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Presented by the Partnership for America’s Health Care Future: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By Sarah Owermohle | Presented by the Partnership for America’s Health Care Future | With David Lim, Susannah Luthi, Brianna Ehley and Emily Martin | | | — Covid relief becomes a vehicle for drug reform with House moves to install new policies — The U.S. is still behind on pandemic response as today looks eerily like 2020. — The FDA letter wars continue with another endorsement of Woodcock. It’s Friday, welcome back to Prescription Pulse. Not be be controversial, but, this. 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 the Partnership for America’s Health Care Future: During this critical time, let’s build on and improve what’s working where private coverage, Medicare and Medicaid work together to help American families get healthy and stay healthy, not start over with a new government-controlled health insurance system like the public option. Learn more. | | | | | | COVID RELIEF BECOMES VEHICLE FOR DRUG REFORM — Most people expected drug prices to take a back seat to the president’s top priority of getting the pandemic under control. And many ambitious drug policies likely will — but a major reform could ride through on the massive coronavirus relief package. This week, House Democrats introduced a reform that now may very well pass along with the massive rescue effort that they plan to approve on a party-line vote through a special budget process. What it is: The House Energy and Commerce Committee has proposed lifting the federally mandated 100 percent cap on rebates that drug companies have to pay Medicaid programs for medications with prices rising faster than the rate of inflation. The proposal, which passed the House last year with bipartisan support as part of a Medicaid maternal coverage expansion bill, would mean drugmakers in some cases could be forced to pay states to provide their medicines for Medicaid patients, POLITICO’s Susannah Luthi wrote this week. Congressional Medicaid advisers recommended the policy in 2019, the year the Senate Finance Committee pitched it as part of their bipartisan drug pricing overhaul that never made it to a final vote. The measure would save $14 billion over ten years according to congressional scorekeepers’ analysis of the Finance Committee measure from last spring. Where it is: The House Energy & Commerce Committee is st to approve the measure as part of their portion of the Democrats’ hefty Covid-19 relief package. E&C Chair Frank Pallone said the measure is “incentivizing states to expand access to health coverage through the Medicaid program” which has “provided a crucial safety net for millions of adults who have lost their jobs or income during the pandemic.” What’s next: Senate Democrats will likely run with the measure when it’s their turn to vote on the rescue package. That doesn’t mean they won’t face some industry angst beforehand, as some lobbyists are looking to at least delay the 2023 start date, Susannah notes. | | | | 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. | | | | | | | | U.S. STILL BEHIND ON PANDEMIC RESPONSE — Almost a year after the first recorded U.S. death linked to coronavirus, the country lacks enough testing, contact tracing and masks. And now, it’s falling far short on the genetic surveillance needed to track the highly contagious new variants as it also races to get tens of millions more Americans vaccinated, POLITICO’s Joanne Kenen writes. “The most important thing you want when you have an emergency is to have good situational awareness,” said Georges Benjamin, the executive director of the American Public Health Association. That didn’t happen during the first year, he said. “We never fixed the fundamentals.” ARTHRITIS MED PROMISING IN COVID TRIALS — A medicine used to treat rheumatoid arthritis has been shown to reduce the risk of death in severely ill Covid-19 patients, according to preliminary results out Thursday from a major U.K. trial. Results from the RECOVERY trial found that tocilizumab lowered the risk of death when given to hospitalized patients with severe Covid-19, reduced the need for a mechanical ventilator and shortened the time until patients were successfully discharged, POLITICO Europe’s Helen Collis writes. The results haven’t been peer reviewed yet. But the study found that for every 25 patients treated with tocilizumab, produced by Swiss drugmaker Roche, one additional life was saved. This was compared with patients receiving standard care, including the life-saving steroid dexamethasone. | | | |   | | | | | | WOODCOCK DRAWS ANOTHER LETTER OF SUPPORT — FDA Acting Commissioner Janet Woodcock should be named the agency’s permanent leader, according to more than 90 people who signed a letter sent Thursday to President Joe Biden. Among the signers: Friends of Cancer Research founder Ellen Sigal, Fred Hutchinson Cancer Research Center President Thomas Lynch Jr., Dana-Farber Cancer Institute President Laurie Glimcher and Patrick Soon-Shiong. The new letter, obtained by the Washington Post, describes the longtime FDA leader as “uniquely qualified” to lead the agency. But critics argue Woodcock should be disqualified due to her involvement with the FDA’s oversight of opioids and the approval of Sarepta’s Duchenne muscular dystrophy medicine over the objections of FDA division director Ellis Unger. US AUTHORIZES USE OF ELI LILLY ANTIBODY COMBO FOR COVID PATIENTS — The U.S. Food and Drug Administration on Tuesday authorized the emergency use of a second COVID-19 antibody treatment from Eli Lilly — a combination of bamlanivimab and etesevimab for people age 12 and older with mild to moderate disease that is at high risk of becoming severe. The FDA had previously authorized the use of bamlanivimab as a standalone treatment in November. It has also authorized a combination antibody treatment from Regeneron, which was given to former President Donald Trump in October. How will it hold up against new variants? Woodcock during an interview on SiriusXM said the therapy combination appears to be effective against the variant that first emerged in the U.K., but added that there is “concern” about