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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, Lauren Gardner and Katherine Ellen Foley | | | | — An independent drug pricing panel unanimously found no benefit to Aduhelm, Biogen’s controversial Alzheimer’s drug. — A who’s who of U.S. public health officials, including acting FDA Commissioner Janet Woodcock, will testify on Capitol Hill next week on the government’s Covid-19 response. — FDA’s inspections chief makes a rare public appearance to push for more funding for the Office of Regulatory Affairs. It’s FRIDAY, welcome back to Prescription Pulse. One of your morning hosts tried to break FDA Twitter yesterday. Be sure to send tips to David Lim (dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM) and Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). | | | | 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. | | | | | | | | CDC PANEL TO DISCUSS J&J VACCINE SIDE EFFECTS, BOOSTER SHOTS — The CDC’s vaccine advisory committee is convening on July 22 to discuss reported cases of Guillain-Barré syndrome in rare instances after individuals have received the Johnson & Johnson Covid-19 vaccine. The committee will also discuss the evidence available on booster Covid-19 immunizations for immunocompromised people. WOODCOCK, PUBLIC HEALTH OFFICIALS HEAD TO THE HILL — The Senate HELP Committee will host Woodcock, CDC Director Rochelle Walensky, Biden’s chief medical adviser Anthony Fauci and Assistant HHS Secretary for Preparedness and Response Dawn O’Connell on Tuesday to get an update on the federal government’s pandemic response. The 10 a.m. hearing will be Woodcock’s first before the HELP Committee this year; Covid update hearings in March and May featured David Kessler, Biden’s chief science officer on Covid and a former FDA commissioner. We’ll be watching to see how the senators who would be the gatekeepers to advancing her nomination — should it ever come — question her and whether they veer off topic toward issues like FDA’s Aduhelm approval. | | | INFLUENTIAL DRUG PRICING PANEL SEES NO BENEFIT FROM ADUHELM — An expert panel convened by the Institute for Clinical and Economic Review concluded Thursday that the controversial Alzheimer's drug does not work better than existing forms of care — and isn’t worth Biogen’s $56,000 price tag. The group rendered its verdict as a unanimous vote at a meeting reviewing Aduhelm, which FDA approved last month. “Looking at the data, if I had to guess, the data is stronger for net harm than it is for net benefit,” said Sai Lee, a geriatrician at the University of California San Francisco and one of 15 voting members of Thursday’s panel. Though ICER can’t determine drug prices, it can influence lawmakers and other stakeholders who do. Currently, CMS is meeting to discuss whether Medicare will cover the drug. | | | NOTABLE QUOTABLE — “Was the process done exactly the best that it could be? Possibly not.” So said Woodcock on the regulatory agency’s accelerated approval of Aduhelm, at the STAT Breakthrough Science Summit on Wednesday. In June, STAT reported that the FDA’s head of neurology drugs had off-book meetings with Biogen execs while Aduhelm was under review. Two Congressional committees are investigating the drug’s approval. Last week, Woodcock herself called for an independent probe into FDA’s relationship with Biogen in order to assuage any concerns that could “undermine the public’s confidence in the FDA’s decision.” Experts are concerned that Aduhelm’s approval will have damaging effects beyond the FDA’s reputation. “It’s a very bad thing for the Alzheimer’s disease field,” Art Caplan, a bioethicist at New York University’s Langone School of Medicine, told POLITICO. With Aduhelm on the market, it’s not clear that patients will want to enroll in any clinical trials that could risk them receiving a placebo or unapproved therapy. MCMEEKIN IN RARE APPEARANCE URGES NEW ORA FUNDS — FDA Associate Commissioner for Regulatory Affairs Judith McMeekin on Wednesday shed light on the agency’s forthcoming Inspectional Affairs Council — which is convening next week — during a rare public appearance at the Alliance for a Stronger FDA. The council, which will be made up of top leadership from across the FDA, will focus on “optimizing inspections” and providing feedback on new technologies that can be used for inspections. “Because inspections cross all the commodities it’s really important that we have these discussions on policy issues surrounding inspections as a cross-agency enterprise so that we can ensure optimal agency resources,” McMeekin said. One priority for the FDA is to boost funding for oversight of medical products in the coming years due to ever-increasing numbers of new drugs and medical devices, according to McMeekin. The agency also wants to work with Congress on changes that would allow inspections to be done on a risk-based frequency, a change she argues will “likely increase” the number of inspections of high-risk facilities. “Unfortunately, our budget authority has been stagnant on the medical product side for the past several years,” McMeekin said. “With technological advancements in medical products this has created some challenges for us. It also prevents us from having the funds to modernize our IT infrastructure and other core functions that are necessary.” FDA KNOCKS AMGEN FOR MISBRANDING BIOLOGIC — The agency released a letter Thursday that it sent to Amgen this month alleging that the company misbranded Neulasta by claiming that the brand-name drug’s administration mechanism is superior to biosimilar pre-filled syringes. FDA ADDS NEW PRODUCT CODES FOR EUA DEVICES — FDA announced Thursday it is creating new