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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 David Lim | With Katherine Ellen Foley, Susannah Luthi, Emily Martin and Lauraine Genota. | | | — Top vaccine regulator Peter Marks says a cluster of New York Yankees infections shouldn’t come as a surprise. — Will more Johnson & Johnson shots emerge from Emergent? Its CEO says manufacturing could resume in “days.” — FDA allows the Pfizer-BioNTech vaccine to be stored for longer periods of time. It’s Friday, welcome back to Prescription Pulse. Your authors are now fully vaccinated and ready to explore the brave new world of (outdoor) source coffees. 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). | | | INFECTIONS AMONG YANKEES NOT ‘SHOCKING,’ MARKS SAYS — Top FDA vaccine regulator Peter Marks said Thursday it’s not surprising that Covid infections occurred among nine members of the New York Yankees organization, all of whom received the Johnson & Johnson vaccine. “It has about a 20 percent lower efficacy against milder forms of Covid-19, so it’s not totally shocking that that occurred,” he said during a Food and Drug Law Institute discussion. When asked if the sick Yankees posed a risk of infection to others, Marks acknowledged it’s a “problem.” “I don’t want this to start a controversy, but there could be a dialogue about the mask-wearing and the wisdom of mask-wearing,” he said, adding that he tells people to continue wearing masks if they’re still comfortable in them. “It’s not a political statement, it’s what gets you to comfort,” Marks said. EMERGENT LOOKS TO RESTART J&J PRODUCTION — Emergent BioSolutions could restart manufacturing J&J vaccines within “days,” CEO Robert Kramer told a House panel Wednesday. The company blamed the federal government and AstraZeneca for the production issues that led to the contamination of 15 million J&J doses, POLITICO’s Sarah Owermohle reports, though lawmakers blasted Emergent over inspection reports they argued foreshadowed the ingredient mixup debacle. FDA ALLOWS LONGER REFRIGERATION FOR PFIZER SHOT — Pfizer and BioNTech’s Covid-19 vaccine may now be refrigerated for up to a month instead of five days, the agency said Wednesday. The decision, which echoes one Monday by the European Medical Association, should allow for easier transportation and distribution globally. FDA: DON’T TEST FOR IMMUNITY AFTER VACCINATION — People should not rely on results from Covid-19 antibody tests to determine if they have immunity from the virus after being vaccinated, the FDA cautioned this week. “While a positive antibody test can indicate an immune response has occurred (seroconversion), and failure to detect such a response may suggest a lack of immune response, more research is needed,” the agency said. | | | | 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. | | | | | | | | WHITE OAK WATCH — Biden has spent 121 days — 11 Scaramuccis, or in FDA terms, 11 Emily Millers — in office without nominating a permanent FDA commissioner. CAVAZZONI: USER FEE PROPOSALS ON TRACK — FDA is on course to submit user fee reauthorization proposals to Congress by January, Center for Drug Evaluation and Research Director Patrizia Cavazzoni said Thursday during the FDLI annual meeting. The agency has been working with industry to develop the package and plans to hold public meetings on it later this year, she said. State of the agency: CDER has seen a lower attrition rate during the pandemic as it continues attracting talent, a development Cavazzoni said was “a bit of a surprise” to her, given the higher salaries and greater flexibilities the private sector typically offers. She expects the center to become more flexible with allowing remote work into the future, which could help it compete against industry job offers. But CDRH is struggling: Top medical device regulator Jeff Shuren told FDLI that despite efforts to help employees during the unprecedented Covid response, he worries many are burning out and may leave. “The health, the wellness and the well being of my colleagues in CDRH is something that keeps me up at night,” Shuren said. “I've never encountered in all my years of government anything like this.” Device reviews impacted: Shuren said presubmission meetings for in vitro diagnostics will likely be limited to Covid-related, breakthrough-designated or companion diagnostics this year. Overall reviews for non-IVD premarket submissions are “actually looking pretty good,” but it is coming at a cost. “Our folks have literally been working around the clock to make it happen. It is unsustainable in the long term,” Shuren said. Eyebrow raise: “I can tell you that the morale at the agency has really improved since January,” Cavazzoni said about a timeframe that represents an acceleration of vaccine distribution — and a new occupant at 1600 Pennsylvania Ave. PRE-MARKET TOBACCO PRODUCT APPLICATIONS FLOOD IN — Vendors submitted over 6 million new tobacco products to the FDA's premarket tobacco product application pathway as of Sept. 9, 2020, the agency said Thursday . Many of these products, like some e-cigarettes are already on the market, even without market authorization. FDA says it will update the list as it approves or denies applications. Time crunch: The agency said it would defer enforcing market authorizations until Sept. 9, 2021, for any tobacco