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Presented by Gilead Sciences, Inc.: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By David Lim | Presented by Gilead Sciences, Inc. | With Emily Martin and Dan Goldberg | | | — The federal government knew about issues at Emergent’s plant last summer. — Michigan lawmakers want Biden to send extra vaccine doses to the hard-hit state. — The Congressional Budget Office takes a deep dive on pharmaceutical R&D. It’s Friday, welcome back to Prescription Pulse. Your author refuses to download TikTok but is intrigued by the platform’s so-called vaccine rivalries. As always, send tips to David Lim (dlim@politico.com or @davidalim). | | A message from Gilead Sciences, Inc.: Known to keep pushing. Decades of discovery lie behind every breakthrough. From HIV to viral hepatitis to today’s battle with COVID-19, Gilead scientists have been pushing boundaries for over 30 years. So that we can bring tomorrow’s life-changing therapies forward today. To know more, visit Gilead.com. | | | | | | FEDS KNEW OF EMERGENT ISSUES MONTHS AGO — Trump administration officials knew about quality assurance issues at Emergent BioSolutions’ Baltimore plant last summer, POLITICO’s Erin Banco and Sarah Owermohle reported this week . The company subsequently accidentally ruined 15 million doses of Johnson & Johnson’s coronavirus vaccine. The June report, authored by a government employee, found that Emergent’s plan to make coronavirus vaccines was inadequate. It also came shortly after an April FDA inspection report that documented several issues at the Baltimore plant. “Employees are not given training in the particular operations they perform as part of their function and current good manufacturing practices,” FDA investigator Marcellinus Dordunoo wrote in the April report, which was publicly disclosed by the agency on Thursday. Trump officials subsequently met with Emergent and J&J and handed the June report to the incoming Biden team during the transition. VARIANT VACCINE MANUFACTURING A QUESTION MARK — Vaccine makers studying potential booster shots and variant-specific vaccines may run into a big challenge securing enough manufacturing capacity if they are needed, Sarah reports. Intense global demand for the original formulation of coronavirus vaccines will not likely abate, meaning factories will not be able to easily switch over to second-generation vaccines. The Biden administration has encouraged AstraZeneca, Sanofi and other drugmakers to concentrate on variant shots, but mRNA vaccines may be the easiest to modify and manufacture. Moderna Chief Medical Officer Tal Zaks told The Economic Club of New York on Wednesday the company anticipates being “in a good place to provide a booster shot by the end of this year.” BY THE NUMBERS — A quarter of American adults are now fully vaccinated, according to CDC data. UPTON, DINGELL WANT BIDEN TO SURGE VACCINES INTO MICHIGAN — Michigan Reps. Fred Upton (R) and Debbie Dingell (D) urged President Joe Biden Thursday to send extra Covid-19 vaccines to the state, which has faced a resurgence in cases that rivals its winter peak. “Currently, federal vaccine allocation is population-based and does not account for the rising COVID-19 case count or public health situation that states like Michigan are facing,” Upton and Dingell write . “Surging additional vaccines into Michigan and other hard-hit areas is consistent with guidance from public health experts.” | | | | CHECK OUT FDA TODAY: Daily regulatory developments, sent directly to your inbox. AgencyIQ's daily newsletter, FDA Today, provides readers with actionable and insightful explanations of the latest FDA developments impacting the life sciences industry. Sign up for free today. | | | | | | | | CBO: DRUG INDUSTRY SPENT $83B ON R&D IN 2019 — The U.S. pharmaceutical industry spent approximately 10 times the amount of funds on research & development in 2019 — $83 billion — than it did in per year in the 1980s after taking inflation into account, according to a new Congressional Budget Office report published Thursday. While the average number of new drugs has risen 60 percent to 38 per year from 2010-2019 compared to the previous decade, several are high-cost specialty drugs for conditions like cancer and nervous-system disorders. “Previously, most drugs were small-molecule drugs based on chemical compounds,” the CBO report states. “Even while they were under patent, those drugs had lower prices than recent specialty drugs have.” R&D spending depends on three primary factors, CBO found: anticipated revenues from a new drug; expected development costs; and the policy environment that affects the supply and demand for prescription drugs. But when a new drug hits the market, companies do not set its price based on its R&D costs, CBO says. “Importantly, when drug companies set the