| | | | | |  | | By Sarah Owermohle | Presented by Genentech | With Zachary Brennan and David Lim PROGRAMMING NOTE: Prescription Pulse will not publish on Friday, Nov. 27. We'll be back on our normal schedule on Tuesday, Dec. 1. | | | — CDC panel: Justice, equity in Covid-19 vaccines but the devil's in the details. — AstraZeneca preps for filing with foreign data suggesting up to 90% efficacy. — Trump's drug pricing stamp may be impossible to fulfill. It's Friday, welcome back to Prescription Pulse. Who do you think should get a televised Covid-19 vaccine? As always, send pharma tips and news to sowermohle@politico.com or @owermohle. Loop in David Lim (dlim@politico.com or @davidalim) and Zachary Brennan ( zbrennan@politico.com or @ZacharyBrennan)! | | | | A message from Genentech: Inequity in our healthcare system is an urgent issue. At Genentech, we strive to put patients — and their experiences — at the center of everything we do. Read about our landmark study that elevates the perspectives of medically disenfranchised individuals and their relationships with the healthcare system. | | | | | | CDC GROUP: JUSTICE, EQUITY KEY IN COVID-19 VACCINES — U.S. government plans for distributing coronavirus vaccines should try to mitigate health inequalities and promote justice and transparency, while maximizing benefit and minimizing risk, the CDC's Advisory Committee on Immunization Practices said Monday. The timeline: Pfizer's and Moderna's shots could be authorized for public use within weeks, speeding the timeline to finalize a framework to distribute the shots to high-risk and needy populations. But with limited supply from each manufacturer — enough for 20 million people through the end of the year and roughly 25 million each month after — there will be tough decisions about who is first. The reality: The CDC panel's focus on justice and health inequities comes amid disproportionate Covid-19 cases, hospitalizations and deaths in Black, Latino and Native American populations, as well as long-held distrust of the medical establishment among those groups because of historical abuse and mistreatment. The hesitation: While American adults seem moderately confident in vaccines, with a boost after Pfizer's positive news this month, no one really wants to be first in line to get the new shots, according to surveys presented to ACIP. Acceptance is lowest among Black respondents and highest among Asian respondents. People who are hesitant about the vaccines express concern about side effects, uncertainty that they work, or simply that they don't think Covid-19 infection is all that severe. While acceptance is higher among people who are advised by providers to get vaccinated, some health care workers seem skeptical too. In one survey of nurses, 63 percent said they are somewhat or very confident in potential Covid-19 shots but only 34 percent said they would voluntarily get them. Distribution will come down to details like which vaccines are available when. Specific storage and handling requirements for different vaccines — like the Pfizer shot's ultra-cold storage needs — could also impact equitable distribution, especially in hard-to-reach areas. ACIP experts also discussed what lack of data for certain populations could mean for prioritizing certain people. For example: Members were divided about whether seniors in long-term care facilities should be top priority (dubbed the '1a' group) or further down in the first group ('1c') to wait for more safety data. ASTRAZENECA TO SUBMIT FOREIGN DATA TO FDA FOR VACCINE EUA — AstraZeneca said Monday that it will submit preliminary data from from large clinical trials in the U.K. and Brazil to the U.S. FDA as part of an application for emergency authorization, Zachary Brennan writes. Data from those trials show the vaccine averaged 70 percent efficacy across two different dosing regimens. When the vaccine was given as a half dose and then a full dose one month later to about 2,700 participants, it had an efficacy of 90 percent. When given as two full doses at least one month apart to about 8,900 participants, the vaccine showed 62 percent efficacy. AstraZeneca, which admitted to Reuters that lower dosing regimen was the result of an error, did not attempt to explain the counterintuitive results. The company is also still working on a late-stage U.S. trial, which has enrolled about 10,000 of a planned 40,000 participants. The company has not released any data from that study, although results are expected by the end of the year or early next year, Ruud Dobber, an AstraZeneca EVP, said on MSNBC. REGENERON ANTIBODY COCKTAIL WINS EMERGENCY AUTHORIZATION — The FDA on Saturday authorized the emergency use of Regeneron's monoclonal antibody cocktail for mild or moderate cases of Covid-19. The company allowed President Donald Trump to use the treatment, now known officially as casirivimab and imdevimab, when he fell ill with the virus last month. The antibody cocktail, which may reduce Covid-related hospitalizations, will be in short supply, Zachary writes. HHS said in a press briefing that the first 30,000 