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Uninsured Americans pay nearly $98 on average for a vial of Eli Lilly’s generic insulin.
Eli Lilly earlier this year vowed to slash the list price of its generic insulin, Lispro, from $82.42 per vial starting May 1.
Sen. Warren’s report surveyed more than 300 pharmacies in the U.S. between June 9 and June 28 to determine whether Eli Lilly’s announced price cut “translated into real relief for patients.”
Warren said the report demonstrates that Congress needs to take additional steps to reduce the excessive prices of insulin from Eli Lilly, Sanofi and Novo Nordisk.

An Eli Lilly and Company pharmaceutical manufacturing plant is pictured in Branchburg, New Jersey, March 5, 2021.
Mike Segar | Reuters

Uninsured Americans pay nearly $98 on average for a vial of Eli Lilly’s generic insulin, even after the company pledged to cut the product’s list price to $25 per vial, according to a report released Thursday by Sen. Elizabeth Warren.
Eli Lilly earlier this year vowed to slash the list price of its generic insulin, Lispro, from $82.42 per vial starting May 1. The Indianapolis-based pharmaceutical company is one of the world’s largest insulin manufacturers.

The Massachusetts senator’s report surveyed more than 300 chain and independent pharmacies in the U.S. between June 9 and June 28 to determine whether Eli Lilly’s announced price cut “translated into real relief for patients.”
The survey found that a third of pharmacies charged uninsured patients $164 or more for a vial of Eli Lilly’s Lispro.
Seven pharmacies charged $200 per vial or more, and two sold the product for more than $300. 
Chain pharmacies charged uninsured customers an average of $123 per vial for the generic insulin, compared with $63 on average at independent pharmacies. 
Eli Lilly did not immediately respond to CNBC’s request for comment on the survey. 

The survey findings suggest “Eli Lilly’s promises of affordable, accessible insulin have not been realized for uninsured patients across the country,” Warren said in a statement.
She said the data also demonstrates Congress needs to take more steps to rein in excessive prices, such as capping insulin copays at $35 per month for all patients, regardless of their insurance status.
President Joe Biden’s Inflation Reduction Act currently caps insulin copays at $35 per month for people covered by Medicare.
“My new report confirms that far too many uninsured Americans cannot access or cannot afford to pay astronomical prices for life-saving generic insulin — lawmakers need to step up and take action,” Warren said in a press release.

Sen. Elizabeth Warren, D-MA, speaks during a Senate Banking Committee hearing on Capitol Hill in Washington, D.C., June 13, 2023.
Michael A. Mccoy | Getty Images

Insured Americans typically pay a fraction of the list price for insulin. But uninsured people often have to pay the full cost, which can force them to ration or stop taking the life-saving diabetes treatment.
Nearly 30% of uninsured patients with diabetes reported skipping doses of insulin, taking less than prescribed or delaying purchases over the past year, Warren said, citing a 2022 study by researchers from Harvard and other institutions.
“No American should ever be forced to choose between life-saving medication, like insulin, and their ability to pay for food, shelter, and their everyday needs,” Warren said.
Earlier this year, Eli Lilly, Sanofi and Novo Nordisk committed to lowering the list prices of their most common prescribed insulins at least 70% later in 2023.
Eli Lilly and Sanofi also capped monthly out-of-pocket insulin costs at $35 for people who have private insurance.
Together, the three companies control 90% of the global insulin market. 
Their commitments drew applause from lawmakers and Biden, who was pleased the companies finally answered calls to help make diabetes care more affordable in the U.S. 
But Warren’s survey raises questions about how effective their cost-cutting efforts will be. 
About 37 million people in the U.S., or 11.3% of the country’s population, have diabetes, according to the Centers for Disease Control and Prevention.
Approximately 8.4 million diabetes patients rely on insulin, the American Diabetes Association said. More

The World Health Organization classified the soda sweetener aspartame as a possible carcinogen, but said the designation is based on limited evidence and more research is needed.
The WHO said aspartame is safe to consume within a daily limit of 40 milligrams per kilogram of a person’s body weight.
An adult weighing 70 kilograms or 154 pounds would have to drink more than nine to 14 cans of aspartame-containing soda daily to exceed the limit and potentially face health risks.
Aspartame is used in Diet Coke, Pepsi Zero Sugar and other diet sodas.
The U.S. FDA said it disagrees with the classification of aspartame as a possible carcinogen.

