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Presented by CVS Health: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By Sarah Owermohle and David Lim | Presented by CVS Health | With Emily Martin | | | — CDC races to bolster U.S. Covid sequencing with lab partnerships. — Congress waits on FDA pick as Senate readies for the first HHS confirmation hearing. — FDA device panel meets today to discuss drug-coated balloon. It’s Wednesday, welcome back to Prescription Pulse. Welcome back from the long weekend! You'll still see us again on Friday too. 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 CVS Health: Throughout the Covid-19 pandemic, CVS Health has been there. We’re nearly 300,000 employees ensuring millions of Americans can access health care services. We’ve opened thousands of COVID-19 test sites and administered millions of tests. Now, we’re providing the vaccine in long-term care facilities. We’ve been on the frontlines, making health care easier to access and afford. Learn more. | | | | | | CDC RACES TO BOLSTER U.S. COVID SEQUENCING — The CDC is in discussions with at least 13 labs to expand its efforts to sequence the genomes of coronavirus samples as the U.S. races against time to track new variants, according to Greg Armstrong, who directs the agency's advanced molecular detection program. More than 40 states have reported cases of the three major coronavirus strains, first spotted overseas; all are more contagious than older versions of the virus, and at least one is more virulent. By sequencing genetic material from virus samples collected around the country, health officials can track where the strains are spreading — and use the information to help contain hotspots and guide vaccination efforts. CDC expects to increase the number of coronavirus samples analyzed each week by the agency and its partners from more than 4,500 now to 7,000 by the end of February. But that would still be less than one percent of all positive samples identified through testing nationwide. Public health experts recommended sequencing 5 to 10 percent. The agency’s best hope for bringing its sequencing effort up to par now rests with a $1.9-trillion relief package now slowly winding its way through Congress. The House version contains $1.75 billion aimed at ensuring the country sequences 15 percent of all positive Covid-19 samples. “A lot of people are getting a little whiplash going in and out of social distancing, we see that people are getting fatigued of it,” said Phil Febbo, chief medical officer of Illumina, one of the companies contributing to the federal sequencing program. “The more that public health officials, governors, mayors have the best information about the variants and the impact on their communities, the less likely they're going to have to over rotate one way or the other.” HHS SIGNS $54M CONTRACT FOR SPECIAL SYRINGES — Retractable Technologies Tuesday disclosed in an Securities and Exchange Commission filing that it signed a five-month, $54.2 million deal with HHS for low dead space syringes that are necessary to extract six doses of Pfizer’s Covid-19 vaccine doses from what were originally labeled five-dose vials. The U.S. government is able to exercise up to seven one-month extensions of the contract for a maximum cost of approximately $92.7 million. | | | |   | | | | | | SENATE HHS HEARINGS BEGIN NEXT WEEK — California Attorney General Xavier Becerra, President Joe Biden’s pick for Health and Human Services Secretary, will appear for his first of two confirmation hearings on Feb. 23, more that two months after Biden tapped him for the job, Alice Miranda Ollstein reports. The Senate HELP committee will set the stage for a Senate Finance hearing—not yet scheduled—where members will ultimately vote on whether to send his nomination to the floor. Becerra’s backers tout the work he did over more than two decades as a member of Congress, in addition to his more recent legal defense of the Affordable Care Act, to argue he’s qualified to steer HHS through a deadly pandemic. But Alice writes that Republicans plan to cast him as the face of California’s rocky virus response and controversial moves like stay-at-home orders and restrictions on houses of worship. CONGRESS WAITS ON AN FDA PICK — Becerra will be Biden’s first health nominee to get a hearing. Senators are still waiting on picks to lead Medicare and Medicaid, and the Food and Drug Administration. It’s frustrating some lawmakers, especially as reports drag on that the administration is weighing its options between FDA veteran Janet Woodcock, now acting commissioner, and a previous deputy commissioner, Joshua Sharfstein. Letters to the White House have filed in on both sides, with some health groups urging for Woodcock’s experience and others including a group of doctors saying Sharfstein can innovate for the agency. Sens. Maggie Hassan (D-N.H.) and Ed Markey (D-Mass.) have also weighed in, saying in a joint statement last month that the agency