Specialty pharmacies and online companies that have been selling off-brand copies of two blockbuster drugs for obesity and diabetes will need to phase out their versions next year under a federal decision issued Thursday.
The Food and Drug Administration said that a nationwide shortage of Eli Lillys Zepbound and Mounjaro has been resolved, eliminating the need for copycat versions of the drugs that have become wildly popular with Americans trying to lose weight.
The decision is a win for Lilly which had been pressing the FDA to take the step for months and is expected to impact how patients access the drugs, including how much they pay.
Zepbound is FDA-approved to treat obesity and Mounjaro is approved for diabetes.
They use the same active ingredient, tirzepatide.
The FDA said Thursday that Lillys supply is currently meeting or exceeding demand, after two years of shortages.
Both drugs are part of the GLP-1 class that has shown unprecedented results for helping people shed weight by decreasing appetite and boosting feelings of fullness.
Wegovy and Ozempic competing drugs from Novo Nordisk remain on the FDAs shortage list.
With demand for GLP-1 drugs booming, compounding pharmacies and telehealth companies like Hims and Ro have jumped into the market, selling cheaper versions online.
People can usually get a months supply for several hundred dollars.
Thursdays decision gives businesses between 60 and 90 days, depending on their size, to phase out their products.
The FDA permits compounded versions of brand name drugs when they are in shortage, and the shift back to Lillys medications could improve safety for consumers.
The FDA warned patients last year about problems with the ingredients and formulations of some GLP-1 drugs sold online.
The agency has limited oversight of compounding pharmacies, which are primarily overseen by state authorities.
Compounding pharmacies use raw drug ingredients to produce customized versions of prescription medications for instance, when patients have allergies to certain ingredients.
The industry has grown into a multibillion-dollar business over the past decade amid increasing drug shortages.
Demand for off-brand GLP-1 drugs has been amplified by aggressive online promotions from telehealth companies, which arent subject to the same marketing rules as drugmakers.
The FDA previously declared an end to the shortage of Mounjaro and Zepbound in early October, but reversed its decision after public pushback and a lawsuit filed by compounding pharmacies.
NHS funding could be linked to patient feedback under new plans, with poorly performing services that “don’t listen” penalised with less money.
As part of the “10 Year Health Plan” to be unveiled next week, a new scheme will be trialled that will see patients asked to rate the service they received – and if they feel it should get a funding boost or not.
It will be introduced first for services that have a track record of very poor performance and where there is evidence of patients “not being listened to”, the government said.
This will create a “powerful incentive for services to listen to feedback and improve patients’ experience”, it added.
Sky News understands that it will not mean bonuses or pay increases for the best performing staff.
NHS payment mechanisms will also be reformed to reward services that keep patients out of hospital as part of a new ‘Year of Care Payments’ initiative and the government’s wider plan for change.
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Speaking to The Times, chief executive of the NHS Confederation Matthew Taylor expressed concerns about the trial.
He told the newspaper: “Patient experience is determined by far more than their individual interaction with the clinician and so, unless this is very carefully designed and evaluated, there is a risk that providers could be penalised for more systemic issues, such as constraints around staffing or estates, that are beyond their immediate control to fix.”
He said that NHS leaders would be keen to “understand more about the proposal”, because elements were “concerning”.
Health Secretary Wes Streeting said: “We will reward great patient care, so patient experience and clinical excellence are met with extra cash. These reforms are key to keeping people healthy and out of hospital, and to making the NHS sustainable for the long-term as part of the Plan for Change.”
In the raft of announcements in the 10 Year Health Plan, the government has said 201 bodies responsible for overseeing and running parts of the NHS in England – known as quangos – will be scrapped.
These include Healthwatch England, set up in 2012 to speak out on behalf of NHS and social care patients, the National Guardian’s Office, created in 2015 to support NHS whistleblowers, and the Health Services Safety Investigations Body (HSSIB).
The head of the Royal College of Nursing described the move as “so unsafe for patients right now”.
Professor Nicola Ranger said: “Today, in hospitals across the NHS, we know one nurse can be left caring for 10, 15 or more patients at a time. It’s not safe. It’s not effective. And it’s not acceptable.
“For these proposed changes to be effective, government must take ownership of the real issue, the staffing crisis on our wards, and not just shuffle people into new roles. Protecting patients has to be the priority and not just a drive for efficiency.”
Elsewhere, the new head of NHS England Sir Jim Mackey said key parts of the NHS appear “built to keep the public away because it’s an inconvenience”.
“We’ve made it really hard, and we’ve probably all been on the end of it,” he told the Daily Telegraph.
“The ward clerk only works nine to five, or they’re busy doing other stuff; the GP practice scrambles every morning.”
Thousands of people have taken to the streets in Tehran to mourn top military commanders, nuclear scientists and others killed in Iran’s 12-day war with Israel.
Iran’s state-run Press TV said the event – dubbed the “funeral procession of the Martyrs of Power” – was held for a total of 60 people, including four women and four children.
