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Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By Lauren Gardner and Katherine Ellen Foley | With help from Leah Nylen and Tucker Doherty. | | | — The Biden administration will roll out Covid-19 booster shots for American adults beginning next month, pending FDA approval. — Pharmacists are urging patience as they balance doling out additional doses to the immunocompromised with the public’s desire to quickly secure booster shots. — Illumina acquired cancer startup Grail this week despite antitrust concerns in the U.S. and Europe. It’s Friday. Welcome back to Prescription Pulse. FDA released initial lots of flu vaccine for the upcoming season, as if vaccinations for one respiratory virus weren't enough to worry about. Lauren is off next week, so be sure to send tips to Katherine Ellen Foley (kfoley@politico.com or @katherineefoley) and David Lim (dlim@politico.com or @davidalim). | | | | STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today. | | | | | | | | U.S. TO DOLE OUT COVID BOOSTERS NEXT MONTH DESPITE SKEPTICISM — The Biden administration pulled a 180 on the Covid-19 booster shot conversation this week, announcing Wednesday that its top scientists had coalesced around the need to administer third doses to all American adults who had received either Pfizer’s or Moderna’s vaccines eight months after their second shots. The rollout is slated to begin the week of Sept. 20, provided the FDA and a CDC advisory panel sign off on the science before then (which, some critics have noted, seems preordained given the order of announcements). What sparked the shift: New CDC data showing a decline in vaccine efficacy over time prompted the pivot, POLITICO’s Adam Cancryn, Erin Banco and Sarah Owermohle reported this week. Officials also cited data from other sources and from abroad showing declines in effectiveness in different populations. Still, some experts on Covid and vaccines have criticized the administration’s move, arguing it makes no sense to re-jab Americans when the shots still protect against severe disease and hospitalization — and while much of the world has yet to get their first doses. CDC ADVISERS DELAY BOOSTER MEETING — Meanwhile, the CDC’s external vaccine advisers were supposed to meet Tuesday to go over what the latest data shows on the need for Covid-19 booster shots, but the confab will now be rescheduled, according to a notice posted online Thursday. One panel member told Lauren the group may now meet the week of Aug. 30, though nothing is set. Committee chair Grace Lee, who’s also associate chief medical officer for practice innovation at Stanford Children’s Health, said she anticipates rescheduling the meeting “soon.” “The data are coming in rapidly and we want to make sure we follow our process for review and to ensure we can have a robust deliberation at the next open meeting,” she said in an email. PHARMACIES PREP FOR BOOSTER MADNESS — Let the mad rush begin… again. The American Pharmacists Association published guidance this week for its members to consider when someone requests an additional vaccine dose under the CDC’s guidelines for the immunocompromised. Still, their administration is predicated on the honor system — patients attesting to their moderate or severe immunocompromised condition — meaning it likely won’t be so difficult for vaccine enthusiasts to jump the line, especially with boosters for all adults on the horizon. “Hopefully for some patients, it will get them not to be so anxious to get a booster before then,” said Kurt Proctor, senior vice president of strategic initiatives at the National Community Pharmacists Association. “Others, it might increase their anxiousness to get one — who knows.” Mitch Rothholz, chief of immunization policy at APHA, urged patience as regulators work through the science to make their booster recommendations. “It’s putting an unnecessary stress on a stressed system already,” he said this week amid early reports about the recommendation. 3 SENATORS REPORT BREAKTHROUGH INFECTIONS — The Covid positivity rate in the Senate is at least 3 percent, with Sens. Roger Wicker (R-Miss.), Angus King (I-Maine) and John Hickenlooper (D-Colo.) all reporting Covid infections Thursday after experiencing mild symptoms. All three are fully vaccinated against the disease and join GOP Sen. Lindsey Graham of South Carolina in the chamber’s breakthrough club. Katherine Tully-McManus, POLITICO’s Congress guru, points out that lawmakers first got access to the vaccines in December to encourage continuity of government, putting them at the leading edge of the tranche of Americans who will soon be eligible for boosters. Add to that their ages and their travel profiles, and you’ve got a recipe for exposure. | | | HOUSE DEMOCRATS PRESS DRUGMAKERS ON INSULIN PRICES — House Energy and Commerce Chair Frank Pallone (D-N.J.) and Oversight and Investigations Subcommittee Chair Diana DeGette (D-Colo.) sent letters Thursday to insulin manufacturers Eli Lilly, Novo Nordisk and Sanofi continuing their probe into the drug’s cost. They follow up on two previous letters sent by the committee members since January 2019, as well as an appearance by the drugmakers’ executives at two hearings the following April. “The committee is troubled that despite your company’s expressions of shared concern, insulin prices in the United States remain unacceptably high," the members wrote. "This is particularly frustrating considering Americans continue to bear a disproportionately high financial burden for their insulin compared to diabetes patients in other countries." | | | AGs URGE FDA TO COME DOWN HARD ON E-CIGS BEFORE KEY DEADLINE — More than 30 state attorneys general are asking the FDA to reject the pre-market tobacco applications of products that they fear could worsen the youth vaping epidemic. The state AGs, in a Wednesday letter to acting FDA Commissioner Janet Woodcock , urge the agency to prohibit all non-tobacco flavors of e-cigarettes, limit nicotine levels and require strict marketing restrictions to prevent them from appealing to minors. The letter comes about three weeks before the agency’s Sept. 9 deadline to review applications of novel tobacco products, the majority of which are e-cigarettes. Woodcock is also under pressure from