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FDA Seeks $8.4 Billion to Further Investments in Critical Public Health Modernization

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FDA Seeks $8.4 Billion to Further Investments in Critical Public Health Modernization

March 28, 2022: “The U.S. Food and Drug Administration announced it is requesting a total budget of $8.4 billion as part of the President’s fiscal year (FY) 2023 budget – a nearly 34% ($2.1 billion) increase over the agency’s FY 2022 appropriated funding level for investments in critical public health modernization, core food safety and medical product safety programs and other vital public health infrastructure.

The request includes $3.7 billion in budget authority – including an increase of $356 million, and $3 billion in user fees – an increase of $153 million.

The request also includes $1.6 billion in mandatory funding to support the FDA’s ability to prepare for future pandemics.

“The funding outlined in this year’s FDA budget request is critical to fulfilling the agency’s mission as we continue our work on a wide range of COVID-19 and non-COVID priorities.

The FDA has focused our budget request on some of today’s most urgent needs such as human and animal food safety, medical device security and e-cigarette oversight.

We also continue to look ahead at our role in public health, including at ways to modernize our efforts to keep pace with evolving science, technology and potential public health emergencies,” said FDA Commissioner Robert M. Califf, M.D.

“Additional funding brings new ways to leverage opportunities to protect and advance the health of every American with reliable and science-based information.

We look forward to continuing our work with Congress to help meet the critical public health challenges ahead.”

The FY 2023 request, which covers the period from Oct. 1, 2022, through Sept. 30, 2023, fully funds initiatives previously requested in the FY 2022 budget request and includes new efforts for high priority program areas. Highlights of the agency’s request include: 

Pandemic Preparedness

  • $1.6 billion over five years to support the FDA’s contributions to the HHS Pandemic Preparedness Plan. The FY 2023 Budget makes transformative investments in pandemic preparedness and biodefense across the U.S. Department of Health and Human Services’ public health agencies to enable an agile, coordinated and comprehensive public health response to future threats and protect American lives, families and the economy.

    This budget increase would allow the FDA to modernize its regulatory capacity by strengthening its IT and laboratory infrastructure.

    The agency will also focus on evaluation of vaccines and therapeutics to respond to any future pandemic or high consequence biological threat, facilitation of rapid development of diagnostics and work to support efforts to expand the personal protective equipment supply chain. 

Food Safety & Nutrition Modernization

  • $43 million in additional investments in food safety modernization, including animal food safety oversight. 
    The budget builds on the successes of human and animal food safety modernization activities and supports the agency’s continued implementation of the New Era of Smarter Food Safety and other core food safety efforts to enable the FDA to strengthen data-driven approaches to protecting consumers, allocating regulatory oversight resources based on risk and improving the FDA’s capacity to quickly respond to ongoing and evolving public health challenges.

    Building on the modernized food safety regulatory framework created by the FDA Food Safety Modernization Act, this funding will allow the agency to improve prevention-oriented food safety practices, strengthen data sharing and predictive analytics capabilities and enhance traceability to more quickly respond to outbreaks and recalls for human and animal food.

    The budget request advances mutual reliance efforts as part of the New Era of Smarter Food Safety by providing significant funding to state animal food programs.

    In partnership with states, the FDA will expand efforts to modernize, harmonize and transform the U.S. animal food inspection system to become more comprehensive and prevention oriented.
  • $14 million to improve health equity through nutrition. Through the Healthy and Safe Food for All initiative, the budget includes additional funding to reduce exposure to harmful chemicals and toxins in food.

    Additional funding and legislative proposals will focus specifically on better protecting mothers, infants and young children through contamination limits in food, product testing requirements, notification of anticipated significant interruptions in the supply of infant formula or essential medical foods, as well as modernization of dietary supplement regulation.

Advancing Access to Safe and Effective Medical Products

  • $20 million for the FDA’s efforts as part of Cancer Moonshot to speed progress in cancer research and improve cancer outcomes. 
    The budget request provides a one-time infusion of funding to advance a variety of research, external collaborations and educational outreach programs and continue to support development and regulation of oncology medical products through the Oncology Center of Excellence.

    The agency will build upon existing programs to advance Moonshot goals. 
  • $5 million increase toward improving the safety and security of medical devices. 
    Developing a more comprehensive cybersecurity program for medical devices will help to identify and mitigate vulnerabilities that could compromise medical systems or disrupt device manufacturing or consumer use, placing national security at risk.

    Dedicated base funding for a cybersecurity program will allow for FDA to hire additional staff to recruit and develop greater cyber expertise within the devices program, as well as administer grants and contracts to develop infrastructure geared towards addressing emerging cybersecurity challenges.
  • $5 million in additional funding to boost review capacity for premarket animal drug submissions. Continuing to meet performance commitments, including reduced application review times for animal drug reviews, is a priority for the agency. The number of animal drug submissions received have steadily increased over time and therefore more effort is needed to review the additional submissions within agreed upon user fee timeframes and subsequently increasing the availability of safe and effective animal drug products. 
  • $30 million in additional funds to advance the goal of ending the opioid crisis. Funding will address four priority areas of the epidemic including decreasing exposure and preventing new addiction, supporting the treatment of those with opioid use disorder, fostering the development of novel pain treatment therapies and improving enforcement and assessing benefit-risk.

