| | | | |  | | By David Lim and Lauren Gardner | Presented by the Coalition for Affordable Prescription Drugs (CAPD) | With Katherine Ellen Foley
| | | — Democrats have not locked up the votes to confirm Robert Califf as FDA commissioner. — A House panel will kick off the FDA user fee reauthorization process next week with a hearing on three of the proposed agreements. — The Trump administration's vaccine allocation strategy favored political allies over the world's neediest countries, per a list described to POLITICO. It's Friday. Welcome back to Prescription Pulse. The Food and Drug Administration took to Twitter to recruit for the upcoming vacancy in its chief tobacco regulator role. Send tips and feedback to David Lim (dlim@politico.com or @davidalim), Lauren Gardner ( lgardner@politico.com or @Gardner_LM) or Katherine Ellen Foley ( kfoley@politico.com or @katherineefoley).
| | A message from the Coalition for Affordable Prescription Drugs (CAPD): New polling shows that Americans aren't fooled by Big Pharma. Voters clearly know that big drug companies are responsible for high drug prices. More than that, they want Congress and the Administration to take immediate action to protect patients by addressing the problem at its root: the high and rising prices set by Big Pharma. Learn more. | | | | | | CALIFF VOTE IN DANGER — President Joe Biden's nominee to lead FDA does not yet have the votes in the Senate needed to give the agency its first political leader in more than a year, David, Lauren and Adam Cancryn report. Democratic skepticism of former FDA Commissioner Robert Califf's regulatory track record and a new GOP push to kill his nomination have sparked deep frustration among top Democrats and touched off a round of finger pointing, with Califf allies privately blaming the White House for doing too little to shore up support for its own nominee. "If the vote were held today, he would not have the votes," said one person with knowledge of the matter. In recent weeks, Senate HELP Chair Sen. Patty Murray (D-Wash.) and ranking member Sen. Richard Burr (R-N.C.) have led a scramble to win last-minute support for Califf, in hopes of holding a floor vote by early February. A person with knowledge of the matter said the White House is now also dispatching senior aides like chief medical adviser Anthony Fauci, Covid-19 coordinator Jeff Zients and White House staff secretary Neera Tanden to make calls on Califf's behalf. "We are confident Dr. Califf will be confirmed with bipartisan support, and it is critical to have confirmed leadership at the FDA in the midst of a pandemic," White House spokesperson Chris Meagher said. SENATE HELP LEADERS RELEASE PANDEMIC PREPAREDNESS DRAFT — Murray and Burr released a discussion draft Tuesday of a pandemic preparedness bill that would make the Centers for Disease Control and Prevention director a Senate-confirmed job for the first time, POLITICO's Ben Leonard reports. The bipartisan proposal comes amid mounting scrutiny of the agency and as Director Rochelle Walensky defends her messaging strategy. The broader measure aims to bolster response capacity, public health data, research and the public health workforce, as well as address potential supply issues. E&C SCHEDULES USER FEE HEARING — The House Energy and Commerce health subcommittee will hold a hearing on reauthorization of PDUFA, GDUFA and BsUFA at 10:30 a.m. on Feb. 3, top committee Democrats announced Thursday. "We look forward to hearing from top officials at FDA and stakeholders next week as we begin the important work of reauthorizing the prescription drug, generic drug, and biosimilar user fees," E&C Chair Rep. Frank Pallone (D-N.J.) and health subcommittee Chair Rep. Anna Eshoo (D-Calif.) said.
