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Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By David Lim and Lauren Gardner | With Katherine Ellen Foley and Emily Martin. | | | — AbbVie CEO Richard Gonzalez will testify today before the House Oversight Committee on price hikes for two of the company’s drugs. — GlaxoSmithKline and Sanofi’s Covid-19 vaccine candidate inches forward. — HHS orders six drugmakers to restore 340B discounts. It’s Tuesday, welcome back to Prescription Pulse. Your authors are happy to know we aren’t the only ones frustrated with the utility of the new Regulations.gov. As always, also send tips to David Lim (dlim@politico.com or @davidalim), Lauren Gardner ( @Gardner_LM or lgardner@politico.com) and Katherine Ellen Foley (@katherineefoley or kfoley@politico.com). | | | | SUBSCRIBE TO WEST WING PLAYBOOK: Add West Wing Playbook to keep up with the power players, latest policy developments and intriguing whispers percolating inside the West Wing and across the highest levels of the Cabinet. For buzzy nuggets and details you won't find anywhere else, subscribe today. | | | | | | | | GSK, SANOFI VACCINE CRAWLS FORWARD — GlaxoSmithKline of UK and France-based Sanofi announced Monday that they expect to begin a late-stage trial of their Covid-19 vaccine “in the coming weeks” after success in a Phase II study, reports our POLITICO EU colleague Carlo Martuscelli. Hundreds of participants showed similar antibody levels after two doses as people who recovered from the disease, the companies said. The Trump administration awarded GSK and Sanofi $1.7 billion in July 2020 through the vaccine program known as Operation Warp Speed, with the potential for the payout to reach $2.1 billion. Despite receiving the largest chunk of Warp Speed funding, the companies have yet to deliver. The companies had to retool their shot late last year after disappointing results in earlier clinical trials. EMA ALLOWS LONGER STORAGE FOR PFIZER-BIONTECH VACCINE — BioNTech announced Monday the European Medical Association is allowing vials of the Covid-19 vaccine it spearheaded alongside Pfizer to be kept between 35.6°F and 46.4C for up to 31 days. The companies are asking the FDA to also allow the change. Previously, the company and regulatory authorities agreed the vaccine could only be at these standard refrigeration temperatures for five days, and needed to be stored in pharmaceutical freezers between -25°C to -15°C. Refrigeration, rather than freezer storage, should make the vaccine easier to distribute globally. Rick Gates, Walgreens senior vice president of pharmacy and healthcare, told POLITICO that if FDA grants the request, the retail pharmacy chain would have more flexibility to expand the reach of some of its mobile vaccination clinics. “It only helps us if you think about our ability to widely support vaccinations across the country,” Gates said. BIDEN ADMINISTRATION DIVERTS HEALTH FUNDS FOR IMMIGRANT CHILDREN — The $2.1 billion in funds include $850 million intended to replenish the Strategic National Stockpile of drugs and medications that has been worn down by the ongoing Covid-19 pandemic, and another $850 million intended for coronavirus testing. Congress is pushing for ways to backfill these funds, Adam Cancryn reports. Meanwhile, the newly-diverted budget dwarfs the funds available to assist unaccompanied immigrant children in the past two years. CDC's DEPUTY DIRECTOR TO STEP DOWN — Anne Schuchat, the second in command at the CDC, will retire later this month, POLITICO’s Erin Banco and Adam scoop. She is the second prominent official at the CDC to step down this month, following Nancy Messonnier, who directed the National Center for Immunization and Respiratory Diseases during the pandemic. Schuchat said in a statement that she plans to take more time for "creative passions." | | | ANTIBODY WARNING — On Monday, FDA clarified that leronlimab, a monoclonal antibody in trials to treat severe cases of Covid-19, did not show the promise in preventing deaths that its maker, CytoDyn, has claimed. While smaller subgroups consisting of dozens of participants may have benefitted from the drug, these findings weren’t statistically strong enough to merit the positive messaging from the company to the public. MEET THE STUDENT JOURNALISTS — Acting FDA Commissioner Janet Woodcock and top vaccine regulator Peter Marks will take questions from middle and high school student journalists this afternoon on the agency’s decision to authorize Pfizer-BioNTech’s vaccine for use in people ages 12 to 15. Your authors look forward to some excellent