A can of Diet Coke in a supermarket, as an artificial sweetener commonly used in thousands of products including diet fizzy drinks, ice cream and chewing gum is to be listed as posing a possible cancer risk to humans, according to reports.
Yui Mok | Pa Images | Getty Images

The World Health Organization on Thursday classified the soda sweetener aspartame as a possible carcinogen, but said it is safe for people to consume within the recommended daily limit.
The International Agency for Research on Cancer, a WHO body, identified a possible link between aspartame and a type of liver cancer called hepatocellular carcinoma after reviewing three large human studies conducted in the U.S. and Europe that examined artificially sweetened beverages.

Aspartame is used in Diet Coke, Pepsi Zero Sugar and other diet sodas, as well as some chewing gum and various Snapple drinks as a substitute for sugar. Artificially sweetened beverages have historically been the biggest source of exposure to aspartame, according to Lancet Oncology.
Dr. Mary Schubauer-Berigan, a senior official at IARC, emphasized that the classification of aspartame as a possible carcinogen is based on limited evidence. The three studies could have been influenced by chance, bias or other flaws, Schubauer-Berigan noted. More research is needed to determine whether consumption of the artificial sweetener can actually lead to cancer, she said.
“This shouldn’t really be taken as a direct statement that indicates that there is a known cancer hazard from consuming aspartame,” Schubauer-Berigan told journalists during a press conference Wednesday before the findings were released to the public.
“In our view, this is really more a call to the research community to try to better clarify and understand the carcinogenic hazard that may or may not be posed by aspartame consumption,” Schubauer-Berigan said.
The U.S. Food and Drug Administration disagrees with IARC’s conclusion that aspartame is a possible carcinogen in humans, an agency spokesperson said on Thursday. The FDA reviewed the the same evidence as IARC in 2021 and identified significant flaws in the studies, the spokesperson said.

“Aspartame is one of the most studied food additives in the human food supply,” the spokesperson said. “FDA scientists do not have safety concerns when aspartame is used under the approved conditions.”

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How much is too much?

The Joint Expert Committee on Food Additives said Thursday the current evidence supporting a link between aspartame and cancer in humans is not convincing. JECFA is an international group of WHO and U.N. scientists that makes recommendations on how much of a product people can safely consume.
JECFA said Thursday that aspartame is safe to consume if a person’s daily consumption of the sweetener does not exceed 40 milligrams per kilogram of body weight during the individual’s lifetime. The FDA’s recommended daily limit is slightly higher, at 50 milligrams of aspartame per kilogram of body weight.
An adult weighing 70 kilograms or 154 pounds would have to drink more than nine to 14 cans of aspartame-containing soda such as Diet Coke daily to exceed the limit and potentially face health risks, said Dr. Francesco Branca, who heads the WHO nutrition and food safety division, during the press conference Wednesday.
Someone who drinks a can of soda now and then or occasionally chews gum that contains aspartame does not need to worry about a health risk, Branca said. The WHO is simply recommending that people use moderation when consuming foods or beverages that contain aspartame, he said.
Branca cautioned that children who consume soda sweetened with aspartame could exceed the daily limit by drinking just three cans. He said children who start consuming aspartame early in life may face a heightened health risk later, though more research is needed on lifelong exposure.
“You may have families that instead of having water on the table, have a big can of sparkling drinks with sweeteners. That’s not a good practice,” he said.
The WHO is not calling for companies to withdraw products that contain aspartame, Branca said. But the food industry should consider changing ingredients to make products without the use of sweeteners, he said.
The American Beverage Association claimed the WHO’s findings as vindication Thursday, saying aspartame is a safe choice for people who want to reduce sugar and calories in their diet.
Though aspartame may reduce the calorie count in some beverages, the WHO concluded in May that sugar substitutes do not help children or adults lose weight over the long term.
Dr. William Dahut, chief scientific officer at the American Cancer Society, said consumers will have to make decisions based on personal risk assessments with the knowledge that aspartame has no health benefits and is a possible carcinogen.