needs to reckon with its role in the opioid crisis and “that the next FDA Commissioner is someone who has demonstrated that they have learned from the FDA’s past mistakes – not someone who has been involved in repeating them.” The pressure is mounting. "President Biden has committed to restoring public trust in the FDA and offices on the Hill are becoming increasingly frustrated with how advocates, organizations funded by industry, and industry alike are trying to force a binary choice between Woodcock and Sharfstein without either of them being officially named as an appointee,” a Senate aide told Prescription PULSE. The aide suggested Biden “start from scratch” with another nominee. But Woodcock’s weeks in the acting commissioner role have largely been cast as a tryout for the permanent spot. | | | | 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. | | | | | | | | MODERNA: VAX PRODUCTION IS ON TRACK — The pharmaceutical company is on track to meet U.S. Covid-19 vaccine targets through summer, with 100 million doses expected by the end of March and another 200 million by the end of July. Moderna has already delivered 45 million doses and recently upped its contract with the U.S. government to supply 300 million total. But it’s also had some production delays. The company said those affected recent shipments but shouldn’t keep it from meeting its monthly goals. Moderna added that it doesn’t stockpile doses to smooth out any problems with production, but rather pushes the doses out as the are ready. “Accordingly, weekly totals of released doses are expected to be volatile and may not reflect the underlying trajectory of manufacturing scale-up,” it said in a statement. ...That could make it tough for the Biden administration to deliver on promises to give state governors more notice—up to three weeks—on what they should expect. LUMINOSTICS TO SEEK EXPANDED NON-PRESCRIPTION EUA — California diagnostics company Luminostics announced Tuesday it plans to soon ask FDA for an expanded authorization of its 30-minute antigen test to allow its use in non-lab settings without a prescription. WHOLESALERS ROLL OUT AD CAMPAIGN — The National Association of Wholesaler-Distributors this week launched a digital campaign lobbying the Biden administration to enlist the industry in vaccine distribution efforts. The campaign is targeted at Washington D.C. and other key areas such as Atlanta, Georgia, home of CDC, said a spokesperson. | | | PACLITAXEL DEVICE FACES ADCOM — A slate of outside experts are scheduled to meet today to evaluate BD’s PMA application for its Lutonix drug-coated balloon for treatment of below-the-knee critical limb ischemia. The Wednesday advisory committee is notable because the device coating contains paclitaxel, a drug that was the subject of FDA scrutiny at a 2019 meeting over a study suggesting increased long-term mortality in peripheral arterial disease patients treated with paclitaxel devices. A Cowen research note Tuesday expressed skepticism the device will receive a favorable vote from the outside advisers and subsequent FDA approval due to the agency’s briefing documents which “highlighted many holes” in the company’s submission. “While a safety signal for increased mortality was noted for use of paclitaxel-coated devices in the superficial femoral artery this trend was not evident in the current study in the BTK anatomy,” FDA’s executive summary states. “However, long-term data are limited. Nevertheless, uncertainty remains, and outstanding concerns associated with paclitaxel-coated devices should be considered, especially if no compelling benefit is identified.” SHUREN, STENZEL SLAM EARLY ANTIBODY TEST POLICY — The FDA’s top medical device and diagnostics regulators once again are doubling down on the importance of strict scrutiny of Covid-19 tests in the New England Journal of Medicine — this time taking a look back at a policy that allowed flood of flawed serology tests onto the market with little agency oversight. “Knowing what we know now, we would not have permitted serology tests to be marketed without FDA review and authorization, even within the limits we initially imposed,” CDRH Director Jeff Shuren and diagnostics director Tim Stenzel write. The aftermath: FDA has issued 15 warning letters to Covid-19 serology test developers and placed 88 firms on import alert for violations. The takeaway: “We should establish the capacity within or on behalf of the federal government to evaluate test performance before outbreaks occur so that independent evaluation can be performed quickly during an outbreak,” the FDA regulators say. FDA WARNS DSUVIA MAKER ON ADS — The agency last week issued a warning letter to AcelRx for ads it says make “false and misleading claims” about the risks and efficacy of the powerful fentanyl pill. The digital ads include the tagline “Tongue and Done” to refer to the ease of ingesting the tiny pill, which manufacturers said could be ideal for battlefield treatment—but is