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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 and Katherine Ellen Foley | With Krista Mahr and Daniel Payne
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CMS has released draft recommendations for inflation rebates. | Joe Raedle/Getty Images | CMS FLOATS RULES OF THE ROAD FOR INFLATION REBATES — Drugmakers now have wonkier than usual technical draft recommendations from the Centers for Medicare and Medicaid Services on the agency’s process to calculate and pay mandatory rebates if the companies raise the price of certain drugs more rapidly than the annual inflation rate. The government will not invoice companies for the inflation rebates until late 2025, according to the Part B and Part D draft guidance documents released by CMS Thursday. However, the first 12-month period for certain Part D drug inflation rebates started Oct. 1, and the first quarterly period for certain Part B drug inflation rebates began Jan. 1. CMS officials said they are seeking feedback over the next 30 days on a number of topics, including the process for determining if a rebate should be reduced or waived due to shortages and the process for imposing civil monetary penalties on drugmakers that fail to pay rebates. IT'S FRIDAY. WELCOME TO PRESCRIPTION PULSE. Send tips and compliments to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, Alice Miranda Ollstein talks with Josh Gerstein about a federal judge’s recent suggestion that a constitutional right to abortion could be conferred by the 13th Amendment.
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During his State of the Union address, President Joe Biden pledged to veto any attempt to raise prescription drug costs. | Chip Somodevilla/Getty Images | BIDEN: I WILL VETO EFFORTS TO REPEAL IRA DRUG PROVISIONS — President Joe Biden made it clear during his State of the Union speech Tuesday that he will veto any effort to weaken the Inflation Reduction Act’s provisions that empower Medicare to negotiate the price of a limited number of prescription drugs in the years ahead. “Make no mistake, if you try anything to raise the cost of prescription drugs, I will veto it,” Biden told Congress. That promise is a key challenge for Novartis CEO Vas Narasimhan, who sat down with POLITICO on Tuesday, the day before he formally assumed his new role as chair of the PhRMA board, to talk about one of the organization’s major focuses for the year: getting adjustments made to the Inflation Reduction Act. “We want to see a couple of changes made [to the IRA],” Narasimhan said. “One is a correction on how small molecule and other drugs that are filed under the new drug application pathway are negotiated and move that timeline from nine years to 13 years, which is where the biologics are negotiated. We don’t see any logical reason why we want to penalize certain classes of drugs vs. others.” The executive acknowledged he is worried Novartis’ heart failure drug Entresto may be selected for Medicare negotiation, depending on what criteria CMS uses to select products. “It’s a classic example of a small molecule medicine in one of the leading causes of death in the United States, highly innovative, and the only drug in its class,” Narasimhan said. “I would argue this would be a place where CMS could ensure that they don’t take deep discounts until year 11 or 13, given how it took us four or five years to get this medicine to be utilized.”
| | | | DOWNLOAD THE POLITICO MOBILE APP: Stay up to speed with the newly updated POLITICO mobile app, featuring timely political news, insights and analysis from the best journalists in the business. The sleek and navigable design offers a convenient way to access POLITICO's scoops and groundbreaking reporting. Don’t miss out on the app you can rely on for the news you need, reimagined. DOWNLOAD FOR iOS– DOWNLOAD FOR ANDROID. | | | | | | | | SENATE JUDICIARY COMMITTEE AIMS AT PATENT REFORM — The Senate Judiciary Committee on Thursday advanced by voice vote five bipartisan bills that aim to boost generic and biosimilar competition. The pharma industry raised alarm about one bill, the Affordable Prescriptions for Patients Act, arguing its effort to address product hopping would “upend the biopharmaceutical innovation ecosystem” and create an “FTC enforcement cloud over almost any post-approval innovation.” But Sen. Chris Coons (D-Del.) argued the package of bills strikes a “good balance” between reforming the drug patent system and maintaining incentives to reward ingenuity. “If we go too far and undermine the patent system, that would create market uncertainty that would disincentivize lifesaving research and weaken us globally,” Coons said. “No one wants us to miss out on the next legitimate improvements in drugs and biologicals.” HOUSE REPUBLICANS GRILL BIDEN ADMIN OFFICIALS ON COVID RESPONSE — Leaders from the FDA, the CDC and the National Institutes of Health faced the GOP-led House Energy and Commerce Committee on Wednesday in a joint Oversight and Investigations and Health subcommittees hearing on the Covid-19 response, POLITICO’s Alice Miranda Ollstein and Krista Mahr report. Republicans aired grievances over how agencies communicated with them when they were in the minority last year. Their questioning focused on federal guidance related to masking and vaccinations, the virus’ origins and whether agencies should have the power to dictate policy during future outbreaks.