Widely used sugar substitute

The food industry widely uses aspartame as a substitute for sugar because it is 200 times sweeter than sugar, which means it can be used in low concentrations with very few calories and achieve a similar taste.
About 6,000 products worldwide contain aspartame, according to the Calorie Control Council, a trade group that represents the manufacturers of artificial sweeteners.
Aspartame was discovered in 1965 by scientists at G.D. Searle & Co. and later sold under the brand name NutraSweet. The artificial sweetener has been controversial since its initial approval.
The FDA first approved the sugar substitute as a tabletop sweetener and as an additive in certain foods in 1974. The agency put that decision on hold for years due to questions about the reliability of safety studies submitted by G.D. Searle on whether aspartame was linked to brain tumors.
The FDA ultimately concluded there was reasonable certainty that aspartame did not cause brain tumors and authorized sales in 1981. The agency subsequently approved the use of aspartame in several other types of food and beverages and finally approved it as a general-purpose sweetener in 1996.
The FDA says it continues to monitor the science for new information on aspartame.
Correction: An adult weighing 70 kilograms or 154 pounds would have to drink more than nine to 14 cans of aspartame-containing soda daily to exceed the limit and potentially face health risks, according to JECFA. A previous version of this story misstated the amount. More

The Biden administration said a federal program will provide free Covid vaccines to uninsured Americans starting this fall through the end of 2024. 
The announcement provided further details on the timing of the U.S. Department of Health and Human Services Bridge Access Program, which was first unveiled in April.
The temporary program aims to fill the gaps after the federal government shifts Covid shots and treatments to the commercial market. 

A health-care worker prepares a dose of the Pfizer-BioNTech Covid-19 vaccine at a vaccination clinic in the Peabody Institute Library in Peabody, Massachusetts, Jan. 26, 2022.
Vanessa Leroy | Bloomberg | Getty Images

The Biden administration on Thursday announced a program to provide free Covid vaccines to uninsured Americans through December 2024 after the federal government’s supply of shots runs out this fall.
Those free shots, which the government is purchasing at a discount, will be available to the uninsured at pharmacies and 64 state and local health departments.

The U.S. Department of Health and Human Services also is hoping vaccine makers will donate shots to pharmacies as part of the program.
There are between 25 million and 30 million uninsured adults in the United States and other Americans whose insurance will not cover free Covid products this fall, according to the Centers for Disease Control and Prevention.
Currently, the government has an inventory of vaccines purchased from three manufacturers, Pfizer, Moderna and Novavax, and those companies do not sell the shots to health-care providers.
In the fall, the companies will begin selling shots directly to health providers and the government’s supply is expected to run out.
The HHS in April first announced the Bridge Access Program, but had not said when the program would stop providing shots for free to the uninsured until Thursday.

The program reflects a broad shift on the Covid-19 pandemic’s effects worldwide. As Covid cases and deaths have dropped to new lows, governments have rolled back stringent health mandates such as masking and social distancing, and the rate at which people get Covid vaccines has slowed to a crawl over the past year.
Earlier this year, the World Health Organization declared an end to the global Covid public health emergency. In May, the HHS declared an end to the emergency in the United States. More

The Biden administration urged Pfizer, Moderna and Novavax to price their updated Covid vaccines at a “reasonable” rate when they roll them out in the U.S. this fall.
None of the three manufacturers have disclosed the exact pricing of their single-strain vaccines, which are being designed to target the circulating omicron subvariant XBB.1.5. 
The price points for the shots will be crucial in the fall, as the federal government is expected to shift Covid vaccine distribution to the commercial market.

A nurse prepares doses of the Pfizer vaccine during a COVID-19 vaccination event at Josephine’s Southern Cooking in Chatham, Illinois, Dec. 30, 2021.
Brian Cassella | Tribune News Service | Getty Images

The Biden administration on Thursday urged Pfizer, Moderna and Novavax to price their updated Covid vaccines at a “reasonable” rate when they roll them out in the U.S. this fall.
In a letter addressed to the shot manufacturers, the U.S. Department of Health and Human Services said price gouging the new jabs would take advantage “of the trust the American people have placed in you through the COVID-19 response.”

