|
Presented by CVS Health: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By David Lim, Lauren Gardner and Katherine Ellen Foley | Presented by CVS Health | With help from Lauren Morello and Alice Miranda Ollstein. | | | — FDA vaccine advisers unanimously recommended that Moderna boosters be administered based on people’s age, health and occupations. They weren’t enthusiastic about the existing data, though. — The White House is eyeing former FDA commissioner Robert Califf to reprise his role at the agency. — E-cig manufacturers and public health experts try to make sense of FDA’s hazy regulatory decisions on vaping products. It’s Friday. Welcome back to Prescription Pulse. Buckle up for today’s doozy of a newsletter — this week insisted on going out with an FDA news bonanza. Send tips to David Lim (dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). | | A message from CVS Health: Throughout the pandemic, in communities across the country, CVS Health has been there. We’ve opened more than 4,800 COVID-19 test sites, administered more than 32 million tests and given more than 34 million vaccines. We’ve expanded access to prenatal and postpartum care via telemedicine, increased remote access to mental health services and invested in affordable housing to help build healthier communities. We’ve been on the frontlines, making health care easier to access and afford. Learn more. | | | | | | FDA ADVISERS BACK MODERNA BOOSTERS FOR THOSE AT ‘HIGH RISK’ — The agency’s advisory committee voted unanimously Thursday to recommend giving booster doses of Moderna’s Covid-19 vaccine to people 65 and older and other “high risk” groups who began their immunization journey with the brand’s product. While that largely entails the populations already eligible for the Pfizer-BioNTech booster, the panel’s recommendation encompassing people 18 to 64 with underlying health conditions was worded a bit more broadly to include those “at high risk of severe” disease. That could provide an opening for the CDC’s own advisory committee to consider specifying that communities of color should seek out boosters, given the poor outcomes seen in those groups. The committee was also united against the notion of broadly recommending Moderna boosters for anyone as young as 18, noting the continued dearth of data on safety risks compared to the benefits of boosting. Members did toss around different age cutoffs — 30! No, 40! — to consider for future discussion of who in the general population should be next in line for additional doses, but remember that the broad criteria regulators endorsed for Pfizer means that a similar approach here will make it easy for virtually anyone who originally received Moderna to access another dose. By the way: The booster dose would be 50 micrograms, or half the dose of each of its two-shot primary series. Immunocompromised patients seeking out third doses would still be able to get the 100-microgram dose, as has been authorized for the last two months. Let’s get ready to rumble: Despite the unanimous vote, committee members made it clear they found the data Moderna submitted subpar for making a fulsome recommendation. Another salient point: How could advisers have recommended anything different for Moderna boosters when regulators have already green-lit the doses for Pfizer recipients? With the committee moving on today to consider Johnson & Johnson’s bid to offer a booster shot, it’ll be interesting to see if that same argument carries over. J&J’s single-shot vaccine uses a different technology to induce an immune response — and FDA has already signaled the company’s supporting data is weak. But will that vaccine’s inferior efficacy rate push the panel to endorse some sort of booster plan, anyway? Be sure to follow along with your RxPulse team on the Pro Health Care page, where we’ll be blogging in real-time. JOHNSON & JOHNSON SHOT EFFICACY DECREASES OVER TIME, FDA ANALYSIS FINDS — The efficacy of Johnson & Johnson's Covid-19 vaccine wanes significantly over time against mild to moderate disease, and booster doses may raise antibodies that help fight off the disease, Lauren reports. The company is seeking FDA signoff on a booster plan that would vary the dose timing based on an individual's health and occupational hazards. Immunocompromised people and health care workers could get boosted after two months, while the general population could get a booster after six months. The agency reviewed J&J's own analyses on the effectiveness of a single shot versus a booster administered two, three or six months after the initial one, as well as the safety of the additional dose, it said Wednesday. FDA SETS ADVISORY PANEL MEETING TO REVIEW COVID-19 ANTIVIRAL PILL — The agency scheduled a meeting of its independent advisers for Nov. 30 to consider authorizing an experimental antiviral drug to treat Covid-19, Lauren reports. Merck and Ridgeback requested the EUA for their drug molnupiravir on Monday. "We believe that, in this instance, a public discussion of these data with the agency’s advisory committee will help ensure clear understanding of the scientific data and information that the FDA is evaluating to make a decision about whether to authorize this treatment for emergency use,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement on Thursday. | | | | Registration is OPEN for Breakthrough Summit 2021, the most important rare disease conference of the year! On Oct. 18 and 19, the National Organization for Rare Disorders will host the virtual Rare Disease and Orphan Products Breakthrough Summit. The Summit brings together the rare disease community from across the globe, including experts from patient advocacy, government, industry, media and academia, to discuss the current and critical topics in rare diseases. For access to two days of networking and dynamic