Cavazzoni named permanent top FDA drug regulator — Pfizer asks FDA to greenlight vaccine for young teens — Biden wants more money for health agencies

By David Lim

Presented by Pharmaceutical Care Management Association

With Emily Martin

— Patrizia Cavazzoni is named permanent top FDA drug regulator.

— Pfizer asks FDA to greenlight its coronavirus vaccine for younger teens.

— Biden wants more money for federal health agencies.

It's Tuesday, welcome back to Prescription Pulse. Your author is contemplating the existence of AI-generated cat pictures. As always, send tips to David Lim (dlim@politico.com or @davidalim).

A message from Pharmaceutical Care Management Association:

The Biden Administration postponed the effective date for the Medicare rebate rule until 2023. Despite the delay, uncertainty remains. The cleanest path forward to avoid disruption to Part D, caused by jarring monthly premium increases, is for Congress to quickly repeal the rebate rule outright.

CAVAZZONI’S ROLE AS TOP DRUG REGULATOR MADE PERMANENT — Acting FDA Commissioner Janet Woodcock announced Monday in an agency-wide email that Patrizia Cavazzoni is now the permanent director of the Center for Drug Evaluation and Research.

The ascension of Cavazzoni — who worked for nearly two decades in the pharmaceutical industry in roles at Eli Lilly, Sanofi and Pfizer prior to joining the FDA in 2019 — likely indicates Woodcock will either be nominated as President Joe Biden’s FDA leader or will retire from the agency.

“I hold a deep appreciation for the CDER Director role, having spent most of my FDA career with the Center. This action means that my official position of record is now the Principal Medical Advisor to the Commissioner, a position I was detailed to last year. Of course, I’m also serving as your Acting Commissioner,” Woodcock wrote to FDA staff.

Cavazzoni became the acting leader of the high-profile drug center last Maywhen Woodcock was detailed to work on Operation Warp Speed, POLITICO’s Adam Cancryn reports. Cavazzoni was previously the center’s deputy director for operations. She also did a monthlong stint as the FDA’s acting principal deputy commissioner in 2019.

ABORTION PILL LIMITS LIFTED — The Biden administration is lifting restrictions on the dispensing abortion pills by mail during the Covid-19 pandemic, reversing a Trump administration policy that the Supreme Court backed in January, Alice Miranda Ollstein reports.

It’s the latest change-up in a longstanding battle over the drug mifepristone. The government previously required people seeking medication abortions to obtain the pills in-person from a medical provider. But FDA said in a letter released late Monday that allowing patients to receive the pills via telemedicine and through the mail will not increase patients' risks and will help keep them from contracting the coronavirus.

Lawmakers in several several states, including Indiana, Arkansas, Iowa, Alabama, Texas, Oklahoma, Wyoming and West Virginia, have been working to preemptively ban the pills or make them more difficult to obtain in anticipation of the policy shift.

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THE SECRET TO NEW MEXICO’S VACCINE SUCCESS — The state’s early decision to rely on a vaccine registry run by its public health department and deep experience delivering healthcare to underserved communities has made New Mexico’s vaccination operation one of the most efficient nationwide . The success comes despite a litany of public health challenges including poverty and poor health care outcomes.

“You’re not chasing a vaccine, we’re chasing you,” Democratic Gov. Michelle Lujan Grisham told POLITICO’s Dan Goldberg.

New Mexico in recent days became the state first to provide at least one dose to half of its adult population, and a nation-leading 38 percent of adults are fully vaccinated. It’s also among the top-performing states on equity: Over 26 percent of Blacks, 32 percent of Hispanics, and 41 percent of Asians received at least one shot, according to a Kaiser Family Foundation review of the 41 states publicly reporting ethnic and racial data.

“They are an exemplar,” said Georges Benjamin, the executive director of the American Public Health Association. “Their model works.”

PFIZER ASKS FDA TO OK VACCINE FOR YOUNGER TEENS — Pfizer and its partner BioNTech on Friday asked the FDA to greenlight its coronavirus vaccine for use in children 12 to 15 years old, just one week after the companies said a late-stage trial showed the vaccine was highly effective in this age group, POLITICO’s Sarah Owermohle reports.

If U.S. regulators clear the request, it would make Pfizer's shot the first to become available to younger teens. The move could also speed the timeline for getting more students back into school and curb costly safety measures being considered by education systems.

Of the three vaccines already in use in the United States, Pfizer's shot is the only one now authorized for 16- and 17-year-olds. Pfizer and BioNTech said they plan to submit similar requests to regulators in other countries in the coming days.