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None of the three manufacturers have disclosed the exact pricing of their upcoming single-strain vaccines, which they are designing to target the circulating omicron subvariant XBB.1.5.
Pfizer and Moderna earlier this year said they expect to price their shots between $110 and $130 per dose, a nearly fivefold increase over current prices for existing vaccines.
That estimate has drawn criticism from lawmakers, who note the two companies and their executives have made significant profits from the shots during the Covid-19 pandemic. 
The price points for the shots will be crucial in the fall, as the federal government is expected to shift Covid vaccine distribution to the commercial market. That means the manufacturers will sell their updated jabs directly to health-care providers rather than to the government.
A Moderna spokesperson reiterated the company’s previous remarks about being ready in time for the fall with ample vaccine supply.

A spokesperson for Pfizer, meanwhile, referred CNBC to a release from last month, which says the company expects to be ready to ship its new shots immediately in the fall, pending regulatory review and approval.
A Novavax spokesperson said the company appreciates its “continued collaboration and partnership” with the U.S. government and intends to make its new vaccine available by late September.
“As we approach this transition, we expect that companies will look to the example that the U.S. government has set in eliminating access hurdles for the American public,” the HHS said in a statement.
The HHS said it expects the manufacturers to work with the Centers for Medicare & Medicaid Services and other payors to ensure they have the required information to cover the updated shots in the fall. The department also advised the manufacturers to plan their regulatory applications to the U.S. Food and Drug Administration for their respective shots.
The HHS said preparing those submissions early would allow the Centers for Disease Control and Prevention to make recommendations for the shots by September.
Federal and corporate programs are planning to help shoulder the out-of-pocket costs of updated shots this fall for uninsured Americans. 
That includes the Biden administration’s HHS Bridge Access Program, a temporary effort that will provide free Covid shots and treatments to uninsured Americans once those products move to the commercial market. 
Pfizer and Moderna also intend to launch patient assistance programs for their Covid shots. But there are still outstanding questions about what those efforts will look like. More

The World Health Organization classified soda sweetener aspartame as a possible carcinogen, which could hurt sales for diet sodas.
Coca-Cola, PepsiCo and Keurig Dr Pepper may decide to change their formulas and swap out aspartame for another sweetener.
PepsiCo removed aspartame from Diet Pepsi in 2020.

The World Health Organization’s cancer research arm, the International Agency for Research on Cancer, has conducted a safety review of aspartame.
Steve Russell | Toronto Star | Getty Images

The World Health Organization reaffirmed its recommended intake of aspartame Thursday, but the agency’s classification of the sweetener as a possible carcinogen could still scare away diet soda drinkers and lead to new beverage formulas.
Soda consumption has fallen over the past two decades as consumers have switched to drinking more water or picking beverages with less sugar. However, diet sodas have been a bright spot for the category in recent years.

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Although full-calorie options still dominate the soda segment, diet sodas now represent more than a quarter of sales. Coca-Cola’s and PepsiCo’s bets on zero-sugar versions of their namesake sodas have been paying off for both companies. Diet Coke, Coke Zero, Pepsi Zero Sugar and Diet Mountain Dew all contain aspartame.
On Thursday, the International Agency for Research on Cancer, a WHO agency, identified a possible link between aspartame and a type of liver cancer called hepatocellular carcinoma. WHO officials said more research on the potential connection is needed.
A separate body, the Joint Expert Committee on Food Additives, said in its own report that the acceptable daily intake of the sweetener is under 40 milligrams per kilogram of body weight, reaffirming prior recommendations. For most adults, that means drinking less than nine to 14 cans of diet soda every day.
While the findings on possible links to cancer may not deter consumers who drink smaller amounts of diet soda, the announcement could at least temporarily hurt sales.
Diet sodas are at least 50% more popular with higher-income consumers than with lower-income people, according to TD Cowen data. Those consumers could be concerned by the WHO’s report, TD Cowen analyst Vivien Azer wrote in a research note last week.

