Biden on the clock to name a permanent FDA commissioner

By David Lim and Lauren Gardner

Presented by The Pharmaceutical Care Management Association

With help from Sarah Owermohle and Megan R. Wilson.

— Time is likely almost up on the acting FDA chief’s tenure atop the agency.

— Moderna’s feud with the Biden administration over its vaccine patent has spilled over onto Twitter.

— Novavax adds another firm to lobby on its behalf.

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FDA COMMISSIONER WATCH — Monday marks the last day Janet Woodcock can remain FDA’s acting commissioner unless President Joe Biden nominates someone permanently to the post.

The agency has been without a confirmed head for more than 10 months despite having to make critical pandemic decisions, including authorizing booster and pediatric shots.

Here are three scenarios that could play out:

— Woodcock is nominated to permanently lead the FDA despite vocal opposition from key Democratic senators.

— A new acting commissioner is named to the role, resetting the 210-day nonpresidential transition Vacancies Act clock.

— Biden nominates someone else and Woodcock stays in the acting role until the Senate confirms a permanent commissioner.

Don’t expect a splashy public announcement today; Biden is scheduled to participate in the Asia-Pacific Economic Cooperation Leaders’ meeting and receive his daily briefing in the morning before holding a Cabinet meeting to discuss the bipartisan infrastructure deal after lunch. The president heads to Camp David in the late afternoon.

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BABY NOW WE GOT BAD BLOOD — Moderna unleashed a tweetstorm Thursday defending its decision not to include three government scientists on its Covid vaccine patent filing, POLITICO’s Sarah Owermohle writes, the latest altercation in its public battle with the Biden administration over its obligations to American taxpayers and global citizens.

The backstory: National Institutes of Health Director Francis Collins told Reuters this week that the U.S. plans to fight for those scientists to be included on the patent. Federal officials worked alongside the company in the pandemic’s early days, sharing resources and know-how in hopes of quickly developing an effective vaccine against the novel virus. But by the summer of 2021, the administration began losing patience with Moderna’s obstinance against sending doses to low- and middle-income countries that couldn’t pay top dollar for them, as Sarah and POLITICO’s Adam Cancryn and Erin Banco reported last week.

What Moderna says: The company argues that the NIH scientists were not part of selecting the messenger RNA sequence — the secret sauce Moderna wants to protect via patent — that became the Covid-19 shot in use today.

Moderna “has recognized the substantial role that the NIAID has played” in the vaccine development by including those scientists on other patents but “just because someone is an inventor on one patent application relating to our COVID-19 vaccine does not mean they are an inventor on every patent application relating to the vaccine,” it tweeted.

“For those who would seek to twist Moderna’s good faith application of U.S. patent law, nothing could be further from the truth,” the company added. “Moderna remains the only company to have pledged not to enforce its COVID-19 intellectual property during the pandemic.”

NOVAVAX ADDS LOBBYING POWER — Vaccine developer Novavax added a fourth lobbying firm to its roster of outside influence shops, POLITICO’s Megan R. Wilson reports. Lobbyists at Crowell & Moring will be working on "issues related to vaccine policy," per disclosure forms. Novavax and lobbyists at the firm didn't respond to a request for more details about the work.

POLITICO reported last month that the company has been running into production and quality problems with its protein-based Covid-19 vaccine that make it unable to pass muster with U.S. regulators, but Novavax expects to apply for FDA for emergency authorization by the end of the year.

Lobbyists on the account include Kate Beale, a former top lobbyist at PhRMA and Obama-era official at the U.S. Agency for International Development, and Jim Flood, former counsel for Senate Majority Leader Chuck Schumer.

IS THERE A LINK BETWEEN LONG COVID AND ALZHEIMER’S? — One aspect of long Covid that researchers are watching is whether there’s a connection between the cognitive symptoms some patients experience and the biological changes some Alzheimer’s experts believe contribute to the disease. A consortium of international researchers has been meeting regularly to compare notes on what doctors are seeing in so-called long-haulers with neurological complications like brain fog and other impairments, Heather Snyder, the Alzheimer’s Association vice president of medical and scientific relations, told Lauren from the sidelines of this week’s Clinical Trials on Alzheimer’s Disease conference.

The University of Texas Health Science Center at San Antonio is recruiting 900 adults who have recovered from Covid to study why some experience prolonged symptoms or develop new ones after their acute infections resolve. Some participants in the study, which is part of NIH’s long Covid initiative, with neurological symptoms will receive MRIs and spinal taps to try to ascertain why those symptoms develop or persist.

Researchers in locations from Argentina to New York have reported changes in the underlying biologies of long Covid patients experiencing cognitive impairments that are associated with Alzheimer’s, like the clumping of proteins in the brain. What’s still unknown, Snyder said, is whether that’s temporary, or if those individuals are somehow predisposed to developing the disease.

“It does underscore the need to continue to look at this relationship, understand what this relationship might be in terms of, does it impact a person’s risk,” she said. “We have to be asking these questions, and we have to understand what that long-term impact is on the brain.”

FDA TALKS DIGITAL HEALTH AT FDLI — The FDA must take an “efficient, risk-based approach” when regulating novel digital health technologies, Deputy Commissioner for Policy, Legislation and International Affairs Andi Lipstein Fristedt told the Food and Drug Law Institute’s digital health conference this week.

