TITLE: Ozempic-producer Novo Nordisk on track for record spending on lobbying in 2024
https://www.opensecrets.org/news/2024/07/ozempic-producer-novo-nordisk-on-track-for-record-spending-on-lobbying-in-2024/
EXCERPT: Novo Nordisk — the pharmaceutical giant behind popular weight-loss drugs Ozempic and Wegovy — spent a record $3.2 million on lobbying in the first six months of 2024 as the Denmark-based company expanded its footprint in the U.S.
In 2017, after two years of clinical trials, the Food and Drug Administration approved Novo Nordisk’s injectable weight-loss drug Ozempic strictly for adults with Type 2 diabetes. Four years later, the FDA approved Wegovy, another weight-loss drug that is not strictly for type 2 patients but contains the same active ingredient as Ozempic, semaglutide.
Although Ozempic was originally approved for patients with diabetes, some non-diabetics buy it for the purpose of general weight loss under “off-label” prescriptions. The popularity of these prescriptions has contributed to a shortage of Ozempic in the United States, leaving it out of the hands of those who need it most.
An estimated 15.5 million Americans, or 6% of the US population, have reported using injectable weight-loss drugs, according to a Gallup poll released in May. These drugs rose in popularity in 2023 as Novo Nordisk launched an aggressive advertising campaign, spending a total of $471 million to market Ozempic and Wegovy in one year.
In 2023, Novo Nordisk and its U.S. subsidiary, Novozymes North America, spent over $5 million on lobbying, hiring a whopping 77 lobbyists across 13 firms. This marked a 51% increase from the number of lobbyists hired in 2022. Of those, 54 previously held government jobs, bringing insider knowledge and industry connections to each role.
Novo Nordisk lobbied a total of six bills in 2023, all of which were related to the pharmaceutical industry. Among these were the Treat and Reduce Obesity Act of 2023, the Affordable Prescriptions for Patients Act of 2023, and the FAIR Labels Act of 2023, all targeted at making medical care more accessible, equitable, and transparent to all Americans.
In addition to its lobbying efforts, Novo Nordisk has also been actively making campaign contributions in the U.S., spending over $497,000 between its PAC, employees, and executives in the 2023-2024 cycle, as of July 16.
Novo Nordisk currently charges around $1,000 for a month’s supply of Ozempic injections. The high cost of this medicine has been criticized for squeezing low-income patients with diabetes out of the market for life-changing drugs.
Medicare only covers Ozempic when it is used to treat patients with diabetes. Similarly, Wegovy is only covered for patients at cardiovascular risk. Yet, when used for general weight loss, Medicare does not cover the cost of Ozempic or Wegovy.
Novo Nordisk hired a law firm, Arnold & Porter, to lobby for Ozempic to be covered by Medicare as more and more Americans became customers in 2023.
TITLE: Why Millions Are Trying FDA-Authorized Alternatives to Big Pharma’s Weight Loss Drugs
https://kffhealthnews.org/news/article/glp1-compounding-pharmacies-wegovy-zepbound-copycat-drugs-shortages/
EXCERPT: Pharmacist Mark Mikhael has lost 50 pounds over the past 12 months. He no longer has diabetes and finds himself “at my ideal body weight,” with his cholesterol below 200 for the first time in 20 years. “I feel fantastic,” he said.
Like millions of others, Mikhael credits the new class of weight loss drugs. But he isn’t using brand-name Wegovy or Zepbound. Mikhael, CEO of Orlando, Florida-based Olympia Pharmaceuticals, has been getting by with his own supply: injecting himself with copies of the drugs formulated by his company.
He’s far from alone. Mikhael and other industry officials estimate that several large compounding pharmacies like his are provisioning up to 2 million American patients with regular doses of semaglutide, the scientific name for Novo Nordisk’s Wegovy, Ozempic, and Rybelsus formulations, or tirzepatide, the active ingredient in Eli Lilly’s Zepbound and Mounjaro.
The drug-making behemoths fiercely oppose that compounding business. Novo Nordisk and Lilly lump the compounders together with internet cowboys and unregulated medical spas peddling bogus semaglutide, and have high-powered legal teams trying to stop them. Novo Nordisk has filed at least 21 lawsuits nationwide against companies making purported copies of its drugs, said Brianna Kelley, a spokesperson for the company, and urges doctors to avoid them. The FDA, too, has cautioned about the potential danger of the compounds, and leading obesity medicine groups starkly warn patients against their use.
But this isn’t an illegal black market, though it has shades of gray.
The FDA allows and even encourages compounding pharmacies to produce and sell copycats when a drug is in short supply, and the wildly popular GLP-1 drugs have enduring shortages — first reported in March 2022 for semaglutide and in December 2022 for tirzepatide. The drugs have registered unprecedented success in weight loss. They are also showing promise against heart, kidney, and liver diseases and are being tested against conditions as diverse as Alzheimer’s disease and drug addiction.
In recent years, the U.S. health care system has come to depend on compounding pharmacies, many of which are run as nonprofits, to plug supply holes of crucial drugs like cancer medicines cisplatin, methotrexate, and 5-fluorouracil.
Most compounded drugs are old, cheap generics. Semaglutide and tirzepatide, on the other hand, are under patent and earn Novo Nordisk and Lilly billions of dollars a year. Sales of the diabetes and weight loss drugs this year made Novo Nordisk Europe’s most valuable company and Lilly the world’s biggest pharmaceutical company.