questions. | | | HHS ORDERS SIX DRUGMAKERS TO RESTORE 340B DISCOUNTS — The Biden administration on Monday ordered six pharmaceutical companies to restore discounts they had stopped providing to a federal drug discount program, likely resolving a long-running standoff between hospitals and the pharmaceutical industry, POLITICO’s Susannah Luthi reports. Drugmakers and hospitals have clashed for years over 340B, which Congress designed in 1992 to try to help fund care for low-income Americans at drugmakers' expense instead of the government's. A spokesperson for PhRMA told POLITICO the lobby will continue to advocate for changes to the 340B program. “We continue to have concerns with the increasing number and role of contract pharmacies in the 340B program and the lack of evidence that their participation in 340B has improved patients’ access to medicines,” the spokesperson said. | | | OVERSIGHT PANEL TO PROBE ABBVIE PRICING PRACTICES — The House Oversight Committee will continue its series of hearings today on drug pricing practices, with a report expected on how AbbVie has priced two of its biggest moneymakers, Humira and Imbruvica. Humira, an anti-inflammatory drug, is the world’s best-selling prescription — the cost of which has soared 470 percent in the U.S. since its 2003 launch. Committee Chair Carolyn Maloney (D-N.Y.) had to threaten to subpoena AbbVie in September to get the company to cooperate with the investigation, so expect some level of fireworks this morning. But the outstanding question for those watching is whether this hearing does anything to push lawmakers to rein in drug prices in a bipartisan manner, said Robin Feldman, director of the Center for Innovation at University of California Hastings. “The question is whether a new administration and a new Congress will be more motivated—or whether it will be more of the same,” she said. CURES 2.0 COMING SOON — Expect the latest iteration of the 21st Century Cures Act to drop in the next few weeks, Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) said Monday during a “fireside chat” (let’s call it “Zoom-side”) hosted by the Alliance for Regenerative Medicine. The discussion draft will focus on delivering treatments to patients, DeGette said, and will aim to expedite drug and device approvals and to ensure federal agencies are better prepared for future health crises. The pair is also working with the White House to bring to life ARPA—H, a proposed health research agency modeled after similar ones for advanced energy and defense technologies. Upton acknowledged that the pandemic has slowed down work on the bill, and the pair called on lobbyists to plug the legislation and help ease opposition to it moving forward. Members on both sides of the aisle were “enthusiastic” about the ARPA—H concept at a recent meeting at the White House, DeGette said. Neither DeGette nor Upton ruled out rolling CURES 2.0 into next year’s reauthorization of drug user fees, though they said they’ve yet to broach the issue with Energy and Commerce Chair Frank Pallone (D-N.J.). That’s awkward: The pair delicately acknowledged the ongoing drug pricing debate in Congress while trying to avoid going down the rabbit hole, with Upton vowing CURES 2.0 will leave that fight for others to hash out. While DeGette said pricing is “the really fine line that we walk” while promoting drug innovations, she reiterated her support for a negotiated price for drugs like insulin. | | | CMS AGAIN PUNTS ON MCIT — CMS announced Friday it is further delaying implementation of a Trump-era regulation directing Medicare to automatically grant four years of coverage to FDA-designated breakthrough medical devices that are greenlit by regulators until December 15. The notice delaying the Medicare Coverage of Innovative Technology pathway — signed by both acting CMS Administrator Elizabeth Richter and HHS Secretary Xavier Becerra — expresses concern that CMS would be limited in its ability to deny coverage to breakthrough medical devices if it becomes apparent they are harmful to the Medicare population. “Early and unrestricted adoption of devices may have consequences that may not be easy to reverse,” the document states. Industry reacts: But the medical device industry has heavily lobbied the government to implement the proposal, arguing it will speed access to new medical devices that can benefit Medicare patients. “MDMA is disappointed that CMS decided to continue to delay the implementation of the MCIT final rule,” MDMA CEO Mark Leahey said Monday. “This is a targeted policy that has strong bipartisan support in Congress, and