With Megan R. Wilson

PHARMA CRITIQUES ABOUND AS BIDEN EYES 2024 — The agency charged with soliciting feedback from patients who rely on drugs chosen for the first Medicare negotiations is holding a series of listening sessions amid a White House messaging blitz criticizing drugmakers for excessive profits at taxpayer expense.

The dichotomy of patients urging CMS to maintain access to their drugs at the same time the Biden administration blasts drug companies suggests Democrats and President Joe Biden are confident the landmark law directing Medicare to bargain over drug prices is a political winner heading into the 2024 elections, Lauren and David report.

One problem: Polling consistently shows many adults aren’t aware of the Inflation Reduction Act provisions intended to drive down health costs. That’s all the more reason for the administration and Biden’s reelection campaign to hammer home the benefits of Medicare’s new authority, even while taking into account concerns over whether the program will succeed, supporters of the law say.

PhRMA, branded drugs’ lobbying group, blasted the White House’s most recent messaging campaign on high drug prices and high drugmaker profits as a distortion of reality.

Meanwhile: The Biden campaign is tying “MAGA Republicans” to “Big Pharma,” arguing that a hypothetical GOP administration would repeal the law and drive up costs for patients. And advocates for lower drug prices say they don’t expect the IRA to become a political wedge like the Affordable Care Act was for years after its passage.

IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Who else is excited that D.C. could become a winter wonderland this season?

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

TODAY ON OUR PULSE CHECK PODCAST, your host Katherine talks with POLITICO health care reporter Megan Messerly, who breaks down the results of Tuesday’s election and discusses voters’ support for abortion rights, which cut across party lines and did significantly better with voters than President Joe Biden and other Democrats — and what that means for the 2024 race.

FDA REORGS DRUG QUALITY OFFICE — The FDA’s Center for Drug Evaluation and Research is restructuring its Office of Pharmaceutical Quality, CDER Director Patrizia Cavazzoni told staff in an email obtained by POLITICO.

Under the reorganization, the Office of New Drug Products, the Office of Lifecycle Drug Products and the Office of Biotechnology Products will become three Offices of Pharmaceutical Quality Assessment — two focused on drugs that mostly come in pill form and the third on drug substance assessment for pills and drugs that require injections or infusions.

The FDA is also centralizing research under a new Office of Pharmaceutical Quality Research and establishing an Office of Quality Assurance.

“The new structure reflects CDER’s lifecycle approach to product regulation, centralizes all OPQ research, and reinforces stronger connections between assessment, inspection, surveillance, research, policy, and administrative operations,” Cavazzoni wrote.

DRUG COMPANIES RESPOND TO FTC CHALLENGES — Drugmakers GSK, Kaléo and Boehringer Ingelheim Pharmaceuticals said they will dispute the Federal Trade Commission’s claims that they engaged in “improperly listed patents.”

“We stand behind our intellectual property where innovation in drug and drug-device combination products have contributed to millions of lives saved,” Lyndsay Meyer, a GSK company spokesperson, told Prescription Pulse.

The FTC said this week that it is challenging 100 patents involving 10 companies listed in what is known as the Orange Book, an annual FDA publication of approved therapies and relevant patents. Drugmakers provide the information in the book, and the move signals a more aggressive FTC stance on patent abuses. Specifically, the FTC said some alleged patent abuses might prevent cheaper generics from coming to market for therapies, such as those administered via inhalers and EpiPens.

Michele Baer, a spokesperson for Boehringer Ingelheim, said the patents in the Orange Book apply not just to the drugs, but also to their delivery methods. “These drug-device products are complex to research and develop and to secure the necessary regulatory approvals from FDA and global regulators, and they are more challenging to manufacture than a typical small molecule drug,” she told Prescription Pulse.

Teva, AstraZeneca, AbbVie, Amneal and Viatris, which also received patent challenges from the FTC, did not respond to a request for comment.

What’s next: The FDA must determine whether the FTC’s challenges are valid. If the FDA agrees with the FTC claims, patent holders will have 30 days to respond. But no deadline has been set for the FDA to complete its review.

