logo
Generic Wegovy, Ozempic compounds may become harder to get as FDA removes drug from shortage list

Generic Wegovy, Ozempic compounds may become harder to get as FDA removes drug from shortage list

USA Today21-02-2025

Bhanvi Satija, Puyaan Singh, Patrick Wingrove
Reuters
Hear this story
Feb 21 (Reuters) - The U.S. Food and Drug Administration said on Friday there was no longer a shortage of Novo Nordisk's NOVOb.CO popular weight-loss and diabetes drugs, Wegovy and Ozempic, a declaration that will curtail widespread sales of cheaper copies made by compounding pharmacies.
Shares of Hims & Hers Health HIMS.N, which advertised its compounded versions of weight-loss drugs during the Super Bowl this month, plunged 22% to $52, on a day it announced the purchase of a plant to make the class of drugs that includes Wegovy and Ozempic.
U.S. regulations allow compounding pharmacies to copy brand-name medicines that are in short supply. Wegovy and Ozempic, both known chemically as semaglutide, were in shortage in the U.S. for much of last year.
More on semaglutide compounds:Shortage of popular drugs Wegovy and Ozempic is over, FDA says.
Americans who cannot afford Wegovy or have struggled to find it have been turning to often cheaper versions sold by pharmacies and telehealth providers like Hims & Hers and WeightWatchers WW.O. Wegovy has been shown to help patients lose as much as 15% of their weight on average.
Need a break? Play the USA TODAY Daily Crossword Puzzle.
WeightWatchers shares were up 5.2% at 77 cents.
Compounders have 60 to 90 days to stop sales
For Hims and other compounders, this development starts the clock on having unfettered market access to Novo's drugs, Leerink Partners analyst Michael Cherny said in a note.
The sale of compounded versions of Eli Lilly's LLY.N rival obesity and diabetes drugs, Zepbound and Mounjaro, was banned in December after the FDA found them to no longer be in short supply. The FDA said in a statement that compounding pharmacies would be given a grace period of 60 to 90 days, as was the case when Lilly's drugs were declared out of shortage.
Robert Califf, who was FDA commissioner under President Joe Biden, said he did not think the agency's declaration would necessarily end obesity drug compounding.
"There so much money to be made. There's just an endless number of tricks that compounders could use," he said in an interview. "So I don't think it's the end of it, but it certainly will bring us into a new era after the time period has passed and all the lawsuits are finished."
Pharmacies cry foul
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, which represents compounding pharmacists and technicians, questioned whether the FDA took into account the number of patients who will need to transition from compounded drugs to FDA-approved versions before making its announcement.
The Alliance wrote to the FDA last year, saying more than 200,000 prescriptions for semaglutide drugs not manufactured by Novo Nordisk were being filled by U.S. patients each month, and the agency should consider their role in alleviating the obesity drug supply crunch before barring them.
Hims CEO Andrew Dudum said in a posting on X that the company was closely monitoring for potential future shortages of the drugs.
Novo said in a statement that the FDA's assessment confirmed that the U.S. supply of its drugs now meets or exceeds current and projected demand.
U.S. listed shares of the Danish drugmaker rose 6.2% to $88.93.
Novo and Lilly have invested billions to ramp up supply of their treatments, which lagged demand for most of last year.
All doses of Ozempic and Wegovy were listed as available on the FDA's website in October, but the treatments had not been taken off the official shortage list at the time.
The agency usually assesses if all back orders have been filled before deciding on whether a shortage has been resolved.
(Reporting by Bhanvi Satija and Puyaan Singh in Bengaluru, and Patrick Wingrove in New York; Additional reporting by Julie Steenhuysen in Chicago; Editing by Arun Koyyur and Bill Berkrot)

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Kennedy names 8 vaccine committee replacements, including COVID shot critic
Kennedy names 8 vaccine committee replacements, including COVID shot critic

