FDA Releases Briefing on Hydrocodone

On October 25th, 2012, the Food and Drug Administration released a briefing on hydrocodone in anticipation of their Drug Safety and Risk Management (DSaRM) Advisory Committee meeting which was held October 29th and 30th of the same year. According to a 2009 FDA fact sheet, hydrocodone is:

Hydrocodone is a semi-synthetic opioid, which acts as an analgesic (pain reliever) and as an antitussive (cough suppressant).  It is one of the strongest and most widely-prescribed medications available for these uses.  It can also produce feelings of euphoria, and is an extremely popular drug of abuse.  The Drug Enforcement Administration has classified hydrocodone alone as a Schedule II narcotic.  The drug products currently sold in the U.S. combine the hydrocodone with other drugs, and are classified as Schedule III controlled substances.  

Hydrocodone is an addictive drug that can lead to serious illness, injury, or death if not used properly.  For example, overdose can result in respiratory depression and cardiac arrest.  In addition, normal use may impair motor skills or judgment, making it unsafe to operate machinery, drive, or engage in other potentially hazardous activities while taking the drug. 

During the summer of 2012, the Senate proposed an amendment to the FDA’s User Fee Reauthorization bill that would move hydrocodone from a Schedule III substance to a Schedule II substance. The Drug Enforcement Administration (DEA) places controlled substances on a class schedule, with Schedule I drugs having a high potential for abuse and no legitimate medical purpose, down to Schedule V substances which have a low potential for abuse and contain very limited quantities of narcotics for medicinal purposes. The DEA has also repeatedly petitioned the FDA to look into hydrocodone’s classification and to support its findings that it should be moved to a Schedule II substance. These suggestions drew criticism from leading pharmacy groups, who claimed the change would have a significant negative impact on patient’s who genuinely rely on hydrocodone containing drugs for their medical needs.

The briefing document covered the main issues the DSaRM committee planned on covering, including discussion points. Discussion points included:

  • What do the pharmacology data and the epidemiology data suggest about the potential for abuse of hydrocodone combination products compared with drugs that are currently in schedule II?
  • What impact would rescheduling of hydrocodone combination products from schedule III to II have on the following:  (1) Prescribing patterns for opioids, including hydrocodone combination products? (2) Delivery of healthcare in the US, including impacts on drug distribution, manufacturing, prescription and dispensing by pharmacies?  (3) Availability of hydrocodone combination products for patients with appropriate needs for them as well as by individuals seeking to abuse opioids? (4) Abuse and misuse of opioids, especially hydrocodone combination products?

In the briefing, Silvia Calderon, Ph.D., the Team Leader of the Pharmacology Controlled Substance Staff, concluded that:

Overall a scientific and comprehensive evaluation of the relative abuse potential of hydrocodone combination product needs to be weighed in the final recommendation of whether to up-schedule or not these products. This evaluation has to take under consideration the pharmacology and reinforcing effects of hydrocodone, the medical use and availability, epidemiological findings used as surrogates of the levels and scope of abuse, as well as measures of the consequences of abuse of the hydrocodone combination products.

 Although no decisions have been made regarding the up-scheduling of hydrocodone drugs, you can expect that it will be a continued discussion in the industry for the foreseeable future.