It said at least 16 scientists and 10 senior commanders were among the dead, including the head of the Revolutionary Guard General Hossein Salami and the head of the guard’s ballistic missile programme, General Amir Ali Hajizadeh.
Their coffins were driven on trucks into the Iranian capital’s Azadi Square adorned with their pictures as well as rose petals and flowers, as crowds waved Iranian flags.
Image: Mourners at the funeral procession in Tehran. Pic: Majid Asgaripour/WANA/Reuters
Mourners dressed in black, while chants of “death to America” and “death to Israel” could be heard.
Attending the funeral were Iranian President Masoud Pezeshkian and other senior figures, including Ali Shamkhani who was seriously wounded during the conflict and is an adviser to Iran‘s Supreme Leader Ayatollah Ali Khamenei.
There was no immediate sign of the supreme leader in the state broadcast of the funeral.
Image: A woman holds a picture of Iran’s supreme leader. Pic: Reuters
Israel, the only Middle Eastern country widely believed to have nuclear weapons, said its war against Iran aimed to prevent Tehran from developing its own nuclear weapons.
The US launched strikes on three nuclear enrichment sites in Iran, which Donald Trump said left them “obilterated”.
The Iranian government denies having a nuclear weapons programme and the UN nuclear watchdog, which carries out inspections in Iran, has said it has “no credible indication” of an active, coordinated weapons programme in the country.
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Over the almost two weeks of fighting, Israel claimed it killed around 30 Iranian commanders and 11 nuclear scientists, before a ceasefire went into effect on Tuesday.
By a majority of 6-3, the highest court in the land has ruled that federal judges have been overreaching in their authority by blocking or freezing the executive orders issued by the president.
Over the last few months, a series of presidential actions by Trump have been blocked by injunctions issued by federal district judges.
The federal judges, branded “radical leftist lunatics” by the president, have ruled on numerous individual cases, most involving immigration.
They have then applied their rulings as nationwide injunctions – thus blocking the Trump administration’s policies.
Image: Donald Trump addresses a White House news conference. Pic: AP
“It was a grave threat to democracy frankly,” the president said at a hastily arranged news conference in the White House briefing room.
“Instead of merely ruling on the immediate case before them, these judges have attempted to dictate the law for the entire nation,” he said.
In simple terms, this ruling – from a Supreme Court weighted towards conservative judges – frees up the president to push on with his agenda, less opposed by the courts.
“This is such a big day,” the president said.
“It gives power back to people that should have it, including Congress, including the presidency, and it only takes bad power away from judges. It takes bad power, sick power and unfair power.
“And it’s really going to be… a very monumental decision.”
Image: The Supreme Court on Capitol Hill in Washington DC. File pic: AP
The country’s most senior member of the Democratic Party was to the point with his reaction to the ruling.
Senate minority leader Chuck Schumer called it “an unprecedented and terrifying step toward authoritarianism, a grave danger to our democracy, and a predictable move from this extremist MAGA court”.
In a statement, Schumer wrote: “By weakening the power of district courts to check the presidency, the court is not defending the constitution – it’s defacing it.
“This ruling hands Donald Trump yet another green light in his crusade to unravel the foundations of American democracy.”
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Trump’s ‘giant’ Supreme Court win
Federal power in the US is, constitutionally, split equally between the three branches of government – the executive branch (the presidency), the legislative branch (Congress) and the judiciary (the Supreme Court and other federal courts).
They are designed to ensure a separation of power and to ensure that no single branch becomes too powerful.
This ruling was prompted by a case brought over an executive order issued by President Trump on his inauguration day to end birthright citizenship – that constitutional right to be an American citizen if born here.
A federal judge froze the decision, ruling it to be in defiance of the 14th amendment of the constitution.
The Supreme Court has deferred its judgment on this particular case, instead ruling more broadly on the powers of the federal judges.
The court was divided along ideological lines, with conservatives in the majority and liberals in dissent.
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In her dissent, liberal Justice Ketanji Brown Jackson wrote: “As I understand the concern, in this clash over the respective powers of two coordinate branches of government, the majority sees a power grab – but not by a presumably lawless executive choosing to act in a manner that flouts the plain text of the constitution.
“Instead, to the majority, the power-hungry actors are… (wait for it)… the district courts.”
Another liberal Justice, Sonia Sotomayor, described the majority ruling by her fellow justices as: “Nothing less than an open invitation for the government to bypass the constitution.”
Conservative Justice Amy Coney Barrett, who Trump appointed during his first term, shifting the balance of left-right power in the court, led this particular ruling.
Writing for the majority, she said: “When a court concludes that the executive branch has acted unlawfully, the answer is not for the court to exceed its power, too.”
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The focus now for those who deplore this decision will be to apply ‘class action’ – to file lawsuits on behalf of a large group of people rather than applying a single case to the whole nation.
There is no question though that the president and his team will feel significantly emboldened to push through their policy agenda with fewer blocks and barriers.