The supply of GLP-1 drugs for weight loss and diabetes treatment is expected to be strengthened this week due to a federal deadline to halt the sale and production of unbranded products that many patients in the US have relied on.

From 2022, increased demand has led to a shortage of semaglutide injections sold by Novonordisk under the brand names Ozempic and Wegovy, as well as Zepbound of tilzepatide injections and tilzepatide injections from competitor Elilyli. The combined pharmacy was allowed to intervene to fill the supply gap while name branded products were shortages and sold copycat products that used the same active ingredients but were not approved by the U.S. Food and Drug Administration.

However, the FDA declared several months ago that the shortage of semaglutide and tilzepatide injections had ended and effectively ended the flexibility of the combined product. The bounty period, when manufacturers stop producing and selling composite tilzepatide, ends in March, with Thursday being the final cutoff date for composite semaglutide.

Thousands, and possibly millions of patients, have used these combined GLP-1 receptor agonist drugs. This is usually sold at a lower price than branded products, making it more accessible to many people.

Michelle Pierce, who receives a Semaglutide injection from Olympia Pharmaceuticals to help with weight management and hyperglycemia, said her insurance had rejected requests for GLP-1 drugs multiple times before exploring combined product options. The effect was “life and change,” says the 25-year-old from Texas, and she is scared to cancel the progress that will help her avoid back surgery and get her lowest blood sugar levels in A1C levels.

“Now, I’m planning on getting my medicine down because it’s lacking. I really have no other options. I definitely can’t afford to pay completely out of my pocket,” she said.

Olympia Pharmaceuticals offers vials of combined GLP-1 drugs to more than 70,000 people each week, said Josh Fritzler, the company’s chief financial officer. The GLP-1 accounts for about 40% of the company’s production, and plans a suspension date after the shortage is announced.

“We sat down and said, “Here’s the goal. Here’s how we handle it. Here’s what we can do to advocate access to patients. Here’s what we can do to make sure we have a product here. “We had to be transparent. … “OK, we’ll prioritize the need for the shortage for the next three months, so that we can meet as many patients as possible before this transition is over.”

Dr. Jody Duchey, an endocrinologist at Beth Israel Deecones Medical Center and an assistant professor of medicine at Harvard Medical School, not only does not support the use of combined GLP-1 drugs, but he also said he is worried that the restrictions could add a new strain to the overall supply.

“There is no security that (combined version) is FDA-regulated. I don’t know what this compound has. I don’t know about purity. I don’t know about safety. I don’t know about dosage. I don’t know about drug interactions,” says Dushay. “I really don’t want to take responsibility for that.”

But the new restrictions could make her look for new prescriptions from providers like her, she said, for some people who rely on compound products.

Those who use GLP-1 injections usually start with a low dose of medication and scale up gradually. Combined versions of drugs do not necessarily follow the same effectiveness and strength standards as branded products, Dushay said, making one-to-one swap difficult, and assessing each patient’s new prescribing needs regardless of the combined drug dose they were using.

“I’ll try them again. I’ll start them with the starting dose,” Dushay said. “So the question is: Will pressure increase at the starting dose of tilzepatide and semaglutide?”

The limitations on composite GLP-1 products are due to concerns over existing shortages budding.

The FDA declared that the shortage of tilzepatide and semaglutide has ended, saying that the drugmaker’s “product availability and manufacturing capacity can meet current and projected national demand.”

“Patients and prescribers may see intermittent localized supply disruptions as products pass supply chains from manufacturers and distributors to local pharmacies,” the agency said when it was declared that the shortages for each were over.

In an email to CNN, Novo Nordisk said it was in Wegovy and Ozempic’s “continued dialogue with the FDA on manufacturing and supply,” and said the company is “confident” in supply since the shortage ended. Recent investments in building and expanding manufacturing capacity have helped grow supply, Novo said.

A spokesman for Lily said in a statement that Zepbound and Mounjaro are “fully available” to patients and “should not be exposed to untested, unapproved, imitation products.”

“People who continue to sell bulk compound Tilze Patide, including what they call “personalized,” “customized,” or similar, are breaking the law and putting their patients at risk,” Lily’s statement said.

Both Novo Nordisk and Eli Lilly are taking steps to reduce costs and make access easier, such as creating online platforms and providing single-dose vials instead of injector pens.