prices of a new drug, they do so to maximize future revenues net of manufacturing and distribution costs,” the CBO report states. “A drug’s sunk R&D costs — that is, the costs already incurred in developing that drug — do not influence its price.” PhRMA’s Brian Newell said the report reaffirms the trade lobby’s often-touted argument. “Our industry invests tens of billions of dollars each year in the research and development of new medicines, and our ability to maintain that investment is directly tied to the unique innovation ecosystem our nation fosters,” he said. | | | MDMA, AMA, FAH ASK CMS TO RECONSIDER PRIOR AUTHORIZATION EXPANSION — The Medical Device Manufacturers Association, American Medical Association and Federation of American Hospitals are among 40 groups urging CMS to reconsider regulations set to go into effect on July 1 expanding prior authorization for certain medical procedures. “MDMA hopes that the agency will consider the perspective of this diverse group of stakeholders, delay the implementation of new ‘prior authorization’ requirements scheduled for July 1, and outline a transparent process for any future ‘prior authorization’ proposals that incorporates stakeholder feedback,” CEO Mark Leahey said in a statement. MICHIGAN COVID-19 LEVELS AFFECTING SURGERIES — Michigan Medicine is beginning to cancel some surgeries due to rapidly accelerating Covid-19 admissions, surgery chair Justin Dimick tweeted Thursday. A spokesperson for the health system said it is currently experiencing record high emergency-room and admission volumes for both Covid-19 and other care this week. “Due to rising occupancy and forecasts for continued high demand for emergency care and admissions, Michigan Medicine has had to make the difficult decision to reschedule a small number of scheduled surgeries late this week and next week in order to maintain safe occupancy levels,” spokesperson Mary Masson told POLITICO. | | | |   | | | | | | CDC: FEDERAL FUNDS CAN BE USED TO BUY FENTANYL TEST STRIPS — The CDC announced Wednesday that federal funding can now be used to buy fentanyl test strips, which identify the presence of fentanyl in illicit drugs, POLITICO’s Dan Goldberg reports. The move is part of the Biden administration’s harm-reduction strategy as the White House contends with record numbers of fatal overdoses. More than 88,000 people died from an overdose in the 12-months ending in August, according to preliminary data from the CDC, a 27 percent increase from the same time period in 2019. Much of that is attributed to the prevalence of fentanyl, a powerful synthetic opioid. The Trump administration opposed using the strips. Elinore McCance-Katz, who led the Substance Abuse and Mental Health Services Administration during the previous administration, worried that substance users would use them to seek out fentanyl rather than avoid it. But the Biden White House argues that it’s a necessary tool for engaging people and could prevent overdose deaths. | | | HOLOGIC TO ACQUIRE MOBIDIAG IN $795M DEAL — Medical device manufacturer Hologic announced Thursday it signed an agreement to purchase diagnostics maker Mobidiag for approximately $795 million. The deal is expected to close in the fourth quarter of 2021. | | | CALIFORNIA ADVANCES BILL TO STOP ‘PATIENT STEERING’ TO PHARMACIES — Health plans would be prohibited from forcing patients to use a specific pharmacy under a California bill aimed at curbing a practice known as “patient steering,” POLITICO Pro’s Victoria Colliver reports. Sen. Nancy Skinner (D-Berkeley) included in the bill that patients would be allowed to choose their preferred pharmacy as long as it’s within the insurer’s network — a proposal that sets up a clash between independent pharmacists and health insurers. | | | | JOIN AN IMPORTANT CONVERSATION, SUBSCRIBE TO "THE RECAST" NEWSLETTER: Power dynamics are shifting in Washington and across the country, and more people are demanding a seat at the table, insisting that all politics is personal and not all policy is equitable. "The Recast" is our twice-weekly newsletter that breaks down how race and identity are recasting politics, policy and power in America. Get fresh insights, scoops and dispatches on this crucial intersection from across the country and hear from important new voices that challenge business as usual. Don't miss out, SUBSCRIBE . Thank you to our sponsor, Intel. | | | | | | | | EUROPEAN REGULATORS FAIL TO ASSUAGE ASTRAZENECA CONCERNS — Confusion over the safety of the AstraZeneca jab is still rampant in the EU as governments continue to limit the shot to certain age groups while regulators push that the shot is safe and vital, POLITICO EU’s Jillian Deutsch and Esther Webber report. The latest assessments by the EU and the U.K. medicines regulators reached the same conclusion — that there is a potential link between the