it would be a boost for the treatment and care of our nation’s seniors, as well as for innovation.” | | | | SUBSCRIBE TO "THE RECAST" TODAY: Power is shifting in Washington and in communities across the country. More people are demanding a seat at the table, insisting that 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 in 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. | | | | | | | | Robert Berlin is the new head of U.S. regulatory policy at GlaxoSmithKline, according to company spokesperson Kathleen Quinn. He previously worked at the FDA for over a decade, and most recently was the director of the clinical policy division of the Office of New Drug Policy. | | | THE US WILL EXPORT 80 MILLION COVID-19 VACCINE DOSES — White House press secretary Jen Psaki said that the U.S. would send countries in need 60 million doses of AstraZeneca’s vaccine and 20 million doses combined of shots from either Pfizer-BioNTech, Johnson & Johnson, or Moderna, reports POLITICO’S Erin Banco . Though it’s not yet clear where those vaccines will end up, they should be en route by the end of June. ...In the meantime, vaccine producers have rejected offers to produce more shots. Pfizer, Johnson & Johnson, AstraZeneca and Moderna have yet to make a deal with companies to help rev up vaccine production, despite the smaller drugmakers’ willingness to partner up, POLITICO EU’s Ashleigh Furlong reports. Biolyse in Canada, Incepta in Bangladesh, Teva in Israel and Bavarian Nordic in Denmark have all asked to assist in the manufacture of vaccines. As yet, none has a deal, but the reluctance to merge forces is puzzling given the fact that several vaccine producers have blamed production capacity for the under-supply to counter arguments in favor of waiving intellectual property rights. Many European policymakers have reiterated the argument that the limiting factor is production capacity and not the patents, yet there are numerous examples of industry turning down offers of help from other drugmakers — citing the complexity of the process, safety concerns and lack of time to carry out technology transfer. | | | Tuesday: The House Oversight Committee holds a hearing on AbbVie’s business practices for Humira and Imbruvica at 10 a.m. ET. The Food and Drug Law Institute kicks off its multi-day annual conference . Woodcock is scheduled to speak at 12 p.m. at ET. Thursday: The National Evaluation System for health Technology Coordinating Center holds a virtual event discussing its real-world evidence initiatives. | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for the FDA. CMS clears the way for novel use of at-home Covid tests – Information provided to AgencyIQ by the Centers for Medicare and Medicaid Services late last week indicates that FDA-authorized Covid-19 diagnostics that are intended for home use may be used in other settings without the site needing additional certification – but only if patients self-administered the test at the site. The confirmation could clear the way for more expansive testing schemes run by schools and businesses without requiring that sites comply with the Clinical Laboratory Improvement Amendments (CLIA). FDA seeks tools to assess abuse-deterrent opioids – The FDA last week announced that it is looking for new tools that could simulate chewing to assess whether generic versions of FDA-approved abuse-deterrent opioids are the same as their brand name counterparts. While the agency already has one tool for simulated chewing, they are looking for an additional tool with different simulation features that can take into account factors like chewing time, the composition of saliva, the shearing angle of teeth, and products with different shapes and material compositions. The agency’s contract notice is open until May 28. | | | People across the country have found their online posts or their very identities hijacked by anti-vaccine activists and others peddling lies about coronavirus, AP News reports. Hospitals owned by one of America's largest chains have filed at least 19,000 lawsuits against their patients over allegedly unpaid medical bills since March 2020, CNN reports. Amazon is considering launching a diagnostics business arm, Insider reports. The Supreme Court declined to review Novartis subsidiary Sandoz's petition over a biosimilar case, setting up Amgen’s Enbrel for years of exclusivity, Endpoints News’ Zachary Brennan reports. | | | FDA issued draft guidance with recommendations to sponsors of master protocols evaluating drugs for the treatment or prevention of Covid-19. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
