Brian Malkin Comments on Orpana Withdrawal for Law360

Arent Fox FDA counsel Brian Malkin spoke to Law360 about Endo International PLC’s recent decision to withdraw its painkiller, Orpana ER, from the market. The prescription medication has been linked to opioid addiction.

The FDA formally requested Endo to remove the drug due to abuse risks. The article “Pulled Pain Pill, Opioid Rates Show Need For Research” explores the legal benefits of withdrawing the drug for the pharmaceutical company and the apparent need to address opioid addiction in the United States. Mr. Malkin argues, “Pulling a product from pharmacy shelves also doesn’t appear to solve the problem of opioid addiction…There needs to be a better understanding of mechanisms to wean someone off addictive opioid medications.” To read the article in full, click here.


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