In the case of the prior formulation of Opana ER, the FDA determined that the product should remain on the market.” … In July 2017 the Company, after careful consideration, decided to voluntarily withdraw it from the market. “In June 2017, the FDA requested that Endo voluntarily withdraw the formulation of Opana ER that is designed to be crush resistant due to unintended use and misuse. “The FDA is charged with – and makes – the sole determination of whether pharmaceutical products are safe and effective,” the company told CNN. “Here’s a situation where the company is talking out of both sides of its mouth, depending on what will make them money.”Įndo defended its decision to cut the deal with Impax. “The pharmaceutical industry is solely driven by its desire to make profits and boost its bottom line,” Carome said. Michael Carome, director of health research for the consumer group Public Citizen, was harsher in his criticism. “They’re the ones who called it dangerous and unsafe,” said Suzanne Robotti, who is also the founder of the MedShadow Foundation, a patient advocacy group. Endo is now poised to make money from a drug that it said shouldn’t be on the market.Įndo’s efforts to profit from a drug that it said was susceptible to abuse raises ethical questions, in the opinion of one member of the FDA advisory committee that recently reviewed Opana ER. So on August 8, Endo cut a deal with Impax Laboratories to split the profits of a generic version of its original drug. The FDA’s action this summer didn’t impact the crushable version Endo stopped selling in 2012. But that’s not the end of the drug’s story.Įndo still has the patent on the original version of the drug, the one it fought to keep off the market. “We’re requiring that a specific opioid, which is truly evil, be taken off the market immediately,” he said.Įndo agreed to halt shipments of Opana ER starting September 1. President Trump alluded to the drug last week when declaring the opioid epidemic a public health emergency. It was the first time the FDA had taken steps to stop sales of a currently marketed opioid because of the consequences of abuse. In June, the regulatory agency concluded that the risks of new crush-resistant Opana ER outweighed its benefits and pressured Endo to stop selling it.
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Even so, addicts quickly learned how to cook the new painkiller and inject the liquid with a syringe.Įndo contended that the new Opana ER and its hard coating deterred abuse, but this summer, the FDA disagreed. The difference was that the new version had a few different inactive ingredients, including a hard coating that made the pills harder to pulverize. Both were called Opana ER.Įndo agreed to halt shipments of Opana ER starting September 1. Both were extended-release pills for long-lasting effects. Both drugs had the same active ingredient, oxymorphone. But some industry observers say the story of Opana ER may better illustrate the lengths a drug company would go to in order to protect its profits.Įndo introduced a new formulation of Opana ER before phasing out the old one, selling two versions of the drug at the same time. It seemed as though a drug maker was taking selfless action to try to curb the growing opioid epidemic. Snorting intensifies the high but heightens the chance of overdosing. The drugmaker argued that given a chance, drug abusers would crush and snort the generic pills, just as they had with the brand-name drug.
When its plan didn’t work, the company made an unusual decision.Īs the opioid epidemic grew, Endo Pharmaceuticals took the extraordinary step in 2012 of pulling a version of one of its best-selling painkillers off the market, saying that the narcotic was susceptible to abuse.Įndo even unsuccessfully sued the US Food and Drug Administration that year to prevent the approval of any generic version of its drug, called Opana ER. But this is a story about a drug company that went to extraordinary lengths to do so, calling into question the safety of a drug it had sold for years. It’s not uncommon for drug companies to try to keep generic versions of their best-selling drugs off the market.
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