Biden targets patents for pricey drugs

Presented by PhRMA: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.

Dec 07, 2023 View in browser   By Chelsea Cirruzzo and Ben Leonard Presented by Driving The Day President Joe Biden has portrayed himself as a chief antagonist of the pharmaceutical industry. | Evan Vucci/AP COSTLY MEDS IN THE CROSSHAIRS — The White House believes it can seize the patents of certain expensive drugs in an effort to create more competition and lower prices and will today give guidance to federal agencies, POLITICO’s Adam Cancryn reports. Price and availability will be among the factors in the forthcoming framework that the Commerce Department will recommend agencies consider. Why it matters: The move signals the beginning of a more aggressive federal campaign to drive down drug prices, which the Biden administration has made a priority as the president seeks reelection. According to people familiar with the matter, federal officials spent months reviewing the government’s so-called march-in rights. Progressives, including Sens. Bernie Sanders (I-Vt.) and Elizabeth Warren (D-Mass.) have said the march-in rights allow the administration to break up patents developed with public funds to create more competition and lower prices. The administration, which declined to comment, isn’t likely to endorse using march-in rights widely and won’t come after any specific drug. Election on the mind: Biden officials were already planning to issue their determination on the government’s march-in authority in the coming weeks, sources told POLITICO, but decided to move up the announcement after former President Donald Trump suggested he would repeal and replace the Affordable Care Act if elected in 2024. Officials will cite this move as evidence that Biden continues to search for new ways to lower prices. Biden plans to put health care at the center of his reelection platform, rolling out proposals in the coming days that would expand on Democrats’ passage of laws capping insulin prices for Medicare recipients and allow Medicare to negotiate the price of certain drugs. Biden has also portrayed himself as a chief antagonist of the pharmaceutical industry, casting his drug-price policies as central to his administration’s battle against “Big Pharma.” In a statement, PhRMA spokesperson Megan Van Etten called the policy “yet another loss for American patients who rely on public-private sector collaboration to advance new treatments and cures … the Administration is sending us back to a time when government research sat on a shelf, not benefitting anyone,” she said. Sen. Bill Cassidy (R-La.), ranking member of the Senate health committee, said in a statement that the administration would lose in court. WELCOME TO THURSDAY PULSE. Sens. Alex Padilla (D-Calif.) and Thom Tillis (R-N.C.) today will co-introduce a bill requiring calls to 988, the suicide and mental health crisis line, to be routed to the nearest call center geographically to the caller — rather than by area code. Send your tips, scoops and feedback to ccirruzzo@politico.com and bleonard@politico.com and follow along @ChelseaCirruzzo and @_BenLeonard_. TODAY ON OUR PULSE CHECK PODCAST, host Alice Miranda Ollstein talks with POLITICO health care reporter Megan R. Wilson about Republican Mike Johnson's rise to House speaker and how he is likely to lean on leaders and aides for health care policy matters. Listen to today's Pulse Check podcast   A message from PhRMA: Middlemen like PBMs are charging fees tied to the price of medicines, which means they make more money when the price of a medicine goes up. This business model allows PBM profits to soar and can lead to higher costs for patients. It’s time to lower costs by holding middlemen accountable.   Congress Rep. Michael McCaul (R-Texas) told POLITICO he was “looking forward to marking up a five-year reauthorization" of PEPFAR. | Mariam Zuhaib/AP STALEMATE ON PEPFAR — The top Republican working to extend the United States’ global HIV/AIDS relief program admitted negotiations are deadlocked, jeopardizing one of the most successful U.S. foreign interventions of this century, POLITICO’s Alice Miranda Ollstein and Carmen Paun report. “I'm disappointed,” Rep. Michael McCaul (R-Texas) told POLITICO. “Honestly, I was looking forward to marking up a five-year reauthorization, and now I’m in this abortion debate.” McCaul, chair of the House Foreign Affairs Committee, which oversees the President’s Emergency Plan for AIDS Relief, which then-President George W. Bush started 20 years ago, was cautiously optimistic that he could broker a deal to re-up a program that is credited with saving 25 million lives and has long enjoyed bipartisan support. Discussions about a compromise that would extend the program for more than one year but fewer than five, with language stressing the existing ban on federal money directly paying for abortions, have collapsed. Talks have also run aground in the Senate. Sen. Ben Cardin (D-Md.) — the top negotiator in the upper chamber — said he has no plans to introduce a reauthorization bill this year. “We’re still negotiating,” he told POLITICO. “We were ready to move a long time ago. But we were not able to secure the necessary support on the Republican side. Why it matters: A lack of reauthorization for PEPFAR would signal to the countries that have long benefited from it that America doesn’t see the fight against HIV/AIDS as a priority, less than a decade before a 2030 target to end HIV as a public health threat. Program supporters say it would also mark the end of bipartisanship on a program that’s been the U.S. signature foreign aid program for two decades. WE WATCHED A LOT OF BILLS SO YOU DON’T HAVE TO — The House Energy and Commerce