|
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. PROGRAMMING NOTE: Prescription Pulse will not publish on Tuesday, June 1. We'll instead publish on Wednesday, June 2. | | | — FDA has updated its EUA guidance for Covid vaccine developers, saying it will prioritize reviewing requests from companies that engage the agency early in the process. — Sanofi and GSK are enrolling participants into a late stage clinical trial for their Covid-19 vaccine candidate. — The government has awarded three contracts to groups that will be tasked with running Covid-19 testing coordinating hubs. It’s Friday, welcome back to Prescription Pulse. One of your authors regretfully is no longer a resident of California — the latest state to spend millions on vaccine lotteries hoping to convince more people to get vaccinated. As always, also 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). | | | | 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. | | | | | | | | FDA UPDATES COVID SHOT GUIDANCE — FDA will now prioritize emergency-use authorization applications for Covid-19 vaccines from companies that work with the agency throughout the development process, the agency said in updated guidance released Tuesday. The agency said that those applications are more likely to contain the information regulators need to give the green light. FDA spokesperson Stephanie Caccomo said the notice “clarifies how the agency intends to prioritize review of EUA requests for the remainder of the public health emergency, and alerts manufacturers that the agency may decline to review and process EUA requests in cases where it is not feasible for FDA to verify the conduct of clinical trials, trial data integrity or manufacturing facility standards.” Another read: The update may also be a nod to the country’s ample vaccine supply, with three authorized shots and more in the pipeline for EUAs, a former senior FDA official told Prescription Pulse. “Time to come in the front door of the agency,” he said. It’s likely also intended to help manage the understaffed EUA review team’s workflow, the former official said. SANOFI, GSK KICK OFF LATE STAGE VACCINE TRIAL — Sanofi and GlaxoSmithKline said Thursday they have begun enrolling participants in a 35,000 person clinical trial in the U.S., Asia, Africa and Latin America studying if their Covid-19 vaccine candidate can prevent symptomatic disease, severe disease and asymptomatic infection. KFF ON THE STATE OF US VACCINATIONS — At least 62 percent of adults in the US have received at least one dose of a Covid-19 vaccine, and another 4 percent say they’ll get theirs as soon as possible, according to a Kaiser Family Foundation report published this morning. A dwindling number of adults are still waiting to see if there are any long-term consequences from vaccines, and roughly 20 percent maintain that they will either not get one, or only get one if it’s required for work or school. Parents want their kids to get the shot: Now that the Pfizer vaccine has been authorized for teenagers aged 12 to 15, 24 percent of their parents reported their child already had their first dose, while 18 percent said they would be getting one as soon as possible. Moderna, which announced positive results in their clinical trial of young adolescents, plans to submit its data to FDA as early as next week for authorization in the same age group. The final hurdles for the hesitant: Roughly a third of the adults who haven’t been vaccinated yet reported that they would be more inclined to so if a vaccine had full FDA approval. Other major motivators? Paid time off from work, compensated transportation, or free food, tickets to events or cold, hard, government cash. FDA OKS COVID ANTIBODY TREATMENT — The agency on Wednesday authorized emergency use of a monoclonal antibody developed by GlaxoSmithKline and Vir Biotechnology. The treatment, intended for senior citizens or patients with underlying conditions with mild-to-moderate Covid-19, was shown in late-stage clinical trials to reduce the chances of hospitalization or death for high-risk adults by 85 percent. FEDS AWARD COVID TESTING COORDINATING HUBS — The Department of Defense quietly announced Wednesday it awarded three contracts worth a total of $650 million to Eurofins, PerkinElmer Health Sciences and Battelle Memorial Institute to help support the Biden administration’s efforts to expand testing in K-8 schools and congregate settings like homeless shelters. | | | CMS PROPOSES DELAYING VALUE-BASED DRUG MEASURES — The agency wants to press pause on several provisions of a Trump-era drug rule meant to let states and manufacturers pay for Medicaid drugs based on their