Another strategy for curbing opioid abuse is for manufacturers to develop extended-release pain medications that resist tampering
and misuse. FDA issued draft guidance in January 2013 that advises manufacturers on the types of studies needed to demonstrate
anti-abuse effectiveness and explains how the agency will evaluate safety data and approve labeling for such products (1).
The document describes how data could support a range of claims in labeling: that a product provides a barrier to abuse, blocks
opioid effect when manipulated, leads to meaningful reduction in abuse, or demonstrates reduced abuse in the community.
The success of newer, tamper-resistant products, however, raises a much trickier issue for FDA: whether to block generic copies
of earlier opioids that are more easily abused. Perdue Pharma gained approval in 2010 for a reformulated version of OxyContin
that was more difficult to crush or dissolve and now wants FDA to rule out generic versions of its original product. Endo
Pharmaceuticals has sought similar protection for an improved version of Opana.
Commissioner Hamburg clarified in a January letter to Congressional leaders that FDA has authority to require generic opioids
to adopt new tamper-resistant formulations, but only if the agency determines that such newer products will "significantly
deter abuse," which FDA has yet to do (2). Hamburg hopes to head off legislation that would block FDA approval of generic
versions of abuse-prone medicines, but recognizes that brand manufacturers are unlikely to develop new tamper-resistant products
if cheaper versions of old drugs come to market.
At the same time, manufacturers may find it difficult to gain FDA approval of new painkillers without anti-abuse features,
as seen in delayed action on approving Zohydro, a high-dose, long-acting hydrocodone product from San Diego-based Zogenix.
An advisory committee rejected the drug last December, expressing fears that Zohydro could lead to dependence and would be
highly attractive to illicit users.
Meanwhile, FDA is being more proactive in the war against opioid abuse. It's promoting prescriber and patient education on
appropriate drug use, and agency scientists are working with academics on research methods for assessing opioid effectiveness
and innovative package designs that may deter misuse.
Public officials also are taking action. New York City Mayor Michael Bloomburg announced in January that city emergency rooms
would provide only three-day supplies of opioid painkillers to patients (3). Hospitals in Utah, Michigan, and Wisconsin are
reducing or eliminating opioids from emergency rooms in favor of non-narcotic medications. Yet, a tough anti-abuse law in
Kentucky is headed for revision because it created access problems for seriously ill patients.
State attorneys general (AGs) also weighed in recently, calling on FDA to require generics makers to produce tamper-resistant
versions of opioid medicines. In a letter to commissioner Hamburg March 11, 2013, 48 AGs raised concerns that illegal users
are shifting to older, more easily abused products as the newer formulations come to market (4). Regulation and production
of dangerous, but clinically important, drugs is not simple from any perspective.
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634, email@example.com
1. FDA, Draft Guidance on Abuse-Deterrent Opioids—Evaluation and Labeling (CDER, Silver Spring, MD, January 2013).
2. M. Hamburg, Letter to House Energy and Commerce Committee chairman Fred Upton (Jan. 8, 2013).
3. Press Release, "Mayor Bloomberg, Deputy Mayor Gibbs and Chief Policy Advisor Feinblatt Announce New Emergency Room Guidelines
to Prevent Opioid Prescription Painkiller Abuse," New York Times, Jan. 10, 2013.
4. K. Palmer, "Forty-Eight State and Territorial Attorneys General Call for Tamper-Resistant Versions of Generic Prescription
Pain Killers," http://www.fdalawblog.net/, accessed Mar. 12, 2013.