doses of the Regeneron treatment will be shipped out to states today, in a manner similar to how the agency has allocated almost 120,000 doses of Eli Lilly's monoclonal antibody after it received an EUA on Nov. 9. An additional 50,000 doses of Regeneron's treatment are expected by the end of November. But the U.S. government has only purchased 300,000 doses so far, all of which are expected to be allocated by the end of January. | | | | KEEP UP WITH THE PEOPLE AND POLITICS DRIVING GLOBAL HEALTH: The global pandemic has revealed just how critical it is to keep up with the politics, policy, and people driving global health. Will America reclaim its leadership on the worldwide health stage with the new Biden administration in 2021? What impact could the president-elect's presidency have on global vaccine access and the international response to the pandemic? Our Global Pulse newsletter connects leaders, policymakers, and advocates to the politics impacting our global health. Join the conversation and subscribe today. | | | | | | | | THE DRUG PRICING PIPE DREAM — Trump's Friday announcement of two long-in-the-works drug pricing reforms let the president boast about progress against high drug costs and throw down the gauntlet for the Biden administration. But both proposals still have an unlikely path to realization. For starters, the timeline. While Trump announced the most-favored nations rule and the rebate rule on the last-possible day to clear a 60-day window before president-elect Joe Biden assumes office, neither rule is in the Federal Register yet. They won't be in the register — the government's official daily publication — until Nov. 27 and Nov. 30 , respectively. Law says that a rule must be published 60 days before becoming codified, but...this is unchartered territory. HHS could argue for speeding it up, or that public availability — i.e. Friday's news — counts. But legal challenges to that logic will abound. So, unless Biden takes a liking to them, the rules may already be dead. Trump seemed to nod to the rules' uncertain future in remarks Friday: "I just hope they keep it. I hope they have the courage to keep it, because the powerful drug lobby, big pharma, is putting pressure on people like you wouldn't believe." The caveats: At least a portion of the more than $85 billion Medicare expects to save from the most-favored nations rule comes from fewer people having access to their medications. "While there are significant savings as a result of this model, a portion of the savings is attributable to beneficiaries not accessing their drugs through the Medicare benefit," states the rule, which estimates that from 2023 onward, roughly 19 percent of beneficiaries will not have access to their medicines through Medicare. But HHS officials denied that in a Friday call with reporters. "I don't think that the savings are related to loss of access," CMS Administrator Seema Verma said before adding, after being pressed again, that the rule includes "an array of potential estimates — we don't know a lot of what's going to happen, so a lot of this has been conjecture." ...In another section of the rule, CMS sketches out the "extreme disruption" possibility that no provider but 340B hospitals could afford to administer drugs covered by the regulation. While the agency said the scenario is unlikely, it's a scary enough prospect that hospitals are sure to raise alarms. Oh, and: Projections for how much the rebate rule could cost didn't change. It could still be a nearly $200 billion increase in federal spending over a decade, despite Trump's executive order this summer demanding that the resuscitated rule did not raise government or patient costs. HHS Secretary Alex Azar insists that despite those official projections, he doesn't think premiums will rise. "In assessing the range of actuarial estimates that we were presented with, I determined that over the 15 year history of the part D drug program, rebates have only ever gone up; premiums have consistently gone down in the face of projections by the actuary that they would in fact go up," he said in a call with reporters. | | | |   | | | | | | PFIZER VACCINE ADCOMM SET FOR DECEMBER 10 — The FDA's independent vaccine advisory committee will meet Dec. 10 to review Pfizer's coronavirus shot, the agency said Friday — just hours after the company filed an application for emergency authorization. Members of the panel, known as the Vaccines and Related Biological Products Advisory Committee, include academic scientists, doctors and officials from other federal health agencies. They will provide the FDA with advice on the safety and effectiveness data that Pfizer submitted as part of its EUA request. The FDA does not have to take that advice, although it often does. | | | | 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. | | | | | | | | HHS, PENTAGON SIGN DEAL WITH PURITAN FOR MORE SWABS — The new $11.6 million contract with Puritan Medical Products will allow the Maine company to produce 3 million more nasal swabs per month by March 2021. The goal is to include the swabs in point-of-care