Two roads for pharma policy, public trust — If Trump wins, health official purge — FDA panel to weigh Alzheimer's drug

Presented by the Pharmaceutical Care Management Association: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Nov 03, 2020 View in browser   By Sarah Owermohle Presented by the Pharmaceutical Care Management Association With David Lim, Zachary Brennan and Emily Martin. On Tap — Two roads for pharma policy, public trust with today's presidential election. — If Trump wins, health official purge despite the ongoing, worsening pandemic. — FDA panel to weigh Alzheimer's drug that has attracted nearly (nearly) as much controversy as the election.   A message from the Pharmaceutical Care Management Association: Amid the ongoing COVID-19 pandemic, PBM mail-service pharmacies are taking all the necessary steps for patients to continue to receive their medications on time and avoid any disruptions in care. PBMs' top priority remains enabling patients to access prescription drugs safely, conveniently and cost-effectively. Learn more about PBMs and mail-service pharmacies at OnYourRxSide.com.   It's Election Day, welcome back to Prescription Pulse. The president's communications director says his promise of a coronavirus vaccine by today was an "arbitrary" deadline. What do you think is a realistic one? 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)! 2020 Watch TWO ROADS FOR PHARMA POLICY, PUBLIC TRUST — We hope you're settled in for a long day and a long week as votes are tallied in what could be the most consequential presidential election in history for public health, drug policy and the future of health care institutions. Just a few things that hang in the balance: — Jobs for scores of career scientists. President Donald Trump signed an executive order last month that would strip protections shielding thousands of federal employees from quick firings. It's still unclear how many people the order could impact — and how much stock staff should even put in it if Trump loses — but agencies are drafting their lists of high-ranking employees that could fall under the new schedule right now, officials tell Prescription PULSE. FDA could be particularly vulnerable. Tensions between the agency and Trump's inner circle have grown over the past couple of months, as White House aides have sparred with the FDA over efforts to fulfill the president's vow of a coronavirus vaccine before Election Day, Adam Cancryn and I report. Multiple top FDA officials have raised concerns about the executive order directly to Commissioner Stephen Hahn in recent weeks, voicing sharp opposition to the prospect of determining which employees would be eligible, said two health officials with knowledge of the matter. ...And Trump also has his sights on ousting top infectious disease expert Anthony Fauci after the election. NIH staff think the order "absolutely" is aimed at Fauci, said one senior official. But the longtime NIAID director's job status means he has to be fired by NIH Director Francis Collins or HHS Secretary Alex Azar — not Trump — and "for cause" in a decision that he can still contest. — Confidence in the FDA. Nearly half of voters across party affiliations believe that Trump is pressuring the agency to move too quickly on Covid-19 vaccines. Public skepticism about potential coronavirus shots has snowballed this year as FDA's decisions on a range of purported coronavirus treatments are thrown into the political crosshairs — and as Trump accuses agency scientists of working against him. The election has kicked political rhetoric up a notch. "Let me be clear: I trust vaccines, I trust scientists, but I don't trust Donald Trump," Democratic presidential candidate Joe Biden said in September. Drug prices. Trump has not delivered on his 2016 promise to slash drug costs for consumers and take pharmaceutical companies to task for "getting away with murder." But he's still trying: Four executive orders this summer revived and in some cases reworked ambitious plans to eliminate rebates, import cheaper medicines and tie payments to lower prices paid abroad. Each plan has a long way to go, including likely legal challenges, long rulemaking procedures and implementation struggles. Despite Trump's promises to crack down on the industry, a second Trump term could be much easier — or at least more navigable — for pharmaceutical companies than a Biden presidency. Biden hasn't offered many details just yet but said in October that he wants to implement a German-type model for reviewing drug costs. That approach could see drugmakers negotiating directly with the government and justifying high prices. GOP lawmakers liken that approach to social drug controls, but Democrats in Congress endorse government negotiation and would be glad to see any kind of momentum behind H.R. 3, Speaker Nancy Pelosi's drug pricing bill that Senate Majority Leader Mitch McConnell (R-KY) refuses to take up for a vote. "HR 3 would clearly be disruptive to the biopharma industry by allowing federally dictated pricing of prescription drugs in the US," wrote Cowen analyst Eric Assaraf in a note to investors. That said: An ambitious pricing reform bill is unlikely to be top priority as long as the coronavirus pandemic continues. And more than anything, it would rely on flipping the Senate so that the bill could actually get out the