HEALTH CARE BRIEFING: Trump Calls FDA Vaccine Rules a ‘Hit Job’

Donald Trump accused the Food and Drug Administration of carrying out a “political hit job” against him by releasing new standards that could delay authorization of a coronavirus vaccine until after the November election.

“New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” the president wrote in a tweet that tagged his hand-picked FDA commissioner, Stephen Hahn.

Trump, who is battling a coronavirus infection himself, commented hours after the FDA issued strict new requirements for Covid-19 vaccine applications, including a review by a panel of experts and two months of safety data. The guidelines are intended to reassure the American public any vaccine is safe and effective, amid accusations that the Trump administration’s response to the virus has been tainted by politics.

The FDA did not immediately respond to a request for comment.

Trump, whose re-election hinges on how the public views his Covid-19 response, has repeatedly suggested a vaccine could be ready by Election Day on Nov. 3 or even sooner, a faster timeline than laid out by public-health experts and drug manufacturers. Read more from Jordan Fabian.

• Earlier: FDA Sets Goals That May Put Vaccine Out of Reach Before Vote

FDA Will Force Vaccine-Safety Disclosures If Makers Don’t: Meanwhile, a top Food and Drug Administration official warned vaccine makers that the agency could call upon rarely-used powers to disclose significant safety issues, after being asked about month-old investigation into an experimental Covid-19 shot from by AstraZeneca.

At an online event hosted by Johns Hopkins University and the University of Washington, FDA Center for Biologics Evaluation and Research Director Peter Marks said he “would encourage any manufacturers of a vaccine, any sponsor of a vaccine to be as transparent as possible.” Marks emphasized that he was not talking specifically about any one company.

He followed up by invoking the potential use of what’s called a commissioner’s finding, a rarely used FDA power by which the agency can announce serious safety concerns on the way to potentially banning use of a product. Read more from Drew Armstrong, Robert Langreth and Angelica LaVito.

Conley Faces Tough Job; Trump Compares Virus to Flu: Trump’s physician Sean Conley faces the daunting task of trying to keep the most powerful Covid-19 patient in the world from worsening his sickness or infecting others, even as the president itches to return to the campaign trail.

Whether Conley and his White House Medical Unit can find success remains in question. In a presidency where politics has taken priority over recommended public health measures, Conley’s office was unable to protect the White House staff, visitors or the president himself from the virus.

With more White House staff testing positive for coronavirus each day, Conley’s unit will have a tough time keeping the rest of the West Wing safe. Still, Conley’s biggest challenge could be containing Trump, who has given every indication of a patient giving orders to his doctor, not the other way around. He showed defiance against the coronavirus on Twitter yesterday, again comparing it to the far less lethal and less contagious common influenza.

“Flu season is coming up! Many people every year, sometimes over 100,000, and despite the Vaccine, die from the Flu,” Trump said. “Are we going to close down our Country? No, we have learned to live with it, just like we are learning to live with Covid, in most populations far less lethal!!!” The post was later taken down by Facebook for violating its policies on disinformation. Jordan Fabian has more.

Democrats Say White House Put D.C. Region at Risk: House Majority Leader Steny Hoyer (Md.) and other lawmakers representing districts in the National Capital Region, including Del. Eleanor Holmes Norton (D.C.) and Reps. Jamie Raskin (Md.) and Don Beyer (Va.), said the Trump administration’s “casual disregard” for the Covid-19 outbreak inside the White House has endangered the region by exposing reporters, staffers, Secret Service agents, and the general public to the novel coronavirus. The lawmakers in a release demanded the White House assist with local contact tracing efforts.

More Headlines:

• Trump Said Restless, Wants to End Isolation, Return to Oval Office
• Joint Chiefs Boss, Other Officers Quarantining as Admiral Infected
• White House Outbreak Shows Testing, by Itself, Can’t Stop Spread
• Trump Fails to Stir Sympathy Bump After Covid-19 Hospitalization

More on the Pandemic

Trump Allies Stumped by Unilateral Move to Scrap Stimulus Talks: Trump stunned campaign advisers and allies in Congress by single-handedly torpedoing any chance of a fresh coronavirus stimulus, saddling himself with the blame for any more layoffs and market losses in the final weeks before the election.

With the president already trailing badly in polls as he recovers from Covid-19, his decision to publicly scuttle talks toward a bill in excess of $1 trillion puzzled allies, who had accused House Speaker Nancy Pelosi (D-Calif.) and Democrats for overreaching in negotiations. Read more from Justin Sink, Mike Dorning and Jordan Fabian.