Core Operations

  • $68 million in further investments in Data Modernization and Enhanced Technologies. 

    The budget provides increases to core programs and infrastructure aligned to the food and medical product programs as well as critical enterprise technology capabilities.

    Data-informed capabilities, such as artificial intelligence, machine learning and state-of-the-art solutions like blockchain, will be critical to support the FDA’s public health priorities.

    Data modernization will also allow the FDA to review large volumes of data more quickly to identify critical safety signals or emerging outbreaks. 
  • $100 million increase in user fees to support the FDA’s mission of reducing the use and harms of tobacco. 
    The request includes funding to enhance the FDA’s ongoing oversight of e-cigarettes and other ENDS products, which remains a high priority and is critical to the agency’s public health mission, especially, to protecting kids from the dangers of nicotine addiction and other harmful health consequences.

    The budget proposes the additional user fees and requests authority to include manufacturers and importers of all deemed products among the tobacco product classes for which the FDA assesses tobacco user fees.
  • $24 million to optimize inspections and enhance inspectional capacity. The budget request increases support for the recruitment and training of new FDA investigators to improve the efficiency of the agency’s human and animal food and medical product inspectional operations.

    With additional personnel, as well as expanding the use of new and existing inspectional tools, the FDA will enhance its inspectional capacity and build on the efforts to keep pace with rapidly expanding industry including medical counter measures and advanced manufacturing. 
  • $5 million in new funding for a comprehensive strategy for new, alternative methods for product testing. The budget includes funding to support a new, FDA-wide New Alternative Methods Program to reduce animal testing through the development of qualified alternative methods and spur the adoption of methods for regulatory use that can replace, reduce and refine animal testing. New alternative methods have the potential to provide both more timely and more predictive information to accelerate product development and enhance emergency preparedness. 

To complement the funding requests the agency’s budget proposal also includes a package of legislative proposals designed to bolster the FDA’s authorities to further its mission to protect and promote public health. Notable proposals include efforts to: 

  • Modernize dietary supplement regulation, seeking to require annual listing with the FDA of individual dietary supplement products, including basic information about each unique product.

    It is estimated the current supplement market is between 50,000 and 80,000 products.

    Additionally, the agency seeks to clarify its authorities over marketed dietary supplement products to better facilitate enforcement against unlawfully marketed products, allowing the FDA to know when new products are introduced, quickly identify dangerous or illegal products on the market and take appropriate action to protect consumers.
     
  • Require firms to notify the FDA of anticipated significant interruptions in the supply of infant formula or essential medical foods for patients with certain inborn errors of metabolism.

    This proposal would ensure the agency routinely receives timely and accurate information about likely or confirmed shortages in the U.S. and help the FDA to take steps to promote the continued availability of these foods.

    Additionally, the FDA is seeking authority to require firms to provide shortage notification for other FDA-designated categories of food during a declared public health emergency.  
  • Enhance drug and biologic accelerated approval provisions to help ensure that the confirmatory studies will progress in a timely manner and reap high-quality, interpretable results.

    This will help minimize the time that a product is marketed before its clinical benefit can be confirmed.

    The FDA is also proposing a technical fix to revise the accelerated approval withdrawal standard.
  • Amend the Hatch-Waxman 180-day patent challenge exclusivity provisions, so that the FDA can approve subsequent generic drug applications unless and until a first applicant begins commercial marketing of a drug and triggers the exclusivity period, at which point approval of subsequent applications would be blocked by 180 days.

    This would ensure that the exclusivity only lasts 180 days, as intended, rather than multiple years.

    This would substantially increase the likelihood that generic versions of patent-protected drugs come into the market in a timely fashion and would allow multiple versions of generic products to be approved quickly leading to significant cost savings. 
  • Require the destruction of imported products by their owner or consignee that have been refused and pose a significant risk to public health.

    The FDA believes this new authority would prevent the potential re-importation of these products and would deter owners and consignees from importing products they know to pose a significant public health risk.

    This authority could also increase efficiencies when Customs and Border Protection seizes an FDA-regulated product.
  • Assure a more resilient domestic supply chain for medical devices.

    This would include authority to require certain firms to provide notification of potential shortages with production volume information.

    In addition, it would establish a requirement for device manufacturers to perform risk assessments, implement risk management plans and identify alternate suppliers and manufacturing sites.

    The FDA is also proposing the temporary importation of unapproved devices, with appropriate scientific and regulatory controls, when needed to prevent or mitigate a shortage.”

https://www.fda.gov/news-events/press-announcements/fda-seeks-84-billion-further-investments-critical-public-health-modernization-core-food-and-medical

Federal judge enters consent decree against New Jersey raw animal food manufacturer

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Federal judge enters consent decree against New Jersey raw animal food manufacturer

March 28, 2022: “The U.S.FDA announced that Bravo Packing, Inc., an animal food manufacturing company of Carney’s Point, New Jersey, has agreed to stop selling, manufacturing and distributing raw pet food and come into compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Today’s action marks the first consent decree of permanent injunction against an animal food manufacturer for violating public safety standards under Part 507 (Current Good Manufacturing Practice (CGMP) requirements) of the Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food Regulation.

