Canada clamps down on drug imports as U.S. finalizes plan — CDC's vax panel calls emergency meeting — Moderna files for emergency use

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Dec 01, 2020 View in browser   By Sarah Owermohle Presented by CVS Health With David Lim, Zachary Brennan and Emily Martin On Tap — Canada clamps down on drug imports just before the U.S. plan goes into effect. — CDC's vax panel calls emergency meeting to discuss top priority groups for the Covid-19 vaccine. — Shots as soon as mid-December says VP Pence in governors meeting. A message from CVS Health: Since the start of the pandemic we've used our unique capabilities and unmatched local presence to help respond to the spread of the virus. We've opened 4,000 COVID-19 test sites since March, and administered nearly seven million tests. We're helping businesses and universities safely reopen, and look forward to playing a critical role in the vaccine distribution process. None of this would be possible without the tireless efforts of our 300,000 employees. Learn more.   It's Tuesday, welcome back to Prescription Pulse. I'm heading out for some R&R this week, so David Lim is helming your Friday newsletter. Send him and Zachary tips and new at dlim@politico.com or @davidalim and zbrennan@politico.com or @ZacharyBrennan. I'll be back Monday! Tell me what I missed at sowermohle@politico.com or @owermohle. Drug Pricing CANADA CLAMPS DOWN ON DRUG IMPORTS AS U.S. FINALIZES PLAN — The Trump administration's rule allowing states and wholesalers to import cheaper medicines from Canada went into effect Monday — and Canada is not happy. The northern neighbor this weekend banned mass exports of its drug supply, citing the risk of shortages. "Our health care system is a symbol of our national identity and we are committed to defending it," Canada Minister of Health Patty Hajdu said in a statement. Health Canada noted that the country represents just 2 percent of global drug sales and sources 68 percent of its medicines internationally — a global system made more complicated by persistent demands during the Covid-19 pandemic. "The need for vigilance in maintaining the national drug supply continues," the Canadian regulators said. There are also questions at home. Florida, where Trump ally Gov. Ron DeSantis was a key proponent of the plan, has had a hard time attracting bidders for its importation model. DeSantis submitted the state's plan to federal regulators last month, but details — like how much it will cost or save, what medicines are included and how safety is ensured — are not public yet. It's not just fears of shortages impeding the plan, pharmacists and drugmakers in both countries argue. PhRMA initiated litigation to stop the rule last week. The Alliance for Safe Online Pharmacies, a lobby with a Canadian counterpart, insists that the U.S. rule "could potentially drive Canadian and American patients to look for medicine through unconventional sources, like unlicensed, illegal internet online drug sellers" that "often distribute counterfeit, substandard or unapproved drugs." But it's one of the president's few remaining drug plans. Despite Donald Trump's effort to release the most-favored nations model and the rebate plan as final rules last month, it's unclear whether they could be finalized before President-elect Joe Biden assumes office.   TRACK THE TRANSITION: President-elect Biden has started to form a Cabinet and announce his senior White House staff. The appointments and staffing decisions made in the coming days send clear-cut signals about Biden's priorities. Transition Playbook is the definitive guide to one of the most consequential transfers of power in American history. Written for political insiders, it tracks the appointments, people, and the emerging power centers of the new administration. Track the transition and the first 100 days of the incoming Biden administration. Subscribe today.     Coronavirus CDC'S VAX PANEL CALLS EMERGENCY MEETING — The CDC's Advisory Committee for Immunization Practices convenes today to discuss the absolute top-priority groups to receive the first tranche of Covid-19 vaccines. ...The panel of doctors, health experts and federal representatives met just a week earlier on the same topic. But now two vaccine makers have filed for emergency use — more on that below — and shots could be available within weeks. Plus, at last week's meeting, ACIP members were divided over whether vulnerable seniors in long-term care facilities should be the top priority group along with health care workers. "But be thinking people in nursing homes, the most vulnerable; be thinking health care workers who are on the frontlines of most interacting with suspected COVID cases, as the first tranches of people that we'll try to get vaccinated," HHS