Do the FDA Commissioner’s Remarks Spell Trouble for Generic Opioids?

In a recent speech given to the 2016 Opioid and Drug Abuse Summit, FDA Commissioner Dr. Robert Califf outlined the FDA’s plans on addressing the opioid abuse epidemic and touched on a number of important and critical issues that underscore the tough job ahead of them.  He emphasized that there needs to be a multipronged approach that reaches practitioners, other healthcare providers, law enforcement, educators, and patients.

He emphasized what FDA has done recently by noting “Our action plan also recognizes the importance of seeking new ways to formulate opioids to discourage tampering with the drugs in order to receive a faster high, a problem that I know you’re grappling with and will talk about during this meeting. Last week we issued a draft guidance for industry that will help them develop abuse-deterrent formulations and ensure that generic versions of approved opioids with ADFs are no less abuse-deterrent than the brand name drug.”

This was one of the bases of the foundation laid in the action plan; however, in additional comments, we find pause to worry about the future of the Agency’s position on continued approval of generic non-abuse deterrent and other abuse-deterrent opioids that could hamper access by increasing costs and limiting the number of alternatives that physicians and other healthcare practitioners use to treat severe and end of life pain.

While Califf acknowledged that “[e]nsuring appropriate access to generic forms of abuse-deterrent opioids is an important element in that broader strategy,” he also followed by saying “[w]e’ve noticed in prescribing patterns that abuse-deterrent formulations have not taken a large share of the market, perhaps in part due to the much higher cost without generic formulations on the market.   So the availability of less costly generic products has the potential to increase the use of abuse-deterrent formulations.” And here is where the uncertainty is introduced into the equation to fix the problem. What does he (the FDA) plan to do about non-abuse-deterrent formulations that are even less costly and may, in some instances, be the only viable treatment for a patient that must either crush a tablet or have it administered through a nasogastric tube?  In addition, I don’t think that anyone would expect even a generic abuse-deterrent product to be less expensive than a currently available non-abuse-deterrent generic.  The FDA, in evaluating its overall approach, must assure that cost and available modes of treatment are not limited.  We have posted about this before here, here, and here.

Califf also acknowledged that there may be limits on what FDA can do by noting “[s]ome have said that one way that FDA could reduce the use of opioids is to limit the number of opioids it approves. But there are limits to what we can do under the current law. Under the current law, FDA is obligated to approve an application for a generic drug unless the product fails to demonstrate bioequivalence to the innovator or it does not meet other standards. This is a difficult problem that we’ll be talking about more in the near future.” And with that the alarms go off.  What does FDA have in store for the generic non-abuse-deterrent formulations already approved and those in the pipeline?

“An essential piece of developing new abuse deterrent products is having the necessary data on the impact of existing ADF products,” which is also an important consideration in taking any adverse action against certain generics.  But there are other areas that perhaps deserve more attention, such as better education for healthcare providers, for instance, as Califf says “we need a much more robust national research effort to inform doctors and patients about the long-term benefits or risks associated with the use of opioids for treating chronic pain.”  However, there is an enforcement element to controlling opioid abuse and those that prescribe them, but also developing a national database so that pharmacists and healthcare providers can see what other prescriptions patients are taking from other providers and in other jurisdictions.  In my opinion, FDA should not be shortsighted with regards to controlling the number of opioid applications it approves, but rather on how best to assure that they are appropriately used.

The entire problem cannot be tackled with a single swipe of a brush, nor can we expect to make progress in the war on drug abuse until there is a national policy that accurately and comprehensively addresses all of the tentacles of the problem.  We need to take precautions to assure access, availability, and a reasonable national policy to deal with a problem that the nation has not been able to successfully address since the war on drugs began decades ago.