The New York Times and numerous other media outlets incorrectly stated on Jan. 25 that the Food and Drug Administration’s (FDA) Drug Safety and Risk Management Advisory Committee recommended changes last week on prescribing hydrocodone products that would “ban nurse practitioners and physician assistants from prescribing the drugs, making it harder for people in underserved and rural areas.”
According to two PAs who serve on the FDA advisory committee, and are AAPA members, it recommended in a 19-10 vote to only reclassify hydrocodone from a Schedule III drug to Schedule II. The recommendation would not ban PAs, nurse practitioners, or optometrists from prescribing hydrocodone products. Rather, it would limit prescribing the drugs in states where PAs and other healthcare professionals are not authorized to prescribe Schedule II drugs. PAs may currently prescribe Schedule II medications in all but 14 states.
In a June 2012 letter to House and Senate conferees finalizing the Prescription Drug User Fee Act (PDUFA), AAPA recommended that a legislative proposal to reclassify hydrocodone products from Schedule III to Schedule II be eliminated from the legislation. AAPA acknowledged the serious problem of diversion and abuse of opioid drugs, as well as hydrocodone drugs. However, the Academy questioned whether limiting access to appropriate pain medication for patients with legitimate clinical need is the appropriate response. Additionally, other barriers are imposed on Schedule II drugs, which can make access more difficult for some patients, such as the inability to phone in prescriptions or refill the prescription. This is what the advisory committee wrestled with in its deliberations.
The recommendation by the FDA Advisory Committee does not automatically mean that hydrocodone products will be moved to the Schedule II classification or that FDA will agree to the advisory committee recommendation. If FDA were to move forward with the advisory committee’s recommendation, it would be subject to the Department of Health and Human Services (HHS) regulatory process. The FDA briefing document from the Drug Safety and Risk Management Advisory Committee may be reviewed online.