FDA Requests Opana ER Be Removed From the Market.  Will They Fight or Switch?

In what (I believe) is only the second opioid that FDA is seeking to remove from the market because the risk no longer outweighs the benefits of the product (first was the original formulation of Oxycontin), the Agency said “After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks.  This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.”

The new FDA Commissioner stated in the FDA’s News Release announcing his recommendation: “We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” said FDA Commissioner Scott Gottlieb, M.D.  “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”

Usually, the FDA will take an action such as this when a product fails the risk benefit ratio, when a product is used per its labeled indications and use instructions.  This action, however, goes beyond that concept, because the product is being abused and used not in accordance with its labeled indications.  This is a new concept that, if taken to the Nth degree, could place many more opioid products at risk of market removal.  I believe that the FDA must be measured in its actions to ensure that it is not handcuffing legitimate practitioners and patients that may truly need opioid treatment for severe pain that cannot be managed in other ways.  In addition, the Agency must be cognizant of cost factors that may make certain new abuse-deterrent products no longer affordable for certain patients.  Will the firm fight to save its product or will they comply with FDA’s request?  Will the Agency then begin action to remove the product from the marketplace by publishing a notice of opportunity for hearing (NOOH)? The full FDA announcement can be read here.

Better monitoring of physician-prescribing habits and enforcement, perhaps limiting the quantity of stronger opioids that can be dispensed in a single prescription, limiting the duration of treatment, requiring better education and having nationwide real time databases that can be used by licensing agencies, pharmacies and enforcement officials to locate aberrant practices, should be considered as options to fight the opioid epidemic as well.

The problem is not new.  It is real, but we need to make certain whack-a-mole actions don’t make things worse.  For instance, when Oxycontin reformulated its product to an abuse-deterrent formulation, the number of deaths from heroin overdoses soared.  When the cost of illicit prescription medications on the street exceeds other illicit drugs, the abusers turn to heroin.  The surge in heroin and other fentanyl-based derivative deaths have soared.  Narcan is carried by most all EMTs and many private citizens to help revise those that overdose.  The battle is on – but so far, it is clear that we are losing this war.  I just want to be sure that any action we take to try to help does not have serious unintended consequences (which is something that, unfortunately, we don’t see until after the action is taken).  I wish I had the answer.  Do you?