Posts tagged with "FDA"

Federal regulations are finally taking aim at the ‘Wild West’ of clean beauty

July 18, 2022

Three years ago, several makeup products at Claire’s, the national retail chain beloved by teenagers, tested positive for the presence of asbestos—a mineral that has been known for decades to be linked to several types of cancer and lung disease, reports Fortune.

The Food and Drug Administration did what it could legally do about the fact that teenagers had been applying asbestos to their faces and possibly absorbing it through their pores: It recommended Claire’s recall the products. Claire’s  disputed  the test results, but ultimately recalled the products, even though the FDA had no further authority to act.

“To be clear, there are currently no legal requirements for any cosmetic manufacturer marketing products to American consumers to test their products for safety,” then-FDA Commissioner Scott Gottlieb wrote candidly in a March 2019 statement with Susan Mayne, director of the Center for Food Safety and Applied Nutrition at the agency.

Not much has changed since then. Federal law regulating the beauty industry hasn’t been updated since 1938—the year that Adolf Hitler marched into Austria and set off the Second World War.

“Cosmetics is the least regulated category in the marketplace: There are more restrictions on the pesticides that we spray on crops to kill weeds than the stuff we spray on our bodies every day,” said Scott Faber, head of Government Affairs at the Environmental Working Group (EWG).

All the same, Congress, where several female legislators—including Sen. Dianne Feinstein of California, Sen. Susan Collins of Maine, Rep. Jan Schakowsky of Illinois, and Sen. Patty Murray of Washington—have introduced bipartisan proposals to update the laws, expand FDA authority to oversee beauty brands, and ban the most harmful chemicals. 

At the same time, several states including California, Maryland, Maine, and Colorado have already moved to increase supply-chain transparency in an industry known for its opacity. 

Last month, those proposals were tucked into the FDA Safety and Landmark Advancements Act—legislation that would reauthorize the agency’s user fee agreements related to prescription drugs and medical devices. Since this reauthorization needs to pass, the ride-on cosmetics regulations have their best chance in over eight decades to move through a gridlocked Congress.

The proposals have widespread support from the beauty industry, including Unilever, Johnson & Johnson, L’Oréal, Sephora, and Procter & Gamble, because many mainstream brands and retailers have already started moving into the clean-beauty space.

Olivia Tong, an equity analyst at Raymond James who follows Ulta Beauty, Estée Lauder, Sally Beauty, and other cosmetics and personal care companies, said regulations could establish some consistency in what “clean beauty” means.

“It’s a little bit of the Wild Wild West right now with anything that has a label of ‘clean,’” Tong said. “Investors along with consumers are typically on board with some consistency in terms of what everybody is talking about.”

David Swartz, equity analyst at Morningstar who covers Ulta, said big retailers don’t have much to fear when it comes to proposed regulations. “If anything, it would allow Ulta to promote its brands and bolster its links with the key suppliers,” Swartz said. “There could be some negative impact on Amazon and others that sell counterfeit and unauthorized beauty products, which could benefit Ulta, Sephora, and other stores.”

Indeed, while not everyone in the industry welcomes stricter regulation, it’s clear that current law has fallen far behind global industry standards and consumer preferences. Clean beauty was the fastest-growing segment as of May, according to NPD Group. Clean-beauty market revenues are up 19% from last year, while vegan makeup revenue is up 27%, and vegan skin care 23%, the market research firm told  Fortune.

“There’s way more concern for what goes into products today than there was even ten years ago,” said Larissa Jensen, industry adviser and vice president at NPD Group.

In response to growing consumer demand, the nation’s largest retailers, including Ulta, Sephora, and Target, are launching clean-beauty standards and disclosing more information about how these products are made.

There are no legal definitions for “clean,” “natural,” or “green” beauty products—so companies can use those terms as they wish without fearing legal consequences. “Organic” is the only industry label regulated in the United States.

“What’s clean to one brand might mean something different to another,” said Emily Spilman, science analyst on EWG’s Healthy Living team. “The onus is on the consumer to do that research.”