how effective it will be against the variant that was first detected in South Africa. If “some of those mutations that are seen in that variant become prevalent in the United States, that we could lose effectiveness there,” she said. | | | FULLY VACCINATED PEOPLE DON’T NEED QUARANTINE — That’s according to an update from the Centers for Disease Control and Prevention that underscores people must meet certain criteria besides being fully vaccinated against the coronavirus. “Fully vaccinated persons who meet criteria will no longer be required to quarantine following an exposure to someone with COVID-19,” the agency said in a website update this week. It is a significant move amid questions about whether people who are vaccinated can still transmit the virus to others. | | | | THE INDISPENSABLE GUIDE TO CONGRESS: Looking for the latest on the Schumer/McConnell dynamic or the increasing tensions in the House? What are the latest whispers coming out of the Speaker's Lobby? Just leave it to Beavers... New author Olivia Beavers delivers the scoop in Huddle, the morning Capitol Hill must-read with assists from POLITICO's deeply sourced Congress team. Subscribe to Huddle today. | | | | | | | | MARYLAND LEGISLATORS PUSH THROUGH DRUG BOARD — The Maryland House of Delegates voted Thursday to override Gov. Larry Hogan’s veto of a drug pricing board, clearing the way for a controversial move that nevertheless may result in major state savings. What happened: The House voted 95 to 38 to override a veto last year by Hogan (after the state Senate did the same last month). The measure would install a Prescription Drug Affordability Board that could set prices paid by government workers for medicines in Maryland. Some lawmakers hope to extend it throughout the state marketplace. The approach has raised alarms from pharmaceutical companies that argue it is a form of price control. There have been questions about its legality, as Maryland trailblazes the idea, (which Biden has also publicly mulled). But it has broad support, and not just among state legislators. “These efforts simply cannot wait,” said U.S. Sen. Chris Van Hollen, a Maryland Democrat, in a statement. “The State’s new Prescription Drug Affordability Board is a smart, innovative way to curb costs, and I was proud to support efforts in the General Assembly to get it done.” | | | BELGIAN PLANT SHIFTS EU SHORTAGE BLAME — The Belgian plant at the center of the EU’s battle with AstraZeneca said it has fulfilled its contract and produced all the doses the drugmaker ordered, Emily Martin writes. AstraZeneca previously blamed filtration problems at the factory as part of the justification for a nearly 75 million-dose shortage in the EU’s vaccine deliveries for the first quarter of 2020. Belgian authorities inspected the plant in January, and EU Internal Market Commissioner Thierry Breton on Wednesday examined the company’s manufacturing hurdles. “The manufacture of vaccines in such a short period of time and for such volumes is unprecedented in Europe and beyond in the world,” Breton said in a statement. | | A message from the Partnership for America’s Health Care Future: Americans are relying on our health care system now more than ever, but creating a new government health insurance system like the public option could put all of our care at risk. In the event of an economic recession, the long-term cost of the public option could balloon by an additional $1.4 trillion, placing an even greater financial burden on working families.
Let’s build on and improve what’s working in health care, not start over with a new government health insurance system we can’t afford. Learn more. | | | | | | DEXCOM LAUNCHES VENTURE FUND — Dexcom announced Thursday it is launching a venture capital fund that aims to invest in glucose sensing and other monitoring technologies. ADVAMED REUPS DEVICE SHORTFALL WEBSITE — Medical device lobby AdvaMed announced Thursday the relaunch of an industry platform to connect buyers and sellers of Covid-19 medical products in short supply. “This revamped platform – the Med Device Network – will support manufacturing and delivery of the 12 critical medical supplies identified in the Biden Administration’s National COVID Plan, and help to close any potential supply gaps as quickly as possible without market-disrupting actions,” AdvaMed said in a statement. | | | — AstraZeneca said its product sales grew by 10 percent in 2020 — the first time in “many years” that quarterly product sales were so strong, CNBC reported. — In a phone call, Indian Prime Minister Narendra Modi assured Canadian Prime Minister Justin Trudeau that his country’s drug manufacturers would do their best to supply Covid-19 vaccines to Canada, Reuters reported. — A viral tweet suggesting that Pfizer and Moderna could share their vaccine formula to boost production is “mostly false,” according to the Poynter Institute’s PolitiFact, because it’s unlikely that companies not already producing the vaccine have the capacity or expertise to do so, and the two drugmakers already have manufacturing partnerships. — Generic drugmaker Teva Pharmaceuticals is in talks with Covid-19 vaccine makers to use its global manufacturing capacity to help produce and distribute shots, though the CEO did not disclose which makers, Fortune Magazine reported. | | | The Government Accountability Office issued a report on Operation Warp Speed’s vaccine development, noting disruptions in the supply chain and workforce needs. Comcast NBCUniversal launched Plan Your Vaccine , a customizable national site with the latest vaccine data and news that aims to help people navigate when and where they can receive their first jab. A study published in the New England Journal of Medicine showed that semaglutide, a drug originally marketed as a treatment for Type 2 diabetes, helped enrollees lose close to 15 percent in body weight. FDA Thursday released its sixth annual Office of Generic Drugs report. The agency also released its CDER Office of Pharmaceutical Quality 2020 annual report. The Johns Hopkins Center for Health Security Thursday launched a Covid-19 Testing Toolkit as a resource on the role different types of tests play. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