Secretary Alex Azar said on CBS This Morning on Monday. The CDC recommendations aren't binding for state governors, who ultimately decide allotment for their populations, but they can provide the clarity governors need to make difficult decisions with limited supplies. Speaking of which ... TRUMP ADMIN LEAVES STATES TO GRAPPLE WITH VACCINE DISTRO — The Trump administration is shunting to the states hard decisions about which Americans will get the limited early supplies of coronavirus vaccines — setting up a confusing patchwork of distribution plans that could create unequal access to the life-saving shots. The federal government is providing early doses based on states' total populations, forcing tough choices in states with a greater proportion of residents at high risk — including Black, Indigenous and Latino communities that have suffered disproportionate rates of hospitalization and death from Covid-19. Public health experts say that could undermine already shaky public confidence in the vaccine effort, whose success depends on convincing large numbers of Americans to get immunized, I write with Zachary Brennan and Rachel Roubein. FIRST IN PRESCRIPTION PULSE: LABS WANT PRIORITY FOR VACCINES — The American Clinical Laboratory Association is asking HHS and CDC to prioritize vaccination of lab workers who are conducting Covid-19 testing. The request is the latest example of a group arguing it should be first in line for an authorized Covid-19 vaccine, David Lim reports. "Without a healthy laboratory workforce, clinical laboratories will be unable to maintain the high volume of testing that is critical to our nation's COVID-19 public health response and economic recovery," ACLA President Julie Khani wrote.     COVID VACCINES AS SOON AS MID-DECEMBER — Vaccine distribution could begin within days of an Dec. 10 expert panel discussion of Pfizer's shot, federal officials told state governors in a Monday call according to notes of the call obtained by POLITICO. "We strongly believe the vaccine distribution process could begin the week of December 14," Vice President Mike Pence said. It'd be a record turnaround for FDA review, especially since this will be the first coronavirus vaccine before its advisory committee. Officials promise that distribution will begin within 24 hours of FDA's green light. "Normally the FDA process would take four or more months after the submission of an application ... We will of course expedite the review," Commissioner Stephen Hahn said on the call. Between Pfizer and Moderna, just 40 million doses are available this year. Governors asked about their allocation with some, like Maine Governor Janet Mills, saying they were getting a third less than originally expected. Officials said that state census records contributed to the allocations, which are not yet public. "The cavalry is coming," said Pence, who acknowledged that cases are rising nationwide but said: "Our country has never been more prepared to combat this virus." The U.S. is nearing 200,000 new coronavirus cases a day. MODERNA SEEKS EUA FOR VACCINE; AD COMM SET FOR DEC. 17 — Moderna on Monday became the second company — behind Pfizer — to file for an emergency use authorization for its coronavirus vaccine. The FDA's independent vaccine advisory group will meet on Dec. 17 to review the Moderna data. The filing is based on a final analysis of its 30,000-person late-stage trial that showed the vaccine is 94.1 percent efficacious, based on 196 cases of Covid-19 reported among the study participants. The vast majority — 185 — occurred in people who got a placebo. All 30 severe cases took place in the placebo group, and one participant in the placebo group died of the virus, Moderna said. NOVAVAX PUSHES BACK U.S. VACCINE TRIAL — U.S. government-funded coronavirus vaccine developer Novavax said Monday that it's pushing back the start of its late-stage clinical trial in the U.S. and Mexico from late November to an unspecified date next month, Zachary writes. The delay comes as the company, which has received $1.6 billion from the Trump administration's vaccine accelerator Operation Warp Speed, said it's working on manufacturing-related issues with its contractor Fujifilm in North Carolina. The company also announced Monday that it fully enrolled another late-stage trial of 15,000 participants in the U.K. More than 25 percent of enrollees in the vaccine trial are over the age of 65, and a large proportion of participants had underlying medical conditions, Novavax said. Interim data from the U.K. trial are expected early next year. According to the trial's protocol , the independent data safety monitoring board will look at interim analyses of data after 66 Covid-19 infections in either the placebo or vaccine groups, and after 110 infections. The data are