Part 507 requires, among other things, that animal food facilities take adequate precautions to prevent animal food from becoming contaminated and that all animal food manufacturing, processing, packing, and holding is conducted under the conditions necessary to minimize the potential for the growth of undesirable microorganisms to protect against the contamination of animal food. 

“The food we give our pets should be safe for them to eat and safe for people to handle,” said Steven Solomon, DVM, MPH, director of FDA’s Center for Veterinary Medicine.

“The FDA has taken this action to protect public health because, despite multiple inspections, notifications of violations, and recalls, this firm continued to operate under insanitary conditions and produce pet food contaminated with harmful bacteria.

We will not tolerate firms that put people or animals at risk and will take enforcement actions when needed.”

The FDA conducted inspections in 2019 and 2021 and issued a warning letter to the facility in 2020.

During these inspections, the FDA found evidence of significant food safety violations including grossly insanitary conditions and the failure to follow CGMP regulations for animal food.

Multiple samples of finished raw pet food products collected during the inspections tested positive for Salmonella.

Pet food that is contaminated with Salmonella can lead to illness in both the pets consuming the food, as well as humans, who handle the food and care for the pets.

Some of these finished samples as well as environmental samples from the two inspections also tested positive for Listeria monocytogenes.

The consent decree of permanent injunction entered by U.S. District Judge Noel L. Hillman between the FDA and Bravo Packing, Inc., along with the company’s owner and secretary, Joseph Merola, and its president, Amanda Lloyd, prohibits the defendants from receiving, preparing, processing, packing, holding, labeling, and/or distributing pet food unless and until the company completes corrective actions.

The decree also allows the FDA to order a shutdown, recall, or other corrective action in the event of future violations and requires the defendants to pay the costs of inspections performed pursuant to the decree.

Failure to abide by the agreement can also lead to civil or criminal penalties.

Consumers who think they or their pets may have been sickened by these products should seek the assistance of a health care professional and contact the FDA to report problems with this or any FDA-regulated product.

The U.S. Department of Justice filed the complaint on behalf of the FDA.”

https://www.fda.gov/news-events/press-announcements/federal-judge-enters-consent-decree-against-new-jersey-raw-animal-food-manufacturer

Jazz Pharma Announces Significant New Investment in UK Manufacturing

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Jazz Pharma Announces Significant New Investment in UK Manufacturing

March 25, 2022: “Construction begins on a new state-of-the-art manufacturing facility at Kent Science Park designed to support the manufacture of regulatory approved cannabis-based medicines

This represents a significant commitment to the UK by GW Pharmaceuticals, now part of Jazz Pharmaceuticals, investing $100 million (£75m) and creating more than 100 highly skilled jobs

LONDON, March 25, 2022 /PRNewswire/ — Jazz Pharmaceuticals plc and its subsidiary, GW Pharmaceuticals (“GW”) – a world leader in discovering, developing and delivering regulatory approved cannabis-based medicines –announced the official initiation of construction of its new, state-of-the-art manufacturing facility at Kent Science Park (KSP) in Sittingbourne.”

http://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-significant-new-investment-uk

Poolbeg Pharma presents new deal with AI in developing new RSV drugs

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Poolbeg Pharma presents new deal with AI in developing new RSV drugs

Poolbeg Pharma PLC  Jeremy Skillington joins Proactive London to talk about their new deal – using a state of the art artificial intelligence tool to find new drug targets for respiratory syncytial virus (RSV).

Under the terms of a deal with OneThree Biotech, it will screen for putative treatments that focus in on the immune-response pathways, have a higher probability of clinical success and have the potential to prevent and/or treat infectious diseases. 

Skillington says their ‘OneThree Biotech’s AI analysis tools will allow us to break new ground in data-driven drug discovery, by allowing us to evaluate and interrogate human challenge trial data like never before’.

https://www.proactiveinvestors.co.uk/companies/news/975001/poolbeg-pharma-s-jeremy-skillington-presents-new-deal-with-ai-in-developing-new-rsv-drugs-975001.html

AZ’s Evusheld combination recommended for prevention of COVID-19

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AZ’s Evusheld combination recommended for prevention of COVID-19

March 24, 2022: “AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union EU for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

People not adequately protected by a COVID-19 vaccine may particularly benefit from pre-exposure prophylaxis with Evusheld.

This includes about three million people in the EU who are immunocompromised or being treated with immunosuppressive medicines.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on a review of Evusheld data, including results from the PROVENT Phase III pre-exposure prophylaxis trial, which showed a 77% reduction in the risk of developing symptomatic COVID-19 compared to placebo at the primary analysis and an 83% reduction at a six month median analysis, with protection from the virus continuing for at least six months.

Evusheld was generally well-tolerated in the trial.2-4

Hugh Montgomery, Professor of Intensive Care Medicine at University College London, UK and Evusheld investigator said: “Despite the success of vaccinations, we still need additional measures to prevent the spread of COVID-19 infections in Europe, where the number of cases of the highly transmissible BA.2 subvariant is rapidly increasing and where public health safety measures have been relaxed in many countries.