members of Congress on the issue, but has stayed mum on any ruling the agency may take — though the FDA has signaled that it will likely miss its deadline. If the agency does not approve a PMTA, the product cannot legally be sold anymore. But some fear tighter regulation on e-cigs for youths may backfire as a whole: “We’ve raised the bar really high for anyone to get into the alternative to cigarettes business,” David Sweanor, a professor of law at the University of Ottawa, told Prescription Pulse. If too many e-cigarettes are taken off the market, he fears that a black market for vapes will form — and skirt regulatory oversight. “Why would we want to move this into the realm of the illicit market? You can’t regulate an illicit market by definition.” | | | ILLUMINA BUYS GRAIL OVER FTC, EUROPE OBJECTIONS — DNA sequencing giant Illumina closed its $7.1 billion merger with cancer startup Grail on Wednesday despite antitrust concerns by U.S. and European regulators. The company said it will operate Grail as a separate entity until Europe’s merger review finishes early next year. Competition authorities are concerned that Illumina’s control of the DNA sequencer technology that Grail and its rivals need will give it an incentive to undermine development of other cancer tests. The FTC challenged the deal in March and an administrative trial is set to begin next week. EU merger regulators opened an in-depth probe last month, though Illumina has filed an appeal questioning Brussels’ decision to review the acquisition. With the merger final, Grail can use the funds to pay off its investors and bulk up staff as it seeks full FDA approval for its blood test, which debuted in June and can detect 50 types of early stage cancer using DNA sequencing. EU merger officials said they were disappointed with Illumina’s move to close the deal while their review was still pending. The FTC didn’t have an immediate comment. CDC CREATES NEW CENTER TO TRACK OUTBREAKS — On Wednesday, the CDC created the Center for Forecasting and Outbreak Analytics, which will analyze disease outbreaks and make data more accessible to public health experts and policymakers. The pandemic exposed a patchwork system in which state officials struggled with outdated surveillance systems that did not allow them to collect and analyze data in real time; the center hopes to address that, with initial funding from last spring's $1.9 trillion Covid stimulus package. | | | RED STATE GOVS PUSH PRICEY COVID TREATMENTS WHILE FIGHTING MASKS — The governors in Florida, Missouri and Texas are promising millions of dollars in antibody treatments for infected people even as they oppose vaccine and mask mandates, saying they can potentially keep people with mild Covid symptoms out of hospitals that are being swamped by new cases, Dan Goldberg reports. The therapy is free to patients, but costs $2,100 per dose, and requires hospitals to set up additional infusion centers — but critics argue they could be avoided entirely with more vaccinations and continued use of masks. INSIDE THE VACCINATION FIGHT THAT’S DRIVING TEACHERS UNIONS — Teachers’ unions across the country are endorsing the Covid-19 vaccine for their members as schools are sent to open for the fall — but in some regions, educators aren’t sold on the shot, POLITICO’s Juan Perez Jr. and Daniel Payne report. “Just because we pass a policy doesn’t mean they’re going to change their minds,” Texas teacher union official Zeph Capo said of his state’s vaccine holdouts. If the virus keeps getting worse, he said, his members won’t need to be convinced. “I just hope it’s not too late for our members and their families.” | | | Johnson & Johnson CEO Alex Gorsky is stepping down at the end of the year. The company’s vice chairman, Joaquin Duato, will transition into that role while Gorsky becomes executive chairman. Verily, Alphabet’s life science spin-off, announced plans to acquire SignalPath, a North Carolina company with a platform to help manage clinical trials. | | | FDA, generics industry near the finish line on negotiations — Recently published meeting minutes indicate that representatives of the generic pharmaceutical industry and the FDA are relatively close to an agreement on the terms of the next iteration of the Generic Drug User Fee Act (GDUFA). The program acts as a sort of trade-off: In return for the generic drug industry paying the FDA fees each time they submit an application for approval or register a facility, the agency uses the money to hire additional staff to review generics more quickly and efficiently. Industry and FDA have reached a general agreement on how the fees will be spent and a draft Commitment Letter that defines what the FDA will do in return for the increased funding, according to the minutes. FDA report highlights drug quality problems in 2020 — FDA’s Office of Pharmaceutical Quality offered new data this week about some of the challenges it faced in 2020 during the onset of the coronavirus pandemic. The agency relied more on inspections conducted by other global regulatory agencies due to travel restrictions caused by the pandemic. As a result, 183 inspections were carried out as part of mutual recognition agreements, up from 109 the year before. FDA also said it used a machine learning model known as XGBoost to predict so-called Site Inspection Scores — a proxy for drug quality. Based on 10 years of data, the FDA’s model determined that factors associated with lower quality scores include being located in India, manufacturing few drug products and the production of analgesic medicines. | | | A handful of health care providers are exploring a form of brain surgery for patients whose severe substance use disorders cannot be treated traditionally, Lenny Bernstein reports for the Washington Post. | | | | Be a Policy Pro. POLITICO Pro has a free policy resource center filled with our best practices on building relationships with state and federal representatives, demonstrating ROI, and influencing policy through digital storytelling. Read our free guides today . | | | | | | | | The National Cancer Institute’s Institute of Technology Transfer is proposing licensing a patent for monoclonal antibodies to treat cancer to the Swiss company ACT Therapeutics Ltd. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