The nonprofit advocates for stronger regulation of the beauty industry and has launched the Skin Deep cosmetics database as an alternative way for consumers to check ingredients in the products they use in the interim. An accompanying mobile app makes it possible to scan barcodes in a store to see how an item rates.

Credo, a San Francisco–based clean-beauty retailer, has established a Clean Standard for the products it carries. It bans the use of 2,700 mainstream beauty ingredients that raise safety and sustainability concerns; restricts animal-derived ingredients and animal testing; and poses questions about ethics, sustainability, and transparency.

“The standard is really the nexus of how we evaluate ingredient and material safety, sourcing, sustainability, and ethics,” said Mia Davis, vice president of Environmental and Social Responsibility at Credo. The company explains on its website that it created the standard because current law is so limited.

Yet the brand does not think the standard is a stand-in for federal action. Instead, it’s one of the industry advocates pushing for Congress to act. The tide has turned in favor of regulation, and many mainstream cosmetics brands also supported an earlier bill introduced by Feinstein and Collins that is the foundation of the current proposal.

As is often the case in Congress, the extent of the regulation is the crux of debate. The Personal Care Products Council, which represents manufacturers, distributors, and suppliers of beauty products, says the industry is very responsible and responsive to consumer concerns about safety and sustainability. While critics point out that the European Union has banned over 1,600 ingredients; and the United States. fewer than a dozen, PCPC vice president Jay Ansell says the statistics are misleading.

“Nearly all of those ingredients banned in the EU have never been nor would ever be used in cosmetics, including jet fuel, radioactive substances, pesticides, pharmaceuticals like chemotherapy drugs, chloroform, hemlock, cyanide, and LSD,” Ansell said

.However, Credo’s Davis agreed that not all of the EU-banned ingredients are present in American products, but she added that the EU’s approach is demonstrably more precautionary than the one taken by U.S. regulators. Some beauty brands change the formula of their products for the European market, and she believes those versions are safer.

“This industry enjoys a lot of secrecy,” she said. “There’s very little federal information required of the industry. We need more in order to protect the consumer and the planet.”

Still, Tong of Raymond James noted that many other priorities are front and center for multinational beauty brands right now—including economic pressures, inventory and supply-chain challenges, and shifts in consumer behavior amid the pandemic. That means regulations are not the focus—at least not until current proposals advance further in Congress.

Research contact: @FortuneMagazine

Walgreens to launch business that will connect customers with clinical trials

June 20, 2022

Some Walgreens customers might soon get a new kind of message from the company, asking if they’d like to participate in a clinical trial, reports The Chicago Tribune.

Deerfield, Illinois-based Walgreens announced on Thursday, June 16, that it plans to launch a clinical trials business—in which pharmaceutical companies can hire Walgreens to help them find participants for clinical trials, which are used to evaluate the safety and effectiveness of new potential types of medications and devices.

Walgreens plans to use its rosters of customers and patients to find those who may match a trial’s criteria, and then ask those people if they would like to participate, said Ramita Tandon, chief clinical trials officer at the pharmacy chain.

As part of the new business, Walgreens also may help companies carry out clinical trials by conducting visits for participants at some of its stores, during which patients may fill out surveys or have blood taken, depending on the type of trial, Tandon said. It’s possible nurses, pharmacists, pharmacy technicians or doctors could help with those visits, depending on what’s needed, she said.

Walgreens leaders believe they can help companies get more clinical trial participants, and a more diverse range of participants, because Walgreens has customers in so many different communities.

Including participants from diverse racial backgrounds has long been an issue in clinical trials. In the U.S., 75% of 32,000 participants in the trials of 53 new drugs approved in 2020 by the U.S. Food and Drug Administration were White, according to FDA. Only 8% were Black, 6% were Asian, and 11% were Hispanic.

People from different backgrounds can react differently to some medications and devices, which is part of the reason it’s crucial to have trial participants from a variety of backgrounds, according to the FDA. Also, a lack of diverse participants may mean that people from certain racial and ethnic groups are not getting early access, through clinical trials, to drugs that could help them.