door and to the president's desk. IN TRUMP WIN, A CABINET PURGE — Trump and his top aides are planning a huge overhaul of his Cabinet if he wins a second term, scuttling officials in key health-related jobs whom Trump views as disloyal, slow-acting or naysayers, reports POLITICO's Nancy Cook. Already, the White House and administration officials have started to vet names of health care experts who could take over the agencies running many elements of the government's pandemic response and overseeing the country's health insurance system, according to two Republicans close to the White House. Who could go: The administration could see the departures of figures like HHS Secretary Alex Azar, CDC Director Robert Redfield, National Institutes of Health head Francis Collins and Centers for Medicare and Medicaid Services head Seema Verma. That's in addition to Fauci, who Trump can't directly fire but who he's hinted he will push out post-election. Some, like Verma, may leave on their own terms to return to their home states, while others, like Collins, may retire. Except: Inside the White House, there is a debate over whether it is prudent to make changes to the health care team in the middle of a once-in-a-century global pandemic. Yet aides have repeatedly criticized or clashed with officials at the CDC, HHS and Food and Drug Administration during the more than seven months of life under Covid-19.   KEEP UP WITH THE PEOPLE AND POLITICS DRIVING GLOBAL HEALTH IN GLOBAL PULSE: This year has revealed just how pivotal it is to keep up with the politics and policy driving global health. Our Global Pulse newsletter connects leaders, policymakers, and advocates to the people and politics making an impact on our global health. Join the conversation and subscribe today.     Coronavirus HOLOGIC GETS NEW $119M TESTING INVESTMENT FROM DOD, HHS — The Trump administration announced Friday it is investing $119 million to further expand manufacturing of Hologic tests that run on high-capacity machines. The goal is to increase supply of the tests to 13 million per month by January 2022. Eye on FDA FDA PANEL TO WEIGH ALZHEIMER'S DRUG — An FDA committee of outside experts on Friday will review Biogen's potential Alzheimer's drug, setting up a debate over whether it really works, Zachary Brennan writes. At issue is the company's decision to pursue FDA approval about seven months after stopping two trials of the drug, known as aducanumab, because it did not seem to work. The company said a re-analysis of one of the two trials showed how some patients received a high dose of aducanumab and appeared to see "significant benefits" in terms of memory, orientation and language. Many are skeptical. "I desperately wish for a genuine therapy that substantially slows or reverses the disease. Yet the evidence that aducanumab is that therapy and has any benefits in persons with [Alzheimer's disease] is terribly weak," said David Knopman, professor of neurology at the Mayo Clinic and a member of the panel meeting on Friday. Knopman recused himself from the meeting because he worked on one of the aducanumab trials. He and colleagues published a perspective in the journal Alzheimer's & Dementia on Sunday calling on Biogen to run a third Phase III trial to prove the drug works. With more than 5 million people with Alzheimer's in the U.S. and Wall Street analysts predicting the drug could bring in about $10 billion annually, the American Academy of Neurology called on the FDA to make sure the drug's label is not too broad if it's approved. The agency will release its internal review documents on Wednesday, and even if the committee calls on the agency to not approve the drug on Friday, the FDA will have the final say. ACADEMICS QUESTION FDA ON NEW DRUG APPROVAL SUMMARIES — The FDA's evolving approach to publicly explaining a new drug's safety and efficacy profile led to some researchers pushing the agency for more transparency at a virtual workshop on Friday. FDA stressed that the new "Integrated Review" documents, which provide a condensed look at a new drug application, offer sufficient detail on the evidence of safety and efficacy, as well as a clearer description of the agency's analysis of scientific issues, Zachary writes. But some stakeholders — including academia and industry — argued that pertinent information on new drugs may be lost or difficult to find in the new format. "All stakeholders find the reporting of trial specific information on design, statistical analyses, efficacy results reporting and safety to be broadly useful and potentially irreplaceable," Joseph Ross, a Yale professor of medicine, told Prescription Pulse. "I hope FDA finds a way to make the medical reviews available as an Appendix to the comprehensive Integrated Review documents." Others participating in the workshop also raised concerns about the FDA's ability to explain its approval decisions to the wider public. "Plain-language reporting of efficacy has been a consistent problem across the decades," Jonathan Darrow, assistant professor at Harvard Medical School, told Prescription Pulse. "Hyper-technical primary endpoint data (like 'Log10 HIV-1 RNA change in the ITT-E population') are inaccessible to the vast majority of the public, and undermine this critical aspect of the FDA's mission."     