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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 David Lim | Presented by CVS Health | With Sarah Owermohle, Alice Miranda Ollstein, Susannah Luthi, Rachel Roubein, Lauraine Genota, Emily Martin and Leah Nylen. | | | — FDA’s advisory panel wrestles through a three-day meeting on cancer drugs. — Democrats hear a drug-pricing mandate from the president. — Regulators map out a path for eventually banning menthol cigarettes. It’s Friday, welcome back to Prescription Pulse. The cicadas are here. As always, send tips to David Lim (dlim@politico.com or @davidalim). | | A message from CVS Health: Throughout the pandemic, CVS Health has been there. We’re nearly 300,000 caring employees ensuring millions of Americans can access health care services. We opened 4,800 COVID-19 test sites and administered more than 15 million tests at our stores and through partners in underserved communities. We have given more than 10 million vaccine doses and are offering vaccines in nearly 6,000 stores across 49 states, Puerto Rico, and Washington, D.C. Learn more. | | | | | | FDA PANEL SPLITS ON KEEPING CANCER DRUG USES — A Food and Drug Administration panel voted this week against limiting the approved uses of several cancer drugs despite sparse data supporting their effectiveness — reinvigorating the debate about pricey medicines with questionable value for many patients. At issue is how to deal with drugs approved through an accelerated process designed to help patients with few treatment options if those medications later fail to show clear benefits. How strictly FDA oversees such medications could have outsized impact on the therapies pharmaceutical companies develop and commercialize in the future. The three-day FDA advisory meeting was the latest test of this accelerated approval process, focusing on increasingly specialized cancer medicines. Although the agency is not bound to follow the recommendations of its advisory committee, it generally does. The panel’s mixed votes offer FDA conflicting guidance about whether it should ask drugmakers to pull approved drugs for uses that show limited or uncertain benefit in the real world. “It isn't as black and white as people would like,” FDA Acting Commissioner Janet Woodcock, who for years helmed the drug center that reviewed these products told POLITICO. “These are hard decisions and there's no really right answers.” The FDA panel of outside experts, several of whom obtained conflict-of-interest waivers, voted on three drugs: Genetech’s Tecentriq to treat triple-negative breast cancer; Merck’s Keytruda for certain bladder and gastric cancers and Bristol Myers Squibb’s Opdivo for certain liver cancers. All three are known as immuno-oncology medicines, a new class of drugs that target specific genetic mutations in tumors. “The percentage of drugs that do not ultimately confirm clinical benefit should not be viewed as a failure of the program, but rather an expected tradeoff to expedite drug development of promising agents for severe and life threatening diseases like cancer,” Julia Beaver, acting deputy director of FDA’s Office of Oncologic Diseases, said Thursday. The panel voted against maintaining two of six drug uses under review: Keytruda for stomach cancer and Opdivo for certain types of liver cancer as a second-line treatment. The no votes came after Richard Pazdur, the director of the FDA's Oncology Center of Excellence, questioned the indications. FDA LAYS OUT ROADMAP TO BAN MENTHOL CIGARETTES — The FDA said Thursday that it will propose a policy to ban menthol cigarettes and all flavored cigars within a year. The agency released the plan in response to a court-ordered deadline. It has long faced calls to act on menthol cigarettes, which are disproportionately smoked by Black Americans and teens just starting to use tobacco. Anti-tobacco groups applauded the move, but some questioned why it would take so long to formulate a rule mulled by the agency for years already. Momentum for banning menthol cigarettes has grown over the past several years, with lawmakers and public health groups pointing to decades of targeted marketing toward Black communities. More than 85 percent of Black Americans who smoke report using menthol products. But critics of the ban argue that it will trigger a black market that could exacerbate over-policing and violence against those communities. While cigarette use has steadily fallen over recent years, menthol use has declined more slowly. Menthol helps mask the harshness found in other cigarettes. Mitch Zeller, the director of FDA’s Center for Tobacco Products, said enforcement of the eventual ban would be aimed at manufacturers, distributors, wholesalers, importers and retailers. But the regulator declined to estimate when the ban would be finalized and go into effect, or if the agency would push back against future legal efforts to compel FDA to take action within a certain time frame. The Biden administration is still considering regulations to cut allowable nicotine levels in cigarettes, according to Woodcock. "We have not finished deliberations on that matter," she said. | | | |   | | | | | | BY THE NUMBERS — More than 100 million Americans have completed a full dosing regime of one of the three authorized coronavirus vaccines, according to the CDC. BIDEN TEAM SPLIT ON SENDING COVID VACCINES ABROAD — Earlier this week, the White House announced it’s sending millions of doses of AstraZeneca’s Covid-19 vaccine overseas, but the decision has split top Biden administration officials, with many arguing the U.S. can’t reduce its stockpile after recent disruptions in production. The divide raises questions about the administration’s confidence in the nation’s