HEALTH CARE BRIEFING: Biden Taps Rahul Gupta for Drug Czar

President Joe Biden nominated Rahul Gupta, a primary care physician who currently serves as the chief medical and health officer at the March of Dimes, for director of the Office of National Drug Control Policy. He previously was the health commissioner of West Virginia under two governors.

“President Biden’s nomination of Dr. Rahul Gupta to be the first physician ever to lead the White House Office of National Drug Control Policy is another historic step in the Administration’s efforts to turn the tide of our nation’s addiction and overdose epidemic,” according to a White House statement. “Dr. Gupta brings firsthand experience as a medical doctor and public health official using evidence-based strategies to address the overdose epidemic in West Virginia. We hope he will be confirmed by the Senate soon.”

The role—often referred to as the “drug czar”—has budget authority over dozens of government agencies that touch drug addiction and enforcement.

Gupta’s nomination will require Senate approval.

The nomination “means someone with firsthand knowledge of the opioid crisis, especially in West Virginia, will be coordinating the national fight against the drug epidemic that continues to ravage our nation,” said Sen. Joe Manchin (D-W.Va.). “Dr. Gupta will bring over a decade of extensive experience combating the drug epidemic to ONDCP—the office charged with addressing the drug epidemic that has killed over 90,000 Americans just last year,” he said.

Sen. Shelley Capito, (R-W.Va.), said she’s “looking forward to working together to increase drug prevention efforts, support treatment and recovery, and reduce the supply of deadly drugs in our communities.” Read more from Valerie Bauman and Alex Ruoff.

Biden also nominated Atul Gawande for as assistant administrator of the Bureau for Global Health at USAID. He was part of Haven, the Berkshire Hathaway, Amazon and JPMorgan Chase health care company, and was an advisor to the Clinton White House.

Happening on the Hill

Covid-19 & Future Diseases: The House Science, Space, and Technology Investigations and Oversight Subcommittee will meet today for a hearing to discuss principles for outbreak investigation.

Senate Budget Agreement Includes Medicare Expansion: Senate Democrats on the Budget Committee last night agreed to set a $3.5 trillion top-line spending level for a bill to carry most of Biden’s economic agenda into law without Republican support. Democrats on the committee had been divided about the size and scope of the package, with Chairman Bernie Sanders (I-Vt.) initially pushing a $6 trillion measure.The Budget Committee agreement includes the Medicare expansion, marking a significant win for Sanders.

“We are very proud of this plan,” Majority Leader Chuck Schumer (D-N.Y.) said last night. Schumer said it would include dental, hearing and vision benefits for Medicare recipients but didn’t detail whether a proposal to lower the eligibility age will be included or if a separate proposal to lower prescription drug prices is in the plan.

Biden plans to go to Capitol Hill on today to discuss the plan. The president did not immediately endorse it publicly, but White House economic adviser Brian Deese and chief legislative liaison Louisa Terrell attended last night’s meeting. Read more from Erik Wasson, Steven T. Dennis and Laura Davison.

Lawmakers Face Push to Limit Drugmaker Deals: Lawmakers will have a hard time objecting to legislation aimed at lowering prescription drug prices by limiting deals between name brand and generic manufacturers, Sen. Amy Klobuchar (D-Minn.) said yesterday at a hearing. Klobuchar, chair of the Senate Judiciary Committee’s antitrust panel, is sponsor of a bill (S. 1428) that would limit arrangements in which brand drugmakers compensate generics for waiting before they enter the market.

The panel’s hearing comes amid an increasing government focus on skyrocketing drug prices. Drugmakers have raised prices on over 580 drugs this past January, while more than a quarter of Americans say they and their family couldn’t afford a medication in the past year, America’s Health Insurance Plans said in testimony. Read more from Ian Lopez.

The Coronavirus Pandemic

Biden Brings in Pop Star for Vaccine Outreach: Biden will host pop star Olivia Rodrigo today to make the case that vaccines are “Good 4 U,” the title of one of her hit songs. Rodrigo will meet top U.S. immunologist Anthony Fauci and record videos urging young people to get vaccinated against Covid-19, according to a White House official. She’ll also answer questions young Americans have about the vaccines. The Biden administration is drawing on Rodrigo’s celebrity amid concerns about the declining vaccination rate in the U.S., especially among young people. Read more from Jordan Fabian.

Airline Masks Stay in Place, Supreme Court Rules: The U.S. Supreme Court rejected a request to undo the CDC’s mask requirement for public transportation, including airline travel. Justice Clarence Thomas yesterday denied Lucas Wall’s calls to lift the requirement for his upcoming international travel. Wall said he suffers from generalized anxiety, including panic attacks when he covers his face. Read more from Kimberly Strawbridge Robinson.

CDC to Discuss J&J’s Covid Shot and Nerve Syndrome: Vaccine safety and Guillain-Barré Syndrome will be the focus of an immunization advisory committee scheduled by the U.S. Centers for Disease Control and Prevention on July 22. The announcement comes a day after the fact sheet for Johnson & Johnson’s Covid-19 shot was revised by federal regulators to warn about a “small possible risk” for the rare condition in which the immune system attacks the nerves. Read more from Fiona Rutherford.

