HEALTH CARE BRIEFING: Trump Urged to Share Virus Data With Biden

Advisers to President-elect Joe Biden yesterday said that the Trump administration’s refusal to allow the transition team access to government facilities and information could hamper their efforts to quickly contain the coronavirus pandemic after Biden takes office in January.

The warning came the same day groups representing doctors, nurses and hospitals called on President Donald Trump to share information about the administration’s pandemic response with Biden’s transition team. Delaying the transition could cost lives as a new surge of Covid-19 cases has sent a record number of Americans to hospitals, the groups wrote in a letter to Trump.

“Real-time data and information on the supply” of therapeutics, testing supplies, ventilators, personal protective equipment and hospital bed capacity “to plan for further deployment of the nation’s assets needs to be shared to save countless lives,” the leaders of the American Hospital Association, the American Medical Association and the American Nurses Association wrote in the letter.

Biden is poised to take power in a crucial period of the pandemic. New therapies and vaccines are getting ever-closer to reaching the public, even as new cases hit record levels and holiday gatherings may accelerate the spread of disease, John Tozzi reports.

“Many parts of President-elect Biden’s Covid plan are going to require working closely with the current administration to make sure we have the best possible plan in place,” said former U.S. Surgeon General Vivek Murthy, one of the co-chairs of Biden’s coronavirus task force. “There is valuable information inside the administration.”

The General Services Administration has refused to ascertain that Biden won the presidential election, a move that would provide the Biden team access to government agencies and their resources. As a result, Biden’s aides are relying on publicly available information like the Covid Tracking Project to devise their plans. If the GSA officially started the transition, Biden advisers would get up-to-date data on Covid-19 cases, insight into how the administration is planning to distribute a vaccine and information about the national stockpile and other critical supplies.

Beyond the detailed information, Biden’s advisers on a call with reporters said it is necessary to begin working with the career officials in the health agencies that will stay on and serve in the Biden administration. In particular, David Kessler, a former FDA commissioner, warned that a lack of access would hinder the Biden administration’s ability to distribute vaccines. Read more from Tyler Pager.

Former Obama administration officials also weighed in on the president’s ongoing refusal to cooperate with transition processes:

• Chris Jennings, a former health policy adviser under President Barack Obama, said at an Alliance for Health Policy webinar that the Trump administration’s delay is “outrageous” and “will undermine an effective transition in the middle of a pandemic.”
• Nicole Lurie, HHS assistant secretary for preparedness and response under Obama, said Biden’s team also isn’t getting information it needs to prepare for distributing Covid-19 vaccines next year. That planning would prove critical for vaccines that could get FDA approval for public use a month before Biden takes office, Lurie said.

Azar Not Concerned: Meanwhile, Health and Human Services Secretary Alex Azar downplayed the chance that the president’s wrangling over the election results would delay vaccine distributions. “The distribution planning is being done by career officials at CDC, on Operation Warp Speed, at the Defense Department,” he said. “These are people whose roles don’t change.” Read more from Josh Wingrove and David Westin.

• Separately, Pfizer CEO Albert Bourla said yesterday the company had hit a key safety-data milestone and would apply for FDA Emergency Use Authorization for its vaccine. Bringing a conventional vaccine from inception to market usually takes over a decade on average. But Pfizer-BioNTech and Moderna are now approaching that finish line, just 300 days after scientists first mapped the genetic profile of the novel coronavirus. Read more from James Paton and Robert Langreth.

The Final Hurdle in the Covid-19 Vaccine Race Is Bureaucracy: Making vaccines that are safe and effective is certainly the hard part of the race to pull humanity from the pandemic brink. Promising results are trickling in, starting with Pfizer and its German partner BioNTech’s early findings that their vaccine prevented more than 90% of symptomatic infections in a trial of tens of thousands of volunteers. On Nov. 16, Moderna reported a 94.5% prevention rate for its vaccine, with a 30,000-plus test group.

Yet if triumph in this scientific, corporate, and nationalistic contest is defined as the first vaccine to get approved and administered on a large scale, the victory is still anyone’s to win. The final phase will require navigating the maze of regulators, scattered across continents and agencies, who will determine when, which, and where shots of the most promising candidates will be approved, produced, and distributed. Read more from Vernon Silver, Suzi Ring and James Paton.

FDA Disclosures for Covid-19 Products Seen Inconsistent: The FDA hasn’t been consistent with the safety and efficacy data it’s disclosed for authorized Covid-19 products and needs to beef up its transparency with providers and the public, the Government Accountability Office said yesterday. The GAO’s recommendations are aimed at improving public trust in the Food and Drug Administration in a time of wavering confidence in federal institutions’ ability to handle the pandemic. Read more from Jacquie Lee.