effectiveness, POLITICO’s Rachel Roubein writes. Drugmakers were originally required to report multiple best prices charged for a drug in a value-based purchasing arrangement beginning in January 2022. But CMS is proposing a six-month delay to that deadline. It also wants to delay by two years plans to include U.S. territories in the Medicaid drug rebate program. ICER READIES STUDY OF PAYER DRUG COVERAGE POLICIES — The Institute for Clinical and Economic Review on Tuesday published an outline of its plans to run an assessment of insurers’ coverage policies for prescription drugs. The first annual report is expected to be published on October 20. | | | CAVAZZONI: REMOTE RESEARCH WILL CONTINUE AFTER PANDEMIC — FDA will still conduct decentralized clinical trials even when it’s safe to ask participants to return to larger health care facilities, Center for Drug Evaluation and Research Director Patrizia Cavazzoni said Tuesday during a webinar with the Alliance for a Stronger FDA. The approach won't work in every case — medical professionals have to administer certain therapies — but “we need to consider these new tools as a permanent part of our tool belt,” she said. The comforts of home: Another thing Cavazzoni noticed: when asked, participants reported liking the fact that they didn’t have to schlep into a hospital or research center nearly as often. FDA RESTRICTS USE OF LIVER DRUG — The agency said Wednesday it would add a contraindication label to Ocaliva to warn prescribers that patients with primary biliary cholangitis, a condition that affects the bile ducts, in combination with advanced cirrhosis could develop serious liver damage after receiving the treatment. FDA RESURRECTS UNAPPROVED DRUGS INITIATIVE — Acting Commissioner Janet Woodcock and Health Secretary Xavier Becerra on Wednesday reversed a Trump HHS attempt to end FDA’s controversial Unapproved Drugs Initiative. The Biden appointees blasted the previous administration for basing its move on “flawed facts,” arguing the notice “erroneously” tied the 2015 price increase for Daraprim to the program. FDA LOOKS TO SOUTH KOREA FOR COVID TESTING LESSONS — The FDA on Tuesday released a report examining the successful early Covid-19 testing response by South Korea. The country benefited from pre-pandemic investments in tests, guaranteed government purchases of emergency tests, streamlined clinical trials, a centrally coordinated nationwide testing program and close collaboration between localities and the government setting up testing sites, FDA medical device regulator Jeff Shuren and diagnostics regulator Timothy Stenzel wrote in Health Affairs. The FDA officials say they are not making recommendations about what “approaches could or should be adopted in the United States for emerging infectious diseases.” | | | AD BLITZ OVER BRAND DRUG LEGISLATION HEATS UP — The Center for a Free Economy announced Thursday it is launching a six-figure digital advertising campaign in 25 congressional districts against House Democrats’ H.R. 3. FIRST IN RxP: The Campaign for Sustainable Rx Pricing is kicking off a seven-figure, four month TV and digital advertising campaign next week in D.C. and 10 states, according to a CSRxP spokesperson. The campaign is focused on “encouraging policymakers to hold brand name drug companies accountable,” CSRxP executive director Lauren Aronson said. | | | BIDEN PRESSURED TO NOMINATE DRUG CZAR — Dozens of addiction specialists and former drug czars penned a letter to President Joe Biden last week urging him to appoint a head of the Office of National Drug Control Policy, POLITICO’s Rachel Roubien and Dan Goldberg report. Preliminary data from earlier this month suggest that opioid overdose deaths reached over 89,000 — an increase likely spurred by stress and isolation during the pandemic. A drug czar and a permanent FDA commissioner are the highest-ranking health officials Biden has yet to fill. FDA, FTC ISSUE WARNINGS TO INFERTILITY SUPPLEMENT COMPANIES — On Wednesday, the agencies sent warning letters to five companies selling supplements illegally advertising that they could treat or prevent infertility and other reproductive health problems. DOJ CHARGES 14 PEOPLE OVER COVID FRAUD — The Department of Justice announced Wednesday it is charging 14 individuals across seven federal districts for allegedly running fraud schemes that resulted in more than $143 million in false billings. | | | | 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. | | | | | | | | ILLUMINA, GRAIL RESPOND TO FTC MOTION — Illumina and Grail are asking the U.S. District Court for the Southern District of California to deny a request by the Federal Trade Commission to dismiss