HEALTH CARE BRIEFING: Califf Gets Bipartisan Support at Hearing

A top Senate Republican joined some Democrats in expressing support for Robert Califf, President Joe Biden’s pick to lead the Food and Drug Administration, at a confirmation hearing yesterday.

Sen. Richard Burr (R-N.C.), the top Republican of the Senate Health, Education, Labor and Pensions Committee, said Califf’s experience in clinical research and his previous time leading that agency during the Obama administration give him a “unique perspective” to serve at the helm once again. “I’m not sure how to write a resume of somebody more qualified to be considered for commissioner of the FDA,” Burr said during the hearing.

Chairwoman Patty Murray (D-Wash.) said she looks forward to working with Califf again “to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first.”

If confirmed, Califf will become the first permanent head of the FDA nearly a year into Biden’s presidency. Installing a permanent commissioner has been seen as necessary to bring a steady presence amid the ever-evolving conditions of the pandemic. “This is a once-in-a-generation time for public health,” Califf said in his remarks. “The FDA must continue to play a vital role in protecting and promoting the health of all Americans by leveraging the acceleration in technology and biomedical knowledge.”

Republican support will be critical in moving Califf’s nomination forward. Several Democrats have already said they oppose the pick, with some questioning whether Califf’s longstanding industry ties could affect his ability to tackle the opioid epidemic and demand transparency from pharmaceutical corporations.

Califf is “no exception” to the trend of FDA commissioner nominees holding significant experience working for drug companies regulated by the FDA, Sen. Bernie Sanders (I-Vt.), who opposed Califf’s nomination during the Obama administration, said during yesterday’s hearing.

Sens. Joe Manchin (D-W.Va.) and Richard Blumenthal (D-Conn.) have both said they would oppose Califf’s nomination due to his pharmaceutical industry connections. “Dr. Califf’s nomination makes no sense as the opioid epidemic continues to wreak havoc on families across this country with no end in sight,” Manchin said in a statement yesterday.

Califf responded by pointing out that he supports allowing Medicare to negotiate drug prices—a key component of Biden’s Build Back Better package (H.R. 5376). He added that he has committed to the administration’s ethics pledge and to advance the FDA’s mission “to make medical products more effective, safer and more affordable.” Califf also said he supports the approval of more generics as alternatives to brand-name products, which many advocates have pressed to help drive down drug prices. Read more from Celine Castronuovo.

• Califf said he would launch an extensive review of opioid regulations if he is confirmed. Lawmakers have long criticized the FDA’s approval of Purdue’s OxyContin and other addictive drugs without requiring more thorough warning labels and other protections that may help fight misuse. “I am committed to do a comprehensive review of the status of opioids early in my tenure,” said Califf. He said the review would include the agency’s labeling process and whether warnings accurately describe the safety risks associated with the drugs. Read more from Castronuovo.
• Meanwhile, health systems and companies collecting drug prescription data could be caught in the crosshairs of opioid liability following a federal jury finding that major pharmacy chains helped create the nationwide addiction crisis, attorneys say. Walmart, CVS, and Walgreens join Johnson & Johnson, McKinsey, and others in the drug supply chain that have faced blame for allegedly fueling an epidemic that’s led to more than 800,000 U.S. overdose deaths. A Cleveland panel found that the three pharmacy chains failed to properly monitor opioid prescriptions. Read more from Ian Lopez.

The Coronavirus Pandemic

New Pfizer Pill Effective Against Hospitalization: New trial data showed Pfizer’s experimental Covid-19 pill was highly effective at keeping patients out of the hospital, but less adept at erasing milder symptoms often associated with breakthrough infections. The firm disclosed results from two studies yesterday. In one, Pfizer’s drug “Paxlovid” failed to meet the primary goal of reducing self-reported symptoms in 673 adults at standard risk of Covid-19 complications. But, the drug did show a trend toward reducing hospitalizations in the group by 70%. Read more from Robert Langreth.

Omicron Is 3% of U.S. Cases: The omicron variant now makes up 3% of all sequenced Covid-19 cases in the U.S., rising from less than 0.1% in early December, health officials said, a sign of the rapid spread of the new coronavirus version. The highly mutated variant has now been detected in 33 U.S. states, the Centers for Disease Control and Prevention said in an email. While the delta variant remains the dominant strain in the country, accounting for 96% of sequenced cases, omicron’s proportion is expected to increase, agency spokesperson Jasmine Reed said. Read more from Fiona Rutherford.