| | | IMMUNIZATION SCHEDULE NOW INCLUDES COVID-19 VACCINES — The CDC on Thursday formally added Covid-19 vaccinations for children, adolescents and adults to its immunization schedule, your co-host reports. Those updates reflect current agency recommendations and do not mandate vaccines for anyone. States and localities determine which vaccines schools require for students, and all states have exemptions for vaccinations. HHS LAYS OUT THE END OF THE PHE — On a call with reporters Thursday, administration officials spelled out some of what the end of the Covid-19 public health emergency would — and wouldn’t — mean for health care. HHS was adamant that the government is entering a new phase of the pandemic and “broad flexibilities for health care providers are no longer necessary and will end,” according to a fact sheet shared by the agency.
| | | FEDERAL JUDGE TOSSES PHARMA’S BID TO BLOCK STATE DRUG IMPORTATION — A federal judge on Tuesday dismissed a bid by the pharmaceutical industry to block a regulation that would allow states to establish programs to import prescription drugs from Canada. PhRMA and two other industry groups sued HHS in November over the Trump-era regulation, which states could implement if HHS determines it does not endanger public health and save consumers money. The drugmakers argue that importation would threaten the supply chain and put undue burdens on companies. But Timothy Kelly, a federal district court judge in Washington, D.C., dismissed the lawsuit on the grounds that the alleged harms lack “a substantial probability of materializing.” BIDEN ADMINISTRATION BRACES FOR RULING THAT COULD BAN ABORTION PILLS — Doctors and advocates are urging people to pre-order and stockpile abortion pills while they still can in the face of a looming court decision that could wipe out access to the drugs nationwide, POLITICO’s Alice Miranda Ollstein and Adam Cancryn report. District Court Judge Matthew Kacsmaryk in Amarillo, Texas, could either strike down the FDA’s decades-old approval of mifepristone — the first of two pills used to end a pregnancy — or roll back more recent agency decisions, making the pills available via telemedicine, mail delivery and pharmacy pickup.
| | | Iya Khalil has been appointed Merck’s new vice president and head of data, AI and genome sciences. She was previously the global head of the AI innovation laboratory at Novartis. Richard Schilsky has been elected to a three-year term as chair of the board of directors for the Reagan-Udall Foundation for the FDA. Georges Benjamin will serve as vice chair.
| | | A large clinical trial shows that a new antiviral can combat Covid, but the FDA might not authorize the treatment because the trial was conducted outside of the U.S. and by the drug manufacturer, Benjamin Mueller reports for The New York Times. Nursing shortages in nursing homes lead to fewer admissions, which creates a vicious cycle of unprofitability, leading to an inability to attract and pay new hires, Nate DiCamillo and Annalisa Merelli write for Quartz. Vuse maker and tobacco giant R.J. Reynolds submitted a citizens petition to the FDA this week to force the agency to pull its disposable vape competitors from the market, STAT’s Nicholas Florko reports.
| | | The Clinical Decision Support Coalition filed a citizen petition to the FDA this week, objecting to the agency’s final guidance on Clinical Decision Support Software. On Thursday, the FDA updated final guidance on compounding some forms of ibuprofen to stretch pediatric ibuprofen supplies.
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