| | | TRUMP VACCINE PLAN FAVORED ALLIES OVER NEEDY COUNTRIES — As the U.S. prepared for authorization of the first Covid-19 vaccines, the Trump administration prepared a secret list of which nations would get the doses first, POLITICO's Erin Banco scoops. The document, described to Erin by five current and former government officials, shows that the administration planned to prioritize distribution of the shots to political allies — like Israel, Canada and Taiwan — rather than the poorest nations, as global health advocates have urged. A year into Joe Biden's presidency, it's still unclear exactly how his administration decides when and where to send vaccine doses. A Biden official said the administration "does not use the previous administration's policy or the cited list to make vaccine sharing decisions." GOP CALLS COVID DRUG GUIDANCE 'RACIST' — Republicans are hammering Democrats over the Biden administration's recommendation that race and ethnicity be considered when deciding who should access the limited supply of new Covid drugs, POLITICO's Alice Miranda Ollstein and Megan Messerly write. The accusations that the policy is racist against white people are the GOP's latest political talking points as they look to fire up the base ahead of the midterm elections. Both establishment and MAGA activists are seizing on the issue. While Democratic strategists say the attacks are baseless, they warn they could move the needle with some voters. Meanwhile, those implementing the recommendation locally say it's rarely an issue they confront, and that no one is being denied the drugs based on race. NIH STUDY: MIX-AND-MATCH COVID SHOTS ARE SAFE, EFFECTIVE — A study backed by the National Institutes of Health found that a booster dose of any of the three Covid-19 vaccines authorized or approved in the U.S. is both safe and effective , Lauren writes. Early results from the study, which has now been peer-reviewed, were used by FDA and CDC to support their decisions in the fall to permit mix-and-match boosters.
| | | FDA ISSUES THREE REVAMPED GUIDANCES FOR GENERIC DRUGS — On Wednesday, the agency issued two finalized rules and one revised rule as part of the Drug Competition Action Plan to bring generic drugs to market faster. The finalized rules clarify submission procedures and information requests for companies submitting a generic drug application for approval, with the goal of minimizing the number of review cycles. The revised guidance updates the way that generic drug manufacturers can update their product applications after the initial reference drug undergoes a labeling change. "By providing recommendations to applicants on how to avoid these common deficiencies, this guidance will help applicants submit high-quality, complete applications the agency can approve in the first review cycle," the agency said in a statement. FDA ADDS THE FIRST BULK DRUG SUBSTANCES FOR 503B BULKS LIST — FDA added four bulk drug substances on Thursday to the agency's list of components that outsourcing facilities may use for compounded medicines. The four bulk drug substances added to the 503B bulk list are all for topical use, and aren't a part of any FDA-approved drug. In the same announcement, FDA also stated it had decided not to add eight other proposed bulk substances to the list. SIPES ON DETAIL TO WHITE HOUSE, JUNGMAN STEPS INTO CDER POLICY ROLE — Grail Sipes, a longtime FDA drug policy staffer, is being detailed to the White House Office of Science and Technology Policy as assistant director for biomedical regulatory policy, CDER Director Patrizia Cavazzoni said in a staff email on Tuesday. "In this role, Grail will provide biomedical regulatory policy leadership to help coordinate OSTP health and life science priority issues, including pandemic preparedness, digital health, biomanufacturing, and health equity," Cavazzoni wrote. Elizabeth Jungman, director of CDER's Office of Regulatory Policy, is stepping up to "serve as the center's primary representative for broad policy matters and issues" as CDER associate director for policy. ROCKEFELLER LAUNCHES NEW FREE COVID TEST INITIATIVE — The Rockefeller Foundation is launching a program to distribute five free at-home Covid-19 tests to vulnerable households in six states: Arkansas, Illinois, Maine, Michigan, New Mexico and Ohio. The effort — initially distributing about 1 million home tests from iHealth Labs through CareEvolution and Amazon — builds upon the Biden administration's efforts to send 1 billion home tests to households that request them. "While the program is currently limited to one order, per residential address during this first phase, The Rockefeller Foundation is actively working to bring in new partners to scale the program to additional states over the coming weeks," the foundation said in a statement.
| | | | A message from the Coalition for Affordable Prescription Drugs (CAPD):   | | | | | | EPA BACKS 2016 IRIS VALUE FOR ETHYLENE OXIDE — The Environmental Protection Agency announced Wednesday it is proposing to continue to rely on a 2016 Integrated Risk Information System assessment of ethylene oxide — a gas used to sterilize medical devices — and declining requests to instead rely on the Texas Commission on Environmental Quality's risk value when assessing cancer risk for the source category. "The EPA's decision today to uphold the 2016 IRIS value, despite the industry pushing for a weaker standard, is a huge step forward for our constituents who have been impacted by EtO," the bipartisan Congressional Ethylene Oxide Task Force said in a statement. AdvaMed CEO Scott Whitaker argued it is critical EPA quickly move to issue federal rulemaking to bring consistency to how EtO is regulated state-by-state. "Having that national standard that will allow our medtech manufacturers to continue responsibly operating while removing EtO emissions is the best step forward to ensuring patient access to lifesaving medical technologies," Whitaker said in a statement.
