Senate Confirms Robert Califf as FDA Commissioner

On February 15th, the United States Senate confirmed Dr. Robert Califf for the role of Food and Drug Administration (FDA) Commissioner in a 50-46 vote. During the nomination process, lawmakers expressed concerns about FDA’s response to the opioid epidemic, including approvals of high-dose opioids and the agency’s lack of action on long-term opioid prescribing, and have urged FDA to consider actions to curb the epidemic, such as developing guidance on opioid prescription labeling. During his nomination process, Dr. Califf maintained his commitment to expand FDA’s provider education, evaluate opioid labeling processes, and review opioid regulations. Following his confirmation, Dr. Califf outlined a set of priorities via a series of Twitter posts on February 17th, writing “With over 100,000 deaths from overdoses in the past year alone, we must accept that all the hard work so far has not been enough. It’s also clear that successfully addressing this issue requires that, in addition to new approaches and redoubled effort from FDA, working with our partners in HHS will be essential.” Dr. Califf, who served as FDA Commissioner for one year under President Barack Obama and founded the Duke Clinical Research Institute, is a cardiologist by training and most recently served as the head of clinical strategy for biotechnology companies Verily Life Sciences and Google Health.

Articles & Resources

The Washington Post – Califf narrowly confirmed for FDA commissioner, providing beleaguered agency with its first permanent chief in 13 months

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

RAPS – FDA’s Califf shares priority list with agency staff


CMS Data Highlights Effects of CARES Act Telehealth Expansion on Access to OUD Treatment

The Centers for Medicare & Medicaid Services released data briefs summarizing two studies that explored who accessed opioid use disorder (OUD) treatments and changes in access to OUD treatment during the COVID-19 telehealth expansion. In the study Access to Medications for Opioid Use Disorder (MOUD) Among Medicare Fee-for-Service Beneficiaries: Influence of CARES Act Implementation (2020), CMS researchers described the sociodemographic and health condition characteristics among Medicare fee-for-service beneficiaries with opioid use disorder overall and by medication access, both before and after the COVID-19 pandemic and CARES Act implementation. Researchers found that after the onset of the pandemic and CARES Act implementation, the percentage of Medicare fee-for-service beneficiaries with OUD who accessed medications for OUD increased to 19% from 14%. Researchers also found that fee-for-service beneficiaries who were older than 65 years of age, Black or African American, located in the southern United States, and had increased comorbidities were underrepresented in accessing medications for OUD.

In another study, Changes in Access to Medication Treatment during COVID-19 Telehealth Expansion and Disparities in Telehealth Use for Medicare Beneficiaries with Opioid Use Disorder, CMS researchers provided an overview of how access to medication treatment for fee-for-service beneficiaries with opioid use disorder changed during the COVID-19 telehealth expansion. CMS researchers found that only 2% of fee-for-service beneficiaries with OUD used outpatient telehealth services prior to the CARES Act telehealth expansion and, following the expansion, the amount increased to 39%. Researchers also found that the largest disparities in outpatient telehealth use were based on eligibility, dual eligibility status, and rurality.

Articles & Resources

CMS – Changes in Access to Medication Treatment during COVID-19 Telehealth Expansion and Disparities in Telehealth Use for Medicare Beneficiaries with Opioid Use Disorder

CMS – Access to Medications for Opioid Use Disorder (MOUD) Among Medicare Fee-for-Service Beneficiaries: Influence of CARES Act Implementation (2020)


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.

Clinical Pain Advisor – How Much Naloxone Does Each US State Need to Combat Opioid Epidemics?

CNN – Middle-school children fall prey to fatal fentanyl overdoses

Congressman Mike Johnson – Johnson Address Overdoses

Healio News – Program helps primary care practices expand access to opioid use disorder treatment

HHS – HHS Secretary Xavier Becerra Welcomes Robert Califf Back to HHS as FDA Commissioner

Inside Health Policy – Califf Says Woodcock Will Stay At FDA As Principal Deputy Commissioner

Senator Rob Portman – At Senate Finance Hearing, Portman Discusses Youth Addiction Crisis, Touts Telehealth

The Hill – Senate Democrats urge DOJ to open criminal investigation into Sackler family members

The Pew Charitable Trusts – Improved Opioid Treatment Programs Would Expand Access to Quality Care


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.


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