not indicated for broad use. Remember: FDA approved Dsuvia in late 2018 after a long public debate about the health impacts of letting a super-potent fentanyl onto the market amid the ongoing opioid crisis. In a rare move, the chair of their expert panel on opioids, Raeford Brown, called on FDA to reject the pill because of its risks just a month earlier. Then-FDA Commissioner said after the approval that the agency would reevaluate the way it assesses new opioids to take difficult public health issues into consideration. Dsuvia has been back in the news after consumer groups including Public Citizen pointed to it in a recent letter decrying acting commissioner Janet Woodcock’s role as director of the drug reviews amid the opioid crisis. | | | | A MUST-READ ON CAPITOL HILL: Looking for the latest insight on the power dynamic in House GOP Leadership? Want to listen in on the whispers coming out of the Speaker's Lobby? Trying to understand what is really going on inside the cloakrooms? Olivia Beavers delivers the scoop in Huddle, our morning Capitol Hill must-read, with assists from POLITICO's deeply sourced Congress team that reveal the state of play in the House and Senate. Subscribe to Huddle today. | | | | | | | | DEVICE REGULATORS RECAP 2020 — The FDA approved, cleared or authorized a record 132 novel medical devices in 2020, top device regulator Shuren and CDRH Office of Product Evaluation and Quality Director William Maisel wrote in a Tuesday blog . The count includes PMA, panel track supplement PMA, De Novo, Humanitarian Device Exemption, breakthrough 510(k) and certain Emergency Use Authorization applications. Breakthrough devices balloon. The agency has now granted breakthrough device designations to more than 400 devices, of which 23 have been approved, authorized or cleared. | | | Shaye Mandle will take over as Chief Operating Officer of the Biotechnology Innovation Organization on March 1. He has worked as CEO of Minnesota’s Medical Alley Association since 2014. Zimmer Biomet announced Tuesday Vafa Jamali will be the CEO of NewCo, the pending spin out company of the medical device giant’s spine and dental units. The device executive previously was the Chief Commercial Officer of Rockley Photonics. The Alliance for a Stronger FDA announced Tuesday that Friedreich’s Ataxia Research Alliance President Ronald Bartek will take over as the advocacy group’s president for 2021. Cystic Fibrosis Foundation chief of policy & advocacy Mary Dwight will serve as the Alliance’s vice president, and The Pew Charitable Trusts’ Kyle Kinner will serve as its secretary and treasurer. Baxter announced Tuesday that University of Virginia School of Medicine dean David Wilkes has joined the company’s Board of Directors. | | | — South Korean intelligence officials said that North Korea tried to hack into the servers of U.S. drugmaker Pfizer to steal coronavirus vaccine information, The Washington Post reported. — Former FDA Commissioner Stephen Hahn formed an unofficial cabinet to navigate the pandemic and pressure under the Trump administration, The Hill reported in a feature. — Public health advisors on the CDC’s Advisory Committee on Immunization Practices are weighing recommendations for extending the time period between first and second doses of Covid-19 vaccines as a method of stretching a limited supply, Bloomberg News reported. — A judge in Hawaii ordered Bristol-Myers and Sanofi to pay more than $834 million to the state for failing to warn non-white patients of health risks from its blood thinner Plavix, Reuters reported. | | | FDA announced a public meeting of the Cellular, Tissue and Gene Therapies Advisory Committee on April 15 at 10 a.m. Johns Hopkins University launched an online data tool called the Covid-19 Vaccine Prioritization Dashboard to help people with disabilities determine when they qualify for a vaccine, while comparing states’ prioritization of the disability community in vaccine rollouts. A study published in JAMA Internal Medicine found that demand for drugs promoted to treat coronavirus with little evidence, including hydroxychloroquine, saw increased demand in 2020. The Medical Device Innovation Consortium released a white paper detailing compliance and quality strategies for device companies. | | A message from CVS Health: Throughout the COVID-19 pandemic, in communities all across the country, CVS Health has been delivering essential care. Thanks to the efforts of our employees, we’ve opened 4,700 COVID-19 test sites since March and administered over 10 million tests at our stores and through partners in underserved communities. With millions staying home, we are increasing access to prescription delivery, virtual visits and mental health services. Now, we’re providing vaccines in long-term care facilities. Every day, CVS Health works to bring quality, affordable health care into neighborhoods, homes and hands—so it’s never out of reach for anyone. 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