“The therapies that are coming out today are not very representative of the U.S. population,” Tandon said. “As we at Walgreens start to tap into our local communities, (we can) educate and empower these communities on the benefits of clinical trials. Not only are they participants in research, but this is yet another opportunity as a care option, (for) patients who may he exhausted other avenues in their care journey.”

She said Walgreens will be able to “mine the vast foundation of patients and consumers who come to our stores and pharmacies on a regular basis” to match potential participants to clinical trials.

Patient data will not be shared with pharmaceutical companies unless patients give consent to share it, and participation will be voluntary. Doctors will work with Walgreens to oversee the clinical trials, and Walgreens may be able to reach out to a patient’s primary care or specialty doctors if needed, Tandon said.

Research contact: @Walgreens

How the Gen Y founder of Helaina may have solved the baby formula shortage

June 2, 2022

Despite the fact that instant baby formula represents a $50 billion global market, a recent shortage shows the need for innovation in the space, reports Fortune.

America has been facing a severe—and already deadly, in several cases—shortage of formula since March, when the FDA found traces of a potentially deadly bacteria at Abbott Nutrition’s plant in Sturgis, Michigan, and shut down production. Recently, the United States imported 70,000 pounds of baby formula from Europe to ease the crisis.

However, as young entrepreneurs in the food industry innovate, an alternative to baby formula is in the works. A case in point: 29-year-old Laura Katz has always been passionate about the food industry. As she learned about its broken parts, she decided to gravitate towards innovation and advancement. Aiming to revolutionize instant formula, she launched Helaina.

Helaina uses fermentation to recreate the proteins found in breast milk. At the company, the design and build team makes sure the yeast will produce first-of-its-kind, nature-equivalent breast milk components that build immunity.

These technologies will give parents access to a healthier option than instant formula, Katz believes. However, once the product hits the market, it will look like instant formula. The founder says the product will be “powdered” and “pretty recognizable,” but it will be different because it will be composed of the proteins that the yeast creates through the fermentation process. So “instead of relying on conventional sources of agriculture,” the founder explained her product was more

Six years ago, when Katz was 23, she learned through a podcast that there was a black market for breastmilk out there, and parents would go on the internet to buy breast milk from strangers because they wanted to give their infants the benefits of baby milk.

“As a food scientist at the time, seeing all this innovation going into alternative dairy and alternative meat, ok, we can make a burger bleed, but why aren’t we channeling that technology towards making the things that are so essential for babies and for parents?” she questioned.

So she set on a quest to make a product that empowered these parents and recreated the immunity properties in breastmilk, and Helaina was born.

“The infant formula category is highly regulated” and “there are a lot of safety steps.” The company has to prove that its product is safe in many different ways, which will take time, explained the founder. This means it could take years for the product to hit the market.

The founder is proud because they are the only company putting human proteins in food. “No one has done that before,” Katz said.

While the company still has a long way to go, Katz is hopeful that innovation will give many parents and infants the immunity they desire and that the food industry will shift towards healthier options.

“I think within the category that we’re in we’re starting to see—and I’m hoping to see—people shift more from focusing a lot of their effort on figuring out how to make food taste better” to “how we can use technology to make food healthier for us and more accessible,” shared the founder.

Research contact: @fortunemagazine

America faces baby formula ‘crisis’ as shortage worsens

May 11, 2022

Major U.S. pharmacies recently have restricted sales of baby formula in response to a spiralling shortage of the special milk. CVS and Walgreens are among the big pharmacy chains to have imposed limits on how many cans of baby formula customers can buy at a time, reports the BBC.

The shortages intensified after Abbott— which makes top brand Similac—shut a key factory and issued a recall in February after finding contamination in its supply.

Pressure is building on the Biden Administration to respond to the issue. Republicans—among them, Senator Tom Cotton (R-Arkansas)—have called it a “national crisis” that the White House must address.

Democratic Representative Rosa DeLauro of Connecticut said she was concerned that the Food and Drug Administration , which regulates formula makers, had responded “far too slowly” to the issue; and to the reports of problems at the Abbott factory in Michigan, which remains closed.

