By David Lim, Lauren Gardner and Katherine Ellen Foley

Senate HELP Committee Chair Bernie Sanders wants the Biden administration to add reasonable pricing requirements for drugs that are developed with tax dollars. | Susan Walsh/AP Photo

THE SOUND OF SETTLING — Senate HELP Committee Chair Bernie Sanders (I-Vt.) agreed to drop his hold on President Joe Biden’s nominee for the director of the NIH following an agreement between Regeneron and the government to limit the price of a Covid-19 therapy under development.

But Sanders says he plans to hold NIH director nominee Monica Bertagnolli’s feet to the fire despite the Biden administration’s commitment to keep working on drug prices. The liberal — a longtime critic of the pharmaceutical industry — is set to press her in October to take further steps to lower the price of drugs under development when the government has a stake in it.

“In my view, the administration must include strong reasonable pricing requirements for all prescription drugs sold in America that were developed at taxpayer expense,” Sanders said.

Legal document: The Regeneron deal — intended to ensure a monoclonal antibody for the prevention of Covid-19 is sold at a list price equal to or less than similar scenarios in other high-income countries — may never materialize.

"[Sanders] made several very aggressive demands several months ago," said a pharmaceutical industry executive who was not authorized to speak on the record about the contract. But this contract "is not meeting those ... I don't think it really does change much."

That’s because of numerous other conditions in the contract. It requires that the drug is granted harder-to-get full FDA approval rather than emergency use authorization.

“Regeneron is permitted to take into account all relevant factors in determining whether sales are comparable sales, including volume commitments, timing of purchase and supply, the terms and conditions of purchase and supply, market conditions and epidemiology of SARS-CoV-2,” the contract clause states.

Regeneron spokesperson Tammy Allen said in an email that it is too early to say whether the company will ask the FDA for emergency use authorization or full approval. However, the company is attempting to develop a monoclonal antibody that could be effective against future Covid-19 variants — suggesting that the agreement may be consequential if Regeneron succeeds.

“By the time a [clinical trial] is completed, there will be a new variant that has mutated around the prior generation of antibodies,” former FDA Commissioner Scott Gottlieb said. “It's possible to develop antibodies against conserved regions on the virus, but that has proven hard as a practical matter.”

For the first time in years: Lawmakers and advocates say the Regeneron deal is important to the return of reasonable pricing clauses common in the 1990s for public-private drug development contracts.

IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Have you seen a missing F-35? The Marine Corps wants to hear from you.

Send news and tips to Lauren Gardner ([email protected] or @Gardner_LM), David Lim ([email protected] or @davidalim) and Katherine Ellen Foley ([email protected] or @katherineefoley).

A message from Coalition to Protect America’s Health Care:

America’s hospitals have been pushed to the brink by broken supply chains, workforce shortages, and high inflation. Now, some in Congress want to reduce hundreds of billions of dollars in funding, jeopardizing patient access to quality care, especially in underserved communities. Congress: protect patient access to 24/7 hospital care.

TODAY ON OUR PULSE CHECK PODCAST, host Ben Leonard talks with POLITICO health care reporter Chelsea Cirruzzo about the new CDC director's plans to improve communication and transparency at the agency.

House Oversight and Accountability Committee Chair James Comer said he will scrutinize pharmacy benefit managers. | Francis Chung/POLITICO

PBMs IN OVERSIGHT HOT SEAT — This morning the House Oversight and Accountability Committee is expected to hear from industry groups hoping Congress will crack down on pharmacy benefit managers, Megan R. Wilson reports.

The leader of the PBM trade group, JC Scott, is up against a bipartisan group of critical lawmakers — and his own industry opponents, including PhRMA, which represents brand drugmakers, the National Community Pharmacists Association and the Biosimilars Council.

Committee Chair James Comer (R-Ky.) said the hearing will hone in on what he argues are PBM practices that drive up drug costs to help the companies’ bottom line.

“We also know that drug manufacturers pay rebates to PBMs in order to be placed in a favorable tier on a formulary, which can make it difficult for competing prescriptions — often generics or biosimilars — to get on formularies,” Comer is slated to say in his opening statement today. “These practices have real world consequences, and impact constituents in all our districts.”

Six committees in the House and Senate have advanced legislation — most of it favored by Republicans and Democrats — that would impose new transparency requirements or restrictions on PBMs.

Scott’s group, the Pharmaceutical Care Management Association, is trying to extol the benefits that PBMs can bring to patients and shift blame to drugmakers.

BREAKTHROUGH DEVICE COVERAGE, REDUX — The Energy and Commerce Health Subcommittee convenes at 10 a.m. today to hold a hearing on a laundry list of bills, including a bipartisan bill that would direct Medicare to promptly cover approved breakthrough medical devices.