This broad recommendation for Evusheld will allow health authorities in the EU to identify priority, high-risk populations needing additional protection such as people with cancer, transplant patients, or anyone taking immunosuppressive medicines, as well as those at increased risk of exposure.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Today’s positive CHMP recommendation represents a significant step forward in our ongoing efforts to introduce additional, important preventative measures for people in Europe at higher risk of developing COVID-19. 

Evusheld has the potential to provide long-lasting protection to vulnerable populations such as the immunocompromised who can’t mount an adequate response to a COVID-19 vaccine, and we’ll continue to work with governments in Europe to make Evusheld available as quickly as possible.”

The recommended dose of Evusheld in Europe is 150mg of tixagevimab and 150mg of cilgavimab, administered as two separate sequential intramuscular (IM) injections.

There is a growing body of evidence from multiple independent in vitro and in vivo (animal model) studies supporting the potential of Evusheld to protect against the BA.1, BA.1.1 and BA.2 Omicron SARS-CoV-2 subvariants in circulation around the world.

New data from Washington University School of Medicine demonstrated Evusheld retained potent neutralising activity against the emerging and highly transmissible BA.2 subvariant, which is the dominant strain in many European countries and currently accounts for nearly 60% of COVID-19 infections in Europe.  

This study also showed Evusheld reduced viral burden and limited inflammation in the lungs (in vivo) across all Omicron variants.

Evusheld is authorised for emergency use for pre-exposure prophylaxis of COVID-19 in the US and in six countries in Europe. Evusheld has also been granted conditional marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain for pre-exposure prophylaxis of COVID-19.

AstraZeneca anticipates that the European Commission will shortly complete its review of the CHMP positive opinion to determine whether to grant marketing authorisation.

Evusheld is the only long-acting antibody combination with positive Phase III data in the prevention and treatment of COVID–19.

AstraZeneca is progressing with filings around the globe for potential emergency use authorisation or marketing approval of Evusheld in both COVID-19 prophylaxis and treatment.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/evusheld-long-acting-antibody-combination-recommended-for-approval-in-the-eu-for-the-pre-exposure-prophylaxis-prevention-of-covid-19.html

First ever country level estimates of unintended pregnancy and abortion

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First ever country level estimates of unintended pregnancy and abortion

March 24, 2022: “The Guttmacher Institute, the World Heath Organization and the UN’s Human Reproduction Programme (HRP) released the first-ever model-based estimates of unintended pregnancy and abortion rates for 150 countries, highlighting major disparities in access to sexual and reproductive health care.

The study, published in BMJ Global Health, analyzes rates from 2015 to 2019, with the aim of providing deeper insights into access to sexual and reproductive health services in countries of all income levels across the globe. 

“To build sexual and reproductive health policies that are truly inclusive and equitable, we need to understand what is happening at a country level,” said Dr Herminia Palacio, President and CEO of the Guttmacher Institute.

“Having current and reliable data at hand will not only help identify and find solutions to disparities, but also make a case for smarter investments that deliver impact.” 

Alongside the estimates, Guttmacher has published more detailed country profiles to allow decision makers and health advocates to better understand and act on sexual and reproductive health needs in their countries, particularly for family planning, including contraception and comprehensive abortion care. 

Regional averages mask large disparities in unintended pregnancy and abortion rates

The new estimates indicate that unintended pregnancy and abortion rates vary widely between countries—even within the same region or geographic area.

The greatest variations were found in Latin America and sub-Saharan Africa, where for instance, unintended pregnancy rates in countries ranged from 41 to 107 per 1000 women, and 49 to 145 per 1000 women respectively.

These disparities are not shaped purely by income-level: in Europe, for example, most countries with higher unintended pregnancy rates than the regional average are classified as high-income, while the two countries with the lowest estimates are middle-income.

This finding reflects how barriers to accessing and using effective sexual and reproductive healthcare exist in settings with greater as well as fewer resources.

“These variations speak to the need for investment, even in regions with low unintended pregnancy rates, that empowers women and girls across countries to choose under what circumstances they want to have children,” says Jonathan Bearak, a senior research scientist at Guttmacher Institute and lead author of the article.

“The proportion of unintended pregnancies ending in abortion—as great as 68%, even among countries that completely prohibited abortion—illustrates the strength of the desire of millions of women and adolescents to avoid unplanned childbearing.”

While the estimates go a long way in increasing the quality of evidence available, there remains a pressing need for more and better data.

The availability of reliable abortion data varied substantially by region, ranging from 12 percent of countries in Western Asia and Northern Africa to 73 percent of countries in Europe and Northern America.

With additional investments in country data collection, it would be possible to make estimates with greater certainty, monitor trends and possibly assess the impact of large-scale programmes in the future.

Sexual and reproductive health and rights are an essential part of universal health coverage and are required to end discrimination against women and girls.

These country-level estimates highlight the importance of equitable investment in comprehensive sexual and reproductive health care, and will further inform countries working to implement WHO’s new guidelines for quality abortion services.

“For good health, people in countries around the world need access to a comprehensive package of sexuality education, accurate family planning information and services, as well as quality abortion care,” said Dr Bela Ganatra, who leads WHO’s Prevention of Unsafe Abortion unit.