test kits made by Cue Health to enable 100,000 of the kits to be manufactured per day by March. HHS is currently conducting a pilot distribution of Cue's kits as part of a separate $481 million October contract. | | | FLORIDA SUBMITS DRUG IMPORT PLAN TO HHS; LAWSUIT LANDS — Florida Gov. Ron DeSantis on Monday formally asked the Department of Health and Human Services to allow the state to import prescription drugs from Canada, following the terms set by new federal drug importation regulation scheduled to take effect Nov. 30. The plan submitted by DeSantis was approved by the Florida Legislature in 2019. A legislative analysis from that year estimated that Canadian drug imports could save U.S. taxpayers at least $289 billion. If approved by HHS, Florida's drug import program and others like it will be placed under the oversight of the FDA. Industry filed a lawsuit challenging the final rule late Monday. PhRMA, the Partnership for Safe Medicines and the Council for Affordable Health Coverage filed a complaint in the U.S. District Court for the District of Columbia against HHS and FDA. HOW THOUSANDS OF SCARCE COVID SHOTS COULD GO TO WASTE — The Trump administration is hoping to begin delivering millions of doses of a coronavirus vaccine in December if one is authorized by FDA. But the short shelf life of Pfizer's shots in particular and uncertainty over how to get them to the right people once vials are cracked open could mean thousands of doses could go to waste, POLITICO's Dan Goldberg, Rachel Roubein and David Lim report. It's one of many issues hanging over the vaccine rollout in the coming months, with pharmacies worried about inefficiency, and cash-strapped state and local health departments warning they need more federal funding and direction. — Use it or lose it: The vaccine must be kept in ultra-cold conditions and will be shipped in specially designed pizza-shaped boxes that hold a minimum of 975 doses in 195 glass vials. Once a vial is thawed and diluted to make five shots, health workers will be in a true "use it or lose it" situation: If there aren't enough people ready for the shots within six hours, the vaccine spoils, slowing efforts to stamp out hot spots and save lives. "This is going to be very hard, I think there's going to be a steep learning curve here," said Paul Offit, a vaccine researcher at the Children's Hospital of Philadelphia and a member of the expert panel advising the FDA on Covid-19 vaccines. "I think there is going to be a lot of waste, and I think we are going to figure this out over time. There is going to be a lot of stumbling. ... You've got six hours once reconstituted, that's unprecedented." — Trump admin says it's ready: Gen. Gustave Perna — the chief operating officer of Operation Warp Speed, the Trump administration initiative charged with bringing a vaccine to market — said large retail pharmacies are ready and his team has worked with states to "make sure that no vaccine is wasted." | | | | A message from Genentech: Inequity in our healthcare system is an urgent issue. For too long, Black, Latinx and other marginalized patients have suffered vastly disparate health outcomes. Genentech recently undertook a landmark study to elevate the perspectives of these medically disenfranchised individuals and better understand how this long-standing inequity impacts their relationships with the healthcare system as a whole. Read more about how our core findings revealed a crisis of trust in our healthcare system among those who need it most, and what comes next. | | | | | | Debra DeShong will move to PhRMA in December to be the branded drug lobby's executive vice president of public affairs. DeShong recently worked on communications for MGM Resorts International and was previously chief of staff to former U.S. Ambassador to Japan Caroline Kennedy. She's also worked for the Democratic National Committee. Meaghan Rose Smith will be the first-ever executive director for the Biosimilars Forum, the group announced Monday. Smith most recently led the health care team at SKDKnickerbocker, and is an alum of the Obama administration's HHS, Sen. Brian Schatz (D-Hawaii) and the Senate Finance committee. Neela Montgomery will be CVS Pharmacy's next president effective Nov. 30, CVS Health announced Monday. She most recently served as CEO of Crate & Barrel and is a partner at venture capital firm Greycroft. | | | — A quiet decision last week by HHS to end an FDA program aimed at generating data about unapproved drugs may result in fewer companies seeking FDA approval and a return "to the Wild West of marketed unapproved drugs," according to an analysis by FDA Law Blog's Kurt Karst. | | | Why the U.S.-Canada-Mexico trade deal matters for the FDA. The FDA released guidance on its current recommendations about including relevant information in labeling for cancer drugs approved for use in a combination with other cancer drugs. The FDA on Monday announced the launch of a cloud-based system that allows electronic submission of requests for new orphan drug designations.
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