The biggest risk for soda makers is how much attention the announcement garners. CFRA analyst Garrett Nelson wrote in a June 29 note that the news could hurt sales volumes of low-calorie sodas if enough consumers see the headlines.
Likewise, Wedbush analyst Gerald Pascarelli told CNBC he thinks the report could hit sales in the category. But the dip might not last long.
“These companies are quick to pivot and to do what’s necessary to maintain momentum for their brands, and we suspect they’ll do the same thing,” he said.
Dr. Francesco Branca, head of the WHO’s nutrition and food safety division, said manufacturers who use aspartame in their food and drinks should consider making their products without the sweetener.
But PepsiCo Chief Financial Officer Hugh Johnston told Reuters on Thursday that the company has no plans to change its use of aspartame. He added that the company doesn’t include the sweetener in much of its portfolio.
Aspartame was used in Diet Pepsi until 2015, when the company tweaked the formula. After backlash from customers, PepsiCo brought it back a year later. But the change didn’t last long — the beverage giant got rid of aspartame in Diet Pepsi in 2020. It still uses it in Pepsi Zero Sugar.
Coke faces more risk of losing out on sales over aspartame concerns, according to CFRA’s Nelson. The beverage giant currently uses the sweetener in both its Diet Coke and Coke Zero, but could swap it out for another, such as stevia, in the future.
Even so, Edward Jones analyst Brittany Quatrochi said she isn’t expecting a big hit to diet soda sales.
“Consumers may trade into a different sugar-free offering, but this isn’t the first kind of food or beverage product to be labeled a carcinogen,” she said.
For example, the IARC classified red meat as a probable carcinogen in 2018.
Makers of diet sodas aren’t fretting over lost sales yet. The American Beverage Association, which lobbies on behalf of Coke, PepsiCo and Keurig Dr Pepper, took the WHO announcement as further confirmation of the sweetener’s safety.
“With more than 40 years of science and this definitive conclusion from the WHO, consumers can move forward with confidence that aspartame is a safe choice, especially for people looking to reduce sugar and calories in their diets,” ABA interim CEO Kevin Keane said in a statement.
Besides diet sodas, aspartame can also be found in a variety of foods, including breakfast cereals, chewing gum and ice cream. It’s widely used as a sugar substitute because it is 200 times sweeter, meaning it can be used in much lower concentrations. More

The Screen Actors Guild – American Federation of Television and Radio Artists union is going on strike.
The failed negotiations with the Alliance of Motion Picture and Television Producers means film and television productions will immediately halt, essentially shutting down Hollywood.
Members of SAG-AFTRA will join up with more than 11,000 already striking film and television writers.

Striking Writers Guild of America (WGA) members walk the picket line in front of Netflix offices as SAG-AFTRA union announced it had agreed to a ‘last-minute request’ by the Alliance of Motion Picture and Television Producers for federal mediation, but it refused to again extend its existing labor contract past the 11:59 p.m. Wednesday negotiating deadline, in Los Angeles, California, U.S., July 12, 2023. 
Mike Blake | Reuters

Hollywood actors are officially headed to the picket line.
Unable to reach a deal with producers, members of The Screen Actors Guild – American Federation of Television and Radio Artists will join up with more than 11,000 already striking film and television writers starting at midnight.

The failed negotiations with the Alliance of Motion Picture and Television Producers means film and television productions featuring actors will immediately halt, essentially shutting down Hollywood. It’ll be the first tandem strike in the industry since 1960.
“We are the victims here,” said Fran Drescher, president of the actors union, during a news conference Thursday. “We are being victimized by a very greedy entity. I am shocked by the way the people that we have been in business with are treating us.”
“It is disgusting,” she said in fiery remarks. “Shame on them.”
SAG-AFTRA members are already taking the strike seriously. “Oppenheimer” actors left the film’s London premiere Thursday. Director Christopher Nolan told the crowd that the cast left and are “off to write their picket signs.” The film opens next week.
During the strike, actors will not be permitted to promote past projects through conventions, interviews or panels. This includes any Emmy Award campaigning. Nominations for the annual award show were announced Wednesday and the ceremony is set to take place Sept. 18 on Fox.

