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Presented by Coalition for Affordable Prescription Drugs: 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 Coalition for Affordable Prescription Drugs | With Emily Martin | | | — Thousands of pharmacies prep for vaccines as Biden aims for mass availibility by Apr. 19. — AstraZeneca's woes continue as Canadian experts suggest suspending use under 55 years old. — FDA rejects new use for Keytruda weeks ahead of broader meeting on these cancer medicines. It’s Tuesday, welcome back to Prescription Pulse. Spied: Former FDA Commissioner Scott Gottlieb in a clip at the start of this SNL earworm on seniors getting the “bodies, anti.” As always, send tips to Sarah Owermohle ( sowermohle@politico.com or @owermohle) and David Lim (dlim@politico.com or @davidalim). | | A message from Coalition for Affordable Prescription Drugs: The Trump Administration’s prescription drug “Rebate Rule” will raise seniors’ premiums by up to 25%, skyrocket government spending, and will not deliver the lower drug costs that patients need. Learn more about why it should be eliminated to protect seniors and taxpayers at https://www.affordableprescriptiondrugs.org/resources/eliminate-the-rebate-rule/ | | | | | | THOUSANDS OF PHARMACIES PREP FOR VACCINES — The number of pharmacies offering coronavirus vaccines will more than double in the next few weeks in President Joe Biden’s bid to make shots broadly available by April 19. What’s happening: Nearly 40,000 pharmacies across the country will be on board to deliver vaccine doses compared to 17,000 earlier. There are 21 pharmacy chains in the government's vaccination program, but thousands of independent pharmacies are also expected to administer shots. The administration will also expand its program for mass vaccination sites, adding 12 more to the 21 existing hubs. The government has already shipped millions of doses to those mass sites, which our colleague Erin Banco reports are administering roughly 67,000 shots per day. But federal data shows that the retail pharmacy program rather than the mass sites strategy could reach many Americans faster, four people familiar told Erin. Now here come pharmacies. “A lot of pharmacies are sitting with waitlists of patients that they're now going to be able to fulfill," said Kurt Proctor, senior vice president of strategic initiatives at the National Community Pharmacists Association. "Some states have engaged pharmacies and then pulled back from that to mass events or hospitalized kinds of approaches. I hope that states recognize what the Biden administration is recognizing." What’s next: Thirty million vaccines from the three authorized manufacturers are ready for states this week, setting a new record for allotments, Biden said in an address. But he also pleaded with Americans and specifically with governors to slow down on the return to normal, directly appealing to governors to reinstitute mask mandates because despite early progress, "cases are rising and the virus is spreading in too many places still." AZ WOES CONTINUE: CANADIAN AUTHORITIES RAISE BLOOD CLOT CONCERNS — A panel of Canadian health experts said Monday that provinces should pause use of AstraZeneca’s vaccine in people under 55, citing European worries over blood clots. Canada's National Advisory Committee on Immunization said provinces should suspend use because of those safety concerns, despites the European Medicines Agency urging countries this month to resume vaccinating with the British drugmaker’s shot. Provinces don’t have to follow the committee’s guidance, but usually do—and most followed suit. What’s next: Health Canada, the national regulator that approved the vaccine, said it “will be issuing additional terms and conditions” that will include requirements for detailed assessments of the benefits and risks by age and sex. Depending on those findings, the regulator will determine if additional action is necessary. This is the latest hit to confidence in AstraZeneca’s vaccine after European countries suspended (then resumed) use and U.S. health officials openly questioned data the company touted last week. To date, 300,000 Canadians have received this shot with no reports of blood clots so far. It has not been authorized in the U.S. yet. Might a new name help? The European Medicines Agency announced Monday that the vaccine will be called “Vaxzevria” in the bloc. | | | | JOIN THE CONVERSATION, SUBSCRIBE TO “THE RECAST” Power dynamics are shifting in Washington, and 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 new twice-weekly newsletter that breaks down how race and identity are recasting politics, policy and power in America. Get fresh insights, scoops and dispatches on this crucial intersection from across the country and hear from new voices that challenge business as usual. Don’t miss out on our latest newsletter, SUBSCRIBE NOW. Thank you to our sponsor, Intel. | | | | | | | | FDA REJECTS NEW USE FOR KEYTRUDA — The agency on Monday rejected Merck’s application to use Keytruda to treat triple negative breast cancer. The news comes as an expert FDA panel preps to discuss whether Keytruda and similar cancer medicines should still be indicated for certain tumors—even if the data have not panned out in post-approval years. The Oncologic Drugs Advisory Committee meets April 27-29 to discuss six such instances: Genentech’s Tecentriq for triple-negative breast cancer; Merck’s Keytruda for certain bladder and gastric cancer; and Bristol Myers’ Squibb’s Opdivo for certain liver cancer. All of those drugs are part of a relatively new class of therapies that attack cancer by targeting proteins on the tumors. While results are notable for lung and skin cancers, there are still open questions about whether they can work in cancers with different levels of proteins. The Keytruda rejection for triple negative breast cancer could indicate FDA’s thinking going into the April meeting. FDA ENLISTS LABCORP FOR EMPLOYEE COVID-19 TESTING — The FDA has signed a yearlong contract with LabCorp to set up a voluntary biweekly Covid-19 testing program for agency employees and contractors returning to FDA buildings or other required in-person work such as inspections of firms. The contract — which is worth up to $4.6 million — will run until March 25, 2022. The lab will be paid $76.31 per test run. “Eligible employees