Category: FDA

Green Light Ahead-Novavax COVID-19 VACCINE

Vaccines and Related Biological Products Advisory Committee Meeting June 7, 2022 FDA Briefing Document Novavax COVID-19 Vaccine Link https://www.fda.gov/media/158912/download

The Vaccines and Related Biological Products Advisory Committee unanimously (one member abstained) voted to grant Emergency Use Authorization to Novavax (the Sponsor) for emergency use authorization (EUA) of the Novavax COVID-19 Vaccine for the treatment in people over the age of 18.

According to Peter Marks, MD, Director of FDA’s Center for Biologics Evaluation and Research: “We do have a problem with vaccine uptake that is very serious in the United States,”. “And anything we can do to get people more comfortable with these potentially life-saving medical products is something that we feel we are compelled to do.” This acknowledgment is a step in the right direction.

Next Steps- FDA will then determine whether to grant the EUA which will most definitely happen. Stay tuned.

Abbott Laboratories Infant Forumula

Here is the proposed consent decree, press release below, complaint and direct links to those documents. The proposed consent decree which Abbott Laboratories agreed to was filed by the United States Department of Justice. Upon Court approval, this will afford the opportunity for Abbott Laboratories to resume operations though under the parameters of the consent decree. The link to the letter from the United States Department of Justice regarding the safety of infant formula is included below and the final link is to the complaint.

https://www.justice.gov/asg/page/file/1506016/download

https://www.justice.gov/opa/pr/justice-department-files-complaint-and-proposed-consent-decree-ensure-safety-abbott

https://www.justice.gov/opa/press-release/file/1506076/download

Monday, May 16, 2022

Justice Department Files Complaint and Proposed Consent Decree to Ensure Safety of Abbott Laboratories’ Infant Formula

The United States has filed a complaint and a proposed consent decree that, if entered by a federal court in the Western District of Michigan, would allow Abbott Laboratories (Abbott) to resume manufacturing powdered infant formula at its Sturgis, Michigan, facility but also would require the company to take specific measures designed to increase safety and ensure compliance with the Federal Food, Drug, and Cosmetic Act (FDCA) and the U.S. Food and Drug Administration’s (FDA) Good Manufacturing Practice Requirements.   

“The actions we are announcing today will help to safely increase the supply of baby formula for families,” said Attorney General Merrick B. Garland. “The Justice Department will vigorously enforce the laws ensuring the safety of our food and other essential consumer products, and we will work alongside our partners across government to help make sure those products are available to the American people.”

In a complaint filed May 16, the United States alleged that Abbott, Division Vice-President of Quality Assurance Lori J. Randall, Sturgis Director of Quality Keenan S. Gale, and Sturgis Site Director TJ Hathaway manufactured powdered infant formula under conditions and using practices that failed to comply with regulations designed to ensure the quality and safety of infant formula, including protection against the risk of contamination from bacteria such as Cronobacter sakazakii. The Cronobacter sakazakii bacteria can live in dry foods, such as powdered infant formulas, and can cause deadly sepsis or meningitis in infants. The complaint further alleged that FDA testing of environmental samples taken in February detected Cronobacter sakazakii in the defendants’ manufacturing facility. 

Abbott has agreed to resolve the complaint in a proposed consent decree of permanent injunction. Under the proposed consent decree, which must still be reviewed and entered by a federal court, Abbott must retain outside expert assistance to bring its facility into compliance with the FDCA and good manufacturing practice regulations. Among other things, the expert will assist Abbott, under FDA supervision, in the development of plans designed to reduce and control the risk of bacterial contamination, and will periodically evaluate Abbott’s compliance with the FDCA, regulations, and the consent decree. The proposed consent decree also follows a thorough FDA inspection of the Sturgis facility and ongoing efforts by Abbott to address observations made during that inspection. The proposed consent decree sets out what Abbott must do to resume safely manufacturing infant formula at the Sturgis facility, which will help to mitigate the shortage of infant formula while also protecting public health.

“Federal laws regarding the safe manufacture of food, particularly food for infants, must be rigorously enforced,” said Principal Deputy Assistant Attorney General Brian Boynton, head of the Justice Department’s Civil Division. “The proposed consent decree underscores the Department’s commitment to protecting our most vulnerable citizens while also ensuring access to an essential product.”

“Parents who feed their babies formula must have confidence these products are safe,” said U.S. Attorney Mark Totten for the Western District of Michigan. “This proposed consent decree aims to protect one of our most vulnerable populations. My office is fully committed to supporting FDA and working with its partners at the Consumer Protection Branch to ensure manufacturers in our district comply with FDA’s safety regulations.”

“Today’s action means that Abbott Nutrition has agreed to address certain issues that the agency identified at their infant formula production facility in Michigan,” said FDA Commissioner Robert M. Califf, M.D. “The public should rest assured that the agency will do everything possible to continue ensuring that infant and other specialty formulas produced by the company meet the FDA’s safety and quality standards, which American consumers have come to expect and deserve. We recognize the hardships that parents and caregivers have faced in obtaining infant formula and the FDA is focused on boosting the availability of the country’s supply of these products, including new steps regarding importation. We are also taking a look at the supply of infant formulas developed by manufacturers across the country and around the world to determine if a reallocation of their distribution can be made to help get the right product to the right place, at the right time.”

