It starts with a tweet:
@HHSGCMikeStuart -- Based on a review of the applicable facts, earlier today @HHSOGC referred Hims & Hers Health, Inc. ("Hims") to the Department of Justice for investigation for potential violations by Hims of the Federal Food, Drug, and Cosmetic Act and applicable Title 18 provisions.
Better late than never.
Last July in the Journal of the Academy of Public Health, I wrote, “The rise of large-scale compounding of GLP-1 drugs raises grave concerns. And those concerns are magnified by compounders’ disregard for the law … Failure to act risks eroding trust in our healthcare system generally. For decades, Americans have relied on the robust regulatory system in place to ensure that the medicines they take are safe and effective. If unscrupulous actors are allowed to continue putting patients at risk by exploiting regulatory lapses, it undermines trust in the whole system. The time to act is now.”
After pussyfooting around the unregulated manufacturing, brazen advertising, and aggressive nationwide distribution of illegal semaglutide products, the federal government has finally decided to act. It’s about time. Per FDA Commissioner Marty Makary, “FDA will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products.” The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs.”
This follows the gloves-off statement from Novo Nordisk, the manufacturer of Wegovy:
“The action by Hims & Hers is illegal mass compounding that poses a significant risk to patient safety. Novo Nordisk will take legal and regulatory action to protect patients, our intellectual property and the integrity of the US gold-standard drug approval framework. This is another example of Hims & Hers' historic behaviour of duping the American public with knock-off GLP-1 products, and the FDA has previously warned them about their deceptive advertising of GLP-1 knock-offs.”
The timing is interesting. The unapproved, inauthentic, and untested knockoff semaglutide pill that HIMs and HERS intends to unlawfully market uses an untested delivery mechanism that lacks supporting evidence and has never been reviewed by FDA. While the FDA-approved Wegovy pill contains salcaprozate sodium (SNAC) technology to ensure absorption of semaglutide, HIMS and HERS claims their knockoff product uses liposomal technology that is intended to support absorption. It is entirely unknown whether this delivery mechanism is safe, what kinds of risks are presented by this absorption pathway, and whether it can effectively deliver the intended dose of semaglutide.
The FDA has expressly identified this technology as posing significant safety and efficacy risks to patients, and patients who take this compounded product are potentially at risk for over- or under-dosing as improper mixing of liposomes with active pharmaceutical ingredients (like semaglutide) could cause the compounded drug product to be potentially hazardous or ineffective.
As posted on Regulations.gov, Novo Nordisk has also carried out tests showing that samples of compounded oral liposomal semaglutide in suspension contained impurities as high as 41%. These findings have been reported to the FDA. These high levels of impurities further demonstrate the manufacturing and quality challenges of liposomal products and the significant safety risks for patients using them.
Science anyone?
Because of these safety and effectiveness concerns, the agency has issued a proposed rule to add liposome drug products to its list of products that may not be compounded due to, among other things, the complexity of their formulation, delivery mechanism, and release of the drug from the liposome.
And then:
Feb 7 (Reuters) - Online telehealth company Hims & Hers (HIMS.N), opens new tab on Saturday reversed course on its launch of a $49 compounded version of Novo Nordisk's Wegovy weight-loss pill after the U.S. Food and Drug Administration said it would take action against it.
"Since launching the compounded semaglutide pill on our platform, we’ve had constructive conversations with stakeholders across the industry. As a result, we have decided to stop offering access to this treatment," the telehealth firm said.
For the company that positioned itself as the poster child for affordable healthcare, it wasn’t a Profiles in Courage moment. But it does show they got the message.
We’ll see. This may not be the final death knell of the illegal, unsafe, and venal exploitation of the American public by semaglutide compounders, but it is certainly the beginning of the end. And the funeral can’t come soon enough.
“I did not attend the funeral, but I sent a nice letter saying I approved of it.”
– Mark Twain
@HHSGCMikeStuart -- Based on a review of the applicable facts, earlier today @HHSOGC referred Hims & Hers Health, Inc. ("Hims") to the Department of Justice for investigation for potential violations by Hims of the Federal Food, Drug, and Cosmetic Act and applicable Title 18 provisions.
Better late than never.
Last July in the Journal of the Academy of Public Health, I wrote, “The rise of large-scale compounding of GLP-1 drugs raises grave concerns. And those concerns are magnified by compounders’ disregard for the law … Failure to act risks eroding trust in our healthcare system generally. For decades, Americans have relied on the robust regulatory system in place to ensure that the medicines they take are safe and effective. If unscrupulous actors are allowed to continue putting patients at risk by exploiting regulatory lapses, it undermines trust in the whole system. The time to act is now.”
After pussyfooting around the unregulated manufacturing, brazen advertising, and aggressive nationwide distribution of illegal semaglutide products, the federal government has finally decided to act. It’s about time. Per FDA Commissioner Marty Makary, “FDA will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products.” The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs.”
This follows the gloves-off statement from Novo Nordisk, the manufacturer of Wegovy:
“The action by Hims & Hers is illegal mass compounding that poses a significant risk to patient safety. Novo Nordisk will take legal and regulatory action to protect patients, our intellectual property and the integrity of the US gold-standard drug approval framework. This is another example of Hims & Hers' historic behaviour of duping the American public with knock-off GLP-1 products, and the FDA has previously warned them about their deceptive advertising of GLP-1 knock-offs.”
The timing is interesting. The unapproved, inauthentic, and untested knockoff semaglutide pill that HIMs and HERS intends to unlawfully market uses an untested delivery mechanism that lacks supporting evidence and has never been reviewed by FDA. While the FDA-approved Wegovy pill contains salcaprozate sodium (SNAC) technology to ensure absorption of semaglutide, HIMS and HERS claims their knockoff product uses liposomal technology that is intended to support absorption. It is entirely unknown whether this delivery mechanism is safe, what kinds of risks are presented by this absorption pathway, and whether it can effectively deliver the intended dose of semaglutide.
The FDA has expressly identified this technology as posing significant safety and efficacy risks to patients, and patients who take this compounded product are potentially at risk for over- or under-dosing as improper mixing of liposomes with active pharmaceutical ingredients (like semaglutide) could cause the compounded drug product to be potentially hazardous or ineffective.
As posted on Regulations.gov, Novo Nordisk has also carried out tests showing that samples of compounded oral liposomal semaglutide in suspension contained impurities as high as 41%. These findings have been reported to the FDA. These high levels of impurities further demonstrate the manufacturing and quality challenges of liposomal products and the significant safety risks for patients using them.
Science anyone?
Because of these safety and effectiveness concerns, the agency has issued a proposed rule to add liposome drug products to its list of products that may not be compounded due to, among other things, the complexity of their formulation, delivery mechanism, and release of the drug from the liposome.
And then:
Feb 7 (Reuters) - Online telehealth company Hims & Hers (HIMS.N), opens new tab on Saturday reversed course on its launch of a $49 compounded version of Novo Nordisk's Wegovy weight-loss pill after the U.S. Food and Drug Administration said it would take action against it.
"Since launching the compounded semaglutide pill on our platform, we’ve had constructive conversations with stakeholders across the industry. As a result, we have decided to stop offering access to this treatment," the telehealth firm said.
For the company that positioned itself as the poster child for affordable healthcare, it wasn’t a Profiles in Courage moment. But it does show they got the message.
We’ll see. This may not be the final death knell of the illegal, unsafe, and venal exploitation of the American public by semaglutide compounders, but it is certainly the beginning of the end. And the funeral can’t come soon enough.
“I did not attend the funeral, but I sent a nice letter saying I approved of it.”
– Mark Twain
