Firm Decides to Remove Opana ER from the Market – What Do I Know?

On Thursday as I was giving a talk to a firm about the abuse-deterrent drug landscape and potential for the future, the firm that makes and markets Opana ER was announcing that it was agreeing to remove its product from the marketplace in accord with the FDA recommendations.

During the presentation, I was   asked by one participant what I thought the maker of Opana ER would do.  I replied, “I have no idea, but if it was me I would fight the urge to give in to the FDA”.  Little did I know that the decision was being announced as I spoke.  Does that change my mind – NO!  I have blogged about this in the past (here) and on numerous other occasions, and I must state that my opinions do not reflect anyone’s but my own, however, I am concerned at the direction that this action may take the Agency.

I know that something must be done to combat the opioid epidemic plaguing our country, but I am not sure that removing products from the market and taking a tool away from a healthcare provider to treat a patient’s intractable pain may be the best solution.  Why?  Let me state my case.

  • The FDA approves drugs for safety and efficacy. The safe and effective use of a product is in accord with the conditions of use described in the approved labeling.  Is illicit use a condition for which the drug is approved?
  • Should healthcare providers and patients be deprived of a product because it is being misused? If so, then perhaps many of the drug products approved to treat ADHD should be removed because too many college students misuse the drugs. I am not naïve, and recognize that this might be a stretch, but it points out the slippery slope that such moves could create.
  • Healthcare costs are soaring and attention on innovator prescription drug products, as well as generics have taken center stage as they have come under fire from Congress, the public, and even FDA. The cost considerations of abuse-deterrent products must be taken into consideration when making approval and removal decisions.  I know that there are more important considerations than drug costs in this situation, but question whether removal of a potentially abusable product (all the opioids can be abused by one route [oral] or another, even if the product does have abuse-deterrent properties) solves the problem of abuse.
  • The nation should look to the root of the problem. Perhaps a national registry of opioid prescriptions, patients who they are prescribed for, and doctors who prescribe them should be developed.  Pharmacists, law enforcement, state medical, and pharmacy practice personnel could access critical information on prescribing habits.  Data could be used to better police dispensing and also root out problems they may find.  In addition, if I were King, I would require that everyone who picks up a prescription for an opioid product should present a driver’s license or other government-issued identification card that would be scanned, whether it be the patient or agent of the patient.  If we can do it to track pseudoephedrine purchases, we should be able to do it for other drugs of abuse to ferret out bad actors.

There are likely many more efforts that could be made by the enforcement community.  Law enforcement or boards of licensure for professional practice could do more to combat drug abuse than taking a product off the market because it is being diverted and not used in accordance with its labeled indications.  The practice of trying a fix like that is like playing Wac-A-Mole.  You hit one problem over the head and another unexpected problem pops up.  Abusers will quickly switch to another drug to abuse when access to their drug of choice is not available.  Case-in-point is the rise in heroin overdoses being experienced across the nation as certain prescription drug products are removed from the market or their street value increases dramatically.  The abuser may likely turn to heroin.  The problem with this is the abuser does not know what’s in the heroin (the fentanyl and fentanyl derivatives).  Just look at the national media reports and pictures of parents overdosed in their cars with a young child in the back seat.  Don’t get me wrong, I am not advocating making prescription drugs illegal  or abandoning the push for creating abuse-deterrent products, but in an effort to protect a potential abuser we also need to be mindful of protecting the treatment options for the patients.  I wish I had the answer to solve the abuse problem, but I am just not sure removing safe and effective treatments from the armamentarium of healthcare providers is the best choice.