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A Super Bowl commercial message put out by the telehealth ship’s company Hims & Hers is draw heating from critic who say the company ’s furtherance of its free weight - loss drug misled consumers by leaving out key data .
At the center of the controversy are so - called compounded medication , which are n’t regulated in the same way as brand - name or generic drug are andaren’t formally approved by the Food and Drug Administration(FDA ) .
A Super Bowl ad has pushed compounded drugs and the laws surrounding them into the limelight.
Hims & Hers offers heighten variation of these drug , which are not FDA - okay .
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It took an bird of Jove eye to spot that disclaimer on the Hims & Hers advertizement , however , as it was publish in small clean typeface on a gray-haired background . The advertizement also did not follow a pattern involve for FDA - approved medications , which is listing potential side effects of the drugs and contraindications — meaning medical condition or treatment that might prevent a someone from using the drug safely .
That ’s a problem , according to critics .
" By mass selling and mass make chemical compound medications , we are devolving the refuge of our drug supply , " saidShabbir Imber Safdar , the executive conductor of the Partnership for Safe Medicines , a non-profit-making coalition of stakeholders in the drug supplying string , from manufacturers to middleman to patient advocates . " We ’re not sustain a disputation about it , and we ’re not even train Americans about it . "
What are compounded drugs?
It ’s a common misconception that what clinic like Hims & Hers sell — at a fraction of the cost of mark pharmaceutic — are generic versions of drugs . But deepen medications are n’t generics , which must be manufactured with the same ingredient and by the same processes as brand - name pharmaceutic .
Instead , compounded drugs are manufactured with the same combat-ready constituent as generics and brand - name , but without the same regulation to ensure their production and labeling .
There are two spot where compounded medication are made . The first is in small or neck of the woods pharmacies , where pharmacists can customize modest batch of drugs for patient with exceptional needs . This is why intensify medications exist , Safdar told Live Science : A pharmacist may call for to make a medication that is in shortage , or might need to somehow modify the " official " version of the drug . For example , they might make a liquid version of a drug only available in pill form for a patient role who ca n’t swallow pills , or they might supervene upon a non - active ingredient for a patient with an allergic reaction to it . These apothecary’s shop are shape under United States Department of State pharmacy boards .
Compounded drugs can also be made in what are called bulk outsourcing facilities , some of which are very large . These quickness are inspect by the FDA for guard , and manufacturer must buy their ingredients from FDA - sanction suppliers . But the result drugs and the process by which they are made are n’t clinically tested , which is why the result drugs are not FDA - O.K. .
They are also not dependent to the same supply - chain trailing as FDA - approved drugs are . Any FDA - approved medicine , whether generic or branded , has a unique serial bit that associate it back to its maker . heighten medicines do n’t return under this requirement .
" A bighearted job , if a compounding facility makes you a drug that was prescribed by a doctor you ’ve never met in mortal , is you ’re now holding a vial you ’re expected to inject into yourself and there ’s actually no way to live where it came from , " Safdar order .
If there ’s a problem , it ’s more difficult to pinpoint who ’s liable , and more challenging to inquire if more substance abuser of the drug might be impacted . Track - and - hint also foreclose counterfeit drug from enter the organization .
Looser labeling requirements for compounded versions of GLP-1s can also lead to discombobulation about dosage , concord to an FDA warning signal go forth in July 2024 . The bureau had incur report of patient role being hospitalized after accidental dose errors with compound weight - release drug . There have also been alarms about compounding pharmacies usingdifferent translation of the active ingredientsin these medications , lead to untoward events .
Compounded medicine have lead to tragedy before . In 2012 , unsanitary circumstance at a compounding pharmacy caused a20 - state eruption of fungal meningitisthat kill 64 mass and infect closely 800 others .
Related : Childhood obesity should be treated early and aggressively , Modern guideline say . Is that good ?
‘Fair balance’
Hims & Hers uses compounded semaglutide only from FDA - regulated bulk outsourcing facilities , saidDr . Craig Primack , the ship’s company ’s aged frailty Chief Executive of free weight loss . Patients can check the testing related to their batch of medication on the company ’s app , Primack told Live Science .
However , the idea that provider of compound medications do n’t have to list side effect or endangerment has gotten pushback from Senators Riachard Durbin ( D - IL ) and Roger Marshall ( R - KS ) . They write a letter to the FDA Friday ( Feb. 7 ) expressing business organization that the deficiency of comely balance is a loophole for those selling compound medications .
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" To the extent this fall within a regulatory loophole for the FDA ’s authorities , we plan to shortly introduce bipartisan legislation to close this gap,“Durbin and Marshall wrote .
company like Hims & Hers are set aside to offer compound versions of Ozempic and Wegovy because the brand - name drugsare in shortageand have been for years . For consumer , it ’s an sympathetic option : The companionship offers blade - name Ozempic for $ 1,799 a month , out of pouch , while their compounded semaglutide starts at just $ 165 a calendar month .
But compounding was never meant to provide a cheaper , aggregative - market version of FDA - approved medicinal drug , Safdar enunciate . Nor were patients ever meant to have to navigate the dispute , he emphasized .
" We need compounding , " Safdar said . " But the principle were designed [ the way they were ] because no one ever thought we would have broad - scale usage of these medications . "
The Hims & Hers Super Bowl commercial message signals a possible shift in this status quo — one that may before long get its moment for argument if Durbin and Marshall ’s bill move forward .
This clause is for informational purposes only and is not meant to offer medical advice .
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