without prejudice its case opposing Illumina’s reacquisition of Grail. “Permitting the FTC to withdraw its case now and refile later would thus make it impossible (as a practical matter) for a court to properly address the merits of a subject matter that is not uncomplicated,” the companies write. “Indeed, dismissal without prejudice would put the FTC in a position to effectively block a pro-competitive, life-saving combination irrespective of its merits, simply by running out the clock. That tactic has no place in an equitable proceeding.” | | | Friday: The American Clinical Laboratory Association meets with the White House Office of Information and Regulatory Affairs to discuss payment policies under the Physician Fee Schedule. Wednesday: The FTC kicks off its administrative trial scrutinizing Alteria’s $12.8 billion investment in JUUL Labs. | | | Francisco Carrillo has joined Pfizer’s Washington office as senior director of federal government relations, where he’ll lobby House Democrats. He was previously district director for Rep. Nanette Barragán (D-Calif.). Kasey Hampton is now Families USA’s senior manager of storytelling and engagement communications. She previously served as press secretary for Sen. Tammy Baldwin (D-Wis.). | | | COMMISSION, ASTRAZENECA FIRE SHOTS IN COURT — The first public hearing of the bitter dispute between AstraZeneca and the European Commission over vaccine-delivery delays was tense and often descended into back-and-forth spats, POLITICO EU’s Jillian Deutsch and Simon Van Dorpe report. BELGIUM RESTRICTS USE OF J&J JAB — Belgium said Wednesday that it would no longer give people under the age of 41 the Johnson & Johnson vaccine after the death of a woman. The health ministry said the vaccinated woman died after being admitted to hospital with severe thrombosis and platelet deficiency — rare side effects the European Medicines Agency has previously said could be linked to the vaccine following analysis of cases in the U.S. Belgium has asked the EMA to evaluate whether the vaccine was linked to the death of the woman. | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for the FDA. Supply chain clarifications coming soon — Four guidance documents describing key details of how the FDA plans to secure the pharmaceutical supply chain are set to soon be released, including how to track drugs at the package level and verification obligations for trading partners, following their clearance this week by the White House’s Office of Information and Regulatory Affairs. The documents all related to various aspects of the Drug Quality and Security Act of 2013, which established a “track and trace” system for pharmaceuticals meant to guard against drug counterfeiting. The documents would clarify how companies can identify and report “suspect” products and label their drugs with “identifiers” to facilitate the tracking process. | | | The DOJ has launched a criminal investigation into alleged manufacturing irregularities and records tampering at an Eli Lilly factory in Branchburg, New Jersey, that produces Covid-19 therapy and other drugs, Reuters reports. U.S. scientists are expanding efforts to study when fully vaccinated people will need booster shots, and, if so, whether people can switch brands, The Washington Post reports. Taking pain relievers known as NSAIDs is one of the most common causes of ulcers, but there’s an education gap about the potentially serious side effects, as evidenced by Rep. Debbie Dingell’s recent emergency surgery, the Post reports. Moderate House Democrats are crafting alternatives to the H.R. 3 drug-pricing package because they’re worried the bill will pass, Bloomberg Government reports. A London-based public relations agency pitched a paid disinformation campaign about the efficacy of Pfizer’s vaccine and a media cover-up to social media influencers in France and Germany, The New York Times reports. The Covax program was supposed to be a model for how to vaccinate humanity, but its plans have been foiled by countries prioritizing their own supply and a delay in shipments out of hard-hit India, the Wall Street Journal reports. | | | FDA published draft guidance of frequently asked questions for Tobacco Product User Fees, with comments open until July 26, 2021. FDA published draft guidance for postmarket surveillance studies for approved therapies and certain cleared medical devices, with comments open until July 26, 2021. The Medical Device Innovation Consortium Wednesday published its 2020 annual report. FDA wants U.S. health care workers and facilities to transition away from using non-NIOSH-approved masks. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