Abbott—the main supplier of baby formula to many of the state government programs for low-income women and children—said it was working with regulators to get the plant re-opened.

The company has been sending extra shipments from a plant in Ireland to try to address the problem—expecting shipments from the country to double this year, it added.

“We know that our recent recall caused additional stress and anxiety in an already challenging situation of a global supply shortage,” the company said in a recent statement.

“We are working hard to help moms, dads and caregivers get the high-quality nutrition they need for their babies.”

As of 24 April, the average out-of-stock rate across the country had jumped to 40%, up from just 30% a few weeks earlier—and 11% in November, according to Datasembly. There were 26 states with out-of-stock rates higher than 40%—compared to just seven states three weeks earlier, it said.

Due to increased demand and various supplier challenges, infant and toddler formulas are seeing constraint across the country,” the major pharmacy chain Walgreens said in a statement, adding, “We continue to work diligently with our supplier partners to best meet customer demands.”

Walgreens has limited families to buying three cans at a time—similar to other retailers. A 12.4 ounce can of formula typically lasts for about 15 bottles—or just a few days’ worth of supply.

Companies that produce items like baby formula—for which demand is typically steady over time—have trouble catching up when there is disruption, said Rudi Leuschner, director of the Masters in Supply Chain Management program at Rutgers Business School.

And as parents rush to buy as stories of empty shelves spread, that only makes the problem worse, he warned. “It’s not a situation where you can just snap out of it,” he said. “It was designed to run at one speed.”

While this year’s formula shortage may expose the fragility of the supply chain, it may not be enough to make a business case for backup inventories, Professor Leuschner added.

Overall, birth rates are falling, reaching the lowest point on record in the United States in 2020. Studies also have found that consumption of infant formula has been declining in favor of breast milk.

Research contact: @BBC

Hard luck: Taking Viagra cuts the risk of Alzheimer’s by up to 69%

December 7, 2021

Now we really know it’s a man’s world: A research study conducted by the Cleveland Clinic’s Genomic Medicine Institute has found that the a drug used to counteract erectile dysfunction, Viagra, may help to boost brain health and cut levels of toxic proteins that trigger dementia, according to a report by The Sun.

Experts analyzed data on 7.2 million U.S. adults and found regular users had a 69% lower chance of being diagnosed with Alzheimer’s disease over the next six years.

Medics say the findings, published in the journal, Nature Aging, suggest that “the little blue pill” soon could be prescribed to tackle dementia.

The authors are now planning a fresh study to test the benefits of sildenafil—the generic version of Viagra—in early Alzheimer’s patients.

A team from Cleveland Clinic looked at whether any of 1,600 approved drugs could be repurposed to tackle the underlying causes of the disease.

Lead researcher Dr Feixiong Cheng, from Cleveland Clinic’s Genomic Medicine Institute, said: “Sildenafil, which has been shown to significantly improve cognition and memory in preclinical models, presented as the best drug candidate.

Two in three cases of dementia are due to Alzheimer’s.

Dr. Jack Auty, lecturer in the Medical Sciences at the University of Tasmania, said: “This is exciting stuff,” adding, ““But we need further research. In the field of Alzheimer’s disease research, we have been excited by many drugs over the years, only to have our hopes dashed in clinical trials.”

However, Dr. Susan Kohlhaas, director of Research at Alzheimer’s Research UK, was more cautious about the findings.

She said: “While sildenafil is most well-known as a treatment for erectile dysfunction, it’s also used to treat high blood pressure in the lungs. In this study, researchers also found that its use is linked with fewer cases of Alzheimer’s disease in American adults. The researchers conducted lab-based experiments to give an indication as to why the drug may have impact diseases like Alzheimer’s, but these early-stage experiments would need follow-up in more thorough tests.”

Meanwhile, health officials in the United States recently approved the first new drug for Alzheimer’s disease in nearly 20 years. Despite controversy over the trial results, the Food and Drug Administration said it granted approval to the drug developed by Biogen.

Research contact: @TheSun

How long are Thanksgiving leftovers safe to eat?