“With any new technology, careful oversight is needed to ensure digital health devices are safe, and their benefits outweigh the risks,” Lipstein Fristedt said. “But we also know that safe and effective technology may be of limited value if patients don't have timely access to it.”

She argued it is critical that digital health technologies are designed in a manner that promotes health equity.

“We believe it's essential that the data used to train artificial intelligence and machine learning enabled devices represent the intended patient population with regard to demographics such as age, gender, sex, race and ethnicity,” she said.

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FTC REQUIRES ANI AND NOVITIUM TO DIVEST TWO GENERICS — The Federal Trade Commission announced Wednesday it is requiring ANI Pharmaceuticals and Novitium Pharma to divest development rights for generic sulfamethoxazole-trimethoprim oral suspension and assets tied to generic dexamethasone tablets to Prasco. The settlement is intended to remedy what FTC described as a likely anticompetitive acquisition of Novitium.

“Today’s settlement preserves future competition in two important generic pharmaceutical markets by ensuring that ongoing product development efforts for both drugs are in the hands of firms that have the same incentive to enter the market and drive down prices as existed between ANI and Novitium prior to the merger,” Holly Vedova, director of the Bureau of Competition, said in a statement.

NIH: SOME CANCER DRUGS COULD BE REPURPOSED FOR ALZHEIMER’S — New NIH-backed research suggests emerging and existing cancer drugs could be tested as Alzheimer’s therapies for people genetically predisposed toward the disease, repurposing the treatments as potential early interventions. One approved and one experimental cancer drug studied did target some of the proteins seen in the brains of Alzheimer’s patients, and lab experiments showed they reduced brain inflammation.

Aduhelm news: Biogen announced Thursday that plasma samples from more than 1,800 participants in the Phase III clinical trial for its Alzheimer’s drug Aduhelm “showed a statistically significant correlation between plasma p-tau reduction and less cognitive and functional decline” in the disease. The company said earlier this week it’s investigating the death of a 75-year-old patient who’d experienced brain swelling while taking the drug.

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Paula Witt joins the Association for Accessible Medicines as its senior manager of state government affairs. She was previously director of judicial education in the Law & Economics Center of George Mason University’s Antonin Scalia Law School.

Boehringer Ingelheim has added Alex Rothenburger as senior associate director of public policy and Kirby Consier as senior associate director for state government affairs covering the Southeast. Rothenburger was most recently manager of strategic and policy analytics at the Children’s Hospital Association, and Consier was most recently associate director for state government affairs at Novartis.

Zachary Kiser is now director of government relations and advocacy for NephCure Kidney International. He is a House Select Subcommittee on the Coronavirus Crisis and Sen. Sherrod Brown (D-Ohio) alum.

A coalition of businesses argued in federal court Tuesday that they would suffer “irreparable harm” if the court fails to permanently halt the Biden administration’s Covid-19 vaccine-or-test mandate for large businesses, as the legal challenges make their way through the courts, POLITICO’s Rebecca Rainey reports.

Secretary of State Antony Blinken laid out three new initiatives on Wednesday that he said would accelerate the equitable distribution of vaccines worldwide, POLITICO’s Carmen Paun reports.

Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA.

FDA’s top biologics regulator talks vaccine manufacturing methods — At a Drug Information Association conference this week, Peter Marks offered his thoughts — and some far-reaching ideas — about how the supply chain for vaccine products might be reimagined to meet the needs of a future pandemic . One idea is to invest heavily in so-called “advanced manufacturing” methods, a term used by FDA to describe novel technologies or production methods. Marks’ hope is that such methods could be used to miniaturize vaccine manufacturing setups such that an entire vaccine production process could fit into standardized shipping containers and be sent to countries that lack sufficient manufacturing capacity or experience. A standardized, miniaturized manufacturing approach might also help standardize product quality across regions, help rapidly scale up production to meet demand, and assist with training workers using common methods. Marks said a combination of both centralized manufacturing techniques (which can make enormous numbers of products) and localized manufacturing (i.e., shippable units) was probably ideal, which he referred to as “diversified manufacturing.”

Abbott is scheduled to discuss durable medical equipment, prosthetics, orthotics and supply policy issues with the White House Office of Information and Regulatory Affairs next Friday.

A message from The Pharmaceutical Care Management Association:

PBMs advocate for patients in the fight to keep prescription drugs accessible and affordable. Here are five ways PBMs improve patient outcomes:

· Keeping patients safe by working with their health care team and reviewing their prescriptions to prevent potentially dangerous interactions.
· Negotiating rebates from drug manufacturers and discounts from pharmacies to make drugs more affordable.
· Supporting proposals to update Medicare Part D to improve affordability, increase choice and competition, and align stakeholder incentives, including rewarding pharmacies that promote quality care and improve clinical outcomes.
· Offering home delivery of chronic medications through mail-service pharmacies.
· Providing real-time benefit tools so physicians and patients know, at the point of prescribing, what drugs are on formulary — covered by insurance — and what patients’ cost-sharing will be.

Learn more at OnYourRxSide.org.

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