vaccine and blood clotting disorders, but that it is extremely rare and that the drug continues to remain licensed for all adults. The head of the European Medicines Agency also acknowledged that a rare but sometimes fatal form of blood clotting is possibly linked to the jab, but said the benefits of the vaccine still outweigh the risks. Belgian and U.K. officials both moved to limit distribution of the shot for anyone under 56 and 30, respectively, after reviewing rare cases of blood clotting just after EMA released a statement acknowledging a “possible link,” while still backing the continued use of doses. | | | Friday: HHS holds a meeting of the COVID-19 Health Equity Task Force at 2 p.m. EST. Wednesday: The House Energy and Commerce Health Subcommittee holds a virtual hearing on how to combat the substance use disorder epidemic. Thursday: The Senate Finance Committee holds a hearing next week on Biden’s nominations of Chiquita Brooks-LaSure to run CMS and Andrea Palm to be HHS deputy secretary, POLITICO’s Rachel Roubein reports. | | | Sonia Wadhwa Nath is joining Cooley as a partner in its business litigation and healthcare regulatory practice groups. She previously worked in FDA’s Office of the Chief Counsel as a senior counsel. CareFirst BlueCross BlueShield announced Thursday David Schwartz is being tapped as its new vice president of public policy and federal affairs. He previously worked at Cigna as its head of global policy. Anne Beal is joining GlaxoSmithKline’s board as a non-executive director on May 6. | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. Ongoing diagnostics challenges: Rates of influenza are so low in the U.S. during the pandemic that it is making it difficult for some developers of so-called “multi-analyte” tests to validate whether the products are capable of detecting both SARS-CoV-2 and the influenza virus, diagnostics companies told the FDA this week. In response to those concerns, FDA officials said they will permit “archived samples” of the virus to support Emergency Use Authorizations – though some diagnostics companies have said even those samples are difficult to obtain. Regulators also offered advice to companies about how viral variants of the coronavirus may affect development strategies and how companies should plan to develop data reporting strategies for tests intended to be taken at home by patients. Lawmakers eye the FDA’s Citizen Petition process for speedier generics: A bill recently re-introduced in the Senate seeks to address a longstanding pain point for the FDA: The use of Citizen Petitions seeking to improperly delay or deny the approval of prospective generic competition. The bill, the Ensuring Timely Access to Generics Act, was first introduced in 2019 and would generally make it more difficult for companies to petition the FDA to not approve competitor generic products. However, the latest version of the bill contains several new provisions, including new restrictions on both petitions and lawsuits against the FDA. | | | Plans to donate any of the U.S.’s extra coronavirus vaccine doses and inoculate the rest of the world are stuck in limbo thanks to America First–style contracts negotiated by the Trump administration and an alarming uptick in domestic cases, Vanity Fair reports. Canada’s vaccination rates are severely lagging behind those of its southern neighbor and 50 other countries, with causes including no specific vaccine-delivery timing on advance-purchase deals the government made to compensate for low domestic manufacturing capacity, the Atlantic reports. A Brazilian Supreme Court judge suspended extensions of drug patents in the country, which could lower costs for drugs that treat Covid-19, Reuters reports. | | A message from Gilead Sciences, Inc.: Decades of discovery lie behind every breakthrough. For more than 30 years, Gilead scientists have been pushing the boundaries of what’s possible. We’ve worked to advance the science that has unlocked therapeutics for HIV, viral hepatitis, and even COVID-19.
Today, Gilead therapeutics are at work, effectively providing treatment for millions. But we’re not stopping any time soon. We’re committed to the relentless pursuit of scientific discovery. To keep pushing to the next goal. To bring tomorrow’s life-changing therapies forward today. And then reach farther.
To learn more, visit Gilead.com. | | | | | | Medical device vendors gave an average of $904 million per year in consulting fees, lunches, lodging and other incentive payments to 196,624 doctors from 2014-2017 compared to $821 million per year drug vendors gave to 331,187 physicians over the same period of time, per a study in Health Affairs. FDA published version 2.2 of specifications for preparing and submitting postmarket individual case safety reports for vaccines. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
