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Presented by the Partnership for America’s Health Care Future: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By Sarah Owermohle | Presented by the Partnership for America’s Health Care Future | With David Lim, Brianna Ehley and Emily Martin | | | — Factions break out for FDA pick as Biden’s commissioner search continues. — Congressional probe highlights plasma pressure amid other allegations. — AstraZeneca shot snagged on production lags and variant challenges. It’s Tuesday, welcome back to Prescription Pulse. Something I read this weekend: My colleague Tina Nguyen’s 11 hours in the MAGA bubble. As always, send tips to Sarah Owermohle at sowermohle@politico.com or @owermohle. Loop in David Lim (dlim@politico.com or @davidalim ) and Brianna Ehley (behley@politico.com or @briannaehley). | | A message from the Partnership for America’s Health Care Future: When it comes to what’s next in health care, we should build on and improve what’s working where private coverage, Medicare and Medicaid work together to expand access to health coverage and care — not start over. Learn more. | | | | | | FACTIONS BREAK OUT IN FDA SEARCH — President Joe Biden has not yet picked a permanent Food and Drug Administration commissioner, and advocates are mounting their own campaigns. On one side are supporters of longtime FDA drug director Janet Woodcock, who is currently serving as acting commissioner; on the other are those backing Joshua Sharfstein, an Obama administration principal deputy commissioner. At the heart of the discussion: who will helm FDA at a critical time. Former commissioners warn that waiting to announce a pick during the pandemic could limit the agency as it makes crucial decisions about coronavirus products and updates the public on its thinking. Both top contenders have FDA experience that supporters say will be vital to taking over at a tumultuous time. In Woodcock’s camp: More than 80 major health organizations penned a letter to President Joe Biden and his Health and Human Services nominee Xavier Becerra on Sunday advocating for Woodcock, arguing her 37 years with the agency serve “as both a touchstone for how to get things done and a master class in understanding the intricacies of the agency’s work.” ... But those decades of experience also bring detractors. Critics argue there has been inadequate opioid oversight under her tenure and point to controversial decisions such as the approval of Sarepta’s Duchenne muscular dystrophy medicine on limited evidence, and Woodcock’s earlier hesitation to make Plan B readily available over-the-counter. In Sharfstein’s camp: Eighteen prominent scientists issued a similar letter supporting Sharfstein on Friday. Those researchers and doctors — who noted that none of them have ever endorsed an FDA candidate — said the current director of the Bloomberg American Health Initiative at the Johns Hopkins Bloomberg School of Public Health can balance needs between public health and the industries that FDA regulates. The White House did not respond to request for comment on the letters or its ongoing FDA commissioner search. CONGRESSIONAL PROBE HIGHLIGHTS PLASMA PRESSURE — An ongoing House investigation into the Trump administration’s coronavirus response on Monday revealed new examples of political pressure — including an HHS advisor’s push for FDA to authorize emergency use of convalescent plasma against Covid-19. In letters to senior White House and health officials, the House Subcommittee on the Coronavirus Crisis reported new evidence that HHS scientific advisor Paul Alexander pressured science staff to get on board with theories that would help reopen the economy. On Aug. 19, Alexander wrote to then-FDA Commissioner Stephen Hahn and aides pushing the agency to authorize emergency use of convalescent plasma despite thin evidence for its effectiveness in treating the virus. Attached to the email were studies “to help give us cover in our decisions. It to me is well positioned,” Alexander wrote, adding that NIH — where officials had called for more evidence — "has stepped out of their lane.” FDA authorized convalescent plasma for emergency use three days later. Last week, it revised that authorization to limit plasma use only to hospitalized patients early in their disease, because it didn’t show benefits for others. Alexander had also tried to tamper with CDC’s weekly Morbidity and Mortality Weekly Reports and shape infectious disease expert Anthony Fauci’s talking points on national television, as POLITICO previously reported. He left the health department after those reports last fall. | | | | Designed specifically for regulatory affairs professionals - AgencyIQ FDA Forecast 2021: In its inaugural year, AgencyIQ's FDA Forecast predicts the FDA regulatory changes that will take place in 2021 and what they will mean for the life sciences industry. Read more about the report and download the summary here. | | | | | | | | COMMERCIAL LABS PASS 100 MILLION TESTS — The American Clinical Laboratory Association announced Saturday its members, which include Quest Diagnostics and LabCorp, have conducted more than 100 million Covid-19 PCR tests since the beginning of the pandemic. FDA SAYS HHS AUTHORIZED LAB TESTS — Two emergency use authorizations signed by former HHS testing czar Brett Giroir on January 19 were posted by the FDA on Monday, David Lim reports. HHS’ unusual decision to directly issue EUAs to Ponce Medical School INNO Diagnostics Reference Laboratory and Hospital of the University of Pennsylvania comes weeks after the Trump administration enlisted a third-party contractor to review laboratory developed tests. FDA declined to comment on the action, and HHS did not respond to questions in time for publication. Giroir told POLITICO Monday he is unsure if HHS will continue to directly authorize LDTs under President Joe Biden, but Giroir said he has “extensively” briefed Biden testing coordinator Carole Johnson on the policy. | | | |   | | | | | | E&C TO GRILL COVID-19 VACCINE MANUFACTURERS — The House Energy and Commerce Oversight and Investigations subcommittee has invited representatives from Covid-19 vaccine makers to testify