IRA SCRUTINY — The E&C Oversight Subcommittee meets at 2 p.m. tomorrow to discuss the Inflation Reduction Act’s impact on drugmakers. The hearing is nearly guaranteed to be a partisan affair with Republicans questioning the law’s impact on research and development, and Democrats defending its Medicare drug price negotiation provisions.

JOIN US ON 9/20 FOR A TALK ON TRANSFORMING HEALTHCARE BILLING: Bipartisan legislation in the House and Senate would align costs for services across hospitals and doctors’ offices and reduce out-of-pocket spending that could potentially save the federal government billions of dollars. Can this legislation survive a polarized Congress? Join POLITICO on Sept. 20 to explore this and whether site-neutral payments and billing transparency policies could help ease health care costs. REGISTER HERE.

AND NOW WE WAIT — A federal judge betrayed no hints Friday as to how he’ll rule in the U.S. Chamber of Commerce’s bid to halt implementation of Medicare’s new drug price negotiation authority.

Michael J. Newman, a Trump appointee to the U.S. District Court for the Southern District of Ohio, asked no questions during the oral arguments over Zoom, which lasted nearly two-and-a-half hours. Because of that, it’s impossible to know when or how he might rule on the chamber’s request for a preliminary injunction.

He signaled he’s aiming to meet the group’s request for a decision to be handed down before Oct. 1, when drugmakers have to decide whether to agree to participate in negotiations or pull their products from Medicare — or refuse both options and pay hefty excise taxes.

J&J ON COLD MED CLASS-ACTION: NOT US — After we wrote about the class-action lawsuits filed last week against makers of common cold medicine products, J&J spokesperson Clare Boyle emailed a statement.

“Johnson & Johnson is not named in the lawsuits, which makes sense because it did not manufacture or sell decongestant cold medicines and, following our separation, Johnson & Johnson Consumer Inc. is not a part of Johnson & Johnson,” her email said.

J&J did not respond to a request for comment before publication of our Friday newsletter. And as we noted in the item, J&J spun off its consumer product portfolio last year into Kenvue, which also didn’t respond to a request for comment on the lawsuits. The suit filed in Florida named “Johnson & Johnson Consumer Inc.” as a defendant.

A message from Coalition to Protect America’s Health Care:

ARTIFICIAL WOMB TECHNOLOGY TO BE DISCUSSED — External advisers to the FDA will convene today and tomorrow to discuss how device manufactures should go about developing and studying Artificial Womb Technology for extremely preterm babies, or those born before 28 weeks.

Extremely preterm babies are more likely to suffer complications related to nutrition, blood flow and external infections due to their underdeveloped organ systems. Briefing documents from the FDA outline how how artificial womb technology — and potential artificial placentas — could mimic the uterus as these babies continue to develop.

The committee will also discuss data from studies on animals and the ethical considerations for companies developing such technology to move into clinical trials.

DECISION DAY FOR  ANAPHYLAXIS INHALERS — The FDA is slated to make a decision today on neffy, a nasal spray containing epinephrine made by ARS Pharmaceuticals that treats severe allergic reactions in children and adults weighing at least 66 pounds. An advisory committee endorsed the spray’s approval in May, and if approved, neffy would become the first non-injectable version of epinephrine.

GO INSIDE THE CAPITOL DOME: From the outset, POLITICO has been your eyes and ears on Capitol Hill, providing the most thorough Congress coverage — from political characters and emerging leaders to leadership squabbles and policy nuggets during committee markups and hearings. We're stepping up our game to ensure you’re fully informed on every key detail inside the Capitol Dome, all day, every day. Start your day with Playbook AM, refuel at midday with our Playbook PM halftime report and enrich your evening discussions with Huddle. Plus, stay updated with real-time buzz all day through our brand new Inside Congress Live feature. Learn more and subscribe here.

OPIOID RESEARCH — Opioid use disorder patients starting buprenorphine treatment who received a higher dose of the drug were associated with better treatment retention than those on a lower dose, according to a new study published Monday in JAMA Network Open.

The final price consumers pay for weight loss drugs is 48 percent to 78 percent lower than the price initially set by drugmakers, according to a new paper from the American Enterprise Institute’s Benedic Ippolito and Joseph Levy.

Emergent BioSolutions, maker of over-the-counter opioid overdose reversal drug Narcan, profited while it maintained the drug’s prescription status for five years, Todd Frankel reports for The Washington Post.

The FDA published draft guidance outlining how it plans to apply labeling requirements for prescription drug use-related software.

The FDA issued draft guidance on product labeling for biosimilars and interchangeable biosimilars, recommending that both types of products include a “biosimilarity statement.”

A message from Coalition to Protect America’s Health Care:

Broken supply chains. Workforce shortages. High inflation. America’s hospitals have been pushed to the brink. More than 100 rural hospitals have already closed and many more are operating in the red. So why do some in Congress want to reduce hundreds of billions of dollars in funding for patient care – jeopardizing patient access to quality care, especially in underserved communities? Tell Congress: no funding cuts to care.

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