“This research aims to support countries as they work to strengthen the lifesaving services they provide for sexual and reproductive health and improve health outcomes – especially for women and girls.”

https://www.who.int/news/item/24-03-2022-first-ever-country-level-estimates-of-unintended-pregnancy-and-abortion

Effect of COVID-19 on Tuberculosis in the U.S.

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Effect of COVID-19 on Tuberculosis in the U.S.

March 24, 2022: “In the United States, reported tuberculosis (TB) disease diagnoses fell 20% in 2020 and remained 13% lower in 2021 than TB disease diagnoses made prior to the COVID-19 pandemic, according to preliminary CDC data published today.

The new data suggest that the pandemic has had a substantial effect on TB trends in the United States. Before COVID-19, TB disease diagnoses typically declined between 1% and 2% each year.

The 2020 and 2021 declines may be related to factors associated with the COVID-19 pandemic, including a true reduction in incidence as well as delayed or missed TB diagnoses. For example:

  • Efforts to prevent COVID-19, such as wearing masks and staying six feet away from others, may also reduce the spread of TB.
  • Widespread disruptions to healthcare during the COVID-19 pandemic may have delayed TB diagnoses. The COVID-19 pandemic has strained public health services, including TB prevention and control services.
  • Similarities in symptoms between COVID-19 and TB disease may have led to missed TB diagnoses.
    Case reports have revealed some people with TB disease were evaluated for COVID-19 — but not tested for TB — during multiple encounters with healthcare systems.
    Initial misassumptions might have contributed to missed diagnoses, or delayed diagnoses until more advanced stages of disease.

TB prevention and control activities are essential public health functions for communities throughout the United States.

To assist in these efforts, CDC launched the Think. Test. Treat TB campaign to help raise awareness of TB and recognize the importance of TB prevention.

Starting a conversation with your doctor is the first step to protecting your family, friends, and community from TB disease.

Please attribute the following quote to Philip LoBue, MD, FACP, FCCP, Director of CDC’s Division of Tuberculosis Elimination

“Delayed or missed tuberculosis disease diagnoses are threatening the health of people with TB disease and the communities where they live.

A delayed or missed TB diagnosis leads to TB disease progression and can result in hospitalization or death – and the risk of transmitting TB to others.

The nation must ensure that healthcare providers understand how to diagnose and distinguish TB disease from potential cases of COVID-19.”

https://www.cdc.gov/media/releases/2022/s0324-tuberculosis-covid-19.html

FDA Issues Decisions on Additional E-Cigarette Products

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FDA Issues Decisions on Additional E-Cigarette Products

March 24, 2022: “The U.S. FDA took additional actions as part of the agency’s work to ensure any electronic nicotine delivery system (ENDS) products available for sale have demonstrated that marketing of the products is appropriate for the protection of the public health. 

What You Need to Know

  • The FDA authorized several tobacco-flavored ENDS products from Logic Technology Development LLC (Logic) under the Logic Vapeleaf, Logic Power and Logic Pro brands, including devices.

    These products were authorized after the agency’s review of the product applications concluded, among other things, that the likely benefit for adult smokers who significantly reduce their cigarette use (or who switch completely and experience cigarette use cessation) outweighs the risk to youth, provided that the company follows postmarketing requirements to reduce youth access and youth exposure to their marketing. While today’s action permits these specific products to be sold in the U.S., it does not mean these products are safe nor are they “FDA approved.”

    All tobacco products are harmful and potentially addictive. Those who do not use tobacco products shouldn’t start. 
  • The agency also issued marketing denial orders to Logic for multiple other ENDS products. Any of those products currently on the market must be removed or FDA may take enforcement action.

    Retailers should contact Logic with any questions about products in their inventory. Applications for Logic’s additional products, including menthol, remain under FDA review.
  • The FDA has taken action on approximately 99% of the nearly 6.7 million ENDS products submitted for premarket authorization, including issuing marketing denial orders for more than 1 million ENDS products. 
  • The agency is close to making additional decisions on applications for popular ENDS products that account for a large part of the market.

    The continued marketing of these products has the potential to have a substantial public health impact—either positively or negatively—as they hold an overall large market share and are used by a lot of people. 

“As a cardiologist, I’ve personally seen the devastating health effects of tobacco use, so I’m highly motivated for the FDA to help reduce death and disability caused by these products,” said FDA Commissioner Robert M. Califf, M.D.

“We know that there is a demand among adult smokers to use e-cigarette products to try to switch from more harmful combusted cigarettes, but millions of youth are using these products and getting addicted to nicotine.

The balance of these issues was considered by the agency’s career scientists when evaluating the potential marketing of e-cigarette products.

They have made great progress and I know they will use the best available evidence with the most robust methods to ensure that products that continue to be marketed are appropriate for the protection of the public health.”

Under the Premarket Tobacco Product Application (PMTA) pathway, manufacturers or importers must demonstrate to the agency, among other things, that marketing of a new tobacco product would be appropriate for the protection of the public health.

That statutory standard requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products.

The FDA must also consider the likely impact of the products on people’s behavior—specifically, the likelihood that existing users will stop using such products and the likelihood that those who do not use tobacco products will start using such products.

