FDA says knockoff versions of Lilly obesity drug must come off the market

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FDA says knockoff versions of Lilly obesity drug must come off the market

MAKE THE POUNDS MELT AWAY AND BEAUTY PRODUCTS AND FILLERS WILL ERASE THOSE FINE LINES. SO MANY PEOPLE WANT THEM. BUT DO YOU KNOW WHAT YOU’RE REALLY GETTING OR WHERE IT’S EVEN COMING FROM? I GOT A RARE INSIDE LOOK AT THE U.S. CUSTOMS AND BORDER PROTECTION RIGHT HERE IN CINCINNATI, AND TAKE A LOOK AT THE AMOUNT OF FAKE PHARMACEUTICALS THEIR OFFICERS ARE INTERCEPTING ON A DAILY BASIS. WELL, MOST OF YOU ARE SOUND ASLEEP. THE U.S. CUSTOMS AND BORDER PROTECTION FACILITY IN CINCINNATI IS BUZZING WITH OFFICERS AND DRUG DOGS, SAYS TORTILLA PRESS. IT DOESN’T LOOK LIKE A TORTILLA PRESS TO ME. IT’S 2 A.M., BUT THEY’RE WIDE AWAKE LOOKING FOR ILLEGAL AND FAKE PHARMACEUTICALS, TRYING TO BE SHIPPED THROUGH GREATER CINCINNATI. THAT IS A PRETTY GOOD INDICATOR THAT WE’VE GOT SOMETHING CONCEALED WITHIN THIS SHIPMENT. ABOUT 250,000 PACKAGES COME THROUGH THIS FACILITY EVERY SINGLE DAY. ANYWHERE FROM 500 TO 1000 ARE FLAGGED AS SUSPICIOUS. IT’S A NEVER ENDING BATTLE, BUT OUR OFFICERS DO AN EXCELLENT JOB. NIGHT AFTER NIGHT, FINDING THAT PROVERBIAL NEEDLE IN A HAYSTACK. WITHIN MINUTES OF SCANNING AND ANALYZING. PORT DIRECTOR ERIC ZIESELMAN FINDS A GIANT STASH OF ILLEGAL MARIJUANA HIDDEN INSIDE A KID’S GAMING CHAIR. TYPICAL CONCEALMENT METHOD. WE’VE SEEN THIS SAME CONCEALMENT METHOD IN THE PAST. THESE OFFICERS HAVE SEEN IT ALL. COCAINE. METH. FENTANYL. ALL HEADED TO CITIES ACROSS THE U.S. OR OTHER COUNTRIES. FOR YEARS, THEY’VE INTERCEPTED THINGS LIKE COUNTERFEIT CONTACT LENSES, STEROIDS, AND MEDICATIONS. BUT THE NEW HOT FAKE FREIGHT IS SOMETHING MANY OF YOU USE OR WANT. AS YOU CAN SEE, THIS TABLE IS FULL. WE SEE THIS DAILY. THIS ROOM IS FILLED WITH BOGUS BEAUTY PRODUCTS AND WEIGHT LOSS DRUGS. IS IN FACT COUNTERFEIT. THE LABELS ARE ALL COUNTERFEIT. OVER THE LAST TEN YEARS, OFFICERS HAVE BEEN SEEING A SPIKE IN FAKE FILLERS, BOTOX AND SKIN CREAMS LIKE THESE TO THE AVERAGE PERSON, THEY LOOK LEGIT, BUT NOT TO THE EXPERTS. CERTAIN FINE LINE DETAILS ON THE PACKAGING, THE ORIGIN, WHERE IT’S ROUTING FROM, ALL YOU KNOW, THE TOTALITY OF THE CIRCUMSTANCES WOULD LET US KNOW IF IT’S LEGITIMATE OR NOT. IN THE LAST SIX MONTHS, THERE’S A NEW DEMAND. WEIGHT LOSS DRUGS LIKE OZEMPIC AND MOUNJARO ARE SO EXPENSIVE. PEOPLE ARE WILLING TO BUY KNOCKOFFS THAT ARE FAR CHEAPER. WHAT THE CONCERN IS HOW IT’S PRODUCED AND WHAT IS IN HERE. YOU HAVE NO IDEA WHAT’S IN HERE. YOU DON’T KNOW IF YOU’RE GETTING A LEGITIMATE PRODUCT, AND YOU DON’T KNOW IF YOU’RE GETTING A SAFE PRODUCT. YOU MIGHT NOT EVEN BE GETTING THE PRODUCT THAT YOU’RE CHOOSING TO PURCHASE IN THIS MANNER. FOR SOME, THE BARGAIN IS WORTH THE RISK. SINCE MAY 65, SHIPMENTS OF PHONY WEIGHT LOSS DRUGS WORTH $1.2 MILLION HAVE BEEN SEIZED IN CINCINNATI ALONE. AND THESE OFFICERS DON’T SEE THINGS SLOWING DOWN ANYTIME SOON. SO BUYER BEWARE. WE SAY THIS WITH COUNTERFEIT PURSES AND WATCHES, BUT IF THE DEAL IS TOO GOOD TO BE TRUE, THERE’S A REASON FOR THAT. ALL RIGHT, SO GET THIS. CINCINNATI CUSTOMS AND BORDER PROTECTION OFFICERS MADE 4400 SEIZURES IN THE LAST FISCAL YEAR. THEY’RE ON PACE TO BEAT THAT THIS YEAR. AND BY THE WAY, ALL OF THE PRODUCTS THAT THEY SEIZE GET DESTROYED UNLESS IT’S FORFEITURES BY THE FDA AND THOSE LAST WORDS WILL BE THE ONES THAT SIT WITH ME IF IT LOOKS TOO GOOD TO BE TRUE, IT PROBABLY IS. WE SHOULD JUST ALWAYS REMEMBER THAT. YEAH. I WAS REMINDED OF IT AS I’M SITTING THERE. YOU KNOW, I WAS RECENTLY GOING TO BUY SOME VITAMINS THAT ARE SUPPOSED TO GROW YOUR HAIR, AND I WAS GOING TO GET A BRAND THAT LOOKED REALLY SIMILAR, SIMILAR ON ANOTHER WEBSITE. AND SURE ENOUGH, YOU COULD TELL THEY WERE SO, SO CHEAP. I WAS LIKE, THESE CAN’T BE THE SAME THING. EVEN THOUGH THE LABEL AND THE NAME LOOKED VERY SIMILAR AND THE PEOPLE ON THE OTHER SIDE OF THE LAW ARE ALWAYS A STEP AHEAD, SEEMINGL

FDA says knockoff versions of Lilly obesity drug must come off the market

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 Lilly’s 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 “Lilly’s 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 FDA’s 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 month's supply for several hundred dollars.Thursday’s 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 Lilly’s 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 aren’t 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.

WASHINGTON —

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 Lilly’s 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 “Lilly’s 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 FDA’s 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 month's supply for several hundred dollars.

Thursday’s 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 Lilly’s 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 aren’t 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.

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