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AOA’s concerns heard: Hydrocodone reclassification provision withdrawn from final FDA bill

July 25, 2012

Last month, the U.S. Senate gave final approval to an amended version of the high-priority Food and Drug Administration Safety and Innovation Act (S. 3187) after the AOA and congressional negotiators rejected a provision that would have rolled back optometrists’ prescriptive authority in 28 states.

Although the aim of the hydrocodone reclassification provision’s sponsors was to target the very real and serious problem of abuse and illegal diversion of hydrocodone-containing substances, the AOA made clear that the approach in the original Senate-passed measure was flawed and would have had serious unintended consequences for ODs and their patients.

Overall, the language would have removed the existing Schedule III classification for certain hydrocodone-containing combinations and would have placed all hydrocodone-containing substances into Schedule II.

For ODs without Schedule II hydrocodone authority, this move would have summarily stripped prescriptive authority for this treatment.

As House-Senate negotiations intensified, the AOA assembled and led a sizeable provider coalition of advanced practice nursing, dental, and other like-minded physician groups, and worked closely with other stakeholders in taking a firm stand against unfair new restrictions on existing prescriptive authority.

In meeting with key lawmakers and providing several detailed briefings on both sides of Capitol Hill, the AOA coordinated closely with the leadership and staff of the West Virginia Association of Optometric Physicians and made full use of the prescribing information provided by the New Jersey Society of Optometric Physicians, the Ohio Optometric Association, and the Georgia Optometric Association, and doctors from across the country.

Instead of rescheduling these substances, the final innovation bill contains a requirement for the Food and Drug Administration (FDA) to hold a public hearing on hydrocodone abuse issues within 60 days, even though the agency already had a similar session scheduled for October.

With the legislative threat successfully addressed for now, the AOA will continue discussions with FDA officials as they consider administrative proposals to respond to hydrocodone abuse and illegal diversion.

AOA members seeking more information on this topic, including those who would like to get more involved as key FDA decisions are made on this topic, should contact the AOA Washington office at 800-365-2219 or ImpactWashingtonDC@aoa.org.

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