• The omicron variant presents a new problem for doctors: Some drugs may work better than others, but knowing what to prescribe will hinge on quickly figuring out what variant of Covid-19 a person has in the first place. Right now, doctors don’t treat people with Covid-19 based on which mutation of the virus has infected them. Even when that information is available, doctors are rarely told which form of Covid-19 a person has. Riley Griffin and Jeannie Baumann have more.
• The scientists who were among a network that was the first to sequence omicron are watching to see if the highly mutated coronavirus variant will dictate the course of the pandemic. Will future strains stem from its lineage or will other variants crowd it out? Read more from Janice Kew.
• Johnson & Johnson’s vaccine produced some antibodies but showed “no detectable” neutralization of the omicron strain in a laboratory experiment, according to Penny Moore, a South African virologist. Moore, from Johannesburg’s University of The Witwatersrand, said experiments were conducted on blood plasma samples. Antony Sguazzin has more.
• The vaccine made by Sinovac Biotech, one of the most widely used in the world, doesn’t provide sufficient antibodies in two doses to neutralize the omicron variant and boosters will likely be needed to improve protection, initial lab findings showed. While the first two studies to be released on the Chinese shot and omicron diverged on how much the vaccine’s immune response is degraded, they both indicated the standard two-dose course would not be enough, Jinshan Hong reports.

U.S. Economic Recovery Tied to Global Vaccination, Panel Hears: A top House lawmaker said yesterday that increasing the global vaccination rate—now below 10%—will be crucial to restoring a robust U.S. economy. “Global vaccination will help us avoid empty shelves and higher prices here at home. A fully vaccinated world is critical to the American recovery,” House Majority Whip James E. Clyburn (D-S.C.), chairman of the Select Subcommittee on the Coronavirus Crisis, said at a hearing on accelerating global vaccine access. But as new variants such as omicron sweep the world, lawmakers and others say that increased global access to vaccines are a critical step to avoiding economic disruptions in the U.S. Read more from Ian Lopez.

MORE HEADLINES:

• Unvaccinated Covid Patients Push Hospital Systems Past the Brink
• Workers With Covid-19 Can Get Disability Bias Protections: EEOC
• Amtrak Reverses Plans to Cut Service, Changes Vaccine Mandate
• N.Y. Feels Virus’ Grip Tighten Again as Hospital Cases Surge 70%
• After U.S. Shift, U.K. Travelers Face Hong Kong Quarantine Camp
• Omicron Splits European Union on Effort to Simplify Travel Rules
• Dimon’s Disdain of Zoom Tested as Health Care Conference Attendees Back Out

What Else to Know Today

High Court Asked to Revive Down Syndrome Abortion Ban: Arizona became the latest state to ask the U.S. Supreme Court for permission to enforce newly enacted abortion restrictions, the request coming on the heels of the court’s decision leaving a six-week abortion ban in place in Texas. The state asked that the court step in now even though briefing in the San Francisco-based U.S. Court of Appeals for the Ninth Circuit is scheduled to be completed by early February. The request suggests that Republican-led states are emboldened by the court’s recent actions on abortion laws out of Texas and Mississippi.

A majority of the court Dec. 1 signaled a willingness to overturn or curtail the court’s landmark abortion verdict in Roe v. Wade during oral arguments on Mississippi’s 15-week abortion ban. And on Dec. 10, the justices kept Texas’ six-week abortion ban in place while allowing abortion providers to continue their federal lawsuit challenging the law. The Arizona law prohibits doctors from performing abortions “knowing that the abortion is sought solely because of a genetic abnormality of the child.” The law provides exceptions for lethal abnormalities and medical emergencies. Read more from Kimberly Strawbridge Robinson.

BGOV OnPoint—Home Health Expansion Push: Democrats are pushing for an expansion of home health care services under Medicaid and a boost in wages for home health workers as part of their sweeping social spending and tax bill. The legislation, which is advancing via the budget reconciliation process, would spend around $150 billion over 10 years on home health—less than the $400 billion that Biden initially sought—by offering states incentives to raise wages and expand home health services. BGOV’s Christina Banoub delves into the home health language in the House and Senate versions of the Build Back Better Act.

More Headlines:

• Humana, Blue Cross Join Antitrust Fight Over Gilead’s HIV Drugs

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com