“We had a direct conversation on behalf of the Outsourcing Facilities Association and provided information to both the FDA and the HHS, which we believe that these products (both GLP-1) are still lacking. “My fear when the deadline comes at the end of this week is that patients and providers don’t have access to the medications they need and will be financially impacted as they move forward for this.”

The Outsourcing Facility Association filed a lawsuit against the FDA over the “sudden removal” of tilzepatide and semaglutide from the drug shortage list, but in both cases the judge ruled that the FDA plan would allow the combined product to continue.

Healthcare providers say they have noticed an improvement in the availability of GLP-1 drugs since the shortage ended, but unstable insurance on drug coverage is hindering accessibility.

“The shortage is much better. Insurance coverage is much worse,” says Dr. Disha Narang, endocrinologist and director of obesity medicine at Endeavor Health. “From a practical standpoint, patients are unable to obtain medication employer benefits, which is currently possible that almost 50% or more in our country will qualify. So it’s a very strange time to try and justify insurance companies that obesity is a chronic disease.”

Pierce, which uses the combined product, said it has stocked supply for six months. However, on the online community forum she is part of it, and some members have just started on combined medicines without knowing that they can lose access right away.

“I’m definitely afraid and I’ll do whatever I need to do to avoid fallout,” she said. “But unfortunately, I don’t have much control over the situation.”

CNN
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Poor diet, environmental toxins, unhealthy habits and medicines have contributed to the nationwide rise in chronic illnesses, especially children, Trump’s top officials said in a report Thursday that they will lay the foundation for an outline of government policy “Re-Our Health in America.”

Maha committee leaders, including Health and Human Services Secretary Robert F. Kennedy Jr., will present President Donald Trump at a White House event Thursday afternoon with conclusions that reflect Kennedy’s longstanding priorities.

The government committee recommends that federal agencies reassess the country’s childhood vaccine schedule, scrutinize ultra-highly processed foods, and study pesticides widely used in commercial agriculture.

The report is the first step in the administration’s plan to address what President Trump called the American chronic disease crisis. In the executive order on February 13th, Trump requested an initial assessment of potential drivers of chronic disease within 100 days. The committee plans to provide the strategy within the next 100 days.

But even before his release this week, farmers, food manufacturers and some Republican lawmakers had raised concerns about the impact of the report on American food supply, particularly the call to reevaluate pesticides approved for use by the Environmental Protection Agency.

Autism advocates and researchers oppose Kennedy’s proposal that environmental and drug factors make the rate of autism spectrum disorder booming. The report suggests a link between autism and food dyes or environmental toxins, but does not discuss Kennedy’s previous claim that there is a link between vaccines and autism.

It is also unclear how much broader recommendations in the report will take to start research into nutritious foods, vaccines and environmental exposures.

“We don’t have a budget,” Kennedy told reporters at a briefing Thursday. “At this point, there are no specific policies that can be funded within the budget. We intend to resolve policy recommendations over the next 100 days.”

However, he added: “If we can reduce the numbers we intend to do during this administration, we will save more money in the long term and in the short term.”

Vaccines and drugs

The MAHA committee is looking for a wider schedule of pediatric vaccines, more research into the potential negative effects of vaccinations, and more research into “true” placebo studies of those childhood vaccinations, reflecting many of Kennedy’s long-standing gathering points to many people regarding vaccine safety. The committee encourages “open dialogue” about the risks and benefits of vaccines.

The report does not explicitly elicit a disproveable link between vaccination and autism, but points out that “many (parents) are concerned about the proper use of vaccines and their potential role in the growing pediatric chronic disease crisis.”

Asked about the subsequent research on vaccines and autism, Kennedy said, “Prescriptions are 100 days and explain how they handle them, but they already have a lot of research. We didn’t wait for this report to begin investigating crises, including the autism crisis.”

Officials are recommending that the National Institutes of Health be linked with Medicare and Medicaid data and expand new projects to examine environmental factors in childhood diseases. HHS launched its platform this month to study the potential causes and economic impacts of autism.

The report also states that drugs, including ADHD drugs, antidepressants, asthma and GLP-1 drugs, are being overprescribed as a result of “false incentives” in the healthcare system. It cites studies that suggest that there is no clear benefit to antipsychotic antidepressant medicine in children.

It also states that ADHD, depression and intellectual disability are diagnosed “disproportionately” in young children, leading to “unnecessary drugs, treatment, and social stigma.”