• Related: More J&J Vaccines Made by Emergent Are Released by FDA
• AstraZeneca and scientists from the University of Oxford are looking at whether their Covid-19 vaccine can be modified to prevent rare blood clots, according to a person with knowledge of the situation. The scientists are doing early-stage research on whether the shot can be tweaked in any way to reduce or remove the risk of the side effect, though there is no formal program or funding in place for the investigations at this stage, said the person, who didn’t want to be identified because the research hasn’t been discussed publicly. Read more from Suzi Ring.

Boosters Without Data Raises Safety Questions: Fully vaccinated people pursuing an additional Covid-19 shot ahead of any recommendations that it’s necessary may face an increased risk of rare, dangerous side effects. Pfizer yesterday met with top health officials on its plans to seek emergency use authorization for a booster shot as Covid-19 infections trend upward and the delta variant continues to gain steam. There is no recommendation for booster shots at this time, and health leaders maintain the available vaccines protect against the original strain of the virus and all of its mutations.

“The COVID vaccines are so immunogenic that there is actually a danger of boosters when not needed since they induce such a vigorous immune response,” Monica Gandhi, a professor and associate division chief in HIV, infectious diseases, and global medicine at the University of California, San Francisco and San Francisco General Hospital, wrote in an email. Read more from Jeannie Baumann.

Family, Doctors Play Vital Role in Curbing Vaccine Hesitancy: Family members, friends, and local doctors are playing a significant role in persuading people to get vaccinated against Covid-19 as the number of adults eager to get the jab continues to dwindle. More than 20% of adults report that they are now vaccinated after saying in January they would either “wait and see,” only get a Covid-19 shot if required, or would definitely not get one, according to a report released yesterday by the Kaiser Family Foundation. Read more from Lesley Torres.

Nurses Push for Mask Mandate: The National Nurses United sent a letter to the CDC urging the agency to update its Covid-19 guidance and reinstate “the recommendation for everyone to wear masks in public or in physical proximity to others outside their own household.” The group cited an increase in cases and “rapid reopening of many states” for the need for a mask mandate.

More Headlines:

• U.S. Sending 1.5 Million Doses of Moderna Vaccine to Sri Lanka
• Norwegian Cruise Line Sues Florida for Barring Proof of Vaccines
• Universal Health Leaders Got Stock at Covid Discount: Suit

What Else to Know

Biogen Drug Scrutiny Seen Adding Limits to Medicare Coverage: Medicare will likely agree to cover Biogen‘s expensive new Alzheimer’s drug Aduhelm in certain circumstances if patients agree to enroll in studies to bolster evidence of its effectiveness. Health analysts said the administration’s decision to open a national coverage assessment of Aduhelm and other Alzheimer’s drugs targeting brain plaques linked to the disease is a way to ensure the drug is only going to those who could benefit from it.

“It’s highly unlikely that Medicare would issue a non-coverage decision here,” Sean Dickson, director of health policy at the West Health Policy Center, said in an email. Limiting coverage while gathering more evidence about the drug would also “significantly reduce the risk of a legal challenge” against the Department of Health and Human Services, which would most likely be sued if Medicare decided not to cover the drug at all, Dickson said. Read more from Jacquie Lee and Tony Pugh.

• Meanwhile, a prominent Harvard doctor who was one of three experts to quit a U.S. advisory panel after Aduhelm was approved said regulators should have tougher standards for granting clearances to unproven medications. In a viewpoint published yesterday in the Journal of the American Medical Association, Aaron Kesselheim and two co-authors urged regulators to promptly take treatments off the market once they’re proven ineffective and to cut back on the use of surrogates as a basis for approval. Read more from Fiona Rutherford.

Moderna’s Next Act Is Using mRNA vs. Flu, Zika, HIV and Cancer: The speed with which Moderna and its primary mRNA competitor, a partnership between Pfizer and BioNTech, devised their shots has made a major contribution to the fight to end the pandemic. With strong efficacy, steady supply, and no show-stopping safety scares (officials are carefully monitoring rare heart inflammation cases in teenagers and young adults), mRNA shots have become the vaccines of choice, at least in countries that can get them. But for Moderna CEO Stéphane Bancel, the Covid vaccine is just the beginning. He’s long promised that if mRNA works, it will lead to a giant new industry capable of treating most everything from heart disease to cancer to rare genetic conditions. Moderna has drugs in trials for all three of these categories, and Bancel says his company can also become a dominant vaccine maker, developing shots for emerging viruses such as Nipah and Zika, as well as better-known, hard-to-target pathogens such as HIV. Read more from Robert Langreth.

More Headlines:

• Allergan Investors Seek First Court OK of $130 Million Deal
• Most Physicians Avoid Major Payment Cuts in Medicare Proposal

With assistance from Alex Ruoff

To contact the reporter on this story: Zachary Sherwood in Washington at zsherwood@bgov.com

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