Committee advanced a slew of health care bills in overwhelming bipartisan fashion, including many aimed at reining in pharmacy benefit managers, which negotiate drug costs for insurers, by requiring them to be more transparent, Ben reports. But Reps. Buddy Carter (R-Ga.) and Larry Bucshon (R-Ind.) expressed concern that provisions banning so-called spread pricing in Medicare and reimbursement differences between vertically integrated pharmacies and independent in-network pharmacies were left out of Carter’s bill. “I’m disappointed with how this process played out,” Carter said at the markup. Committee Chair Cathy McMorris Rodgers (R-Wash.) said she’s working to address the PBM reimbursement differences and to ban spread pricing in Medicare as the House reconciles PBM legislation. A spread-pricing ban would prohibit PBMs from reimbursing a pharmacy less for a drug than what it charged the insurer. The House is set to vote next week on sweeping legislation that would ban spread pricing in Medicaid and add transparency requirements for PBMs, insurers and hospitals. The committee also advanced legislation that would make CMS’ national coverage determination process more transparent and address doctor pay under Medicare. Other bills advanced included legislation facilitating midyear formulary changes for new biosimilars and another bill requiring CMS to review drugs individually in coverage decisions. Going forward: The House and Senate will also ultimately have to reconcile PBM legislation, a top focus for lawmakers in this Congress.   GET A BACKSTAGE PASS TO COP28 WITH GLOBAL PLAYBOOK: Get insider access to the conference that sets the tone of the global climate agenda with POLITICO's Global Playbook newsletter. Authored by Suzanne Lynch, Global Playbook delivers exclusive, daily insights and comprehensive coverage that will keep you informed about the most crucial climate summit of the year. Dive deep into the critical discussions and developments at COP28 from Nov. 30 to Dec. 12. SUBSCRIBE NOW.     At the Agencies A NEW TELEHEALTH PLAN — A new proposal to determine whether doctors can continue to prescribe a drug used to treat opioid use disorder via telemedicine is expected this month. The fall 2023 unified agenda, published Wednesday on the Office of Management and Budget’s website, lays out the government’s regulatory plans over the next few months, though dates aren’t set in stone. What’s in the proposal? The DEA’s proposed rule comes after the agency received backlash on its previous proposal to limit telemedicine prescribing of buprenorphine, a drug used in medication-assisted treatment, to a 30-day initial supply. Under pandemic rules, providers could prescribe such controlled substances without an in-person visit. Those rules were extended through November after pushback from treatment advocates. The agency held listening sessions this fall on whether it should create a special registration process to continue those rules. Final abortion privacy rule: HHS’ Office for Civil Rights is also expected to finalize a rule in March that would bar providers and insurers from giving information to state officials to be used to investigate, sue or prosecute someone for seeking or providing a legal abortion. The rule, initially proposed in April, adds language to HIPAA and covers people who cross state lines for an abortion and those who qualify for an exception to their home state’s ban.   A message from PhRMA:   Names in the News Brent Dover has been appointed CEO of Carta Healthcare. He was previously CEO at Kalderos. Lucy Westerfield is now senior director of economy campaigns at the Hub Project. She most recently ran advocacy campaigns at Patients For Affordable Drugs. Larry Sandigo is now chief of staff at the HHS’ Administration for Children and Families. He most recently served as senior adviser at HHS. The Children's Hospital Association hosted roughly 100 lobbyists from children’s hospitals in Washington for its annual policy gathering on Wednesday.   JOIN WOMEN RULE ON 12/12: For centuries, women were left out of the rooms that shaped policy, built companies and led countries. Now, society needs the creativity and entrepreneurship of women more than ever. How can we make sure that women are given the space and opportunity to shape the world’s future for the better? Join POLITICO's Women Rule on Dec. 12 for Leading with Purpose: How Women Are Reinventing the World to explore this and more. REGISTER HERE.     WHAT WE'RE READING Bloomberg reports that a cyberattack against HHS early in the pandemic was much bigger than first reported. Ben and Chelsea report on HHS’ plans to propose cybersecurity rules for hospitals.   A message from PhRMA: Middlemen like PBMs are charging fees tied to the price of medicines, which means they make more money when the price of a medicine goes up. This business model allows PBM profits to soar and can lead to higher costs for patients. It’s time to lower costs by holding middlemen accountable.     Follow us on Twitter Dan Goldberg @dancgoldberg Chelsea Cirruzzo @chelseacirruzzo Katherine Ellen Foley @katherineefoley Lauren Gardner @Gardner_LM Kelly Hooper @kelhoops Robert King @rking_19 Ben Leonard @_BenLeonard_ David Lim @davidalim Megan Messerly @meganmesserly Alice Miranda Ollstein @aliceollstein Carmen Paun @carmenpaun Daniel Payne @_daniel_payne Evan Peng @thepngfile Ruth Reader @RuthReader Erin Schumaker @erinlschumaker Megan R. Wilson @misswilson   Follow us

To change your alert settings, please log in at https://www.politico.com/_login?base=https%3A%2F%2Fwww.politico.com/settings This email was sent to rouf@idiot.cloudns.cc by: POLITICO, LLC 1000 Wilson Blvd. Arlington, VA, 22209, USA Unsubscribe | Privacy Policy | Terms of Service