Drug pricing policy under Harris

Presented by CVS Health: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Jul 23, 2024 View in browser   By David Lim Presented by  With Robert King Driving The Day Vice President Kamala Harris' 2019 presidential campaign platform hinted at drug pricing policy, an issue she could possibly pursue if she were elected president. | Chip Somodevilla/Getty Images DRUG PRICE SCRUTINY LIKELY CONTINUES — Drugmakers aren’t likely to catch a break from Vice President Kamala Harris if she becomes the Democratic nominee and is elected president. The Californian will tout the Biden administration’s Inflation Reduction Act on the campaign trail in the coming months — and her 2019 presidential campaign hinted at additional drug pricing policy that could resurface. That platform included legislative calls to empower HHS to set a fair price for any prescription drug that is no more than 100 percent of its average price in comparable high-income countries such as Australia, Canada, France, Germany, Japan and the United Kingdom. Harris called for that price to be updated at least annually — and capped for inflation. “All profits pharmaceutical companies make from selling a drug above the fair price in the United States will be taxed at a rate of 100 percent. These funds will go directly back to consumers in the form of rebates,” Harris’ 2019 platform stated. A reviled pharmaceutical industry policy — so-called march-in rights — appears to have an ally in Harris. The National Institute of Standards and Technology recently sought comment on a draft framework for how agencies should consider exercising march-in rights — where the government can award a patent for research it funded to another firm to potentially lower prices. “If the actions outlined above are not sufficient to bring down an abusive price for drugs that resulted from publicly funded R&D, Harris will use existing authority under the Bayh-Dole Act to ‘march-in’ and license a drug company’s patent to a lower-cost competitor,” her 2019 policy platform stated. Catherine Hill, spokesperson for the Pharmaceutical Research and Manufacturers of America, said the trade lobby would work with any presidential administration on policies to increase patient access and innovation. “Previous price controls adopted by the Biden administration threaten to stifle that innovation,” Hill said in an email. Harris said she would also urge HHS to use its authority to allow drug importation for “excessively priced” drugs from other comparable countries, such as Canada, “consistent with rigorous safety standards.” Under the Biden administration, the FDA granted Florida permission to pursue a drug importation plan from Canada, but the program has not gotten off the ground. The likely 2024 Democratic nominee also wanted to end what she described as a “tax loophole” on direct-to-consumer advertising by pharmaceutical companies — and direct proceeds to the National Institutes of Health for research treatments. The former attorney general said she would appoint a Department of Justice head “who will prioritize investigations of abusive drug pricing practices to ensure pharmaceutical companies are not violating federal law or engaging in anticompetitive behaviors.” IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. The CDC is actively investigating an outbreak of Listeria linked to meats sliced at delis that has led to 28 hospitalizations and two deaths across 12 states. Send news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM). A message from CVS Health: Paying less out-of-pocket means our members can focus on living healthier lives. Learn more about how CVS Caremark is ensuring access and affordability to critical medications for millions of Americans.   Eye on the FDA Prospects for passing the Agriculture-FDA bill next week are grim and looking increasingly unlikely. | J. Scott Applewhite/AP FDA FUNDING VOTE DELAYED — The Biden administration said Monday that it would veto the FDA funding bill in its current form. The Office of Management and Budget said the administration is concerned with the bill’s provisions that place limits on the FDA’s ability to regulate tobacco products until the agency takes stronger enforcement actions related to illicit e-cigarettes as well as the legislation’s funding levels for the agency. But the measure will not hit the floor this week as planned, POLITICO’s Caitlin Emma and Jennifer Scholtes report. The FDA funding bill failed to clear the floor last year when conservative policy riders that aimed to prevent abortion pills from being mailed to individuals split Republican support for the bill. Those same issues are ensnaring the measure again this year — even though such language was not included in the bill advanced out of the House Appropriations Committee. POLITICO’s Meredith Lee Hill reports that some Republicans want that mifepristone rider back in the bill, contributing to its challenges. The decision to yank the Agriculture-FDA and Financial Services spending bills from the floor comes after the surprise failure of Republicans’ $7 billion Legislative Branch funding measure earlier this month.   Live briefings, policy trackers, and procedural, industry, and people intelligence from POLITICO Pro Analysis gives you the insights you need to focus your policy strategy this election cycle. Secure your seat.      BIRD FLU ANOTHER CASE — Colorado’s public health department announced over the weekend a presumptive positive human avian flu infection at a second poultry farm in the northeast part of the state. That brings the total number of humans confirmed with an infection in the state this year to eight — one person at a dairy farm and seven at poultry farms. “To date, approximately 80 poultry workers have been tested for avian flu at the first poultry farm and 23 workers at the second poultry farm,” Kristin Richmann, spokesperson for the Colorado Department of Public Health and Environment, said in a Monday email. The CDC continues to assess that the risk to the public is low, according to the state's public health department. The public health agency is helping state health officials investigate the virus’ spread. Scott Bookman, senior director for public health readiness and response at Colorado’s public health department, told POLITICO last week that it is possible that dozens of people who tested negative for avian influenza at an egg-laying facility were tested too early or too late to detect an active infection. But the state health official said it is conceivable that those workers had conjunctivitis symptoms for a number of potential reasons — pointing to the high temperatures and conditions the workers were exposed to when working to kill poultry believed to be infected with the virus. “We’re thinking about the cutoff lines on this one, looking at limits of detection," Bookman said. But CDC Principal Deputy Director Nirav Shah told reporters last week that “a negative result at the Colorado lab rules out H5N1 entirely.” Bookman said Colorado is having conversations with the CDC about potentially conducting blood testing to understand whether workers now testing negative had bird flu in the past. “We are very interested in working on the serology,” Bookman said.   A message from CVS Health:   In Congress PBMs RETURN TO HOUSE HOT SEAT — Several major pharmacy benefit managers are set to return to Capitol Hill for the first time since reports that the Federal Trade Commission plans to pursue new lawsuits against them, Robert writes. The House Oversight and Accountability Committee will hold a hearing this morning on “anticompetitive practices” employed by PBMs, the middlemen who negotiate drug prices for insurers and large employers. Executives from the three biggest PBMs — CVS Caremark, OptumRx and Express Scripts — are expected to attend. “Information the committee has obtained shows spread-pricing and rebates benefit PBMs and have helped the three largest PBMs monopolize the pharmaceutical market,” Committee Chair James Comer (R-Ky.) said in a statement. Sen. Chuck Grassley (R-Iowa) praised Comer on Monday, saying it is “past time PBMs get a good dose of sunshine.” “PBM executives must answer to the American people for their role in driving up drug costs,” Grassley said in a statement.   SUBSCRIBE TO GLOBAL PLAYBOOK: Don’t miss out on POLITICO’s Global Playbook, our newsletter taking you inside pivotal discussions at the most influential gatherings in the world. Suzanne Lynch delivers the world's elite and influential moments directly to you. Stay in the global loop. SUBSCRI     Document Drawer The FDA issued draft guidance for biosimilar manufacturers containing recommendations for what information should be given to the agency to support postapproval changes to how biosimilars are manufactured. Biden physician Kevin O’Connor said in a letter that the president completed his tenth dose of Paxlovid on Monday morning and his symptoms “have almost resolved completely.” A message from CVS Health: CVS Caremark works every day to put medicine within reach of people who need it. Our members have an average out-of-pocket cost of less than $8 for a 30-day supply of medication, and we’re actively working to bring down costs for plan sponsors and their members. Learn more about how we’re making medicine more affordable for all Americans.     Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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