Nominee for FDA Commissioner Pledges Actions to Address the Opioid Epidemic

On December 14th, the Senate Health, Education, Labor and Pensions (HELP) Committee held a confirmation hearing for President Joseph Biden’s nominee for Food and Drug Administration (FDA) Commissioner, Dr. Robert Califf. During the confirmation hearing, lawmakers expressed concerns about the opioid epidemic, the FDA’s approach to opioid approvals, including the recent approvals of high-dose opioids, and the agency’s lack of action on long-term opioid prescribing. In response to the lawmaker’s questions, Dr. Califf committed to expanding FDA’s provider education, evaluating opioid labeling processes, and reviewing opioid regulations, saying “I am committed to do a comprehensive review of the status of opioids early in my tenure.” While Senators Joe Manchin (WA), Richard Blumenthal (CT), and Bernie Sanders (VT) have noted their intention to oppose the nomination, citing concerns with Dr. Califf’s connection to the pharmaceutical industry, the majority of HELP Committee members expressed their support of the nomination.

Articles & Resources

Bloomberg Government – Califf Commits to Opioid Review as Wary Senators Weigh FDA Pick

STAT – Califf sails through confirmation hearing for FDA job, despite tensions over opioids

Lawmakers Introduce Bill to Curb Fentanyl Trafficking

On December 16th, Senators Marco Rubio (FL) and Amy Klobuchar (MN) introduced the Domain Reform for Unlawful Drug Sellers (DRUGS) Act. The bill, which is based on a Food and Drug Administration and National Telecommunications and Information Administration pilot program, would suspend and lock websites that sell illicit fentanyl and counterfeit medications, and would also create an appeals mechanism for online pharmacies operating legally to continue to sell medications. In a press release, Senator Klobuchar said, “The opioid epidemic is hurting communities across our nation—none have been immune to its devastating effects. This bipartisan legislation will help eliminate unlawful digital pharmacies and other marketplaces illegally selling opioids or substandard drugs online, a major step as we work to address this public health emergency. Moving forward, I’ll keep pushing for policies to stop illegal sale of opioids and assist families impacted by this epidemic.”

Articles & Resources

S.3399 – A bill to amend the Federal Food, Drug, and Cosmetic Act to provide a process to lock and suspend domain names used to facilitate the online sale of drugs illegally, and for other purposes.

Senator Marco Rubio – Rubio Introduces Bill to Combat Illegal Sale of Fentanyl, Other Drugs Online

What We Read Last Week

Several articles were published last week pertaining to the opioid epidemic, covering a variety of different components of the issue. Links to relevant articles are provided below.

Associated Press – Cities wracked by opioids close to getting $26B settlement

Health Affairs – Addiction Is An Emergency: End Wait Times For Services And Expand Access To Life-Saving Medications

HHS – Many Medicare Beneficiaries Are Not Receiving Medication to Treat Their Opioid Use Disorder

JAMA – Substitution of Nonpharmacologic Therapy With Opioid Prescribing for Pain During the COVID-19 Pandemic

NIH – Percentage of adolescents reporting drug use decreased significantly in 2021 as the COVID-19 pandemic endured

NPR – To save lives, overdose antidote should be sold over-the-counter, advocates argue

Penn Today – Pregnancy and opioid-use disorder: How to keep pregnant patients and babies healthy

STAT – How much naloxone is needed to reverse an opioid overdose? New high-dose treatments are raising questions

The Hill – Fentanyl deaths ‘sharply’ rose in Western, Southern, Midwestern states: CDC

The Hill – Judge overturns Purdue Pharma bankruptcy deal over protections for Sackler family

The Pew Charitable Trusts – State Policy Changes Could Increase Access to Opioid Treatment via Telehealth

The White House – FACT SHEET: The Biden Administration Launches New Efforts to Counter Transnational Criminal Organizations and Illicit Drugs

VAntage Point – Provider webinar: Addressing the fourth wave of the opioids crisis

This Week’s Calendar

In the week ahead, there are no relevant events or hearings noticed at this time. In the event that there are any changes to the schedule for this week, we will make additional information available.

All-Participants Meeting

The next All-Participants Meeting will be held Monday January 31, 2022 at 3:00 PM – 4:00 PM Eastern.

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