vaccine pipeline — which is for now mostly reliant on Pfizer and Moderna — and underscores just how much Biden’s Covid response team disagree about how to protect Americans while also helping other countries. The administration’s decision comes as the need for vaccines in several foreign countries has escalated at the same time U.S. demand appears to be slowing. Sharing vaccines could help accelerate the end of the pandemic and lower the chance that additional variants will emerge. UNITED AIRLINES WEIGHING CREW VACCINE REQUIREMENTS — United Airlines is considering requiring Covid-19 vaccinations for crews flying to India, Brazil and Peru, CEO Scott Kirby said Thursday. Kirby previously floated the idea of requiring full vaccination for all employees, POLITICO’s Stephanie Beasley reports. The airline is not currently planning to move forward with a broad vaccination requirement, but is considering if it should be necessary for employees flying to countries like India where variants have spread and led to a surge in Covid infections, Kirby said during an event hosted by The Washington Post. MORE WARNING LETTERS FROM FTC — The Federal Trade Commission has sent warning letters to 30 more marketers, ordering them to stop making unsubstantiated claims that their products and therapies can prevent or treat Covid-19. Some of the products include intravenous Vitamin C infusions, ozone therapy, peptide therapy and supplements. The letters warned of FTC’s new authority to seek civil penalties under the COVID-19 Consumer Protection Act. Marketers are subject to penalties of up to $43,792 per violation. | | | | JOIN AN IMPORTANT CONVERSATION, SUBSCRIBE TO "THE RECAST": Power is shifting in Washington and across the country. More people are demanding a seat at the table, insisting that all politics is personal and not all policy is equitable. “The Recast” is a twice-weekly newsletter that explores the changing power dynamics in Washington and breaks down how race and identity are recasting politics and policy across America. Get fresh insights, scoops and dispatches on this crucial intersection from across the country and hear critical new voices that challenge business as usual. Don't miss out, SUBSCRIBE . Thank you to our sponsor, Intel. | | | | | | | | DEMS HEAR A DRUG PRICING MANDATE IN BIDEN SPEECH — President Joe Biden pitched drug pricing reforms separately from his new sweeping economic package -- a call that some key Democratic lawmakers heard as a green light to try to tack on measures addressing high prices to the administration’s $1.8 trillion plan. This is stoking fresh nervousness in the pharmaceutical industry. “We're going to look at every possible vehicle, starting today,” said Senate Finance Chair Ron Wyden (D-Ore.), who told POLITICO he’s already spoken with Democratic and Republican colleagues about how to add drug-price legislation to the newest Biden package, known as the American Families Plan. Meanwhile, House Democrats announced their plans to hold multiple hearings on their drug pricing negotiation bill, HR3, which they reintroduced last week as reports swirled that Biden was ditching a drug price overhaul in his plan. The caveat: Democratic lawmakers have little time to force consensus on big reforms that will draw fierce industry resistance, which could help explain why Biden kept it out of the package focused on bolstering the country’s safety net in the first place. KLOBUCHAR: WOODCOCK IS ‘DOING A GOOD JOB’ — Sen. Amy Klobuchar (D-Minn.) praised acting FDA Commissioner Janet Woodcock at the Medical Device Manufacturers Association’s annual conference Thursday, but said she doesn’t know when Biden will nominate a permanent leader of the FDA. “I just know that we need someone that understands the critical role that the FDA plays, yes in safety, but also in approvals,” Klobuchar told MDMA CEO Mark Leahey. “I believe they're going to make a formal nomination when they have a candidate that meets high standards.” HUMIRA IN THE HOT SEAT — Abbvie CEO Richard Gonzalez will testify at a May 18 House Oversight hearing about the pricing of the company’s blockbuster drug Humira, Oversight Chair Rep. Carolyn Maloney (D-N.Y.) said Thursday. “The committee has obtained internal documents, previously not public, to show the tactics Abbvie used to suppress competition for Humira and other drugs and maintain monopoly prices in the U.S.,” Maloney said. Maloney testified Thursday at a House Judiciary hearing on anticompetitive conduct in the pharmaceutical industry, and backed bipartisan legislation introduced in the House and Senate this week that would prohibit “product hopping” -- a tactic where pharmaceutical companies seek to extend their exclusivity on an expiring patent by switching doctors and patients to a newer, patent-protected version of a drug and off the old version. Last year, Maloney threatened to subpoena Abbvie for documents related to Humira, a rheumatoid arthritis drug that brought in more than $19.2 billion in 2019, as part of an ongoing investigation into drug pricing. That subpoena threat yielded results and Abbvie agreed to assist with the oversight panel’s investigation. | | A message from CVS Health: At CVS Health, we have a long history of working to address physical and mental wellbeing to help people on a better path to overall health. With many still staying home, we’re supporting safer pregnancies by expanding access to prenatal and postpartum care via telemedicine. Nothing should stand in the way of mental health and wellbeing, so we’re increasing remote access to mental health services. 