This is especially important for youth. Before a product is authorized under the PMTA pathway, the agency reviews a tobacco product’s components, ingredients, additives, constituents and health risks, as well as how the product is manufactured, packaged and labeled.

“Ensuring new tobacco products undergo premarket evaluation by the FDA is a critical part of our work to reduce tobacco-related disease and death,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products.

“For the authorized products, the manufacturer demonstrated that possible benefits to adult smokers outweigh the risk of youth possibly initiating.

We are making progress in our review of flavored ENDS, and we will continue to deny marketing of products where the applicant hasn’t provided enough evidence to show that the potential benefit to adult smokers outweighs the considerable risk to youth.

We are committed to continuing to take the appropriate actions to protect our nation’s youth from the dangers of all tobacco products, including e-cigarettes, which remain the most commonly used tobacco product by youth in the United States.”

Logic Authorizations 

The FDA’s review of the applications for the products authorized today determined that the marketing of the tobacco-flavored products and associated components is appropriate for the protection of the public health.

The FDA authorized these tobacco-flavored ENDS products because, among several key considerations, the data submitted by the company and the available evidence show that marketing these products may help addicted adult smokers transition away from combusted cigarettes and reduce their risk of exposure to harmful and potentially harmful toxins compared to combusted cigarettes.

At the same time, the data showed there was low risk for non-users, including youth, to use the products. The risk was also low for non-users, including youth, to progress to regular use of the products.

Specifically, available data showed that current tobacco users who used these tobacco-flavored products were more likely to significantly decrease their use of combusted cigarettes and that those who don’t smoke are unlikely to start using these products.

Most study subjects decreased the number of combusted cigarettes they smoked each day by greater than 80%, from an average of 13-16 cigarettes per day at screening to 1-2 by day 59.

The data also showed that the products produce fewer or lower levels of some toxins, like carbon monoxide, than combustible cigarettes and the products’ abuse liability, or their ability to encourage continued tobacco use, addiction or dependence, was lower than combusted cigarettes. 

Additionally, today’s authorization imposes strict marketing restrictions on the company to greatly reduce the potential for youth exposure to tobacco advertising for these products.

The FDA will closely monitor how these ENDS products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers—including youth—using these products. 

As evidenced through data collected via the National Youth Tobacco Survey, compared to users of non-tobacco-flavored ENDS products, young people are less likely to start using tobacco-flavored ENDS products.

The data also suggest that most youth and young adults who use ENDS begin with flavors such as fruit, candy or mint, and not tobacco flavors.

These data reinforce the FDA’s decision today, consistent with past decisions, to authorize the marketing of the tobacco-flavored ENDS products in part because they are not significantly appealing to youth and authorizing these products may be beneficial for individual adult combusted cigarette users who completely switch to ENDS or significantly reduce their cigarette consumption.

The FDA may suspend or withdraw a marketing order issued under the PMTA pathway for a variety of reasons, including if the agency determines the continued marketing of a product is no longer “appropriate for the protection of the public health,” such as if there is a notable increase in youth initiation.”

https://www.fda.gov/news-events/press-announcements/fda-issues-decisions-additional-e-cigarette-products

FDA to Hold Advisory Committee Meeting on COVID-19 Vaccines to Discuss Future Boosters

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FDA to Hold Advisory Committee Meeting on COVID-19 Vaccines to Discuss Future Boosters

March 21, 2022: “The U.S. FDA is announcing a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Wed., April 6, to discuss considerations for future COVID-19 vaccine booster doses and the process for selecting specific strains of the SARS-CoV-2 virus for COVID-19 vaccines to address current and emerging variants.

Along with the independent experts of the advisory committee, representatives from the U.S. Centers for Disease Control and Prevention and the National Institutes of Health will participate in the meeting.

“As we prepare for future needs to address COVID-19, prevention in the form of vaccines remains our best defense against the disease and any potentially severe consequences,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

“Now is the time to discuss the need for future boosters as we aim to move forward safely, with COVID-19 becoming a virus like others such as influenza that we prepare for, protect against, and treat.

Bringing together our panel of expert scientific external advisors in an open, transparent discussion about booster vaccination is an important step to gain insight, input and expert advice as we begin to formulate the best regulatory strategy to address COVID-19 and virus variants going forward.”

The April 6 VRBPAC meeting is intended to assist the agency in developing a general framework that will inform its regulatory decision-making on:

  • What might warrant updating the composition of COVID-19 vaccines to address specific variants. 
  • Timing and populations for COVID-19 vaccine booster doses in the coming months.  

No vote is planned at this meeting and there will not be any discussion of any product-specific applications. 

The FDA intends to make background material available to the public, including the meeting agenda and committee roster, no later than two business days before the meeting. 

In general, advisory committees include a Chair, members with scientific, medical and public health expertise and a consumer and industry representative.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-hold-advisory-committee-meeting-covid-19-vaccines-discuss-future

COVID-19 vaccines continue to protect against hospitalization and death among adults

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COVID-19 vaccines continue to protect against hospitalization and death among adults

March 18, 2022: “COVID-19 vaccination continues to help protect adults against severe illness with COVID-19, including hospitalizations and death, according to two reports released in today’s MMWR.