• Centrist members of both parties bemoaned Trump’s abrupt move. Some moderate Republicans running for re-election on the ballot with an unpopular president broke with Trump and urged a return to negotiations. Opponents of another giant aid package after the $2 trillion approved in March cast blame instead on Democratic leaders for failing to come further down from their $2.2 trillion offer. Read more from Erik Wasson and Billy House.
• Trump rejected Democratic proposals to expand the earned income and child tax credits, to provide funds to school, to fund child care, and to boost workplace safety requirements, among others, Pelosi said in a letter to colleagues yesterday, Jack Fitzpatrick reports.
• The speaker suggested last night at a 92nd Street Y virtual event that if there is still no stimulus deal in the post-election lame duck session of Congress, some of the virus relief funding could be added to a must-pass spending bill needed to keep the government open after Dec. 11. Read more from Erik Wasson, Saleha Mohsin and Billy House.
• Meanwhile, the CEO of the American Health Care Association and National Center for Assisted Living, an industry group representing nursing homes, warned against abandoning stimulus talks. The group has asked for more relief targeting to long-term care facilities. “Without adequate funding and resources,” the U.S. will “repeat the same mistakes made during the initial outbreak last spring and the major spike over the summer,” said CEO Mark Parkinson in a letter.

Trump Official Resigns, Criticizes Covid Response: Dr. Rick Bright, former director of the Biomedical Advanced Research and Development Authority, submitted his resignation to National Institutes of Health leadership effective immediately and filed an updated Office of Special Counsel charge, according to a statement from his attorneys. Bright claimed NIH leadership declined to support his recommendations for responding to the Covid-19 pandemic for political reasons and sidelined him from doing any meaningful work to combat the virus, Megan Howard reports.

Hospitals Get Short Time to Report Covid, Flu Data: Some 6,200 U.S. hospitals will have 14 weeks beginning today to comply with federal Covid-19 data-reporting requirements or risk being excluded from the Medicare and Medicaid programs.

The aggressive timeline announced yesterday allows the Centers for Medicare & Medicaid Services to notify noncompliant hospitals, inform them of their violations, work with them to correct the problems— and if after 14 weeks that doesn’t work: “Termination from Medicare and Medicaid is the only sanction at our disposal,” CMS Administrator Seema Verma said. Read more from Tony Pugh.

WHO Power to Probe Outbreaks Gets Support: A rare glimmer of consensus appeared over the World Health Organization as France and Germany floated a proposal to give the body more powers to quickly investigate disease outbreaks. In a joint report circulated ahead of this week’s WHO executive board meetings, the nations promoted the idea of enabling the agency to dispatch multinational teams with authority to immediately investigate disease outbreak sites in every member state. Read more from Thomas Mulier and Corrine Gretler.

More Headlines:

• HHS Funding New Patch to Take the Sting Out of Getting a Vaccine
• Businesses in N.Y.C. ‘Hot Spots’ Must Close by Friday, Cuomo Says
• Mask Policies Helped Arizona Stem Virus Spread: CDC Report Says
• Europe’s Regulator Starts Review of Pfizer-BioNTech Covid Vaccine
• Hologic Rises as FDA Expands Covid-19 Test Use for Asymptomatic
• OSHA’s Low Fines Won’t Protect Workers from Virus, AFL-CIO Says
• Malaysia Outbreak Shows How Mishandled Elections Can Turn Deadly

What Else to Know Today

Grassley Tosses Lifeline to Children’s Hospitals: Children’s hospitals at risk of losing millions for treating low-income patients are looking to Congress for help after the Supreme Court declined to review their case. Senate Finance Chairman Chuck Grassley (R-Iowa) wants Congress to tackle the issue as it deals with another upcoming funding deadline, according to a spokesman. The court declined to take up a Department of Health and Human Services rule that cuts Medicaid payments to safety-net hospitals. Read more from Christopher Brown.

More Headlines:

• States Ask Supreme Court to Review Trump Family Planning Rule
• Justices Question State Law Guiding Pharmacy Drug Middlemen
• Johnson & Johnson Says Thermocool Smarttouch Gets FDA’s OK
• Kiniksa Soars After Inflammatory Disease Drug Meets Trial Goals
• Dubious Alternative Lyme Treatments Are Killing Patients
• Nobel Prize for Chemistry Awarded to Charpentier And Doudna (AP)

With assistance from Jack Fitzpatrick

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