FDA AdComms Critical of Potential New Opioids as Hill Discusses State Epidemic Responses

Following remarks earlier this week from FDA Drug Center Director Dr. Janet Woodcock indicating that addressing opioid abuse remains a core component of her group’s efforts for the year ahead, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Committee (AADPAC and DSaRM AdComms, respectively) jointly reviewed three opioid products this week with largely negative implications for the drugs. On Tuesday, the dual panels unanimously voted against approval for Nektar Therapeutics’ new opioid entity, oxycodegol, 27-0 causing the manufacturer to withdraw its NDA.  On Wednesday, the panels reviewed Esteve Pharmaceuticals’ dual tramadol-celecoxib product for severe acute pain as well as Intellipharmaceutics Corp.’s ER oxycodone, Aximris. The panels were split 13-13 on the Esteve product while overwhelmingly against Intellipharmaceutics (26-2). On Thursday, Durect Corp. put forth its post-surgical pain treatment, Posimir, an injectable long-lasting local anesthetic. The AADPAC was split 6-6 on this product. The results of these four Advisory Committee meetings highlight concerns around any new opioid-based products for the treatment of acute and chronic pain and ongoing encouragement to develop novel products with reduced abuse potential. While non-binding, FDA will now take the AdComm recommendations under consideration in its forthcoming decisions.

The House Energy & Commerce Committee simultaneously held a hearing on Wednesday looking at state responses to the epidemic hearing from those on the ground in heavily impacted states such as Rhode Island, Massachusetts, North Carolina, West Virginia and Pennsylvania. Those witnesses were a part of an earlier inquiry from the Committee to states in September looking deeper into their use of federal funding to address the epidemic. Witnesses focused on the importance of consistent funding and the role that Medicaid expansion has had in facilitating care to a broader cadre of patients. However, many stressed the limitations of these funds and impermissible use to help address other abusable substances such as cocaine and methamphetamine, both of which have been cause for concern within the last several years. Flexibility, the witnesses argued, is a critical tool to allow states the ability to address the multifaceted and fluid issue of substance use disorders.

Articles & Resources

Link – FDA’s Advisory Committee Calendar and Related Documents

Inside Health Policy – FDA Panel Split On Approval Of Reformulated Bupivacaine For Pain

Inside Health Policy – FDA Panels Unanimously Vote Down Approval Of New Chronic Pain Opioid

POLITICO – FDA Panel, After Rejecting New Opioids, Deadlocks on Anesthesia Drug

Energy & Commerce Committee Hearing –  “A Public Health Emergency: State Efforts to Curb the Opioid Epidemic”


DEA Outlines Plan to Combat Substance Abuse in Higher Ed

Over the course of eight chapters, the Drug Enforcement Administration’s new Strategic Planning Guide offers help to address dangerous activities, including illicit drug use, in higher education from issue and scope assessment through impact analysis and project expansion. While the issue of alcohol misuse on college campuses has garnered significant focus over the last several decades, drug misuse remains an issue not adequately addressed. Recent research indicates that greater than 10% of college students had misused a prescription drug within the past year and marijuana use remains on the rise. The intent of the strategic plan is to help encourage action among universities and their prevention professionals along with a wide variety of active stakeholders on and off-campus.

DEA Acting Administrator Uttam Dhillon, on the release of the guide, was quoted, “With vaping, marijuana use, and the abuse of prescription drugs on the rise, it is critical we continue to do everything we can to reach at-risk populations such as college students…DEA’s new publication provides valuable information unique to prevention experts working in higher education to help ensure the health and wellbeing of our nation’s college students.”

Additional information on the prevention program can be found at www.CampusDrugPrevention.gov.

Articles & Resources

DEA Newsroom – DEA Releases Strategic Planning Guide to Prevent Drug Use Among College Students

LINK – Prevention with Purpose: A Strategic Planning Guide for Preventing Drug Misuse Among College Students


Senate Advances Fentanyl Scheduling Bill

With the existing order set to expire at the end of next month, the Senate passed S. 3201 this week, by unanimous consent, extending the DEA’s ability to schedule all fentanyl-like substances as Schedule I drugs. Extending the order an additional 15 months provides the Senate with additional time to consider related legislation aimed at protecting U.S. citizens from the deadly analogues and better address the influx of illicit fentanyl from China and elsewhere.

The Senate vote comes at a time when another bill, S. 3148, works its way through the chamber in an effort to formally provide DEA such authority. To date, the bill has been hampered by ongoing concerns expressed around the impact that a Schedule I classification could have on future medical research. The bill has been placed on the Senate Legislative Calendar but has set to see any further action.

Articles & Resources

Bloomberg Government – Senators Eye Expanding DEA Fentanyl Powers as Deadline Nears

Bloomberg Law – Senate Extends Power to List Fentanyl Among Most Dangerous Drugs


What We Read Last Week

The New York Times – Who Killed the Knapp Family?

The Economist – The Wider Effects of America’s Opioid Epidemic

Associated Press – DHS Seeks Pentagon Funds for 270 Miles of Border Wall

Wall Street Journal – Opioid-Maker Insys Wins Court Approval of Bankruptcy Plan

NIH Newsroom – Patients with Newly Diagnosed Musculoskeletal Pain Are Prescribed Opioids More Often Than Recommended

Journal of Pain – Management of Patients with a Musculoskeletal Pain Condition that is Likely Chronic: Results from a National Cross Sectional Survey.

Office of the Oklahoma Attorney General – Attorney General Hunter Files Lawsuit Against Three Leading Opioid Distributors for Fueling Opioid Epidemic

Centers for Disease Control and Prevention – Link to Board of Scientific Counselors/NCIPC December 2019 Meeting Materials

U.S. Attorney for the District of Rhode Island – Providence Woman Admits to Role in Fraudulent Opioids Prescription Conspiracy

U.S. Attorney for the District of Utah – Former ER Nurse Sentenced to 60 Months in Prison for Fraudulently Obtaining, Tampering with Patient Drugs


This Week’s Calendar

The House is out this week while the Senate begins impeachment proceedings on Tuesday at 1:00pm following their return from the MLK Day holiday. Should there be any additions to House or Senate schedules or updates with respect to additional events, this information will be made available.


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