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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. | | | | | |  | | By David Lim and Sarah Owermohle | Presented by the Pharmaceutical Care Management Association | With help from Erin Banco. | | | — D.C. residents snap up J&J Covid-19 vaccine appointments. — NIH makes moves on Covid-19 therapy research. — Medicaid rebate change nested inside relief legislation. | | | | A message from The Pharmaceutical Care Management Association: Pharmacy benefit managers (PBMs): the only part of the drug supply and payor chain working to lower prescription drug costs. Learn more about PBMs’ 21 policy recommendations for the Biden Administration and the new Congress to increase competition and reduce prescription drug costs for patients. | | | It’s Friday, welcome back to Prescription Pulse. Your authors will someday trek to the National Museum of American History to check out Anthony Fauci’s 3-D model of the coronavirus. As always, send tips to Sarah Owermohle ( sowermohle@politico.com or @owermohle) and David Lim (dlim@politico.com or @davidalim). | | | DEMAND FOR J&J VAX IN INITIAL ROLLOUT — Thousands of appointments to receive the Johnson & Johnson single-dose vaccine were quickly snatched up by D.C. residents on Thursday, quelling some fears that consumers might buck the shot in favor of the Moderna and Pfizer options. “6 minutes and 48 seconds: time it took for DC residents to book 4,622 appointments on the online portal this morning,” D.C. Deputy Mayor for Planning and Economic Development John Falcicchio tweeted Thursday. “There are 2,726 J&J vaccine appointments available today. 2,420 were on the online portal. It seems like demand was there for J&J today.” Nationally, there are some extra doses around. A total of 2.2 million J&J shots — 60 percent of the available total — have been ordered by states according to a FEMA briefing document obtained by POLITICO. Additional supplies are expected in two weeks. FDA: FEVER CAMERAS SHOULD NOT BE USED FOR MASS SCREENING — Health care providers and the public should not only or primarily rely on body temperature readings from thermal imaging systems to screen people for Covid-19, the FDA said Thursday. The agency said it is aware such systems are being used in airports, schools, stores and other workplaces, but cautioned they should only be part of a larger risk management system. "To date, these systems have not been shown to be effective or accurate when used to take the temperature of multiple people at the same time and should not be used for 'mass temperature screening,'" the FDA safety communication states. A diagnostic test should be used to determine if someone is infected with Covid-19, according to the agency. | | | | DON'T MISS "THE RECAST": Power dynamics are changing. "Influence" is changing. More people are demanding a seat at the table, insisting that all politics is personal and not all policy is equitable. "The Recast" is our new, twice-weekly newsletter that breaks down how race and identity are recasting politics, policy, and power in America. And POLITICO is recasting how we report on this crucial intersection, bringing you fresh insights, scoops and dispatches from across the country, and new voices that challenge "business as usual." Don't miss out on this important new newsletter, SUBSCRIBE NOW. Thank you to our sponsor, Intel. | | | | | | | | MEDICAID REBATE CHANGE IN RELIEF BILL, BUT DELAYED — President Joe Biden’s $1.9 trillion coronavirus relief package is now with the Senate, where Democrats are pushing to pass the legislation before a March 14 deadline, but Republicans are promising a fight. The sweeping bill channels significant funds towards the health care system and state vaccine distribution efforts. It also includes a previously bipartisan measure that would let Medicaid programs fine drug companies that hike prices beyond the rate of inflation. Except: The package now pushes the implementation date to 2024 (from a year earlier in the House bill) which could leave time for pharmaceutical companies to lobby against it. “It is likely to survive in the final bill and become law. The later start date gives drug makers more time to try to undo the provision,” Cowen analyst Rick Weissenstein wrote in a note to investors. The implementation delay could cost millions, according to Lower Drug Prices Now. “House Democrats should reverse the negative change