November 29, 2021

If your turkey lurks for just a little too long in your refrigerator, is it still okay to eat it? And what about stuffing, cranberry sauce, pie, and all your other holiday favorites?

All cooked leftovers should be refrigerated or frozen within two hours after preparation, according to the Food and Drug Administration. And as a general rule of thumb, leftovers should be eaten or thrown out four days after refrigeration. If you freeze your food, it can last from two to six months, reports HuffPost.

In addition to taking food safety into account, these recommendations also consider the quality of your food. In other words, leftover turkey tastes pretty rank after a week, even if it doesn’t give you food poisoning.

If you’re craving more specifics besides “no longer than four days,” here’s what the U.S. Department of Agriculture’s Food Safety and Inspection Service suggests:

  • Discard any turkey, stuffing, or gravy that’s been left out at room temperature for longer than two hours, or one hour in temperatures above 90 degrees Fahrenheit.
  • Divide leftovers into smaller portions. Refrigerate or freeze in covered shallow containers for quicker cooling.
  • Use refrigerated turkey, stuffing, and gravy within three to four days.
  • If freezing leftovers, use within two to six months for best quality. Turkey, specifically, will last for four months in the freezer.

As for desserts, in general, fruit, pumpkin, pecan, custard, and chiffon pies can be safely stored in the refrigerator for three to four days, according to FDA guidelines. But many pies ― especially fruit ― are best eaten within just a couple of days.

Essentially, you have until the Monday after Thanksgiving to enjoy your delicious leftovers from the fridge. After that, chuck ’em.

Research contact: @HuffPost

FDA moves closer to clearing Moderna and J&J COVID booster shots this week

October 12, 2021

Millions of Americans will be one step closer to receiving a COVID-19 booster shot this week when a key Food and Drug Administration advisory panel meets Thursday and Friday, October  14 and 15, to debate extra doses of the Moderna and Johnson & Johnson vaccines, reports CNBC.

The FDA’s Vaccines and Related Biological Products Advisory Committee meetings come less than a month after U.S. regulators authorized COVID booster shots of Pfizer and BioNTech’s vaccine to a wide array of Americans, including the elderly, adults with underlying medical conditions; and those who work or live in high-risk settings, like health and grocery workers.

More than 7 million Americans have received a booster dose in the United States as of Saturday, October 9, according to the latest data available from the Centers for Disease Control (CDC).

Members on independent committees by the FDA and CDC and Prevention said at the time they were frustrated that only Pfizer recipients would be eligible to get the extra shots, leaving out millions of Americans who got Moderna or J&J’s shots.

The FDA advisory group is scheduled Thursday to discuss data on the safety and effectiveness of a Moderna booster shot in adults. On Friday, the committee is expected to debate J&J booster shots for adults. The FDA could make a final decision within days of the meetings, handing it off to the CDC and its vaccine advisory committee to make their own decision.

The CDC’s next vaccine advisory meeting is scheduled to take place from October 20 to October 21, when it’s expected to discuss the boosters.

Research contact: @CNBC

Like falling off a log? Viral milk crate challenge on TikTok is denounced by orthopedists

August 26, 2021

The latest challenge to take the Internet by storm involves precariously stacked milk crates, balance—and some painful falls, The Guardian reports.

To complete the challenge, which recently started on TikTok, participants face a set of milk crates piled up in the shape of a pyramid—and attempt to climb to the top and then back down again without toppling over.

As videos of people falling painfully go viral on social media and rack up millions of views, doctors across the US are coming out to warn people of the dangerous injuries that can occur.

“It’s perhaps even worse than falling from a ladder,” Shawn Anthony, an orthopedic surgeon at Mount Sinai Hospital in New York City told The Washington Post this week, adding, “It’s very difficult to brace yourself from the falls I’ve seen in these videos. They’re putting their joints at an even higher risk for injury.”

With many hospitals nationwide already overwhelmed by COVID-19 patients and running short on space and staff, health departments are urging people to reconsider their choices before taking on the challenge.

George Gantsoudes, a Virginia-based orthopedic surgeon, wrote on Twitter: “The orthopaedic surgeries required to fix problems caused by this may fall under the umbrella of ‘elective surgeries’.”

