FDA Regulatory Update: FDA to Recommend Reclassifying Hydrocodone Combination Drugs; Issue Highlights Cooperative Relationship Between FDA, DEA

Nov 15, 2013   

On October 24, 2013, Janet Woodcock, the U.S. Food and Drug Administration’s (“FDA”) Director for the Center for Drug Evaluation and Research (“CDER”),issued a statement explaining that the FDA will recommend that the U.S. Drug Enforcement Administration (“DEA”) reclassify hydrocodone combination products from Schedule III to Schedule II under the Controlled Substances Act (“CSA”). This statement comes ten years after the DEA first approached the U.S. Department of Health and Human Services (“HHS”) for a recommendation. The reclassification, however, will not go into effect unless the proposed change is approved and accepted by the DEA.

Regulatory Framework for Controlled Substances

Pursuant to the CSA, the DEA has regulatory authority over controlled substances, which are certain drugs that have potential for abuse and dependence. (For more information on the regulation of controlled substances, please read 21 U.S.C. § 801  et seq.  and the DEA’s Office of Diversion Control Controlled Substance Schedule, which can be accessed here.) Controlled substances are classified into five distinct categories, or schedules, depending on the drug’s acceptable medical use and potential for abuse or dependency.

Schedule I consists of the drugs with the highest potential for abuse and Schedule V represents the class of drugs with the lowest potential for abuse. Specifically, Schedule I drugs are defined as having “no currently accepted medical use,” lacking accepted safety for use under medical supervision, and carrying a high potential for abuse. Examples of Schedule I drugs are heroin, ecstasy, peyote, and marijuana. (To read our previous posts regarding the federal regulation of marijuana as a controlled substance, please click hereherehere and here.) Schedule II drugs are also considered dangerous but have a lower abuse potential than Schedule I drugs, with use potentially leading to severe psychological or physical abuse. Examples of current Schedule II drugs are methamphetamines and oxycodone. Schedule III drugs are defined as having a “moderate to low potential for physical and psychological dependence” and pose a higher abuse potential than Schedule IV drugs, which are defined as having a “low potential for abuse and low risk of dependence.” Carrying the lowest risk of drug abuse potential are Schedule V drugs, which usually consist of preparations containing limited quantities of certain narcotics, such as those used for antidiarrheal, antitussive, and analgesic purposes. (For more information about the scheduling of controlled substances, please visit the DEA’s website here.)

Proceedings to control, remove from control, or re-schedule a drug or substance may be initiated by the DEA, HHS, or by petition from any interested party, such as a drug manufacturer, medical society, public interest group, state agency, or individual. When a petition is received by the DEA, the agency begins its own investigation of the drug. Once the DEA has collected the necessary data, the DEA Administrator, by authority of the Attorney General, requests from HHS a thorough scientific and medical evaluation and recommendation “as to whether such drug or other substance should be so controlled or removed as a controlled substance.” See 21 U.S.C. § 811(b). Then, HHS solicits information from the FDA, the National Institute on Drug Abuse, and if it so chooses, the scientific and medical community. The scientific and medical matters contained in the recommendation “shall be binding on the Attorney General.” Id. Once the DEA has received the scientific and medical evaluation from HHS, the DEA will evaluate all available data and make a final decision. Section 811(c) of the Controlled Substances Act directs the DEA to consider the following factors:

  1. Its actual or relative potential for abuse;
  2. Scientific evidence of its pharmacologic effect, if known;
  3. The state of current scientific knowledge regarding the drug or other substance;
  4. Its history and current pattern of abuse;
  5. The scope, duration and significance of abuse;
  6. What, if any, risk there is to public health;
  7. Its psychic or physiological dependence liability; and
  8. Whether the substance is an immediate precursor of a substance already controlled under this subchapter.

Although the DEA works hand-in-hand with HHS with respect to controlled substances, the DEA has the ultimate decision-making authority to take

DEA Seeks Recommendation Regarding the Reclassification of Hydrocodone Combination Products

        FDA’s recent statement that it intends to formally recommend the reclassification of hydrocodone combination products comes after nearly ten years of debate. Back in 2004, the DEA asked the FDA to investigate and recommend whether to reclassify hydrocodone combination products from Schedule III to Schedule II. In response, the FDA concluded that hydrocodone combination products should remain a Schedule III drug because “hydrocodone combination products have a less potential for abuse than the drugs or other substances in Schedule II.” (For more information regarding the FDA’s scientific and medical investigation of hydrocodone, please click here.)

        As a result of continued pressure from the public and industry organizations, the DEA collected and re-analyzed new data regarding the abuse of hydrocodone combination products in 2008. The following year, DEA submitted another request to FDA to reconsider moving all hydrocodone combination products to Schedule II. On January 24 – 25, 2013, the FDA’s Drug Safety and Risk Management Advisory Committee convened to discuss the public health benefits and risks of drugs containing hydrocodone, as well as the potential for abuse or dependency. (For a comprehensive review of the FDA’s recommendation, please read the FDA Briefing Document, Drug Safety and Risk Management Advisory Committee (DSaRM) Meeting 1 here and here.) At the culmination of this meeting, the FDA Advisory Committee voted 19 to 10 in favor of rescheduling hydrocodone combination products from Schedule III to Schedule II. (To read FDA’s Memorandum summarizing the events of this meeting, please click here.) Nine months later, the FDA announced its intention to formally recommend reclassifying hydrocodone combination products to Schedule II.

In light of the Advisory Committee’s decision in January 2013, the FDA’s statement that it intends “to recommend to HHS that hydrocodone combination products should be reclassified to a different and more restrictive schedule” comes as no surprise. (To read the FDA’s statement, please click here. For additional news coverage, please click hereherehere, and here.) The FDA’s recommendation to reclassify hydrocodone combination products could have a significant impact on how physicians prescribe these products. For instance, Schedule II drugs require patients to present a written prescription to the pharmacy, as physicians cannot call in a prescription for Schedule II drugs. Most notably, if the DEA accepts the FDA’s recommendation, hydrocodone combination products will be subject to stricter security controls, including a restriction on the amount of medication that a patient can be prescribed. If reclassified as Schedule II drugs, a physician would only be permitted to prescribe refills of hydrocodone combination products for up to three months, which is half the amount allowed for Schedule III drugs.

The FDA has not submitted a final recommendation package to HHS, but expects to do so by early December 2013. If this recommendation is accepted by the DEA, new regulations could go into effect as early as 2014. (For more information, please read the New York Times’s coverage here.)

Fuerst Ittleman David & Joseph, PL will continue to monitor the developments in the classification of hydrocodone combination products. For more information, please feel free to contact us by email at contact@fidjlaw.com or by phone at (305) 350-5690.