product codes for certain medical devices authorized for emergency use. The goal is to help improve monitoring of reported adverse events tied to the devices and tracking of imported EUA devices. | | | HOUSE PANEL APPROVES HEALTH SPENDING BILL — The Appropriations Committee advanced the $254 billion package, which also would roll back a longstanding ban on federal funding for abortions, almost entirely along party lines, POLITICO’s Alice Miranda Ollstein and Sarah Owermohle report. The measure also would fund President Joe Biden's proposed Advanced Research Projects Agency for Health, known as ARPA-H, at $3 billion, less than half of what he proposed in his fiscal 2022 budget blueprint. HOUSE DEMS IN BATTLEGROUND STATES PUSH FOR DRUG PRICING REFORM — Fifteen Democratic members of the House in competitive seats urged Speaker Nancy Pelosi and Senate Majority Leader Chuck Schumer to include substantial measures for Medicare to negotiate drug prices in the upcoming spending package, Sarah Ferris writes for POLITICO. These sweeping changes, however, are unlikely to garner support from top Democrats, many of whom hail from pharma-heavy districts and advocate instead for more incremental changes that Republicans would also likely back. For now, the budget resolution would expand Medicare to cover dental, vision and hearing benefits for seniors, Sarah, Caitlin Emma and Anthony Adragna report. | | | ‘TERRIFYINGLY LETHAL’ — A bipartisan group of former senior national security officials, retired generals and diplomats is urging Biden to declare the drug fentanyl and its chemical analogues weapons of mass destruction. “Fentanyls are terrifyingly lethal,” they wrote in a letter to Biden on Wednesday. “A quantity of fentanyl equal in mass to a single packet of sweetener (1 gram) can kill 500 people. A similar amount of carfentanil can kill 50,000. Fentanyls can enter the body through ingestion, inhalation, and absorption through the skin and kill quickly, often before an antidote can be administered.” They called on Biden “to bring the federal government’s full, coordinated force to bear in mitigating this continuing and growing threat. We strongly recommend that you declare fentanyls — in sufficient quantities and specific configurations — to be Weapons of Mass Destruction.” “Such an Order,” they add, “will unify the federal government's approach to fentanyls and allow for better coordination across the executive branch and with state and local authorities.” CONFIRMATION WATCH — The White House submitted two health care-related nominations of note to the Senate on Thursday: Rahul Gupta to be director of national drug control policy and Atul Gawande to be assistant administrator of USAID. | | | SUMMER RECALL — Johnson & Johnson announced it had found trace levels of benzene, a carcinogen, in samples of five of its Neutrogena and Aveeno spray sunscreen products, and is currently investigating the issue. While not all products were contaminated, the company has asked consumers to stop using the affected products at once. | | | Michael Barnard will be a senior policy adviser in Akin Gump’s public law and policy practice. He most recently was Johnson & Johnson’s director of federal affairs and was previously a top health care aide to Senate Finance Committee member Bob Menendez (D-N.J.). Melea Atkins joined HHS last month as deputy chief of staff to U.S. Surgeon General Vivek Murthy. | | | Problems with the FDA’s naming of biologics: When the FDA approves a new biologic or biosimilar product, it is supposed to give that product a random, four-character suffix that is “devoid of meaning.” The goal of this suffix is to help identify the product and to distinguish it from any biosimilar competitors. But according to AgencyIQ’s review, the application of the agency’s biological suffix policy has nearly a dozen major exceptions, exemptions and loopholes that have caused the policy to be sparsely applied and potentially cause confusion to prescribers. In addition, a key FDA database, the Purple Book, omits information about the suffixes of some biologics that have them. FDA to study Kratom: The FDA announced last week that it wants to study Kratom, a compound sometimes sold as an herbal supplement that can cause opioid- or stimulant-like effects. FDA currently advises consumers not to use Kratom-based products and “encourages more research to better understand kratom’s safety profile, including the use of kratom combined with other drugs.” FDA now says it wants to initiate a pilot study to assess the appropriate dosing and abuse potential of botanical Kratom. A second study will “examine the abuse liability of botanical Kratom, including its subjective effects.” | | | | TUNE IN TO DISPATCH+ ON APPLE PODCASTS : POLITICO Dispatch, our daily podcast that cuts through the news clutter and keeps you up to speed on the most important developments of the moment, is expanding. In collaboration with the new Apple Podcasts Subscription platform, Dispatch+ launches this week! This new podcast gives premium Dispatch+ s exclusive bonus weekly reporting and analysis from POLITICO's newsroom. Don't miss out, subscribe and listen to Dispatch+ on Apple Podcasts. | | | | | | | | A recent appellate court ruling may allow hospital employees to speak without going through their employer’s media relations offices if they believe their institution is engaging in unsafe practices, Harris Meyer writes for Kaiser Health News. | | | The FDA submitted a report to the Office of Management and Budget on the role of health care provider-directed promotion of prescription drugs and how it affects provider opinions of therapeutics. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