programming on topics including drug pricing, genetic testing, Covid-19, equity and inclusivity, REGISTER NOW. | | | | | | | | BIDEN EYEING FDA VETERAN ROBERT CALIFF TO LEAD THE AGENCY — President Joe Biden is likely to nominate former Food and Drug Administration Commissioner Robert Califf to return to the top role at the sweeping regulatory agency, people with knowledge of the situation told POLITICO. Califf previously worked closely with Biden on the Cancer Moonshot initiative launched by the Obama administration. Califf also has a long history with North Carolina, which could give his nomination a boost, noted Alston & Bird attorney Marc Scheineson, who previously served as FDA associate commissioner for legislative affairs under former Commissioner David Kessler. "Califf should have an inside track for a lot of different reasons," Scheineson said. "Sen. Richard Burr (R-N.C.) can help smooth a confirmation ... to have North Carolina's senator as the ranking member on the committee that confirms him is very important." The White House has not finalized its decision, and people with knowledge cautioned the situation could still change. But nine months into its search for a permanent FDA chief, Califf is now viewed as the leading candidate for the job. But consumer advocacy group Public Citizen slammed Califf as a "recycled FDA Commissioner pick" with close ties to the pharmaceutical industry. "The country desperately needs an FDA leader who will reverse the decades-long trend in which the agency’s relationship with the pharmaceutical and medical-device industries has grown dangerously cozier — resulting in regulatory capture of the agency by industry," Michael Carome, director of Public Citizen's Health Research Group, said in a statement. "Califf would not be that leader." SHUREN PLUGS TECHNOLOGY MODERNIZATION PLAN PROGRESS — FDA device center director Jeff Shuren laid out CDRH’s progress toward overhauling a number of IT systems in a new blog post Thursday. Congressional funds are being used to help sponsors and FDA staff track 510(k) submissions via a web-based dashboard; implement automated tools like the Submission Memo and Review Template for 510(k) and De Novo reviews; and utilize the agency’s electronic Submission Template and Resource and an internal Decision Management Portal that aims to consolidate where FDA staff can to track their various workflows. | | | |   | | | | | | CONFUSION CLOUDS FDA’S APPROACH TO E-CIGARETTES — The FDA’s decision to officially clear the first e-cigarette for sale only made its approach to regulation more hazy, Katherine reports. The high-nicotine vape cartridges the agency authorized gave several public health experts pause due to their potential for abuse. Last week, FDA rescinded the marketing denial orders it issued to one company, putting hundreds of products back in review — and potentially opening the door for more firms to appeal the agency’s orders to take their products off the market. And although it has made decisions on over 98 percent of applications, taking millions of e-cigarette products off the market, it has not said whether any type of vape flavors are acceptable. FDA’s decisions so far have left e-cigarette manufacturers and anti-vaping groups scratching their heads. The industry is looking for a clear path forward, while public health groups argue that FDA’s actions haven’t helped reduce vaping’s appeal to teens. “I don’t know exactly what’s going on here,” said a former senior official in FDA’s Center for Tobacco Products. The official feared that companies would look for any way possible to delay final decisions to reap more profits by stalling orders to remove their products from their shelves. “If their product is allowed to stay on the market, they want to drag this thing out as long as possible,” they said. The price of regulating a thriving industry: Though the agency just authorized the first e-cig, the products have already been on the market for years while awaiting FDA’s stamp of approval. “I think you're seeing the challenge of trying to apply new regulation to an existing industry,” said Scott Gottlieb, a former FDA commissioner who spent a large portion of his tenure focused on tobacco regulation. “We’re going to get to the proper end result ... This is just a challenge.” | | | PELOSI, PETERS THROW COLD WATER ON DEMS’ DRUG PRICING DREAMS — In interviews and appearances on Thursday, both House Speaker Nancy Pelosi and Rep. Scott Peters (D-Calif.) confirmed that Democrats still have a ways to go on securing a deal on drug price reform — and even if they succeed, it will be far narrower than leadership’s sweeping H.R. 3 (117), POLITICO’s Alice Miranda Ollstein writes. "We’re still making that fight,” Pelosi said in an interview with the California station KQED about drug price negotiation. “I’m not even sure we’ll even get it in this bill.” Pelosi added that while the bill is likely to include “something” on the issue, “it won’t be the complete package that many of us have been fighting for a long time” — aka, the H.R. 3 bill the House already passed twice. Peters, a key holdout who opposes HR.3 and who is pushing his own, more industry-friendly alternative, said Thursday on a Zoom panel organized by the Alliance for Aging Research that negotiations on the legislation remain at an impasse. “We’re not ready to vote on this,” he said. “The premise is that we're going to pay for this bill, and to construct something you have to know how much money you have. So it’s very hard to know what is in the bill before we know what the Senate wants in terms of funding.” Peters also revealed some key details about where he may draw the line as leadership continues to try to get him and other centrists on board: — Like the pharmaceutical industry, he wants to get rid of H.R. 3’s excise tax on companies