at a virtual hearing on Feb 23., the committee announced Monday. Expected to join: Executives from AstraZenca, Johnson & Johnson, Moderna, Novavax and Pfizer. “We currently have two safe and effective vaccines authorized for use here in the U.S. and more could soon be on the way,” said panel Chair Diana DeGette (D-Colo.). "This hearing will give us a chance to hear directly from the manufacturers of these vaccines on their efforts to scale up production so that every American can be vaccinated in the coming months.” LAWMAKERS REVEAL BIPARTISAN BILL TO BOOST RESEARCH FUNDING — More than 75 members of the House and Senate unveiled legislation this week that authorizes $26 billion for research and innovation that they say has been derailed by the Covid-19 pandemic, Brianna Ehley writes. “It comes as tens of thousands of researchers – including graduate students, postdocs and technical support staff – find themselves at risk of losing their jobs — and their work — as universities and independent research institutions look to cut costs as a result of the ongoing pandemic,” according to a release from DeGette, a co-author of the legislation. The Research Investment to Spark the Economy (RISE) Act (H.R.869) includes: — $10 billion for the National Institutes of Health
— $5 billion for the Department of Energy
— $3 billion for the National Science Foundation
— $3 billion for the Defense Department
— $ 2 billion for NASA The bill also includes funding for the Education, Interior, Transportation, EPA and Agriculture departments | | | | THE INDISPENSABLE GUIDE TO CONGRESS: Looking for the latest on the Schumer/McConnell dynamic or the increasing tensions in the House? What are the latest whispers coming out of the Speaker's Lobby? Just leave it to Beavers... New author Olivia Beavers delivers the scoop in Huddle, the morning Capitol Hill must-read with assists from POLITICO's deeply sourced Congress team. Subscribe to Huddle today. | | | | | | | | COUNTRIES LIMIT ASTRAZENECA SHOT USE — South Africa this weekend suspended plans to roll out the AstraZeneca/Oxford University vaccine after a small trial suggested it isn’t effective in preventing mild to moderate Covid-19 illnesses caused by a dominant strain in the country. What is happening: The strain, first found in South Africa and dubbed B.1.351, sparked similar concerns about other vaccines that are less effective against the variant, but still protective. B.1.351 is one of three variants raising public health officials’ alarms, along with two first found in the United Kingdom and Brazil that are more transmissible than the original virus. Each variant has been found in the U.S. Elsewhere, European officials are setting age restrictions for the AstraZeneca shot, which they claim are based on data that doesn't show the jab is effective in people over the age of 55. Other experts, however, suggest it’s because the bloc has limited supplies as it continues to face systemic production issues. Less than 3 percent of people in the EU have received their first dose, and they say the age limits will only exacerbate the issue of vaccinating vulnerable populations. Commission President Ursula von der Leyen confirmed that the EU underestimated how difficult it would be to ramp up manufacturing on a global scale and warned that supply issues will “certainly happen over and over again." What’s next: The AstraZeneca shot was billed as the world’s vaccine because it is cheaper than others and the drugmaker struck deals with international groups. But production lags and B.1.315’s spread could raise questions about widespread use. Meanwhile Oxford researchers reported Friday that the shot is less effective, though still protective, against the strain first found in the United Kingdom. That variant is credited with causing a case surge last fall that fueled a second lockdown in the country. | | | — Fewer challenges to patents listed in the FDA’s Orange Book are being launched as generic drug companies have become smarter dealing with the Patent and Trademark Office, Bloomberg Law reported. — Anthony Fauci said that U.S. vaccine supply may start to meet demand in the spring as Pfizer and Moderna ramp up production, and with FDA poised to authorize the Johnson & Johnson shot, The Washington Post reported. — Many states are now redistributing hundreds of thousands of excess doses from elder-care facilities to other sites in an attempt to expand vaccinations after the federal government allocated too much to such facilities, the Post reported. — Many residents of long-term facilities are still waiting for vaccination against Covid-19, despite the promise that they’d be at the front of the line, The New York Times reported. — A health care worker in London prepping for his first dose well before his at-risk father in Ghana, who hadn’t received any information on when a vaccine might arrive, is a perfect example of disparities in global vaccine distribution, Quartz reported. | | A message from the Partnership for America’s Health Care Future: We should build on and improve what’s working in health care, not start over with a new government-controlled health insurance system like the public option that we can’t afford. A recent study finds that a recession or other economic crisis could exacerbate the costs of the public option. In the first ten years after its enactment, the federal deficit could grow by $932 billion if unemployment relief is needed during a recession – a $132 billion increase from original projections. As a result, politicians could be forced to either raise taxes on working families or increase the federal debt to pay for a new government-controlled health insurance system. Learn more. | | | | | | A coronavirus variant first spotted in the U.K. is spreading rapidly across the U.S. and outcompeting other strains, according to a preprint study by academic, government and industry researchers that supports a forecast from the CDC that predicted the variant would become dominant by March. The Lancet published a report that found a 60 percent decrease in new clinical trials for cancer drugs and biological therapies during the pandemic. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