products that had applications in the system. What happens after that date is unclear. | | | DEMS PRESS FTC FOR ABBVIE DRUG PRICE INQUIRY — Three House Democrats asked the Federal Trade Commission Tuesday to open an investigation into AbbVie's actions to prevent biosimilars from entering the market to compete with Humira, an anti-inflammatory drug. An Oversight Committee staff report showed that the company had expected generic competition with the drug by 2017, before negotiating settlements that delayed those biosimilars' market entry until 2023. The report is the latest in a series examining how pharmaceutical companies increase product prices, and thus their profits and bonuses. ELI LILLY SUES TO BLOCK BIDEN’S 340B ORDER — Eli Lilly served HHS with a blistering lawsuit late Thursday over the department’s recent mandate to restore generous drug discounts to contract pharmacies working with hospitals, under the federal discount program known as 340B. The Biden administration, threatening fines, on Monday gave some half-dozen drug companies, including Lilly, a June 1 deadline to reverse 340B cutbacks they started last year. A tangled legal battle is still raging around the 340B program, which was created in 1992 to help poor patients but, after explosive growth, became the focus of a bitter feud between hospitals and pharmaceutical companies. The standoff came to a head last year when manufacturers decided to cut discounts to contract pharmacies. Manufacturers argue these pharmacies shouldn’t benefit from discounts since they weren’t originally part of the 340B program — although they play a big role now in dispensing medications for hospitals without an in-house shop. In the complaint, Lilly accuses the Biden administration of sending the notice “out of the blue” and undercutting the already-pending litigation over 340B, arguing that the administration's timing was politically driven. | | | LANDER GETS COMMITTEE NOD — The Senate Commerce Committee on Thursday approved Eric Lander to lead the Office of Science and Technology Policy, POLITICO’s Julia Arciga and Benjamin Din report. Lander is a top geneticist and director of the Broad Institute of MIT and Harvard. He is the last of Biden’s Cabinet members awaiting Senate confirmation, and would be the first biologist to lead OSTP and the first Cabinet-level head of the office. | | | VACCINE BOOSTER TRIAL BEGINS IN U.K. — A study looking at the effects of an extra coronavirus vaccine dose has launched in the U.K. It will compare the immune response booster shots of the AstraZeneca/Oxford, Pfizer/BioNTech, Moderna, Novavax, Valneva, Johnson & Johnson and CureVac vaccines that would be given 10 to 12 weeks after the second dose. Drugmakers, such as Moderna, have also started studying the efficacy of booster shots. | | | CDRH ASKS HOW TO CONVEY RISKS RELATED TO DEVICE MATERIAL— The FDA’s medical device center on Thursday published a draft framework for how patients and providers should be informed about the potential long-term health effects of materials used in medical devices. FDA is asking for feedback on the paper by July 19. “Providing such information to patients and providers could allow them to make better informed decisions ... and facilitate identifying whether an immunologic/hypersensitivity response to a material in a device was the cause of adverse health consequences experienced by the patient,” the paper states. TASK FORCE RECOMMENDS EARLIER COLORECTAL SCREENING — The U.S. Preventive Services Task Force Tuesday formalized recommendations that people with an average risk of colorectal cancer be offered screened starting at age 45. CMS EXAMINING COVERAGE FOR LUNG CANCER SCREENING — CMS announced this week it may reevaluate a national coverage determination for low dose computed tomography screening for lung cancer following a recent USPSTF recommendation. | | | | 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. | | | | | | | | FTC DROPS ILLUMINA INJUNCTION REQUEST — Federal Trade Commission Acting Director Maribeth Petrizzi said Thursday the commission is dismissing its court complaint seeking to prevent Illumina’s $7.1 billion proposed acquisition of Grail to conserve FTC and judicial resources. “Now that the European Commission is investigating, Illumina and GRAIL cannot implement the transaction without obtaining clearance from the European Commission,” Petrizzi said in a statement. An administrative trial in the U.S. is scheduled to begin on Aug. 24. TELEFLEX TO SELL RESPIRATORY BUSINESS TO MEDLINE — Pennsylvania-based Teleflex announced Tuesday it agreed to sell a “significant portion” of its respiratory device business to Medline for $286 million in cash, minus $12 million in working capital not part of the deal. The companies expect the transaction to close in the third quarter. | | | Nicole Lurie is the U.S. director of the Coalition for Epidemic Preparedness Innovations, the group announced Thursday. She previously served as HHS assistant secretary for preparedness and response during the Obama administration. Elizabeth Claverie-Williams announced on LinkedIn she is retiring from the USPHS Commissioned Corps. Bristol Myers Squibb announced Thursday Manuel Hidalgo Medina will join its board on June 1. PhRMA added a team from Roberti Global to its sizable stable of outside lobbyists, which includes more than