MEDICAL DEVICES MEDPAC WEIGHS IN ON AUTOMATIC BREAKTHROUGH DEVICE COVERAGE — The Medicare Payment Advisory Commission is warning against a proposal by CMS to automatically provide national coverage for breakthrough medical devices that receive market authorization from FDA, David Lim reports. The commission argues that FDA's role is to determine if a device is safe and effective, and that Medicare should remain in charge of deciding coverage and spending determinations. "The Commission does not support using the FDA's Breakthrough Program as a proxy for Medicare coverage determinations, but if CMS proceeds with the proposal, the agency should cover new devices under a coverage with evidence development (CED) policy," MedPAC wrote in comments to CMS Administrator Seema Verma. "Under CED, beneficiaries have access to medical services while clinical evidence is being collected in prospective clinical studies and registries." But medical device lobby AdvaMed is urging CMS to finalize the Medicare Coverage of Innovative Technology proposal, arguing the rule would speed beneficiary access to innovative technology. "MCIT will help to spur future advancements in patient care because CMS is sending a signal to the entire innovation ecosystem that taking the risk to develop new breakthroughs will be rewarded if those devices receive FDA marketing authorization and improve patient care," AdvaMed writes. BOSTON SCIENTIFIC GETS APPROVAL FOR PACLITAXEL DEVICE — The medical device manufacturer announced Monday it received FDA approval to market its Ranger paclitaxel-coated PTA balloon catheter used to mitigate the effect of plaque that can build up and narrow arteries. The action comes more than a year after the agency held an advisory committee meeting examining a study that found evidence of higher risk of mortality for patients with peripheral artery disease in the femoropopliteal artery who were treated with paclitaxel-coated devices.   SPEND ELECTION NIGHT WITH POLITICO FOUR SQUARE: People have been voting for weeks, but Election Day is finally upon us! Join us for a special election night episode of POLITICO "Four Square," where host Eugene Daniels will break down the latest developments from across the country with Chief Political Correspondent Tim Alberta, Chief Washington Correspondent Ryan Lizza, and one of our top political reporters and CNN contributor Laura Barrón-López. Joined by colleagues from across the newsroom throughout the show, expect the group to share the latest exit poll readouts, analyze the closing Trump and Biden campaign strategies, and to share their favorite moments of this long and winding election. Tune in at 9:00 p.m. EST here.     Pharma in the States NEW YORK OPIOIDS TRIAL GETS A RESET — New York State's case against opioid manufacturers and distributors for their alleged role in promoting the addiction epidemic that killed hundreds of thousands of Americans will move forward in March — one year after its postponement due to Covid-19, Dan Goldberg writes. The case in Suffolk County State Supreme Court is separate from a New York court's bankruptcy proceedings with OxyContin maker Purdue Pharma and Mallinckrodt.   A message from the Pharmaceutical Care Management Association: Patients using PBM mail-service pharmacies have more affordable drug options and are often more adherent to their medication regimen. Throughout the public health emergency brought on by COVID-19, PBMs' mail-service pharmacies have continued to be a safe, convenient and reliable way for patients to get their maintenance medications and other essential prescription drugs. Learn more about how PBMs and mail-service pharmacies help patients at OnYourRxSide.com.   Pharma Moves The Institute for Clinical and Economic Review elected Leigh Purvis, director of Health Care Costs and Access in AARP's Public Policy Institute, to ICER's Governance Board. ICER's Advisory Board added former FDA Commissioner Mark McClellan, founding director of the Duke-Margolis Center for Health Policy at Duke University. Karin Rosén joined Horizon Therapeutics as Chief Scientific Officer and executive vice president of research and development. Rosén previously worked as senior vice president of U.S. medical affairs at GlaxoSmithKline. Quick Hits — Kaiser Health News analyzed seasonal flu vaccines distributed by states in the 2019-2020 season to shed light on how the Covid-19 vaccination rates may vary once one is developed. — Russian drugmaker Pharmasyntez asked the Kremlin to allow it to produce a generic version of remdesivir, despite lacking the authority to do so, Reuters reported. — Executives of health care companies, including Kaiser Permenante, favor Joe Biden for president, according to an analysis of campaign donations by Business Insider. — AP reported that the Trump administration gave funds to a plasma company that is based in the Charleston, South Carolina, condo of its majority owner. Document Drawer FDA gave notice it is withdrawing approval of 11 abbreviated new drug applications from various applicants by Nov. 30. Public Citizen called on Gilead to relinquish the priority review voucher it won as part of remdesivir's approval. FDA rescheduled the public participation period of a virtual meeting for the Cardiovascular and Renal Drugs Advisory Committee.   Follow us on Twitter Sarah Owermohle @owermohle   Follow us

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