While the companies can’t keep up with demand, they heatedly dispute the right of compounders to make and sell copies. Lilly spokesperson Kristiane Silva Bello said her company was “deeply concerned” about “serious health risks” from compounded drugs that “should not be on the market.”
Yet marketed they are. Even Hims & Hers Health — the telemedicine prescriber that got its start with erectile dysfunction drugs — is now peddling compounded semaglutide. It ran ads for the drugs during NBA playoff games. (According to a Hunterbrook Media report, Hims & Hers’ semaglutide supplier has faced legal scrutiny.)
The compounded forms are significantly cheaper than the branded drugs. Patients pay about $100 to $450 a month, compared with list prices of roughly $1,000 to $1,400 for Lilly and Novo Nordisk products.
Five compounders and distributors interviewed for this article said they conduct due diligence on every lot of semaglutide or tirzepatide they buy or produce, upholding standards of purity, sterility, and consistency similar to those practiced in the commercial drug industry. Compounders operate under strict federal and state standards, they noted.
However, the raw materials used in the compounded forms may differ from those produced for Novo Nordisk and Lilly, said GLP-1 co-inventor Jens Juul Holst, of the University of Copenhagen, adding that care must be taken in drug production lest it cause potentially harmful immune reactions.
To date, according to FDA spokespeople, reports of side effects from taking compounded versions haven’t raised major alarms. But everyone with knowledge of the industry, including the compounders themselves, worry that a single batch of a poorly made drug could kill or maim people and destroy confidence in their business.
“I liken the compounding industry to the airline industry,” Mikhael said. “When you have an airline crash, it hurts everybody.”
TITLE: For companies in the Ozempic-fueled weight-loss economy, it’s survival of the fittest
https://www.latimes.com/business/story/2024-07-18/toned-in-the-time-of-ozempic-how-weight-loss-drugs-are-changing-the-fitness-industry
EXCERPTS: Executives and investors are nervously wondering whether droves of slimmed-down users will soon ditch their dieticians, skip the gym, order less at restaurants, and throw out their favorite snack brands. Many companies, acknowledging that the blockbuster class of drugs are a medical breakthrough and not just a fad, are swiftly repositioning themselves with new products and services in a bid to persuade customers that they still have plenty to offer in the booming age of Ozempic.
“We had to up our game,” said Dr. Gary Foster, chief scientific officer at WeightWatchers. “A lot of people said, ‘Was it an existential crisis for you?’ Absolutely not. When science evolves, we evolve. What we have to do as a brand is think about how we incorporate that.”
The changes to consumer behavior have already had far-reaching ramifications. Apparel retailers say they’ve noticed customers buying smaller sizes. Plastic surgeons are reporting a rise in facelifts and other procedures to correct so-called Ozempic face, the sagging skin that often accompanies rapid weight loss. In February, Lars Fruergaard Jorgensen, the chief executive of Ozempic maker Novo Nordisk, said food company leaders had called him because they were “scared.”
“The question is, how widespread is Ozempic going to become?” said Simeon Siegel, an analyst at BMO Capital Markets. “As it grows, so too will its impact.”
With studies predicting that the market for GLP-1 drugs — which help manage blood sugar levels, slow digestion and reduce appetite — will exceed $100 billion by 2030, businesses aren’t waiting around.
In November, WeightWatchers began offering the prescription medications through its WeightWatchers Clinic, which charges $99 per month for access (the cost of the drugs is separate). Foster said tens of thousands of people have since been prescribed GLP-1s directly from the company’s doctors.
It also introduced the WeightWatchers GLP-1 program, designed for members taking the drugs regardless of where they got them. The program aims to help users develop healthy lifestyle habits by teaching them about nutrition, meal timing, proper protein and hydration intake and the importance of a consistent exercise routine.
Atkins, a WeightWatchers rival, also wants a bite of the lucrative market and has adopted similar language: We’re “your ally in a new era of weight loss,” the low-carb diet program says on a dedicated GLP-1 page on its website.
With many GLP-1 users reporting muscle loss as a side effect, Atkins is pushing its line of high-protein bars and shakes, “a deliciously easy way to meet your protein requirements to help you maintain lean muscle mass and bone health while you’re losing weight.”
Two months ago, Nestlé, the world’s largest food and beverage company, introduced Vital Pursuit, a line of frozen foods that the company said is “intended to be a companion for GLP-1 weight-loss medication users and consumers focused on weight management.” The Swiss-based giant cited research from J.P. Morgan that predicted that GLP-1 users in the U.S. could reach 30 million by 2030 — or around 9% of the country’s population.
“As the use of medications to support weight loss continues to rise, we see an opportunity to serve those consumers,” Steve Presley, chief executive of Nestlé North America, said in a statement. By tapping into the emerging category with its new high-protein pasta bowls and sandwich melts, the food giant is trying to “stay ahead of the trends.”
Abbott, the company behind Ensure and Pedialyte, in January introduced Protality, a line of chocolate and vanilla shakes with 30 grams of protein that “provides nutritional support for adults pursuing weight loss.”
“We’re serving a new group of people who may be at a higher nutritional risk because they may be overweight or have obesity and use weight-loss medications,’’ Hakim Bouzamondo, Abbott’s division vice president of nutrition research and development, said in a statement. The shakes are now sold at stores including CVS and Walmart.