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. | | | | | | DRUG PRICES STILL HIGHER IN THE U.S. THAN IN OTHER COUNTRIES — The U.S. spends more on prescription drugs as a share of its economy and per person than most of the other countries in the Organization for Economic Cooperation and Development, according to a GAO report to Senate Budget Chair Bernie Sanders (I-Vt.). The GAO compared estimated 2020 net prices in the U.S. to publicly available 2020 prices in Australia, Canada and France — all developed economies with relatively large gross domestic products and similar GDP per capita. What the GAO found: On average, the estimated U.S. net prices for selected drugs at the retail and manufacturer level were more than two to four times higher than publicly available retail prices in Australia, Canada and France. Out-of-pocket prescription drug costs paid by consumers vary more in the U.S. and Canada, as multiple payers have a role in price setting and designing cost-sharing for consumers. GILEAD RAKES IN $1.5B FROM REMDESIVIR — Gilead disclosed Thursday to investors it made $1.5 billion from sales of Veklury, the brand name for remdesivir, during the first quarter of 2021. The antiviral drug is frequently used to treat hospitalized Covid-19 patients. | | | JOINT REPLACEMENT MEDICARE PAYMENT MODEL GETS EXTENSION — CMS is granting a three-year extension to an experiment testing how Medicare pays for one of the most common inpatient surgeries: hip and knee replacements. The agency finalized a rule extending the Comprehensive Care for Joint Replacement model, which includes changes like including procedures performed in a hospital’s outpatient department. The payment project is projected to save Medicare $217 million over three years. | | | Friday: HHS convenes the COVID-19 Health Equity Task Force at 2 p.m. EST. | | | | CHECK OUT FDA TODAY: Daily regulatory developments, sent directly to your inbox. AgencyIQ's daily newsletter, FDA Today, provides readers with actionable and insightful explanations of the latest FDA developments impacting the life sciences industry. Sign up for free today. | | | | | | | | ILLUMINA FILES APPEAL OVER BRUSSELS ACQUISITION REVIEW — Illumina announced it’s appealing to the EU’s General Court to annul the European Commission’s decision to review the biotech company’s Grail acquisition, POLITICO EU’s Thibault Larger reports. “The acquisition of Grail did not fall for review” under EU or national merger rules, a spokeswoman for Illumina told POLITICO. “We therefore view this unprecedented action by the EC as illegal.” PARIS PROSECUTORS LAUNCH PROBE INTO DEATHS AFTER ASTRAZENECA JAB — Paris prosecutors specializing in health-related investigations have opened an involuntary manslaughter probe into deaths that occurred after receiving AstraZeneca vaccines, POLITICO EU’s Marina Adami reports. The team is taking over and combining three investigations from local prosecutors that began following complaints from the families of the deceased. The prosecutors have not charged any entity or individual yet. Two of the cases involve people who died as a result of blood clots while under the age of 55, the minimum age set by France last month to receive the AstraZeneca vaccine. EU WARNS OF DISINFORMATION CAMPAIGN LINKED TO SPUTNIK VACCINE — EU diplomats warned that Moscow is waging a concerted media campaign to promote its Sputnik V coronavirus vaccine, POLITICO EU’s Carlo Martuscelli reports. Since January, Russia has stepped up its efforts to promote the jab, while engaging in "antagonistic messaging, using disinformation to accuse the West and the EU of sabotaging the Russian vaccine," the European External Action Service wrote. The report discusses more broadly vaccine disinformation during the pandemic and mentions China's Sinovac and Sinopharm as well. | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. FDA issues first warning about failure to post trial results – This week the FDA issued the very first “Notice of Noncompliance” to a company for reportedly failing to report the results of its clinical trial to a federal database. The requirements were established under a 2007 law, the FDA Amendments Act, and are meant to ensure that unfavorable trial results aren’t hidden and that results associated with the trials are made available to doctors and patients alike. Companies are supposed to report results within one year of a study’s completion. Companies that fail to report the data can be subject to fines of up to $10,000 per day. New FDA policy on ultra-rare disease drug development – There has been growing interest in treating some patients with severely debilitating or life-threatening diseases with a class of drug known as antisense oligonucleotides (ASOs). The targeted treatments, which can interfere with or moderate gene expression, can be especially helpful for patients with inherited conditions. This week the FDA published a new guidance document describing how companies that are developing a drug for a single patient (or a small group of patients) can initiate clinical testing. Put simply: Ordinarily to begin a clinical trial, the FDA wants to see extensive data about the drug’s potential effects, but providing that data may not be possible if a drug is developed to benefit a single person. FDA’s guidance explains that it will require comparatively little data to support these therapies as long as they are intended to treat very small populations with severely debilitating or life-threatening diseases. | | | Executives at Hologic and Thermo Fisher Scientific told investors this week demand for Covid-19 testing could fluctuate in the coming months as more Americans become fully vaccinated, MedTech Dive reports. | | | FDA announced a publication containing modifications it is making to the standards it recognizes for use in premarket reviews. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
