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Did the FDA Have a Choice?
Do you think that this is a sensible decision by the FDA? Multiple currently marketed ER and long-acting medications (some of which have been denoted as preferred medications on certain payers' formularies) do not possess any abuse-deterrent properties. These include certain forms of ER morphine, the generic form of ER oxymorphone, generic transdermal -- or even brand-name transdermal -- fentanyl, and methadone. Did the FDA have any choice but to approve ER hydrocodone, if it otherwise met all current FDA requirements for approval? Was that a reasonable decision on the part of the FDA? Why is the FDA in this position?
Given that improving the safety of available medications is part of the FDA's stated mission, how is it that a new medication such as Zohydro ER can be approved when the technology to develop an abuse-deterrent formulation of ER or long-acting opioids exists? We have ER opioids (oxycodone ER) that have been deemed to have abuse-deterrent properties, and as mentioned, the FDA has guidelines for developing abuse-deterrent formulations. Will this product be prescribed by our colleagues if ER and long-acting medications with abuse deterrent features are currently available? Airbags save lives. Could any car be developed and sold in the United States without airbags? Let's think about this as we go forward. Yes, a new medicine has been approved, but is it the medicine that you will be willing to prescribe?
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