA inspectors found potentially dangerous bacteria.
The plant inspection was tied to an outbreak of Cronobacter sakazakii that had sickened at least four infants and killed two, although investigations did not find a genetic link between bacteria samples from the facility and bacteria found in the water and powder used to mix the formula that the infants had consumed.
Mayne testified that it was difficult to trace the cases and determine how big of a concern the outbreak was. The bacteria is a common pathogen in the environment “but one about which we have limited information.”
The FDA has urged the US Centers for Disease Control and Prevention to make Cronobacter infection a notifiable disease – meaning providers would be required to report cases to local or state public health officials – so public health experts would be able to more quickly determine the source of any contamination.
In addition to the bacteria, an FDA inspection of the Sturgis plant found unsanitary conditions and several violations of food safety rules.
A whistleblower had alerted the FDA to alleged safety lapses at the plant in February 2021, months before Abbott’s formula was recalled. The complaint suggested that the plant lacked proper cleaning practices and that workers falsified records and hid information from inspectors.
Like other FDA leaders who have been called before Congress, Mayne testified that she was not made aware of the complaint right away. She called it “a failure of escalation.”
“I do wish I had been made aware of this particular whistleblower complaint, but just to reiterate, the complaint was acted upon,” Mayne said. However, she noted, it was “less than ideal” how quickly there was an FDA inspection of the plant and how quickly the agency was able to act.
When the whistleblower made the complaint, there was no process within the FDA to escalate it. The process has since changed so that if a complaint meets certain criteria involving vulnerable populations, hospitalizations or deaths, leadership would be immediately informed. If a consumer complaint involves an infant death or hospitalization, it also immediately gets escalated to leadership.
To prevent future shortages, Mayne testified, it won’t just be the FDA that needs to change. The industry should do more to adopt enhanced food safety measures to “deliver the safest possible” infant formula, she said.
The agency would also like better regulations. There have been been two infant formula recalls already in 2023, and in neither case was the manufacturer required to notify the FDA that it had found contamination before the formula left the plant.
The FDA has asked formula makers to inform the agency about positive tests, but such reporting is only voluntary. If it were mandatory, the FDA could know about problems in real time and could take action.
“Our food safety experts, our compliance experts can work with the manufacturers,” Mayne said. In such a collaboration, they could quickly identify what product to focus on to prevent a shortage.
The FDA has taken recent steps to improve. In February, it announced that it is restructuring its food division to be more responsive and that it is creating an office of critical foods. The FDA is also hiring specialized infant formula inspection staff, Mayne said.
The infant formula supply is generally in good shape, she said, but there are still some distribution issues.
The in-stock rate is near 90%, even higher than pre-recall levels. But some rural areas are having a hard time getting all the formula they need.
Formula manufacturers have been producing more than is being purchased week after week to build up supply, Mayne said. The Biden administration has also worked to bring in formula from manufacturers overseas.
But another shortage is not out of the question, particularly if one of the country’s main manufacturers is taken offline for any significant amount of time.
“We never want to have this happen again,” Mayne said.
Lawmakers have proposed significant cuts, about 22%, to the FDA’s budget for 2023. Mayne said that consumers and the industry would be “adversely affected” if the cuts go through.
“Broadly, across the FDA, I can say it would be devastating,” she said, resulting in a loss of 32% of domestic inspections and 22% of foreign inspections. The cuts would also disproportionately affect its food programs, which get much of their funding from the budget, unlike divisions involving drugs that get money from user fees.
“We would be unable to do what I think American consumers expect us to do,” Mayne said.