STUDY: REGENERON ANTIBODY COCKTAIL CAN PREVENT COVID-19 — An antibody cocktail made by Regeneron reduced the risk of symptomatic Covid-19 by 81 percent in people living with a person infected with the virus, the company said Monday.

The findings, from a late-stage clinical trial of about 1,500 people, suggest that monoclonal antibodies — lab-made drugs that mimic the body's natural defenses — can prevent Covid-19, rather than just treating it.

The Regeneron drug, known as REGEN-COV, also appears to reduce the length of symptomatic Covid-19 infections. People who got the treatment cleared their symptoms in one week, compared to three weeks in those who received a placebo.

GILEAD HALTS STUDY OF REMDESIVIR IN NON-HOSPITALIZED PATIENTS – Gilead announced late Monday it is ceasing its late-stage clinical trial of Veklury (remdesivir) in high-risk, non-hospitalized Covid-19 patients.

The antiviral medication — which received FDA approval in October — has been widely given to hospitalized Covid-19 patients. But Gilead said it has had trouble enrolling patients in the Phase 3 study in part because it required a multiday IV infusion treatment in a health care setting.

“The decision to stop the study is not due to efficacy or safety concerns,” the company said in a press release. Gilead still expects results from an early-stage study of an inhaled version of remdesivir under development later this year.

BIDEN BUDGET SEEKS MORE MONEY FOR HEALTH AGENCIES — The CDC and other federal health agencies would be in line for significant funding boosts under President Joe Biden's fiscal 2022 budget blueprint.

POLITICO’s Adriel Bettelheim reports the CDC would see a $1.6 billion funding bump over fiscal 2021 enacted levels, to $8.7 billion, to upgrade public health data collection and enhance the agency's ability to respond to global threats. Biden also calls for $905 million in spending on the National Strategic Stockpile, to replenish medical supplies and continue a restructuring that began during the health crisis.

The National Institutes of Health would get a $9 billion increase to $51 billion. The sum includes $6.5 billion to establish an Advanced Research Projects Agency for Health, which would initially focus on cancer, diabetes and Alzheimer's research.

But the document, released Friday, contains few details for FDA watchers: the document states that the administration “would make investments to enhance FDA’s organizational capacity.”

“Major new investments in FDA are justified and we are hopeful that will be reflected in the full budget request,” the Alliance for a Stronger FDA wrote in an email. “Until that document is released, the answer to virtually all budget questions will fall into the category of ‘not enough information to know or even knowledgeably speculate.’”

A message from Pharmaceutical Care Management Association:

FIRST IN PRESCRIPTION PULSE: CSRxP LAUNCHES DRUG PRICING CAMPAIGN — The Campaign for Sustainable Rx Pricing is launching a campaign in 10 states and DC that aims to push policymakers to implement “bipartisan market-based solutions” to lower prescription drug prices.

“While Americans battled a pandemic and provided drug companies billions of taxpayer dollars for vaccines, Big Pharma continued to hike drug prices at egregious rates and engage in anti-competitive behavior to keep prices high,” CSRxP executive director Lauren Aronson said in a statement.

FDA OKS FIRST AI DEVICE TO HELP DOCTORS DETECT COLON CANCER — The FDA on Friday announced it has granted De Novo marketing authorization to the first AI device that can help providers detect polyps or suspected tumors in the colon during a colonoscopy.

“Studies show that during colorectal cancer screenings, missed lesions can be a problem even for well-trained clinicians,” said Courtney Lias, the acting director of the FDA’s GastroRenal, ObGyn, General Hospital and Urology Devices Office. “With the FDA’s authorization of this device today, clinicians now have a tool that could help improve their ability to detect gastrointestinal lesions they may have missed otherwise.”

IRHYTHM THREATENS TO WITHDRAW CONTINUOUS ECG DEVICE FROM MEDICARE — Health technology company iRhythm Technologies announced Monday it is planning to discontinue its long-term continuous ECG monitoring service for Medicare fee-for-service patients due to recently announced reimbursement rates by Medicare Administrative Contractor Novitas.

“Due to the cost of providing the service relative to the updated rates published by Novitas, iRhythm will not be able to provide its Zio XT service to the Medicare fee for service segment if these rates remain unchanged,” the company said in a statement Monday. “Accordingly, iRhythm is preparing an operating plan to discontinue serving this Medicare segment with Zio XT that it expects to begin implementing in the second quarter.

MICROSOFT AGREES TO BUY NUANCE FOR $19.7B — Microsoft said Monday that it has agreed to acquire conversational AI company Nuance Communications for approximately $19.7 billion. The deal — which is expected to close this year — would give Microsoft a suite of clinical speech recognition products.

