FDA advisory panel ignores Congress, calls for new restrictions on pain medsJanuary 31, 2013
Over the objections of the AOA and national provider groups representing dentists, nurse practitioners, physician assistants and others, a U.S. Food and Drug Administration (FDA) advisory panel on Jan. 25 voted 19 to 10 in favor of moving hydrocodone-combination drugs, such as Vicodin and Lortab, from schedule III controlled substances into the more restrictive schedule II category. If allowed to be fully implemented, this action could block many ODs from prescribing these drugs.
The advisory panel’s review of the issue follows last year’s successful effort to convince Congress not to make the very same change in how hydrocodone is currently classified. After meetings with doctors and staff representing AOA and state affiliates, including the West Virginia Association of Optometric Physicians, key lawmakers agreed last June to remove the hydrocodone reclassification provision from the Prescription Drug User Fee Act reauthorization bill before the legislation came up for a final vote.
Overall, the push to reschedule hydrocodone-combination drugs, a move sought by the U.S. Drug Enforcement Administration (DEA), has been aimed at curbing near-epidemic levels of abuse and diversion of opioids nationwide, though no organization nor individual official has ever cited optometry’s prescribing authority as being a contributing factor to the problem. Addiction counseling groups have also been calling for the rescheduling by arguing that the drugs are pharmacologically similar and as susceptible to abuse as other opioids that fall into the more tightly-regulated schedule II.
Testifying on behalf of AOA at the FDA Drug Safety and Risk Management Advisory Committee meeting earlier this month, Jimmy Bartlett, OD, explained optometrists’ role in caring for most of the eye problems that most people have most of the time and warned that, while abuse and diversion of these drugs are issues to be taken very seriously, simply moving hydrocodone-combination drugs into schedule II would have harmful health consequences for patients and would limit proven treatment options for providers.
For some health care providers, moving the drugs from schedule III to schedule II would impact the ability to prescribe up to a six-month supply and remove the option to call-in a prescription instead of issuing a paper version. But for many ODs and other provider groups opposing the change, it would mean no longer being able to prescribe hydrocodone-combination drugs altogether in states that have not specifically granted schedule II prescribing authority.
The AOA views the advisory panel’s action as misguided and incomplete and has already begun urging the federal officials who will soon review it to discuss the modifications needed to safeguard optometry patients. In addition, the AOA is also educating officials about the important role that optometrists play in helping to fight addiction and guide patients into treatment.
At every step in this process, the AOA has reminded officials that optometrists are among law enforcement’s most committed allies in the battle against illicit drug use, often serving as sentinels in the early detection and identification of abuse and linking individuals at risk to necessary health services.
As outlined under the Controlled Substances Act, the advisory committee’s recommendations will now be delivered to FDA leaders, who will in turn make a recommendation to U.S. Department of Health and Human Services (HHS). Following the Act’s guidelines, HHS will then make its official medical and scientific evaluation on this issue to the U.S. Drug Enforcement Administration, which has the ultimate authority on the scheduling of controlled substances.
ODs concerned about the advisory panel’s decision and interested in working with Dr. Bartlett and the AOA Advocacy Group to ensure that optometry’s concerns are heeded going forward are urged to contact Matt Willette of the AOA Washington, D.C., office at 800-365-2219, ext. 1001 or firstname.lastname@example.org