Biden Nominates Former FDA Commissioner Dr. Robert Califf to Lead Agency Again

On November 12th, President Joseph Biden nominated Dr. Robert Califf, who served as Food and Drug Administration (FDA) Commissioner for one year under President Barack Obama, to lead the agency. Dr. Califf, who founded the Duke Clinical Research Institute, is a cardiologist and currently serves as a senior advisor for Verily and Google Health. While some lawmakers have expressed concern over Dr. Califf’s nomination due to his connection to the pharmaceutical industry, several public health advocates and FDA experts have expressed their support, highlighting Dr. Califf’s experience in clinical research and trials at Duke University and addressing the opioid epidemic during his previous tenure at FDA. In a statement, President Biden said, “Dr. Robert Califf is one of the most experienced clinical trialists in the country, and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation’s fight to put an end to the coronavirus pandemic.”

Articles & Resources

Politico – Biden nominates Califf as FDA chief

The Washington Post – Biden nominates Robert Califf, former Obama FDA chief, as agency commissioner

President Biden Signs Drug Diversion Prevention Bill Into Law

On November 11th, President Joseph Biden signed into law the Ensuring Compliance Against Drug Diversion Act of 2021 (PL 117-53). The new law would require that the Drug Enforcement Agency (DEA) terminate an entity’s registration to manufacture or dispense controlled substances if the entity discontinues its work, and would also prevent the modification or transfer of the registration. In press release, Senator Dianne Feinstein (D-CA) said, “I’m pleased President Biden signed our legislation into law, making it harder to abuse the legal manufacturing and sale of controlled substances. We’ve seen far too many drugs — particularly opioids — flooding our communities and leaving devastation behind. This legislation will help put a stop to these community-destroying practices.”

Articles & Resources

Senator John Cornyn – Cornyn, Feinstein Bill to Close Loophole Enabling Illegal Opioid Distribution Signed Into Law

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.

American Heart Association – Illicit drugs, high alcohol consumption both linked to first-time, irregular heart rhythm

Bloomberg Philanthropies – Bloomberg Philanthropies Commits Additional $120 Million to Reduce Overdose Deaths in U.S.

Centers for Disease Control and Prevention – New estimates reveal declines in hepatitis C treatment in the U.S. between 2015 and 2020

Congressman Gregory Murphy – Murphy, Courtney Reintroduce Bipartisan Veteran HOPE Act to Combat Opioid Epidemic

Congressman Ted Budd – Making a Difference in the Opioid Crisis

Congressman Vern Buchanan – Buchanan Calls for Action on His Bill to Combat Veteran Suicides

Congresswoman Kathy Manning – Reps. Manning, Trone, Kuster, Thompson, and Guthrie Introduce Bipartisan Legislation to Support Mothers and their Infants Affected by the Opioid Epidemic

Hartford Courant – Yale Medical School, The Hartford team up to better identify substance abuse in the workplace

Health Affairs – Expanding Access To Treatment For Opioid Use Disorder: Beyond “X-ing The X-Waiver”

JAMA – Higher-Dose Naloxone Nasal Spray (Kloxxado) for Opioid Overdose

Kaiser Health News – As Overdose Deaths Soar, DEA-Wary Pharmacies Shy From Dispensing Addiction Medication

Missouri Regulations – Substance Use Disorder Prevention and Treatment Programs

MPR – Intranasal Nalmefene Fast Tracked for Opioid Overdose Treatment

NPR – DEA takes aggressive stance toward pharmacies trying to dispense addiction medicine

STAT – New court rulings add to the confusing and controversial dispute over a U.S. drug discount program

The Hill – A fresh approach to fighting America’s opioids epidemic

The Hill – Expanding treatment for the opioids crisis is critical to saving lives, but isn’t enough

The New York Times – How Psychologists Can Help Treat Chronic Pain

The Pew Charitable Trusts – How Licensed Counselors Could Help Address Harmful Substance Use

The Washington Post – Oklahoma Supreme Court overturns historic opioid ruling against J&J

U.S. Immigration and Customs Enforcement – HSI investigation results in multiple federal drug and firearm convictions including contributing to an overdose death

University of Florida – New AI tool will predict patients at high risk for opioid use disorder and overdose

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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