DIASORIN SIGNS $1.8B DEAL TO ACQUIRE LUMINEX — Diagnostics company DiaSorin announced Sunday it signed an agreement to purchase Luminex for approximately $1.8 billion. The deal is expected to close in the third quarter of 2021.

ITALY FEARS MOB INFILTRATED VACCINE CAMPAIGN — Italian lawmakers fear the mafia is diverting vaccines away from those who need them the most, POLITICO EU’s Hannah Roberts reports.

With Italy struggling to get its vaccination campaign on track, the parliament's anti-mafia commission is investigating whether crime syndicates are redirecting vaccines to their friends, particularly in the south where they often exert control over health authorities.

EU COURT RULES MANDATORY CHILDHOOD VACCINES OK — The European Court of Human Rights ruled that the Czech Republic’s law requiring childhood vaccination doesn’t violate the European Convention on Human Rights, POLITICO EU’s Ashleigh Furlong reports.

The case brought before the ECHR concerned several parents who had refused vaccines for their children and had received a fine, while other parents had been unable to send their children to nursery school.

The ECHR, however, said that the Czech policy “pursued the legitimate aims of protecting health as well as the rights of others” and that in all decisions concerning children “their best interests must be of paramount importance.”

TUNE IN TO GLOBAL TRANSLATIONS: Our Global Translations podcast, presented by Citi, examines the long-term costs of the short-term thinking that drives many political and business decisions. The world has long been beset by big problems that defy political boundaries, and these issues have exploded over the past year amid a global pandemic. This podcast helps to identify and understand the impediments to smart policymaking. Subscribe and start listening today.

Wednesday: Acting FDA Commissioner Janet Woodcock virtually addresses the Alliance for a Stronger FDA at 11:30 a.m. EST.

The House Energy and Commerce Health Subcommittee holds a virtual hearing on how to combat the substance use disorder epidemic at 10:30 a.m. EST.

Thursday: The Senate Finance Committee convenes to weigh the nominations of Andrea Joan Palm to be HHS deputy secretary and Chiquita Brooks-LaSure to be CMS Administrator at 9:30 a.m. EST.

Biogen said Friday that the Foundation for the National Institutes of Health’s Maria Freire and CityLink Investment Corporation’s William Jones are being nominated to stand for election to its board of directors at the company’s annual shareholder meeting on June 2.

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

MACPAC: Increase rebates for drugs granted accelerated approval: The Medicaid and CHIP Payment and Access Commission (MACPAC) last week approved a recommendation to Congress to increase Medicaid rebates for drugs approved by the FDA under its Accelerated Approval pathway until confirmatory testing is completed. If adopted, these recommendations could provide an extra financial incentive for firms to complete post-market studies. According to a 2018 report from the FDA, 31% of required studies were not completed on time.

What’s next for AstraZenca’s vaccine? The FDA is expected to receive an application for emergency authorization from AstraZeneca in the coming weeks for its COVID-19 vaccine candidate, AZD1222. But following a series of development setbacks for the vaccine, the FDA’s review process is slated to be more challenging than it was for vaccine developers Pfizer, Moderna and Janssen. In this analysis, AgencyIQ explores some of the factors that may complicate the FDA’s review of AstraZeneca’s vaccine, including whether it will meet the statutory criteria to obtain an Emergency Use Authorization by the time of its application.

BioPharma Dive’s Ben Fidler and Ned Pagliarulo recap the American Association of Cancer Research's virtual meeting.

STAT’s Usha Lee McFarling takes a deep dive into the lack of diversity at top medical journals.

FDA announced a virtual public meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee will be held on May 11.

FDA, NIAID and the CDC announced an April 23 public workshop to discuss the nonclinical and clinical pharmacology data and clinical trial design considerations regarding developing antimicrobial drugs for the treatment of gonorrhea.

FDA posted a list of Accreditation Scheme for Conformity Assessment-accredited testing laboratories.

The Institute for Clinical and Economic Review posted a protocol for how it will examine “unsupported price increases” for U.S. prescription drugs.

The American College of Radiology announced Monday it is launching the ACR National Clinical Imaging Research Registry.

A message from Pharmaceutical Care Management Association:

Medicare beneficiaries appreciate the Biden Administration’s decision to delay the prescription drug rebate rule which would increase Medicare Part D premiums 25% and cost taxpayers $170 billion. Congress and the Administration should now permanently repeal the rebate rule and instead advance real solutions that lower the costs of prescription drugs.

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