Dr. Dougherty's Mission to Reschedule Hydrocodone

Last year’s rescheduling of hydrocodone combination products has an interesting and uplifting story behind it. It begins in the small town of Brewerton, NY, named for Major George Brewerton, Jr., an officer of the British Army, who in 1759 constructed a fort on the banks of the Oneida River to defend against the French and Native American forces in the region. By the late 1800s, the town of Brewerton had become home to a number of Irish immigrants. Among them was a railroad worker named Dougherty.

In 1954, Ronald J. Dougherty, grandson of the railroad worker, graduated from LeMoyne College in Syracuse and enrolled in nearby Upstate Medical University. After finishing his residency at St. Joseph's Hospital, Ronald J. Dougherty, MD, had returned to Brewerton to become the town’s second physician. As such, he performed surgical procedures, delivered babies, and made house calls, sometimes bringing along his wife, a registered nurse whom he met while at LeMoyne. For Dr. Dougherty and his growing family, the practice of medicine was far more than a profession. 

A watershed event occurred early in the new doctor’s life one day when he delivered a baby to a mother with heroin addiction. Other doctors had referred the sick mother to Dr. Dougherty, who became her last hope. As is common in such situations, the infant was born with addiction to its mother’s heroin. To save the child’s life, Dr. Dougherty relied on his medical training aided by some prayers learned from the Jesuits at LeMoyne. The baby survived and shortly thereafter Dr. Dougherty began what would become his life’s mission caring for those facing the disease of addiction and their families. Along the way, he became a proud member of the American Society of Addiction Medicine.

In 1993, Dr. Dougherty wrote to the New York State Board of Health asking that hydrocodone tablets (“Vicodin or Lortab”) be placed in Schedule II of the state’s drug control statute. In his letter, Dr. Dougherty mentioned that he was medical director of a drug treatment center where 60 percent of all the referrals involved hydrocodone-dependent patients. Dr. Dougherty also requested that “Meprobamate and its analog Soma” be placed in a higher schedule “to identify and perhaps lessen their abuse potential.”

The Board of Health thanked Dr. Dougherty for his information but took no immediate action. Over the next several years, Dr. Dougherty would continue his campaign, meeting with representatives of the media, academia, the public and various state agencies. In January 1999, Dr. Dougherty filed a citizen’s petition with the federal Drug Enforcement Administration (DEA), asking that all hydrocodone combination products be rescheduled from Schedule III to Schedule II. Dr. Dougherty’s petition was filed under a provision of the Controlled Substances Act that permits “any interested party” to seek a rule change in the regulations, including one that affects the scheduling of rescheduling of controlled substances.

The DEA reviewed Dr. Dougherty’s petition but under the law would need a medical and scientific evaluation along with a recommendation from the Department of Health and Human Services (DHHS) in order to proceed. In 2004, DEA forwarded Dr. Dougherty’s request, along with an 85-page technical analysis, to the DHHS asking that it concur and authorize the rescheduling of hydrocodone combination products. In 2008, the Assistant Secretary for Health, DHHS, rejected DEA’s request. The following year, DEA resubmitted the request along with additional supporting evidence.

By 2009, the abuse of prescription opioids, including hydrocodone, was being described by the Centers for Disease Control and Prevention (CDC) as an “epidemic.” In 2012, the U.S. Senate considered a bill that would reschedule hydrocodone by amending the statute, thus bypassing the administrative route that already had taken more than a decade and seemed to be going nowhere. By the time the bill reached the President it called, instead, for the Food and Drug Administration (FDA) to hold a public meeting to solicit recommendations for amending the control status of hydrocodone.

A meeting of the FDA’s Drug Safety and Risk Management Advisory Committee was convened for this purpose on January 24-25, 2013. FDA provided each member with a 363-page briefing document that, among other things, repudiated the DEA’s analysis and concluded “that there is insufficient evidence to support DEA’s finding that combination hydrocodone-containing products have a similar potential for abuse to oxycodone products.” In its analysis, the DEA had used oxycodone, a C-II controlled substance, as a comparator drug.

On January 25, 2013, over the advice of the FDA, the Committee voted 19 to 10 to place hydrocodone combination products in Schedule II. Although not bound by the Committee’s decision, the DHHS nonetheless reversed its previous position and on December 16, 2013, provided DEA with a recommendation to “upschedule” hydrocodone combination products.

After completing its rulemaking procedures, the DEA’s Final Rule placing all hydrocodone combination products in Schedule II became effective on October 6, 2014. Within days, this information was communicated to Dr. Dougherty who retired several years ago after almost a half century of caring for patients with substance abuse disorders. According to family members caring for him, when told of the news, Dr. Dougherty had tears of joy in his eyes.

While it took more than fifteen years and a lot of bureaucratic maneuvering, in the end one person -- a concerned and caring physician who refused to take no for an answer -- prevailed. When told of Dr. Dougherty’s efforts to have hydrocodone combination products rescheduled, Michele Leonhart, the DEA’s current Administrator, expressed her agency’s gratitude and said that she would personally be honored to present Dr. Dougherty with an award in recognition of his life’s work to improve the nation’s public health and safety.