During Omicron, COVID-19-associated hospitalization rates increased for all adults, regardless of vaccination status, but rates were 12 times higher among adults who were unvaccinated compared to adults who received a booster or additional doses.

Hospitalization rates were also highest among non-Hispanic Black adults and nearly 4 times as high among Black adults than White adults during the peak of Omicron.

Additionally, mRNA vaccines continued to be highly effective at protecting against COVID-19-associated ventilation or death, including during the Omicron period.

Protection was highest in adults who received a third vaccine dose, reducing the risk for COVID-19-associated ventilation or death during the Omicron period by 94%.

CDC continues to recommend that everyone 5 years and older stay up to date on their COVID-19 vaccines, including a booster dose for those who are eligible.

We also must work to ensure everyone has equitable access to vaccines and treatments by focusing efforts on reaching people who have been disproportionately affected, so that they can be protected from the effects of the virus, including severe illness, hospitalization, and death.”

https://www.cdc.gov/media/releases/2022/s0318-COVID-19-vaccines-protect.html

Pfizer to Supply UNICEF up to 4 Million Treatment Courses of Novel COVID-19 Oral Treatment

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Pfizer to Supply UNICEF up to 4 Million Treatment Courses of Novel COVID-19 Oral Treatment

March 22, 2022: “Pfizer Inc. announced an agreement with UNICEF to supply up to 4 million treatment courses of its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), to 95 low- and middle-income countries, pending authorization or approval.

This includes all low- and lower-middle-income countries and some upper-middle-income countries in Sub-Saharan Africa as well as countries that have transitioned from lower-middle to upper-middle-income status in the last five years, accounting for approximately 53% of the world’s population.

Financial details of the agreement were not disclosed. Pfizer expects supply to be available to support orders in April 2022, and supply will continue throughout 2022, pending regulatory authorization or approval and according to country needs.

All low- and lower-middle-income countries will be offered the treatment courses at the not-for-profit price while upper-middle-income countries will pay the price defined in Pfizer’s tiered pricing approach.

“We have seen the negative impacts of COVID-19 in every part of the world and know that we must work towards access for all people regardless of where they live or their circumstances,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

“Supplying to UNICEF is an important part of our comprehensive strategy to accelerate access to PAXLOVID to treat COVID-19 infection as quickly as possible and at an affordable price in order to decrease the strain on healthcare systems and help save lives in low- and middle-income countries.”

Our Commitment to Equitable Access
Pfizer is committed to working toward equitable access to PAXLOVID for all people, aiming to deliver safe and effective antiviral therapeutics as soon as possible and at an affordable price.

During the pandemic, Pfizer will offer its oral therapy through a tiered pricing approach, pending country authorization or approval, based on the income level of each country to promote equity of access across the globe.

High and upper-middle income countries will pay more than lower income countries.

Pfizer continues to invest to support the manufacturing and distribution of PAXLOVID, including exploring potential contract manufacturing options.

As a result of these efforts, Pfizer has raised its production projections, with the ability to produce up to 120 million courses of treatment by the end of 2022, pending global demand.

The company has initiated bilateral outreach to more than 100 countries around the world and has entered into agreements with multiple countries.

Additionally, Pfizer has signed a voluntary license agreement with the Medicines Patent Pool (MPP) for its oral treatment to help expand access, pending country regulatory authorization or approval, in 95 low- and middle-income countries that account for approximately 53% of the world’s population.

About PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets)
PAXLOVID is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy.

It was developed to be administered orally so that it can be prescribed at the first sign of infection or, pending clinical success of the rest of the EPIC development program and subject to regulatory authorization, at first awareness of an exposure – potentially helping patients avoid severe illness (which can lead to hospitalization and death) or avoid disease development following contact with a household member who contracts COVID-19.

Nirmatrelvir [PF-07321332], which originated in Pfizer laboratories, is designed to block the activity of the Mpro, an enzyme that the coronavirus needs to replicate.

Co-administration with a low dose of ritonavir helps slow the metabolism, or breakdown, of nirmatrelvir in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.

Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication.

In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions.

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus.

PAXLOVID, however, works intracellularly by binding to the highly conserved Mpro of the SARS-CoV-2 virus to inhibit viral replication.

Nirmatrelvir has shown consistent in vitro antiviral activity against earlier and current variants of concern (i.e., Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron).

PAXLOVID is generally administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice-daily for five days.

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

U.S. FDA Emergency Use Authorization Statement

PAXLOVID has not been approved, but has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS CoV-2 viral testing, and who are at high-risk for progression to severe COVID-19, including hospitalization or death.

The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.

AUTHORIZED USE

The U.S. FDA has issued an EUA for the emergency use of the unapproved product PAXLOVID for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

LIMITATIONS OF AUTHORIZED USE

  • PAXLOVID is not authorized for initiation of treatment in patients requiring hospitalization due to severe or critical COVID-19
  • PAXLOVID is not authorized for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19
  • PAXLOVID is not authorized for use for longer than 5 consecutive days

PAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which PAXLOVID belongs (i.e., anti-infectives).

PAXLOVID is not approved for any use, including for use for the treatment of COVID-19.

PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act unless the authorization is terminated or revoked sooner.

IMPORTANT SAFETY INFORMATION
PAXLOVID is contraindicated in patients with a history of clinically significant hypersensitivity reactions (eg, toxic epidermal necrolysis [TEN] or Stevens-Johnson syndrome) to its active ingredients (nirmatrelvir or ritonavir) or any other components of the product.

PAXLOVID is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions:

  • Alpha1-adrenoreceptor antagonist: alfuzosin
  • Analgesics: pethidine, propoxyphene
  • Antianginal: ranolazine
  • Antiarrhythmic: amiodarone, dronedarone, flecainide, propafenone, quinidine
  • Anti-gout: colchicine
  • Antipsychotics: lurasidone, pimozide, clozapine
  • Ergot derivatives: dihydroergotamine, ergotamine, methylergonovine
  • HMG-CoA reductase inhibitors: lovastatin, simvastatin
  • PDE5 inhibitor: sildenafil (Revatio®) when used for pulmonary arterial hypertension
  • Sedative/hypnotics: triazolam, oral midazolam

PAXLOVID is contraindicated with drugs that are potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance. PAXLOVID cannot be started immediately after discontinuation of any of the following medications due to the delayed offset of the recently discontinued CYP3A inducer:

  • Anticancer drugs: apalutamide
  • Anticonvulsant: carbamazepine, phenobarbital, phenytoin
  • Antimycobacterials: rifampin
  • Herbal Products: St. John’s Wort (hypericum perforatum)

There are limited clinical data available for PAXLOVID. Serious and unexpected adverse events may occur that have not been previously reported with PAXLOVID use.

Risk of Serious Adverse Reactions Due to Drug Interactions: Initiation of PAXLOVID, a CYP3A inhibitor, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving PAXLOVID, may increase plasma concentrations of medications metabolized by CYP3A. Initiation of medications that inhibit or induce CYP3A may increase or decrease concentrations of PAXLOVID, respectively. These interactions may lead to:

  • Clinically significant adverse reactions, potentially leading to severe, life-threatening, or fatal events from greater exposures of concomitant medications
  • Clinically significant adverse reactions from greater exposures of PAXLOVID
  • Loss of therapeutic effect of PAXLOVID and possible development of viral resistance

Consult Table 1 of the Fact Sheet for Healthcare Providers for clinically significant drug interactions, including contraindicated drugs.

Consider the potential for drug interactions prior to and during PAXLOVID therapy; review concomitant medications during PAXLOVID therapy and monitor for the adverse reactions associated with the concomitant medications.

Hypersensitivity reactions have been reported with PAXLOVID including urticaria, angioedema, dyspnea, mild skin eruptions, and pruritus.

Cases of anaphylaxis, TEN, and Stevens-Johnson syndrome have also been reported with components of PAXLOVID (refer to NORVIR labeling).

If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue PAXLOVID and initiate appropriate medications and/or supportive care.

Hepatotoxicity: Hepatic transaminase elevations, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir. Therefore, caution should be exercised when administering PAXLOVID to patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis.

Because nirmatrelvir is co-administered with ritonavir, there may be a risk ofHIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection.

Adverse events in the PAXLOVID group (≥1%) that occurred at a greater frequency (≥5 subject difference) than in the placebo group were dysgeusia (6% and <1%, respectively), diarrhea (3% and 2%), hypertension (1% and <1%), and myalgia (1% and <1%). The proportions of subjects who discontinued treatment due to an adverse event were 2% in the PAXLOVID group and 4% in the placebo group.

The following adverse reactions have been identified during post-authorization use of PAXLOVID. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders: Hypersensitivity reactions.”

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-supply-unicef-4-million-treatment-courses-novel

FDA Statement on Medical Device User Fee Amendments (MDUFA)

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FDA Statement on Medical Device User Fee Amendments (MDUFA)

March 22, 2022: “The FDA and representatives from the medical device industry have reached an agreement on proposed recommendations for the fifth reauthorization of the medical device user fee program.

Under the new agreement, the FDA would be authorized to collect at least $1.78 billion in user fees over five years, plus additional funding, for a total of up to $1.9 billion to further improve performance if specified goals are met.

This funding would provide critical resources to the FDA medical device review program.

The proposed recommendations have been posted on our website and will be published in the Federal Register for public comment.

Additionally, the MDUFA V public meeting will be held virtually April 19, 2022, to provide the public an opportunity to learn more about and provide their views on the proposed recommendations.

The final recommendations are scheduled to be delivered to Congress in April 2022, after FDA considers public input on the proposed recommendations and revises them as necessary.

“The agreement underscores the continued commitment by the FDA and medical device industry to prioritize innovation and increase patient access to safe and effective medical devices,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

“In addition, MDUFA V represents a substantial investment in the future of the agency’s medical device program and would provide for important improvements, including new hiring targets, greater engagement with developers of innovative technologies based on lessons learned from the pandemic, broadened international harmonization efforts and expanded opportunities to ensure patient perspectives are an integral part of medical device development.” 
 

https://www.fda.gov/news-events/press-announcements/fda-statement-medical-device-user-fee-amendments-mdufa

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