in the American Rescue Plan and stand up for patients by stopping drug corporation price-gouging in Medicaid,” said Margarida Jorge, campaign director for the consumer advocacy group. DELAURO SLAMS U.S. CONFERENCE OF CATHOLIC BISHOPS OVER J&J VAX POSITION — Rep. Rosa DeLauro (D-Conn.) late Thursday slammed the U.S. Conference of Catholic Bishops for urging Catholics who have the opportunity to choose Pfizer or Moderna's Covid-19 vaccine over Johnson & Johnson's, saying it "is not the time to politicize our chance at ending this dark time." "The statement of the Chairmen of the Committee on the Doctrine and the Committee on Pro-Life Activities is both irresponsible to society and antithetical to previous statements made by the Vatican about the use of vaccines that clearly state, ‘it is morally acceptable to receive COVID-19 vaccines that have used cell lines from aborted fetuses in their research and production process,’" DeLauro said in a statement. | | | AMGEN AGREES TO BUY FIVE PRIME FOR ABOUT $1.9 BILLION — Amgen announced Thursday it will purchase Five Prime Therapeutics, a California biotech that owns a gastroesophageal junction cancer treatment with a promising mid-stage trial. BOSTON SCIENTIFIC TO ACQUIRE SURGICAL ARM OF LUMENIS — Boston Scientific announced Wednesday it will pay a private equity firm $1.07 billion for the global surgical business arm of Lumenis. | | | |   | | | | | | NIH MAKES MOVES ON POTENTIAL COVID THERAPIES — The agency announced this week that four potential Covid-19 treatments entered phase 2 and 3 under the Accelerating COVID-19 Therapeutic Interventions and Vaccines, or ACTIV, program. The studies are focused on an inhalable treatment from Synairgen, a long-acting monoclonal antibody from AstraZeneca being studied as both an infusion and an intramuscular injection, and an oral medicine from Sagent Pharmaceuticals. But at the same time, NIH halted two monoclonal antibody studies — for candidates from Vir Biotechnology and Brii Biosciences — because they didn’t show any benefit against Covid-19. The move comes days after NIH halted a different clinical trial of convalescent plasma for treatment of mild to moderately ill Covid-19 emergency room patients because it did not appear to help prevent hospitalization or death. The agency also is beginning childhood Covid studies with a new program, led by the National Heart, Lung, and Blood Institute, National Institute of Child Health and Human Development and National Institute of Allergy and Infectious Diseases to better understand how the coronavirus affects children who account for roughly 13 percent of Covid-19 cases in the U.S. | | | FDA TELLS FIRMS TO STOP TOUTING REGISTRATION CERTIFICATES — The FDA announced Wednesday it sent letters to 25 firms telling them to stop deceptive marketing that uses so-called ‘FDA registration certificates’ that “create the misimpression that FDA has reviewed, approved, cleared, or authorized their products.” “To be clear, the FDA does not issue any type of registration certificates to medical device establishments that register with the agency using our Establishment Registration & Device Listing system,” said Rear Adm. Sean Boyd, director of FDA CDRH Office of Regulatory Programs. FDA ISSUES WARNING LETTER TO MERCOLA — FDA on Thursday disclosed it sent a warning letter to Joseph Mercola’s company in February for selling unapproved and misbranded drugs misleadingly marketed as effective Covid-19 treatment. The regulatory action comes months after the Center for Science in the Public Interest urged FDA and the Federal Trade Commission to take action against Mercola. “Being misled to believe that supplements could prevent or treat COVID-19 could cause consumers to fail to take protective measures such as mask-wearing, putting themselves and others at risk, or fail to seek actual medical treatment if sick,” CSPI President Peter Lurie said in a statement. | | | | For regulatory affairs professionals: AgencyIQ FDA Forecast 2021. In its inaugural year, AgencyIQ’s FDA Forecast predicts the FDA regulatory changes coming in 2021 and how they will impact the life sciences industry. Follow this link to learn more and download the summary. | | | | | | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. — The FDA this week provided a rare degree of transparency regarding two drugs that are unlikely to be approved. In one announcement, it said it planned to reject