| | | BIOGEN STUDY OF ADUHELM TO MEET DIVERSITY REQUIREMENTS — Biogen announced on Thursday that 18 percent of participants in its FDA-mandated confirmatory clinical trial for its controversial Alzheimer's therapy would be Black and Latino , Katherine reports. Earlier this month, CMS proposed that it would only cover Aduhelm for those enrolled in clinical trials that met certain standards, including a participant pool that tracks with the broader population. The diversity of Biogen's study would meet CMS' proposed standard, allowing the company to conduct only one trial to meet both health agencies' needs. The company also agreed to sell its joint biosimilar venture to Samsung Biologics. Samsung Biologics will acquire Biogen's share of their joint venture Samsung Bioepis for $2.3 billion, Biogen announced Thursday.
| | | FDA ON TRACK FOR PROPOSED RULE TO BAN MENTHOL, FLAVORED CIGARS — The FDA remains committed to issue two proposed rules in April, one that would ban the sale of all menthol cigarettes, and another that would bar the sale of all flavored cigars. Black smokers and youth are disproportionately likely to use these products, leading to more tobacco-related disease and death. "These actions are an important opportunity to achieve significant, meaningful public health gains and advance health equity," Mitch Zeller, the director of FDA's Center for Tobacco Products, said in a statement on Thursday . Zeller plans to step down from his role at CTP that same month.
| | | CMS WANTS DRUGMAKERS TO PARTAKE IN PDSS MODEL — CMS announced Thursday it is requesting applications from drugmakers interested in participating in its 2023 Innovation Center Part D Senior Savings Model. The deadline for new manufacturers to apply is Feb. 4.
| | | Chris Middendorf, former FDA investigator and senior policy adviser, has joined law firm Hogan Lovells' Global Regulatory practice as a director of regulatory affairs in Washington. He has more than 20 years' experience involving FDA inspections, compliance and policy development. Galapagos, a small-molecule medicines developer, appointed Paul Stoffels as chief executive officer. He was previously Johnson & Johnson's chief scientific officer. Charles Slacik and Kathy Ordoñez announced they intend to retire from Quidel's board of directors.
| | | THURSDAY: The House Ways and Means Health Subcommittee will hold a hearing at 2 p.m. on Feb. 3 on "Bridging Health Equity Gaps for People with Disabilities and Chronic Conditions."
| | | MICHIGAN AG LAUNCHES INSULIN INVESTIGATION — Michigan Attorney General Dana Nessel launched an investigation this week into Eli Lilly over the company's insulin pricing practices. The state is seeking residents to share their experiences buying insulin by filling out a complaint form.
| | | EU REGULATOR BACKS PFIZER'S ANTIVIRAL PILLS TO TREAT COVID-19 — The European Medicines Agency on Thursday recommended the use of Pfizer's antiviral therapy Paxlovid to treat people diagnosed with Covid-19, POLITICO's Helen Collis reports. The therapy, a combination of two pills, is intended for people who do not require supplemental oxygen, but are at an elevated risk of developing severe disease.
| | | FDA published final guidance Wednesday outlining recommendations on how device companies can use patient input to improve the design of clinical trials. It also issued final guidance on how patient-reported outcome instruments can be used to evaluate devices. FDA announced Tuesday it will hold a virtual workshop on considerations for studies of transbronchoscopic thermal ablation devices to treat tumors in the lungs on April 5-6.
| | A message from the Coalition for Affordable Prescription Drugs (CAPD): Americans aren't fooled by Big Pharma. According to new polling, 80% of Americans want Congress to rein in big drug companies' skyrocketing prices. American voters clearly know that big drug companies bear responsibility for high drug prices and are looking to Congress and the Administration to take immediate action to protect patients. Learn more. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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