or contractors may request Covid-19 testing for any reason no more than every 14 days,” FDA spokesperson Michael Felberbaum told POLITICO. Employees can also ask for a test if they are told by a public health authority that they had a close contact with an infected person no matter when or where the exposure occurred. | | | PENNSYLVANIA MAN PLEADS GUILTY TO GENETIC TESTING KICKBACK SCHEME — Acting U.S. Attorney Rachael Honig announced Monday an individual who helped run Ark Laboratory Network admitted to a role in a $4.6 million kickback scheme where certain clinical labs paid the company bribes for orders of genetic tests. “Ark concealed these kickback arrangements through issuing sham invoices to laboratories that purportedly reflected services provided at an hourly rate even though the parties had already agreed upon the bribe amount, which was based on the revenue the laboratories received from Medicare or an amount paid for each DNA sample,” the U.S. Attorney’s Office said in a press release. | | | | A message from Coalition for Affordable Prescription Drugs:   | | | | | | STATES CONTINUE TO EXPAND ELIGIBILITY — California and New Jersey are among the latest states to expand their vaccine eligibility. — California on April 1 will allow vaccination of residents aged 50 and older, and everyone at least 16 years old will be eligible to make an appointment starting April 15, POLITICO Pro’s Victoria Colliver reports. — New Jersey Gov. Phil Murphy said that people 55 and older, as well as individuals 16 and older with developmental disabilities, will be eligible for coronavirus vaccines starting April 5. POLITICO Pro’s Daniel Han reports that Murphy still aims for all state residents aged 16 and older to become eligible by May 1, the target date set by President Joe Biden. California Gov. Gavin Newsom’s announcement puts the state well ahead of the curve of meeting that same date. | | | | TUNE IN TO GLOBAL TRANSLATIONS: Our Global Translations podcast, presented by Citi, examines the long-term costs of the short-term thinking that drives many political and business decisions. The world has long been beset by big problems that defy political boundaries, and these issues have exploded over the past year amid a global pandemic. This podcast helps to identify and understand the impediments to smart policymaking. Subscribe and start listening today. | | | | | | | | GSK TO PRODUCE NOVAVAX VACCINE — GlaxoSmithKline has agreed to help produce up to 60 million doses of Novavax’s coronavirus jab in the U.K., Ashleigh Furlong reports. The agreement in principle between the two companies, as well as the U.K.’s Vaccines Taskforce, will mean that GSK’s Barnard Castle facility is used for the last step — “fill and finish” — that could begin in May. The Novavax vaccine has yet to be approved by regulators in the U.K., EU or U.S., but the U.S. company has reported high efficacy against the virus, preventing severe illness entirely. The European Medicines Agency began a rolling review of Novavax in February. The company has said its sharing data with the U.S. FDA. EU APPROVES NEW VACCINE MANUFACTURING SITES — The European Medicines Agency has approved new sites for the manufacturing of AstraZeneca, Pfizer and Moderna’s vaccines, POLITICO EU’s Asleigh Furlong reports. The approval means that the EU now has four sites producing the active substance for the jab, including the Halix site in the Netherlands that previously had not gotten the sign off from the regulator but was still producing for the U.K.’s portion of the AstraZeneca vaccine. Health Commissioner Stella Kyriakides said it’s expected that vaccines produced in Halix will be delivered to EU countries “in the coming days.” U.K. PLANS ON BOOSTER SHOTS IN THE FALL — The U.K. vaccine minister announced plans to provide coronavirus booster jabs for people over 70 years old in an effort to protect against variants of the virus, POLITICO EU’s Rym Momtaz reports. The most likely date would be September. The plan is to provide booster shots for people in the main priority groups, which include those over 70, as well as healthcare and social workers. | | | JAMA editor-in-chief Howard Bauchner was placed on administrative leave last week in continued fallout after a deputy editor, Ed Livingston, made offensive comments about racism on the medical journal’s podcast, which has since been withdrawn. Livingston has since left the journal; an interim editor will take Bauchner’s place for now, the New York Times reported. | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. — Late-stage pandemic approach? The FDA last week quietly announced that it will no longer allow new products to be added to its “umbrella” Emergency Use Authorization for non-NIOSH approved respiratory equipment. As AgencyIQ explains, the decision may be an early indication of how the FDA plans to wind down some of its other emergency policies. — FDA supporting continuous manufacturing: The FDA last week released a contract solicitation meant to support research on continuous manufacturing processes – a longtime goal of FDA’s Acting Commissioner, Janet Woodcock. FDA has touted the technological approach as a means of lessening reliance on foreign supply chains and solving drug shortages. | | A message from Coalition for Affordable Prescription Drugs: Approved in a last-minute push under the Trump Administration, the Rebate Rule would raise seniors’ Medicare Part D premiums by up to 25%, increase federal spending, and threaten the success of Medicare Part D. The Biden Administration has delayed the Rebate Rule and protected seniors temporarily. Seniors can’t afford a 25% spike in their premiums. Now is the time to eliminate the Rebate Rule and protect seniors and taxpayers. Learn more at https://www.affordableprescriptiondrugs.org/resources/eliminate-the-rebate-rule/ | | | | | | — A French court has fined one of the country’s biggest pharmaceutical firms €2.7m after finding it guilty of deception and manslaughter over a diabetes pill linked to the deaths of up to 2,000 people, the Guardian reports. — Black doctors, preachers and respected community figures across the South are trying to combat vaccine skepticism while also overcoming logistical hurdles that have led to a troubling disparity in vaccination rates, the New York Times reports.
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