Associated Press

time9 minutes ago

  • Associated Press

Kennedy names 8 vaccine committee replacements, including COVID shot critic

NEW YORK (AP) — U.S. Health Secretary Robert F. Kennedy Jr. on Wednesday named eight new vaccine policy advisers to replace the panel that he abruptly dismissed earlier this week. They include a scientist who researched mRNA vaccine technology and transformed into a conservative darling for his criticisms of COVID-19 vaccines, and a leading critic of pandemic-era lockdowns. Kennedy's decision to 'retire' the previous 17-member panel was widely decried by doctors' groups and public health organizations, who feared the advisers would be replaced by a group aligned with Kennedy's desire to reassess — and possibly end — longstanding vaccination recommendations. The new appointees to the Advisory Committee on Immunization Practices include Dr. Robert Malone, the former mRNA researcher who emerged as a close adviser to Kennedy during the measles outbreak. Malone, who runs a wellness institute and a popular blog, rose to popularity during the COVID-19 pandemic as he relayed conspiracy theories around the outbreak and the vaccines that followed. He has appeared on podcasts and other conservative news outlets where he's promoted unproven and alternative treatments for measles and COVID-19. He has claimed that millions of Americans were hypnotized into taking the COVID-19 shots. He's even suggested that those vaccines cause a form of AIDS. He's downplayed deaths related to one of the largest measles outbreaks in the U.S. in years. Other appointees include Dr. Martin Kulldorff, a biostatistician and epidemiologist who was a co-author of the Great Barrington Declaration, an October 2020 letter maintaining that pandemic shutdowns were causing irreparable harm. Dr. Cody Meissner, a former ACIP member, also was named. Kennedy made the announcement in a social media post on Wednesday. The committee, created in 1964, makes recommendations to the director of the Centers for Disease Control and Prevention. CDC directors almost always approve those recommendations on how Food and Drug Administration-cleared vaccines should be used. The CDC's final recommendations are widely heeded by doctors and determine the scope of vaccination programs. ___ Associated Press reporter Amanda Seitz contributed to this report. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

Kennedy names 8 vaccine committee replacements, including COVID shot critic
Kennedy names 8 vaccine committee replacements, including COVID shot critic

Yahoo

time9 minutes ago

  • Yahoo

Kennedy names 8 vaccine committee replacements, including COVID shot critic

NEW YORK (AP) — U.S. Health Secretary Robert F. Kennedy Jr. on Wednesday named eight new vaccine policy advisers to replace the panel that he abruptly dismissed earlier this week. They include a scientist who researched mRNA vaccine technology and transformed into a conservative darling for his criticisms of COVID-19 vaccines, and a leading critic of pandemic-era lockdowns. Kennedy's decision to 'retire' the previous 17-member panel was widely decried by doctors' groups and public health organizations, who feared the advisers would be replaced by a group aligned with Kennedy's desire to reassess — and possibly end — longstanding vaccination recommendations. The new appointees to the Advisory Committee on Immunization Practices include Dr. Robert Malone, the former mRNA researcher who emerged as a close adviser to Kennedy during the measles outbreak. Malone, who runs a wellness institute and a popular blog, rose to popularity during the COVID-19 pandemic as he relayed conspiracy theories around the outbreak and the vaccines that followed. He has appeared on podcasts and other conservative news outlets where he's promoted unproven and alternative treatments for measles and COVID-19. He has claimed that millions of Americans were hypnotized into taking the COVID-19 shots. He's even suggested that those vaccines cause a form of AIDS. He's downplayed deaths related to one of the largest measles outbreaks in the U.S. in years. Other appointees include Dr. Martin Kulldorff, a biostatistician and epidemiologist who was a co-author of the Great Barrington Declaration, an October 2020 letter maintaining that pandemic shutdowns were causing irreparable harm. Dr. Cody Meissner, a former ACIP member, also was named. Kennedy made the announcement in a social media post on Wednesday. The committee, created in 1964, makes recommendations to the director of the Centers for Disease Control and Prevention. CDC directors almost always approve those recommendations on how Food and Drug Administration-cleared vaccines should be used. The CDC's final recommendations are widely heeded by doctors and determine the scope of vaccination programs. ___ Associated Press reporter Amanda Seitz contributed to this report. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into the world of global news and events? Download our app today from your preferred app store and start exploring.
app-storeplay-store