With the release of a draft guidance on the evaluation and labeling of abuse-deterrent opioid formulations, FDA is one step closer to clarifying its thinking on acceptable formulations for this product class.
FDA’s actions in recent months with regards to opioids have been inconsistent: in December 2012, they refused to block the market entry of generic oxymorphone that was not formulated to be abuse-resistant. Endo Pharmaceuticals, who reformulated their branded product, Opana, to be abuse-resistant, filed a lawsuit against FDA to block approval of the generic drugs, claiming that the reformulation was done for reasons of safety, and that generic manufacturers should be held to the same safety standards. Shortly thereafter, however, an FDA approval committee voted against approval of an extended-release hydrocodone made by Zogenix, because of its potential for abuse. So, while FDA was clearly considering abuse potential in its approval process, an abuse-deterrent formulation was not a prerequisite for approval.
A January 8, 2013 letter from FDA Commissioner Margaret A. Hamburg to Rep. Fred Upton contains more insight. In the letter, Hamburg says, “FDA has concluded that if FDA determines that a formulation of a product significantly deters abuse, we have legal authority, under the drug approval and drug safety provisions of the federal Food, Drug, and Cosmetic Act, to require generic version of that product to have abuse-deterrent formulations as well.” FDA is still considering whether to act on that authority, according to the letter. Hamburg tells Upton that FDA is evaluating data on opioid formulations to determine whether abuse-deterrent formulations do, in fact, deter abuse and will base their policy accordingly.
The newly released draft guidance, Abuse-Deterrent Opioids—Evaluation and Labeling, contains a section on designing and conducting premarketing studies to demonstrate abuse-deterrence, a clear first step in being able to evaluate a product. As the data roll in, we should see more consistent policy regarding opioid formulations.