More Headlines:

• NIH Director Hopes Most Americans Get Covid Vaccines by Summer
• Vaccine Safety to Remain Unclear Until Millions Get Their Shots
• U.S. Midwest Covid-19 Surge Lasts Longer Than Coasts’ Agony

Happening on the Hill

Stimulus Update: Pelosi, Schumer Ask McConnell to Resume Stimulus Talks

Health Measures Set for Passage: The House today plans to consider 22 measures under expedited procedure. Health-related legislation include the following:

• H.R. 6334, which would allow the U.S. to participate in the Coalition for Epidemic Preparedness Innovations, an international partnership on vaccine development. The House Foreign Affairs Committee approved the bill by unanimous consent on July 29. Read the BGOV Bill Summary by Michael Smallberg.
• H.R. 7990, which would require the State Department to create programs to help foreign countries combat fentanyl trafficking and drug use. The House Foreign Affairs Committee approved the bill by a voice vote on Oct. 1. Read the BGOV Bill Summary by Danielle Parnass.

Grassley Tests Positive for Virus: Senate Finance Chairman Chuck Grassley (R-Iowa), 87, yesterday in a tweet said he tested positive for coronavirus but is “feeling good” and will continue to quarantine, Mike Dorning and Laura Litvan report.

• Meanwhile, the Office of the Attending Physician announced yesterday it will offer post-travel rapid, RT-PCR Covid-19 testing for all members and staff when they return to Washington D.C., an effort to comply with the city’s orders, which recommend incoming travelers receive a test within three to five days of arrival.

Opioid Abuse Treatment for Freed Inmates: Health-care advocates want Congress to bring Medicaid through the jailhouse door to prevent gaps in opioid treatment for inmates ready to reenter society. Dozens of groups have been pushing lawmakers to include a provision in the next coronavirus relief package that would allow states to restart health benefits for Medicaid-eligible inmates from prisons and jails within 30 days of their release. Rules dating back to the 1960s prevent use of Medicaid funds for inmates, shifting the burden of their care to states or counties that may not have the funding to provide it. Christopher Brown has more.

Portman Enlists in Johnson & Johnson Vaccine Trial: Sen. Rob Portman (R-Ohio) announced yesterday he’ll participate in a late-stage human trial for Johnson & Johnson’s single-dose coronavirus vaccine candidate. “I look at it as a way I can play a small role in supporting our country’s health care response to this pandemic,” he said in a statement, adding that he hopes it will “reassure people about the safety and effectiveness of vaccines once they have gone through the trials and FDA approval process.” Read the statement here.

• In comments on the Senate floor last night, Portman said he will introduce bipartisan legislation to “support a national awareness campaign that would empower HHS to cut through the politics and promote the scientific advancements we’ve made in order to increase public confidence” in a vaccine. Read his comments here.

What Else to Know

HHS Eyes Input on A.I.-Driven Health Tools: The Health and Human Services Department is seeking public comment on technologies that will improve chronic disease management and access to care for under-served, elderly populations. The goal is to assess how public-private partnerships can be used to enable data sharing, comprehensive analytics, and other tools to improve health care for low-income, Medicaid-eligible, and rural populations, the HHS said in a request for information yesterday. Read more from Christopher Brown.

Purdue Wins Approval of $8.3B Opioid Settlement: Purdue Pharma’s $8.3 billion settlement with the U.S. government calling for the drugmaker to plead guilty to three felonies for illegally marketing its opioid-based OxyContin painkiller can move forward, a judge concluded. Purdue officials said yesterday U.S. Bankruptcy Judge Robert Drain’s approval of the deal is an “essential step” in their push to resolve more than 2,000 lawsuits accusing the company of helping to fuel the U.S’s opioid epidemic by wrongfully promoting the painkiller. Read more from Jef Feeley.

More Headlines:

• Public Option Health Plan in Washington State a Caution to Biden
• Evolus Lobbies Trump to Avoid U.S. Ban on its Botox Alternative
• FDA Grants ViiV Healthcare’s HIV PrEP Breakthrough Designation
• FTC, AbbVie Seek Rehearing in Antitrust Sham Litigation Lawsuit
• NIH to Recompete $700M Scientific, Technical Services Contract
• Praxis Sinks as FDA Proposes Further Toxicological Investigation
• Man Wrongly Covered by Health Plan Keeps $477,000 in Benefits
• For Flu Fighters, a Big Boost From the Battle Against Covid

With assistance from Alex Ruoff, Shira Stein, and Nancy Ognanovich

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