WHAT’S NEXT FOR OBESITY DRUGS? The FDA’s approval this week of Eli Lilly’s obesity drug Zepbound creates an opening for more insurers to cover GLP-1 agonists, the booming class of medications treating diabetes and weight loss, Lauren writes. The injection joins Novo Nordisk’s Saxenda and Wegovy as drugs indicated specifically for weight management; others in the class are indicated for type 2 diabetes and have increasingly been prescribed off-label for obesity.

Dr. Katherine Saunders, an obesity expert and professor at Weill Cornell Medicine, said she hopes more competition in the weight-loss drug market will help drive down prices but anticipates coverage will be sparse unless Congress passes legislation reversing a 2003 law that prohibits Medicare coverage of weight-loss drugs. Lilly said Zepbound’s list price is about 20 percent lower than Wegovy’s.

Looking to the future: The next frontier for the drug class is oral medications, and at least three GLP-1s are in development, Saunders said.

A comparable pill alternative could be a game changer for the market, she said, in patient experience by providing a nonshot option and in price since pills tend to be cheaper to produce. Oral drugs are also less likely to be vulnerable to shortages, Saunders said, in contrast to the ongoing shortages of injectable medicines.

“Now that we have the most powerful anti-obesity medication ever approved, we need to focus on cost, coverage and supply to improve access to care for our patients,” Saunders said.

Novo Nordisk expects to file for FDA approval of a once-daily tablet for weight loss by the end of the year.

MODERNA BEEFS UP K STREET ROSTER — Moderna, known for its work on the Covid-19 vaccine and other messenger RNA-based technology, is expanding its footprint in Washington, Megan reports. The biotech company recently registered its first in-house lobbyist, John Lepore, who joined Moderna in August 2020 — signaling a desire to increase engagement with Capitol Hill and regulators.

Moderna also brought on its fourth lobbying firm, according to newly filed forms. The Washington Tax & Public Policy Group will work on corporate and international tax issues for the Massachusetts-based company. Moderna also has Brownstein Hyatt Farber Schreck, the No. 1 K Street firm by revenue; health care heavyweight Avenue Solutions; and Stanton Park Group on retainer.

A PUSH FOR POSTMARKETING TRIALS — Experts agree with FDA Commissioner Robert Califf’s assessment that his agency could play a leading role in requiring more postmarketing data to be used to reverse the recent declines in life expectancy in the U.S.

Billing and electronic medical records can “give regulators more latitude and a broader toolbox for evaluating safety and benefits in real-world settings,” former FDA Commissioner Scott Gottlieb told Prescription Pulse.

Gottlieb’s comments bolstered remarks Califf made this week at the Milken Future of Health Summit in Washington. “We need an evidence-generation system for the post-market phase,” Califf said.

In 2021, the average life expectancy in the U.S. was 76.4 years, according to the latest data from the CDC — about six years lower than the life expectancy in comparable countries. The U.S. life expectancy has also fallen for two straight years, even as peer countries have rebounded after the height of the pandemic.

But pharma companies may not want to play ball without prodding from Capitol Hill, Joseph Daval, a postdoctoral research fellow at Harvard Medical School who studies the FDA, told Prescription Pulse. “Reliance on post-market evidence is tough because companies already have what they want, which is approval,” Daval said. “There is absolutely a role for Congress to grant FDA clearer authority to require and gather post-market data.”

FDA APPROVES OTC COVID ANTIGEN TEST — The transition away from emergency use authorization inches forward — the FDA cleared on Thursday the first over-the-counter Covid antigen test.

The test — Acon Laboratories’ Flowflex — is intended to be used at least twice over three days with a minimum of 48 hours between tests to ensure accuracy, similar to many of the free at-home antigen tests provided by the government.

Emma Sands has joined Patients for Affordable Drugs as director of media and communications. Previously, she was at the communications firm BerlinRosen.

The FDA announced a Nov. 29 advisory committee meeting on the design of multicancer detection tests.