that don’t comply with price negotiation. — He wants to leave new drugs alone, saying Thursday that “negotiation should occur after the period of exclusivity” — when drug patents expire. “Negotiation can be used where the market has failed,” he added. But regulating prices “right from the go is a dangerous message to send to the people investing in developing these cures.” | | | | TELL US WHAT YOU THINK: Do you listen to POLITICO podcasts? We want to hear from you! Tell us what you like, what you could do without, and what you want to see in the future from the POLITICO Audio team! Your responses will help us improve our offerings and tailor our podcast content to better fit your needs. Find the survey here. | | | | | | | | WAYS & MEANS DEMOCRATS PROBE CLINICAL ALGORITHM BIAS — A report released Thursday by House Ways and Means Committee Democratic staff scrutinizes how bias in the data underlying clinical decision support tools can contribute to a widening of racial inequalities instead of improving health outcomes. “CDSTs play an important role in health care planning and delivery, offering clinicians timely information within the context of individual patient conditions,” the report states. “However, their potential to advance equity while addressing disparities is complicated by the reality that the methods and assumptions used in the algorithms at the core of CDSTs may themselves import biases that are detrimental to patients of color.” | | | ITALY’S VACCINE REBELS PROTEST PASSPORT PLAN — Protests against an obligatory coronavirus health passport for the entire workforce are threatening to bring Italy to a halt, POLITICO EU’s Hannah Roberts reports. Italy is introducing the strictest rules in Europe today. By law, all workers must be able to show a so-called Green Pass, proving they are vaccinated against COVID-19 or have tested negative in the past 48 hours. Roughly 81 percent of Italians over 12 are fully vaccinated. HUNGARY, RUSSIA LAUNCH SPUTNIK VAX DEAL — Hungary will receive technology to start local production of the Russian Sputnik V vaccine, Foreign Minister Péter Szijjártó said during a visit to Moscow on Thursday. Hungary was the first European country to purchase the Russian-made vaccine, which still awaits approval from the European Medicines Agency, reports POLITICO EU’s Carlo Martuscelli. | | | DESANTIS VOWS TO FIGHT BIDEN VACCINE MANDATES — Florida Gov. Ron DeSantis has opened a multimillion-dollar battle against vaccine mandates, and on Thursday took the fight to the Biden administration, POLITICO’s Arek Sarkissian reports. The GOP governor said Florida will challenge in federal court and through legislation any vaccine mandates introduced by the Biden administration. The president announced plans last month to issue mandates for businesses with more than 100 employees and for federal workers through the U.S. Occupational Safety and Health Administration. | | | New guidance on continuous manufacturing — The FDA this week opened up a comment period on a new draft guideline that aims to facilitate the acceptance and use of continuous manufacturing methods for drug products. Continuous manufacturing differs from traditional “batch” manufacturing of pharmaceuticals in that input materials such as chemicals are continuously fed into a manufacturing process, and the finished drug products are continuously removed from the system without “hold times” between steps. The process is meant to be more efficient and flexible than traditional manufacturing, and a key benefit is that continuous manufacturing systems can typically be quickly scaled in an emergency without needing to build new facilities. But the new approach also raises new regulatory questions. One example: How does a facility define what a “batch” of drug product is if there isn’t a defined start or an end to production? (The answer: Fixed quantities or product or according to time intervals). The guideline, which FDA is developing in conjunction with an international consortium of regulators, is open for comment for the next 60 days. | | A message from CVS Health: At CVS Health, we’re more than 300,000 caring employees ensuring millions of Americans can access health care services.
We’re using our experience and infrastructure to play a leading role in providing booster shots to eligible populations, following CDC guidelines.
We’re also vaccinating adolescents 12+ at more than 5,600 Pharmacy locations.
Nothing should stand in the way of mental health and well-being, so we’re increasing remote access to mental health services.
With many still staying home, we’re supporting safer pregnancies by expanding access to prenatal and postpartum care via telemedicine.
Recognizing the strong connection between housing and health, we’re investing in affordable housing to support underserved populations and build healthier communities.
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.
That’s health care, from the heart. Learn more. | | | | | | J&J placed its liabilities over claims linking its talcum powder to cancer into bankruptcy Thursday in an effort to push for settlement, the Wall Street Journal reports. | | | FDA published draft guidance on Thursday laying out recommendations on which low-risk devices the agency will exercise enforcement discretion for Global Unique Device Identification Database submission requirements. Hologic announced Thursday it signed an agreement to buy Bolder Surgical for about $160 million. The deal is expected to close by the end of 2021. FDA on Thursday publicized a recall for two Abbott Molecular Alinity test kits, noting the products have a risk of potential false positive results for Covid-19. NIH’s RADx initiative announced Thursday it awarded $77.7 million in new contracts to 12 rapid Covid-19 tests. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