two dozen firms. | | | CALIFORNIANS SUPPORT VACCINE PASSPORTS — A new poll suggests that most Californians support the use of vaccine passports at some businesses, POLITICO’s Victoria Colliver reports. The Berkeley Institute of Governmental Studies poll found that 63 percent of registered voters approve of allowing businesses such as concert venues, stadiums, cruise ships and casinos to verify that their patrons are vaccinated or have received a negative test. A similar majority supported allowing employers to require workers in certain jobs to get vaccinated, while 33 percent were opposed. | | | EU SET TO WELCOME VACCINATED TRAVELERS — The EU will open its borders to vaccinated travelers this summer after national ambassadors agreed to allow inoculated non-EU visitors without restrictions, POLITICO EU’s Mari Eccles and Jillian Deutsch report. The European Commission intends to ease restrictions on non-essential travel to the EU, providing travelers have been fully vaccinated with a European Medicines Agency-approved jab 14 days before traveling. Countries can also choose to accept a vaccine on the World Health Organization's Emergency Use Listing. | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for the FDA. House votes to close ‘piggybacking’ loophole – The House of Representatives on Wednesday voted to approve the Fairness in Orphan Drug Exclusivity Act, which would close a loophole that permitted a drugmaker to obtain orphan drug designation for two versions of the addiction treatment buprenorphine. Companies that obtain the designation are eligible for special benefits like 7 years of protection from generics and a 25% tax credit. The legislation would make it harder for companies to obtain the designation if their product treats more than 200,000 people and is expected to recover its development costs within its first 12 years of sales. Read AgencyIQ’s bill explainer. Medical-device cybersecurity project launches - Amid rising concerns about the cybersecurity of digitally integrated medical devices, the Medical Device Innovation Consortium – a public-private consortium including the FDA and members of the device industry — sid this week that it will initiate a project to measure the maturity of the medical device industry’s cybersecurity efforts. Known as the Medical Device Cybersecurity Benchmarking Initiative, it will leverage a 2018 security plan put together by the FDA and industry to measure the maturity and adoption of cybersecurity best practices, according to CDRH Office of Strategic Partnerships and Technology Innovation Director Suzanne Schwartz. | | | The U.S. is eyeing a summer of rejuvenation, but most Americans have also endured a year of grief and are just starting to grapple with the state of their mental health, The Atlantic’s Ed Yong reports. Congress should not rely on the FDA to determine how to regulate laboratory-developed tests, FDA Law Blog’s Jeffrey Shapiro argues. Some scientists predict that the coronavirus pandemic will end with the virus becoming endemic, STAT News’ Helen Branswell reports. | | | FDA announced a virtual public meeting for the Vaccines and Related Biological Products Advisory Committee on June 10 to discuss vaccine approvals for children. FDA announced a virtual public meeting on June 18 to discuss the financial transparency and efficiency of the Prescription Drug User Fee Act, the Biosimilar User Fee Act and Generic Drug User Fee Amendments. FDA announced a virtual public meeting of the Cardiovascular and Renal Drugs Advisory Committee on July 15. FDA published guidance with recommendations for Q-Submissions and Investigational Device Exemptions for implanted brain-computer interface devices for patients with paralysis or amputation. FDA published draft guidance with recommendations for feasibility and early feasibility clinical studies for medical devices intended to therapeutically improve glycemic control in patients with Type 2 Diabetes Mellitus, independent of medication delivery. FDA published guidance with recommendations on the use of National Health Related Item Code or National Drug Code numbers on device labels and packages. FDA is out with draft guidance with recommendations on adjusting for covariates in the statistical analysis of randomized, parallel group clinical trials in drug development programs. FDA published guidance with recommendations for 510(k) submissions for peripheral vascular atherectomy devices, which aim to promote consistency and facilitate efficient review. FDA published guidance with recommendations on testing to assess the safety and compatibility of medical devices in the Magnetic Resonance Environment and the recommended format for MRI Safety Information in medical device labeling. FDA published guidance to clarify whether an application for a synthetic peptide drug product that refers to a previously approved peptide of rDNA origin should be submitted as an abbreviated new drug application rather than as a new drug application. FDA has draft guidance to help sponsors in the clinical development of drugs to prevent chemotherapy-induced nausea and vomiting. FDA released draft information sheet guidance to assist sponsors, clinical investigators and IRBs involved in clinical investigations of investigational drugs and biological products. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