an attempt to market a diabetes drug based on its “modest clinical benefits” and substantial safety risks. It then described 14 reasons why it had initially rejected the application – information that is typically not made available under longstanding FDA regulations. — In the second announcement, FDA said a stem cell product intended for use in patients with amyotrophic lateral sclerosis (ALS) had not been shown to be effective in a Phase III clinical trial. Notably, FDA generally does not offer any information about drugs or biologics under development and treats that information as commercially confidential. | | | EU PROBES TEVA FOR GENERIC DRUG DELAY — The European Commission opened an investigation into Teva Pharmaceuticals for illegally delaying the market entry of medicines that compete with its multiple sclerosis drug Copaxone, it announced Thursday. The probe follows a €60.5 million EU fine in November last year for Teva and Cephalone, another pharma company, for similar anticompetitive behavior over Cephalon’s sleep disorder drug, POLITICO Europe’s Simon Van Dorpe reports. The Commission is now investigating whether Teva — after Copaxone’s crucial patent expired in 2015 — “artificially extended the market exclusivity of Copaxone by strategically filing and withdrawing … patents, repeatedly delaying entry of its generic competitor who was obliged to file a new legal challenge each time.” CUREVAC ENLISTS NOVARTIS TO PRODUCE VAX — German biotech CureVac signed an initial agreement with Novartis this week to help produce messenger RNA and bulk drug product needed for Curevac’s coronavirus vaccine, POLITICO Europe’s Ashleigh Furlong reports. Novartis will begin production in the second quarter, with the first deliveries expected to be handed to CureVac in the summer. By the end of the year, Novartis plans to produce up to 50 million doses of the mRNA and drug product needed for the vaccine, with another 200 million doses coming in the following year. CureVac’s vaccine, which is still in large-scale human trials, is currently undergoing a rolling review process by the European Medicines Agency. If approved, the Commission has secured up to 405 million doses. | | | Bristol Myers Squibb and Fresenius Kabi are joining the Alliance to Modernize Prescribing Information, a coalition founded by seven pharmaceutical companies last summer to digitize prescribing information. | | | | A message from The Pharmaceutical Care Management Association: The 21 policy solutions supported by America’s PBMs are aimed at reducing prescription drug costs for patients and health plan sponsors. For the Biden Administration and new Congress, these 21 policy solutions should be a guide to effective ways to increase competition and reduce patients’ prescription drug costs. | | | | | | Detroit appears to be backpedaling on a decision to refuse doses of Johnson & Johnson’s Covid-19 vaccine, the Detroit Free Press’ Christina Hall and Kristen Jordan Shamus report. Eli Lilly’s experimental diabetes drug tirzepatide beat out Novo Nordisk’s ozempic in a late-stage study, BioPharma Dive’s Jonathan Gardner reports. Pfizer is walking a vaccine distribution tightrope as it attempts to balance the demands of countries around the globe, Bloomberg’s Stephanie Baker, Cynthia Koons and Vernon Silver report. | | | FDA announced Thursday it is seeking nominations for a nonvoting industry representative on its Device Good Manufacturing Practice Advisory Committee. HHS announced Thursday will hold a Covid-19 Health Equity Task Force virtual meeting on March 26. The Agency for Healthcare Research and Quality on Thursday announced it is asking for the public to submit research on whether clinical algorithms can influence access to care and health outcomes for minorities and the socioeconomically disadvantaged. FDA on Thursday issued guidance outlining changes manufacturers can make to the glass vials and stoppers for certain sterile drugs and biological products during the Covid-19 public health emergency. Reps. Ami Bera (D-Calif), Bill Foster (D-Ill.) and Mark Green (R-Tenn.) sent a letter to FDA Acting Commissioner Janet Woodcock and CDC Director Rochelle Walensky last week asking the agency to monitor data coming out of countries like the U.K. that are extending the timeframe of the second dose of certain Covid-19 vaccines to deliver more first doses sooner. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