On Monday, the Baltimore city health department tweeted: “With COVID-19 hospitalizations rising around the country, please check with your local hospital to see if they have a bed available for you, before attempting the #milkcratechallenge.”

The Food and Drug Administration (FDA) also weighed in on the challenge after comedian Conan O’Brien  joked about how he needed federal officials to grant permission to the challenge before attempting it—playing off the FDA’s approval of Pfizer’s COVID-19 vaccine earlier this week.

“Waiting for FDA approval before I take the Milk Crate Challenge,” O’Brien tweeted on Monday. The FDA responded shortly after, writing: “Although we regulate milk, we can’t recommend you try that. Perhaps enjoy a nice glass of 2% and return all those crates to the grocery store?”

The milk crate challenge is the latest of a slew of dares that have gone viral on TikTok. In recent months, the video-sharing platform has seen a rise of dangerous challenge—among them, the blackout challenge, which encouraged young people to hold their breath until they passed out, and the Benadryl challenge, which challenged young people to intentionally consume large amounts of the antihistamine to induce hallucinations.

In a statement about the most recent challenge, a TikTok spokesperson said: “TikTok prohibits content that promotes or glorifies dangerous acts, and we remove videos and redirect searches to our community guidelines to discourage such content. We encourage everyone to exercise caution in their behavior whether online or offline.”

Research contact: @guardian

Shot heard round the world: FDA gives full approval to Pfizer-BioNTech COVID-19 Vaccine

August 24, 2021

The COVID-19 vaccine from Pfizer  and partner BioNTech received full approval from U.S. regulators on Monday, August 23, which many public health officials and vaccine experts hope will encourage hesitant populations to get the shot, reports The Wall Street Journal.

The Food and Drug Administration’s clearance of the shot for people 16 years and older is the agency’s first full approval of a COVID-19 vaccine. The decision was expected this week, the Journal and other news outlets reported.

The vaccine was first cleared in December by the FDA on an emergency-use basis for people 16 years and older after the drugmakers showed it to be highly effective at preventing symptomatic COVID-19. The two-dose shot, resulting from the fastest vaccine development ever in the West, has since become the most-received COVID-19 vaccine in the United States.

The vaccine was authorized for children as young as 12 years in May. Pfizer plans to request full approval for that group once it has collected and analyzed six months of safety data from clinical-trial subjects, according to the company.

Pfizer—which will market the vaccine under the name Comirnaty—is now permitted to market the vaccine to doctors, providers, and the general public, as it does with other approved products. The FDA is permitted to restrict such communications with emergency authorization.

The vaccine is also eligible for off-label prescriptions, which could include booster doses, according to the FDA.

The FDA, under pressure to give COVID-19 vaccines full approval swiftly, made its decision less than four months after Pfizer began its approval submission. The process of reviewing applications normally takes up to approximately ten months.

The FDA said its review found the vaccine to be safe and effective in preventing COVID-19 as well as severe disease, hospitalization, and death. The most common side effects by clinical trial participants who received the vaccine included fatigue, headache, joint pain, chills and fever.

“We have not lost sight that the COVID-19 public health crisis continues in the U.S.A. and that the public is counting on safe and effective vaccines,” said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research. “The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the United States.”

The approval comes as U.S. hospitals are seeing a surge in cases tied to the contagious Delta variant, and as the government weighs when vaccinated adults should receive additional doses (the consensus: eight months after the second shot).

Pfizer already has submitted data to the FDA showing that a third dose of its vaccine boosts the immune system against the original virus and against the Beta and Delta variants to higher levels than the standard two-dose regimen. Pfizer plans to submit a request for booster authorization as an amendment to the full approval.

Of the three authorized vaccines in the United States, only Pfizer had submitted all the required information to the FDA, according to the companies, and analysts expected it to be the first to receive clearance.

Moderna, whose authorized two-dose shot uses similar mRNA technology as the Pfizer-BioNTech vaccine, has said it is still completing rolling data submissions. Johnson & Johnsonwhose shot was authorized in February, has said it plans to file for full approval later this year.