The committee’s report flagged studies suggesting a link between commonly used atrazine and glyphosate-based herbicides such as Roundup and diseases such as reproductive disorders, cancer and liver complications. However, it also quickly cited research from the Food and Drug Administration and the EPA, which states that the majority of food samples and agricultural practices are in compliance with federal regulations.

The EPA previously said that these products are unlikely to cause cancer. However, the media reports that the MAHA committee is likely to emphasize that widely used herbicides will be pushing forward with reports by lawmakers representing agricultural groups and agricultural regions.

“We welcome efforts to improve health outcomes in America, but recommendations to limit agricultural practices based on unproven theories can have unintended consequences,” the United States Farm Bureau Federation said in a statement Tuesday ahead of the release of the report. “History tells us that even if the loss is caused by inaccurate or incomplete information, it takes a very long time to rebuild public trust after it is lost. This is certainly true when it comes to the food system.”

In a statement to CNN, the National Association of Corn Growers said the report is deeply troubled.

“Declines of extensive research and testing have shown that pesticides, including atrazine and glyphosate, can be safely applied to intended applications,” the association states. “We are urging the administration to respect existing scientific organizations on pesticides and to proceed to include American farmers in the debate as this process evolves.”

Mississippi Republican Sen. Cindy Hyde Smith also raised the concern that day during a Senate budget hearing with Kennedy.

“If Americans lose faith in the safety and integrity of their food supply due to inappropriate claims that mislead consumers,” Hyde Smith said.

Agriculture Secretary Brooke Rollins told reporters Thursday that the question in the report was aimed at improving agricultural technology, not to destabilize America’s trust in food supply.

“Do we all agree with everything? Of course not. But I think we all agree where we landed. This means that this is not a binary choice between industry, agriculture and health,” Rollins said. “What has been so encouraged by Secretary Kennedy and me, when I was with Texas, and dozens of conversations, is that this doesn’t compromise our ability to do our best.

Food and Nutrition

The report states that children consume too much ultra-highly processed grains, sugars and fat, which contributes to childhood obesity and diabetes rates. It also cites food additives containing artificial sweeteners and preservatives, suggesting that some studies may be linked to chronic diseases.

The committee recommends independent studies of food ingredients that are generally recognized as safe, and recommends long-term NIH trials that compare ultra-highly processed food diets with whole food regimens.

“I think everyone is trying to prioritize the ultra-processed food crisis and reduce our trust,” Kennedy told reporters Thursday.

The report also calls for industry lobbying and “business capture” by health agencies long-deeply lamented by Kennedy.

“The drug money strongly influences Congressional law through lobbying and manipulation of patient advocacy groups, suggesting it exerts substantial financial control over the FDA and its employees,” he said, reflecting comments by the Health Secretary to FDA employees last month.

The report details lobbying, advertising campaigns and scientific literature funding by the pharmaceutical and food industries, and lays the foundation for crackdown that can be recorded in the committee’s subsequent strategic reports.

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Federal regulators gave SpaceX a green light for another test flight of the spacecraft, the most powerful launch vehicle ever built, after two explosive accidents rained debris near islands in the Caribbean and Atlantic Oceans earlier this year.

The Federal Aviation Administration, which exempts commercial rockets from launch, said Thursday that SpaceX could move forward with its next launch attempt. Meanwhile, investigation into the latest failure of a vehicle that exploded near the Bahamas was underway, and the agency was confirmed to CNN.

The regulator has decided to allow the company to move forward on another test mission called Flight 9 after determining SpaceX meets all of its strict safety, environmental and other licensing requirements.

The update from the FAA comes after the agency issues a launch license for future test flights on May 15th.

Approval of that license was a key milestone for SpaceX and won as it marked the final step in the much-anticipated approval process. For many years, the company has sought to expand the largest launch it can perform each year from its South Texas facility, home to Starship manufacturing and operational facilities.

“The FAA has approved a change in license for SpaceX Starship Flight 9 Mission,” the FAA said in a May 15th statement. “The approval includes a final lawsuit that allows SpaceX to increase spacecraft operations from 5 to 25 per year at Texas’ Boca Chica.”

At the time, the FAA also noted that it would expand the size of hazard zones that would be locked during the next spacecraft flight, or stopping the aircraft area.

