Late last week, the U.S. Food and Drug Administration (FDA) announced that it would move ahead with plans to submit a formal recommendation to reclassify hydrocodone-combination drugs. In doing so, the agency has consented to granting authority long-sought by the U.S. Drug Enforcement Administration (DEA) to designate all hydrocodone-containing drugs as Schedule II controlled substances.
The AOA is on record as opposing the FDA's action. Over the last year, the AOA and several likeminded groups, including those representing cancer patients, MDs, dentists, pharmacists and pharmaceutical manufacturers and distributors, have been trying convince lawmakers and agency officials that patient need and existing doctor prescribing authority should not fall victim to a one-size-fits-all approach aimed at preventing opioid abuse and diversion, which is recognized to have reached near-epidemic levels in certain parts of the country.
Though Congress and the FDA have listened to and even confirmed the validity of concerns raised by the AOA and others, the decision to go ahead with upscheduling of hydrocodone-combination drugs stems directly from what the agency has said is the "unique history of this issue and the tremendous amount of public interest." While some outside observers rightly question how effective the move would be at curbing abuse and misuse of these products, it is also important to note that no organization or individual official has ever cited optometry's prescribing authority as being a contributing factor to the problem.
Despite the validity of optometry's arguments and backing on Capitol Hill, this is the AOA's second consecutive setback at the FDA on the hydrocodone upscheduling issue. Based on the AOA Advocacy Group's assessment of the current regulatory and political environment, there is the immediate prospect that the DEA will begin a formal rulemaking process in 2014 to make the reclassification final. If this happens, it is estimated that ODs in 24 states will summarily lose prescribing authority for hydrocodone-combination drugs, unless a state-level fix can be implemented.
The AOA will continue working - both in concert with allies and separately - to present the concerns of doctors and patients to every government official who can influence the ultimate outcome. All ODs with questions about the impact this change would have on their practices or who can share information bolstering the AOA's position that it is absolutely essential for Doctors of Optometry to retain existing prescriptive authority for hydrocodone-combination drugs should contact Matt Willette of the AOA Washington Office at 1-800-365-2219.