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By LAUREN GARDNER and DAVID LIM 

Presented by The American Association of Kidney Patients (AAKP)

With Katherine Ellen Foley and Rachael Levy.

— FDA limits use of two monoclonal antibodies as Omicron dominates U.S. case count.

— Pfizer and BioNTech have begun testing an Omicron-specific vaccine in adults.

— FDA issued complete response letters to two therapy applications from Pfizer and Merck.

It’s Tuesday. Welcome back to Prescription Pulse. One of your co-authors achieved a 20-day Wordle streak to begin the week.

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

A message from The American Association of Kidney Patients (AAKP):

Kidney disease affects an estimated 37 million Americans and disproportionately impacts individuals in black and brown communities across this country. The AAKP’s fundamental purpose for advocating and representing the interests of kidney patients has improved treatments for those who suffer, but tremendous work remains to be done. A new FDA-approved treatment to alleviate some patient suffering is finally available, but CMS must make changes to ensure all patients have access. The time is now.

FDA RESTRICTS 2 MONOCLONAL ANTIBODIES AS OMICRON DOMINATES — FDA limited use Monday of two monoclonal antibody treatments believed to be ineffective against the Omicron variant, Lauren reports. The cocktails by Eli Lilly and by Regeneron are not permitted for use in any U.S. jurisdictions because the highly contagious strain now accounts for nearly all domestic infections, regulators said. They can be prescribed only when a patient is likely to have contracted a variant that’s responsive to the treatment.

FDA’s move comes as the number of authorized Covid treatments has grown, but some are in short supply. Omicron’s dominance has strained the availability of sotrovimab, GlaxoSmithKline and Vir’s monoclonal antibody that’s shown effectiveness against the variant, and the two antiviral pill options are in short supply and have their own limitations, Lauren writes.

Not happy: Florida health officials are livid about FDA’s decision. Republican Gov. Ron DeSantis has pushed for the administration to keep shipping all three antibody cocktails while arguing that some people are still getting infected with the Delta strain. Kenneth A. Scheppke, Florida's deputy secretary for health, accused federal health officials of canceling a phone meeting Monday to discuss the state’s request for 30,000-plus doses of sotrovimab and Regen-COV, Regeneron’s treatment, according to an email shared by the agency.

PFIZER: 3 VACCINE DOSES FIGHT OFF OMICRON — A pair of manufacturer-backed lab studies suggests a third dose of the current Pfizer-BioNTech vaccine formulation provokes enough antibodies to fight off the Omicron variant, the companies announced Monday. People who received two doses were shown in tests to have limited antibody levels against the strain, though the companies said they believe the primary series still protects against severe illness thanks to the body’s memory immune cells.

PFIZER, BIONTECH LAUNCH OMICRON VACCINE TRIALS — Participants in Pfizer and BioNTech’s Omicron-based Covid-19 vaccine have received their first doses, the companies announced today. The study will compare Pfizer’s current Covid-19 vaccine to one based on the widely circulating variant as a booster or fourth shot in adults who have received two or three doses and a primary vaccine series and booster in those who haven’t been vaccinated yet.

“While current research and real-world data show that boosters continue to provide a high level of protection against severe disease and hospitalization with Omicron, we recognize the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future,” Kathrin Jansen, Pfizer’s senior vice president and head of vaccine research and development, said in a statement.

Pfizer and BioNTech have plans to produce 4 billion vaccine doses this year, regardless of whether regulators and public health officials deem an Omicron-specific shot necessary.

CMS EXPLORING HAVING MEDICARE COVER HOME TESTS — Biden officials are working to figure out how Medicare will cover rapid covid tests for the program’s roughly 64 million beneficiaries, a senior official at the Centers for Medicare and Medicaid Services told POLITICO’s Rachael Levy.

“Medicare has not covered over-the-counter tests before, so this is a new area that we are very quickly developing operations,” the senior administration official said Friday.

The official declined to specify the agency’s approach or provide a timeline for rollout. But, the official said, “we are thinking through all different options… we want to make sure that we are turning over every stone to try to improve access as best we can.”

FDA AUTHORIZES NEW AT-HOME TEST — FDA announced Monday it granted emergency use authorization to a new over-the-counter serial test. The test, made by Maxim Biomedical, can be used as a single test by people with Covid-19 symptoms.

REGULATORS BACK REMDESIVIR USE IN NON-HOSPITALIZED PATIENTS — FDA late Friday expanded the permitted use of remdesivir, an intravenous antiviral drug, to include nonhospitalized Covid patients ages 12 and up who are at risk of progressing to severe illness. The treatment was previously limited to hospitalized patients. Regulators also revised the drug’s emergency use authorization to permit treatment of at-risk pediatric Covid patients weighing 3.5 kilograms to less than 40 kilograms, which opens remdesivir use up to younger children.

N95 MASK GIVEAWAY ROLLING OUT — A nationwide distribution of N95 masks kicked off at a Hy-Vee in West Des Moines, Iowa, on Friday, according to a Biden administration official. The first set of federally qualified health centers are scheduled to receive the more protective masks this week and next.