Heading into negotiations last month, Hollywood performers were looking to improve wages, working conditions, and health and pension benefits, as well as create guardrails for the use of artificial intelligence in future television and film productions. Additionally, the union is seeking more transparency from streaming services about viewership so that residual payments can be made equitable to that seen on linear TV.
“You cannot change the business model as much as it has changed and not expect the contact to change, too,” Drescher said.
The Writers Guild of America, which has been on strike since May, is seeking higher compensation and residuals, particularly when it comes to streaming shows, as well as new rules that will require studios to staff television shows with a certain number of writers for a specific period.
The guild also is seeking compensation throughout the process of pre-production, production and post-production. Currently, writers are often expected to provide revisions or craft new material without being paid.
The WGA also shares similar concerns over the use of artificial intelligence when it comes to script writing.

SAG-AFTRA said producers have been unwilling to offer its members a fair deal and have worked to delay negotiations.
The AMPTP responded to the strike declaration by issuing a statement that it “presented a deal that offered historic pay and residual increases, substantially higher caps on pension and health contributions, audition protections, shortened series option periods, and a groundbreaking AI proposal that protects actors’ digital likenesses.”
It blamed SAG-AFTRA for stalled talks.
Addressing the producers’ statement, Duncan Crabtree-Ireland, national executive director and chief negotiator for SAG-AFTRA, dismissed the AMPTP claims, especially when it came to its AI proposal.
“In that groundbreaking AI proposal, they proposed that our background performers should be able to be scanned, get paid for one day’s pay, and their company should own that scan, their image, their likeness, and should be able to use it for the rest of eternity in any project they want with no consent and no compensation,” he said. “So if you think that’s a groundbreaking proposal I suggest you think again.”
Drescher called the AMPTP members “crazy” and called their response to the actors’ proposals “insulting.”
SAG-AFTRA’s comments come as reports have surfaced about tactics studio producers allegedly plan to implement against writers, namely, that producers don’t plan on attempting to negotiate with writers for several more months. According to the reports, producers expect writers will run out of money and possibly lose their homes and be forced to come to the bargaining table.
While the AMPTP has denied these reports, studio executives have remained outspoken about what they consider unreasonable contract requests.
“We managed as an industry to negotiate a very good deal with the Directors Guild, that reflects the value that the directors contribute to this great business,” Disney CEO Bob Iger told CNBC on Thursday morning, ahead of SAG-AFTRA’s announcement. “We wanted to do the same thing with the writers. And we’d like to do the same thing with the actors. There’s a level of expectation that they have that is just not realistic. And they are adding to the set of challenges that this business is already facing, that is quite frankly, very disruptive.”
Iger noted that the industry has not completely recovered from the coronavirus pandemic and these strikes come at “the worst time in the world.”
“It will have a very, very damaging effect on the whole business,” he said. “And unfortunately there’s huge collateral damage to the industry, to people who are, you know, support services. I could go on and on. It will affect the economy of different regions, even, because of the sheer size of the business. It’s a shame. It is really a shame.”
Disclosure: Comcast is the parent company of NBCUniversal and CNBC. NBCUniversal is a member of the Alliance of Motion Picture and Television Producers. More

The valuation of Elon Musk’s SpaceX hit near $150 billion following a share sale by existing investors announced this week, CNBC has learned.
SpaceX has an agreement with new and existing investors to sell up to $750 million in stock from insiders at $81 a share, according to a copy of the purchase offer that CNBC obtained.

The valuation of Elon Musk’s SpaceX hit near $150 billion following a share sale by existing investors announced this week, CNBC has learned.
SpaceX has an agreement with new and existing investors to sell up to $750 million in stock from insiders at $81 a share, according to a copy of the purchase offer sent by CFO Bret Johnsen on Thursday, which CNBC obtained.

The company did not announce a raise of new capital at this time, with the purchase offer representing a secondary sale of existing shares. Musk in April said that the company does “not anticipate needing to raise funding” to further bolster the programs for Starship, Starlink and other initiatives. SpaceX typically performs these secondary rounds about twice a year, to give employees and other company shareholders a chance to sell stock.

A Starship prototype stands on the company’s launchpad in Boca Chica, Texas on March 16, 2022.