expected to serve as the basis for the vaccine's licensure application in the U.K., European Union and other countries, the company said. GAO: CDC SHOULD EXPLAIN SCIENCE BEHIND CHANGES TO TESTING RECS — HHS and CDC's rollout of Covid-19 testing recommendations "has not always been transparent, raising the risk of confusion and eroding trust in government," the Government Accountability Office wrote in a new report released Monday. Over the summer, CDC walked back a widely criticized guidance that left it up to local public health officials and health providers if asymptomatic close contacts of people with Covid-19 should be tested for the disease. GAO said that while it is not unexpected that recommendations by the government will change as more information about the pandemic emerges, HHS and CDC should disclose the scientific rationale for changes to testing guidelines. The federal health department agreed with the recommendation.   NEXT WEEK - DON'T MISS THE MILKEN INSTITUTE FUTURE OF HEALTH SUMMIT 2020: POLITICO will feature a special edition Future Pulse newsletter at the Milken Institute Future of Health Summit. The newsletter takes readers inside one of the most influential gatherings of global health industry leaders and innovators determined to confront and conquer the most significant health challenges. Covid-19 has exposed weaknesses across our health systems, particularly in the treatment of our most vulnerable communities, driving the focus of the 2020 conference on the converging crises of public health, economic insecurity, and social justice. Sign up today to receive exclusive coverage from December 7–9.     Transition 2020 MONCEF SLAOUI PREPS TO DEPART SOON — The Operation Warp Speed head may step down from the government's coronavirus vaccine and treatment accelerator "by the end this year or early next year," he told Zachary in an interview last week. He said it's not about the new presidency. "I do not want my departure from the role to have anything to do with the new administration. I have more affinity for the new administration than the current one," said Slaoui. "The way I look at it is: Am I adding value or no?" Pharma Moves Jeff Zients, who led OMB during the Obama administration and helped oversee the HealthCare.gov repair job, is a finalist to be Biden's manager of the coronavirus response, POLITICO Playbook first reported last week. A message from CVS Health: Our mission of helping people on their path to better health has never been more relevant, as the nation faces the grim realities of a pandemic. As an essential business our doors have remained open, and our frontline employees have helped millions of customers and patients safely fulfill their health care needs, from filling a prescription to seeing a MinuteClinic practitioner. Our Coram nurses have helped create hospital bed capacity by transitioning eligible IV-therapy patients to home-based nursing care. Use of our telehealth offerings has increased dramatically as more people discover this convenient option. We're not just your corner drugstore – we're a diversified health services company transforming health by meeting people where they are and making health care more accessible, affordable and simply better. Learn more.   Quick Hits Top pharmaceutical executives that the Trump administration enlisted for Operation Warp Speed kept major investments and continue to receive payouts, Kaiser Health News reports. Biogen and Sage Therapeutics struck a $1.5 billion deal to jointly develop treatments for depression and other neurological disorders, Reuters reported. Canadian health officials predict a Covid-19 vaccine could get regulatory approval by mid-December, putting Canada on the same timeline as the U.S., The Star reported. Document Drawer FDA updated information on its DDT approval process under the Innovative Science and Technology Approaches for New Drugs pilot program. FDA will host a public meeting of the Vaccines and Related Biological Products Advisory Committee on Dec. 10 to discuss Pfizer's coronavirus vaccine. FDA published draft guidance with recommendations for gastric pH-dependent DDI assessments and when clinical DDI studies with acid-reducing agents are needed. FDA reopened the comment period for a May 2019 public docket on the fixed quantity unit-of-use packaging for immediate-release opioid analgesics. An analysis by the Government Accountability Office found CDC's Early Detection Program screened nearly 300,000 people for breast or cervical cancer in 2018, a 46 percent decrease from 2011. The decrease is largely attributable to people gaining insurance coverage due to provisions of the Affordable Care Act, GAO wrote.   Follow us on Twitter Sarah Owermohle @owermohle   Follow us

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