Research contact: @WSJ

In controversial decision, FDA approves new Alzheimer’s disease drug

June 9, 2021

On June 7, the U.S. Food and Drug Administration approved the use of the experimental drug aducanumab for patient treatment during the early phases of Alzheimer’s disease—overriding the conclusion of an FDA advisory committee last year that there was not enough evidence to support the effectiveness of the treatment.

According to a report by CNN, the drug was developed for patients with mild cognitive impairment, not severe dementia, and intended to slow progression of Alzheimer’s disease —not just ease symptoms.

The FDA has not approved a novel therapy for Alzheimer’s disease since 2003.

The FDA approved aducanumab, also known as Aduhelm, using its “accelerated approval” program, which allows for the earlier approval of a drug for a serious or life-threatening illness even though more study into the drug’s benefits may be needed.

“There has been considerable public debate on whether Aduhelm should be approved. As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in Monday’s announcement.

“At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward,” she said, noting that the FDA ultimately decided to use accelerated approval and “concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.”

“FDA will continue to monitor Aduhelm as it reaches the market and ultimately the patient’s bedside,” Cavazzoni said.

In November, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee was asked to vote on several questions about evidence of the drug’s effectiveness. In response to a question about whether it was reasonable to consider data from one positive study as the primary evidence of aducanumab’s effectiveness for the treatment of early Alzheimer’s disease, none of the committee members voted yes; ten voted no and one was uncertain.

The committee’s opinions were then left with the FDA as the agency mulled whether to approve the drug or pump the brakes.

“In all studies in which it was evaluated, however, Aduhelm consistently and very convincingly reduced the level of amyloid plaques in the brain in a dose- and time-dependent fashion,” Cavazzoni said on Monday. “It is expected that the reduction in amyloid plaque will result in a reduction in clinical decline.”

The pharmaceutical company Biogen and its Japanese partner Eisai developed aducanumab—administered through intravenous infusion to treat early Alzheimer’s disease. The drug was developed for patients with mild cognitive impairment, not severe dementia.

Dr. Richard Isaacson, director of the Alzheimer’s Prevention Clinic at Weill Cornell Medicine and NewYork-Presbyterian in New York, who had patients in the original aducanumab clinical studies, told CNN the drug targets the earliest symptomatic phase of the disease, called mild cognitive impairment due to Alzheimer’s. Treatment of the pre-dementia period was the focus of the FDA’s decision.

“We have to really temper expectations and explain to people that this drug is meant for the earliest symptomatic phases,” he said. “It pains me to say this, but if I have a severe Alzheimer’s patient that can no longer speak or interact much with others and their family member is begging me to give them this drug, I won’t be able to do it.”

Some groups, including the nonprofit Public Citizen’s Health Research Group, argued that the FDA should not approve aducanumab for treatment of Alzheimer’s disease due to lack of evidence of its effectiveness.

There have also been concerns around cost: Biogen announced on Monday that the wholesale cost of treatment with aducanumab—which requires an infusion once every four weeks—is about $4,312 per infusion, making the annual cost around $56,000 for a high dose.

However, the participating companies said, “Biogen and Eisai are committed to providing access to ADUHELM for patients across a spectrum of financial situations,” the company noted in its announcement. “For qualified, commercially insured ADUHELM patients, co-pay and infusion cost assistance programs may reduce out-of-pocket costs to as low as $0. Patients who are covered by Medicare through a Medicare Advantage plan have a maximum annual out-of-pocket cap.”

In May, the Institute for Clinical and Economic Review released a draft report estimating that the drug should cost between $2,560 to $8,290 per year, and noted that “the evidence is insufficient to conclude that the clinical benefits of aducanumab outweigh its harms or, indeed, that it reduces progression” of Alzheimer’s disease.

Other organizations, such as the Alzheimer’s Association, have supported approval of the drug.

“This approval is a victory for people living with Alzheimer’s and their families,” Harry Johns, the association’s president and CEO, said in a post on Twitter on Monday.

Research contact: @CNN