SpaceX continues to spend heavily on development of its next-generation Starship rocket. Musk expects the company to spend about $2 billion on the vehicle’s development this year. The first Starship flight got off the launchpad and achieved several milestones, but also had multiple problems. SpaceX is preparing to attempt a second launch in the coming months, but awaits Federal Aviation Administration approval in order to do so. The FAA is also fighting an environmental lawsuit over how it regulates SpaceX’s Starship.
But SpaceX remains quiet about the potential IPO of its Starlink business. President Gwynne Shotwell said earlier this year that there is “no update.” Last year, CNBC reported that Musk told employees that the company isn’t likely to take Starlink public until 2025 or later. More

The U.S. Food and Drug Administration approved the first over-the-counter birth control pill, which will allow more women and girls to prevent unintended pregnancies without a prescription. 
Opill, which contains a hormone called progestin and is taken daily, was first approved by the FDA as a prescription in 1973. 
The pill’s manufacturer, Paris-based HRA Pharma, said the contraceptive would most likely be available at stores and online retailers nationwide in early 2024.
HRA Pharma, a unit of Dublin-based pharmaceutical company Perrigo, said there will be no age restrictions on sales of the daily pill.

HRA Pharma expects a final decision by the FDA this summer on its application for nonprescription sales of Opill, which is generically called norgestrel.
Source: Perrigo

The Food and Drug Administration on Thursday approved the first over-the-counter birth control pill, a landmark decision that will allow more women and girls in the U.S. to prevent unintended pregnancies without a prescription. 
The daily pill, called Opill, was first approved by the FDA as a prescription in 1973. 

The pill’s manufacturer, Paris-based HRA Pharma, said the contraceptive would most likely be available at drugstores, convenience stores, grocery stores and online retailers in the U.S. in early 2024.
HRA Pharma, a unit of Dublin-based pharmaceutical company Perrigo, said there will be no age restrictions on sales of the pill.
HRA Pharma has not announced the price of the pill, which will determine how affordable it will be to the public. But the company is committed to making the pill “accessible and affordable to women and people of all ages,” Frederique Welgryn, Perrigo’s global vice president for women’s health, said in a statement.
Perrigo’s stock price jumped 5% in early trading Thursday following the announcement. 
Opill could significantly expand access to contraception, especially for younger women and those in rural and underserved communities who often have trouble getting their birth control. 

The pill’s approval is a win for the Biden administration, which has tried to shore up reproductive rights as abortion restrictions rise in many states. 
The Supreme Court’s decision to overturn the landmark Roe v. Wade ruling more than a year ago – which ended 50 years of federal abortion rights – has led to shrinking availability of the procedure nationwide and renewed calls for expanded access to birth control.
“Today’s approval is a groundbreaking expansion for women’s health in the U.S., and a significant milestone towards addressing a key unmet need for contraceptive access,” Welgryn said in the statement.
Oral contraceptives have long been the most common form of birth control in the U.S., used by tens of millions of women since the 1960s. But until now, all of them required a prescription.
Medical organizations like the American College of Obstetricians and Gynecologists and women’s health advocates have pushed for wider access.
More than 50 members of Congress in March 2022 also called on FDA Commissioner Dr. Robert Califf to ensure the agency reviewed applications for over-the-counter birth control pills without delay.
Those groups have noted that an estimated 45% of the 6 million annual pregnancies in the U.S. are unintended.
Unintended pregnancies have been linked to negative outcomes, including the reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, according to the FDA. Those complications are also associated with adverse developmental and child health outcomes, the agency said.Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a release that daily oral contraception is safe and “expected to be more effective than currently availablenonprescription contraceptive methods in preventing unintended pregnancy.”Other nonprescription methods include condoms and spermicide.
Opill was found to be 93% effective in preventing pregnancy, similar to prescription oral contraceptives.

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The pill contains a hormone called progestin, which prevents pregnancy by thickening the cervix mucus to block sperm from reaching and fertilizing an egg.
FDA scientists in May expressed concerns about whether women who have or had breast cancer would know not to use the drug. The hormone progestin can increase the risk of breast cancer returning.
The agency’s scientists were also concerned about whether some women with unexplained vaginal bleeding between menstrual cycles would know not to take Opill before consulting a doctor first. 
But ultimately, a panel of advisors to the FDA agreed that most women could determine on their own whether the medication was appropriate for them to use.
That panel also voted unanimously to recommend making Opill available without a prescription. More