The agency said it made changes in response to two previous accidents, flight 7 in January and flight 8 in March.

SpaceX is also intended to try and reuse the super-heavy rocket booster on Flight 9. The Super Heavy is the largest part of the spacecraft launch system and consists of a 232-foot (71 meters) steel cylinder, a fuel tank, and all 33 rocket engines that give an initial burst of thrust in the lift-off.

SpaceX safely retrieved three super-heavy heavy boosters after launch, with the goal of renovating and reusing rocket parts to reduce costs.

Extended Hazard Area

The FAA said it would increase the size of the spacecraft’s hazard area. It aims to keep aircraft and other vehicles out of the flight path of the launch system – mapped from 885 nautical miles (1,018 miles) in previous documents and then mapped to 1,600 sailing miles (1,841 miles).

According to the FAA, the expanded keepout zone will affect up to 175 flights, with an average delay time of 40 minutes. The agency estimates that such delays would be around $50 per hour for travelers, and passenger airlines would cost $100.80 per minute or $6,048.00 per hour per delayed flight.

“To minimize confusion,” the document states that “the launch window is scheduled outside the peak transport period.”

SpaceX has not yet announced the target launch times for Flight 9.

The FAA also maps debris response areas that it believes can cause a fragment of the vehicle to land if a midway flight explodes.

SpaceX said the wreckage has mostly remained in such areas after both Flight 7 and Flight 8 accidents.

However, in January, fragments of failed spacecraft vehicles from Flight 7 are scattered, especially across the islands of Türkiye and Caicos. There was also one report of property damage. The FAA confirmed at the time that a car had hit the island of South Caicos.

Debris from a failed March test flight also landed near the Bahamas.

“The FAA is in close contact and working with the UK, Turkey & Caicos Islands, the Bahamas, Mexico and Cuba as the agency continues to monitor compliance with all Public Safety and other regulatory requirements on SpaceX,” the agency said in a statement Thursday.

“SPACEX is necessary to update flight safety analysis to take into account all the outcomes of pre-flighted flights and calculate and establish hazard areas,” the statement said.

There were no reports of injuries related to Starship’s previous accident.

In a January statement to CNN, the FAA said it would need to map “sufficient danger areas to ensure SpaceX “on the land or on the maritime ship’s ship, with no chance of casualties exceeding one million.”

Spaceship and the whole picture

The company has faced backlash in relation to recent test flight failures and CEO Elon Musk’s current presidential administration, but the ultimate success of Starship Vehicle is considered important to NASA’s goals.

The space agency has already agreed to pay up to $4 billion of SpaceX to transport astronauts to the moon on two lunar missions scheduled for the second half of the decade.

As the Trump administration suggested, SpaceX’s partnership with NASA could also expand if the agency decides to abolish its own Space Launch System Rocket (SLS). SLS has long elicited criticism for its price tag, according to the 2023 government accountability report.

A White House preliminary budget document issued on May 2 recommended that SLS rockets be abolished after three flights.

Phasing off the SLS rocket could leave the spacecraft as the only option for incorporating astronauts into deep space. This is the destination for the choice of Musk and Mask and Jared Isakuman, Musk confidant who tapped to lead the NASA. (The Space Agency is still waiting for the Senate’s final confirmation of Isaac Man’s appointment.)

SpaceX has long touted Starship as a way to offer affordable prices that will change the game towards its size.

Musk says the price per test flight is around $50 million to $100 million. However, the prototypes that have been fed so far only travel in suborbital orbit and do not have the functions necessary for crew missions, such as life support systems.

SpaceX also needs to haveh the way to refuel the vehicle while sitting in orbit around the globe.

The Starship development process employs an engineering approach called “fast iterative development,” which has sparked controversy.

The philosophy emphasizes launching relatively inexpensive prototypes during the development process, aiming to quickly identify and fix design problems. This method focuses on extensive ground testing that ensures success in the first launch attempt, as opposed to NASA, which accepted SLS, for example.

Due to its unique development approach, SpaceX is known to embrace fiery disasters, but even the failure of a test flight highlights that it can help engineers improve the Starship design.

“In tests like this, success comes from what we learn,” the company frequently states in a statement issued after the failed flight of the spacecraft.

However, such rapid and frequent testing has long served as a fierce cry for critics, having led to prominent and explosive failures throughout the history of the company.