“Last week masks began shipping and arriving at pharmacies and grocers around country,” the official said. “We expect that throughout the week the number of stores and N95s arriving to scale up significantly.”

A message from The American Association of Kidney Patients (AAKP):

FDA DECLINES TO APPROVE THERAPIES FROM MERCK, PFIZER — FDA issued complete response letters to Merck for an oral chronic cough treatment and Pfizer and OPKO Health for their recombinant human growth hormone treatment, each company announced.

WALENSKY CALLS FOR OVERHAUL OF U.S. PUBLIC HEALTH SYSTEM — The U.S. needs to rethink its approach to tackling Covid-19 by rebuilding the nation’s public health system, Centers for Disease Control and Prevention Director Rochelle Walensky told POLITICO’s Erin Banco. As she and her agency face criticism for confusing public messaging and the agency’s inability to track critical Covid data more quickly, Walensky pointed out that it needs other players — including other federal agencies and private companies — to cooperate.

“I actually really think many people have thought, this is CDC’s responsibility, to fix public health [and] the pandemic,” she told Erin. “The CDC alone can’t fix this. Businesses have to help, the government has to help, school systems have to help. This is too big for the CDC alone.”

I AM ALS has named Laura Dalle Pazze its chief executive officer. She was previously president and chief operating officer at Charley’s Fund, a Duchenne muscular dystrophy advocacy group.

TODAY: Johnson & Johnson holds its earnings call at 8:30 a.m. EST.

FDA Acting Chief Scientist Jacqueline A. O'Shaughnessy speaks on an Alliance for a Stronger FDA webinar at 1 p.m. EST.

THURSDAY: Altria Group, Inc. holds its earnings call at 9 a.m. EST.    

QUESTIONS FOR J&J — Are you invited to be on the line this morning for J&J’s earnings call? Allow your Prescription PULSE scribes to propose some questions:

— How has the CDC’s stated preference for messenger RNA vaccines targeting Covid affected the company’s plans for its own shot? Is there an ETA for J&J to apply for full FDA approval?

— What’s the status of J&J studying its vaccine in children?

— What’s the latest on J&J’s plans to pursue an Omicron-specific vaccine?

WHO EUROPE HEAD HOPES PANDEMIC EMERGENCY TO END THIS YEAR — Hans Kluge, director of the World Health Organization's Europe region, said Monday that Europe and the Central Asia region are entering a new phase in the coronavirus pandemic that could lead to a more stable situation, POLITICO EU’s by Carlo Martuscelli reports. “The pandemic is far from over, but I am hopeful we can end the emergency phase in 2022 and address other health threats that urgently require our attention,” Kluge said to members of the media at an event marking two years of the pandemic in Europe.

The tendency for viruses to mutate has public health experts worried antiviral pills could lead to resistant Covid infections that require combinations of treatments, The Wall Street Journal’s Jared S. Hopkins and Felicia Schwartz report.

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

FDA wholesale drug distribution regulation clears White House review — The White House Office of Information and Regulatory Affairs has completed its review of an FDA proposed rule aimed at unifying the licensing system for wholesale distributors and third-party logistics providers, indicating the proposed rule may soon be published. The rule in question is an offshoot of the Drug Supply Chain Security Act of 2013, which sought to strengthen the pharmaceutical supply chain.

The FDA’s new proposed rule aims to “establish standards for State licensing of prescription drug wholesale distributors and third-party logistics providers,” and “establish a Federal system for wholesale drug distributor and third-party logistics provider licensing for use in the absence of a State licensure program.” However, the rules are unlikely to go into effect for several years, according to AgencyIQ’s analysis.

FDA issued draft guidance Friday laying out the agency’s thinking on how a digital health technology can be verified and validated for use in a clinical investigation, how they can be used to collect data for trial endpoints, and how to identify and manage related risks.

FDA also published technical specifications Friday outlining how companies should submit clinical trial data sets for treatment of noncirrhotic nonalcoholic steatohepatitis, a subcategory of nonalcoholic fatty liver disease, to the agency.

A message from The American Association of Kidney Patients (AAKP):

Kidney disease has an incredibly alarming and growing impact on Americans and their families, and a disproportionate impact across minority communities, with black Americans being four times more likely to suffer from kidney failure than their white peers. This means a need for kidney replacement therapy, such as regular dialysis treatments, which are often linked to miserable side effects, including itching under the skin. This condition, called Chronic Kidney Disease-associated Pruritis (CKD-aP), affects 30-70% of kidney patients and has been associated with poor quality of life, poor sleep, depression, and an increased risk of infection, hospitalization, and death. No FDA-approved treatment has been available until recently, but doctors aren’t ready to offer this treatment to their Medicare patients until there is long-term coverage from CMS. This is a health equity issue with a clear solution. Learn more and help ensure all Americans have choice and access to available treatment options.