All Matters FDA March 31 Virtual Symposium

Food and Drug Law books  published 2022 new editions —Full Print and 12 Subject specific E-Books and a full print E-Book.  Please pass on to colleagues and anyone  you think would benefit.
https://fortipublications.com print and subject specific E-book links

1pm-5pm Virtual

Registration NOW OPEN >

all-matters-fda-2022Download PDF

12th Annual Food and Drug Law Symposium

Find out the latest about COVID-19 from FDA’s Biologics Center Director Dr. Marks and other notable speakers. Other topics include criminal and civil enforcement, mandatory food recalls, vaping, e-cigarettes, unsafe pet products in the marketplace. 

Moderator:

■   Christopher Mondics  —  Legal Affairs Journalist, Philadelphia, PA

Invited Speakers:

■   Hon. Giovanni O. Campbell  —   Philadelphia Court of Common Pleas   —   Ethics and Professional Conduct

■   Brook Duer, Esquire  —   Center for Agricultural & Shale Law, Penn State Univ.   —   Food Law Cases

■   Michael Helbing, Esquire  —   Associate Chief Counsel for Enforcement, U.S. Food & Drug Administration   —   Enforcement

■   George D. Lapsley  —   Food Safety Expert  —   Court Appointed Expert – Miller’s Organic Farm 

■   Peter Marks, M.D., PhD.,  —   Director, Center for Biologics Evaluation & Research U.S. Food & Drug Administration   —  
COVID-19 Vaccines

■   Matthew Noonan and Lillian Hsu  —   U.S. Food & Drug Administration FDA Preventive Controls (PC) experts in CFSAN Office of Compliance   —   Enforcement

■   Jessica J. Sleater, Esquire  —   Andersen Sleater Sianni LLC, New York,  NY    —   Pet Product Safety

■   Roseann B. Termini, Esquire  —   Food & Drug Law Legal Scholar, Food & Drug Law Courses, Delaware Law School   —  
Symposium Director   —   Year in Review

■   Julia Tierney, Esquire  —   Chief of Staff, U.S. Food & Drug Administration   —   FDA Through the Pandemic: COVID-19 and Beyond 

4 CLE credits (2 Ethics & 2 Substantive) in DE and PA

REGISTRATION NOW OPEN! All Matters FDA March 31 Virtual

Save the Date March 31, 2022

1pm-5pm Virtual

Registration NOW OPEN >

all-matters-fda-2022Download PDF

12th Annual Food and Drug Law Symposium

Find out the latest about COVID-19 from FDA’s Biologics Center Director Dr. Marks and other notable speakers. Other topics include criminal and civil enforcement, mandatory food recalls, vaping, e-cigarettes, unsafe pet products in the marketplace.  Invited Speakers/Designees to date include:

Moderator:

■   Christopher Mondics  —  Legal Affairs Journalist, Philadelphia, PA

Invited Speakers:

■   Hon. Giovanni O. Campbell  —   Philadelphia Court of Common Pleas   —   Ethics and Professional Conduct

■   Brook Duer, Esquire  —   Center for Agricultural & Shale Law, Penn State Univ.   —   Food Law Cases

■   Michael Helbing, Esquire  —   Associate Chief Counsel for Enforcement, U.S. Food & Drug Administration   —   Enforcement

■   George D. Lapsley  —   Food Safety Expert  —   Court Appointed Expert – Miller’s Organic Farm 

■   Peter Marks, M.D., PhD.,  —   Director, Center for Biologics Evaluation & Research U.S. Food & Drug Administration   —  
COVID-19 Vaccines

■   Matthew Noonan and Lillian Hsu  —   U.S. Food & Drug Administration FDA Preventive Controls (PC) experts in CFSAN Office of Compliance   —   Enforcement

■   Jessica J. Sleater, Esquire  —   Andersen Sleater Sianni LLC, New York,  NY    —   Pet Product Safety

■   Roseann B. Termini, Esquire  —   Food & Drug Law Legal Scholar, Food & Drug Law Courses, Delaware Law School   —  
Symposium Director   —   Year in Review

■   Julia Tierney, Esquire  —   Chief of Staff, U.S. Food & Drug Administration   —   FDA Through the Pandemic: COVID-19 and Beyond 

4 CLE credits (2 Ethics & 2 Substantive) in DE and PA

UPDATE! All Matters FDA March 31 Virtual

UPDATE!

Save the Date March 31, 2022

1pm-5pm Virtual

Pre Registration: https://bit.ly/all-matters-fda-2022

all-matters-fda-2022-save-the-date

12th Annual Food and Drug Law Symposium

Find out the latest about COVID-19 from FDA’s Biologics Center Director Dr. Marks and other notable speakers. Other topics include criminal and civil enforcement, mandatory food recalls, vaping, e-cigarettes, unsafe pet products in the marketplace.  Invited Speakers/Designees to date include:

Moderator:

■   Christopher Mondics  —  Legal Affairs Journalist, Philadelphia, PA

Invited Speakers:

■   Hon. Giovanni O. Campbell  —   Philadelphia Court of Common Pleas   —   Ethics and Professional Conduct

■   Brook Duer, Esquire  —   Center for Agricultural & Shale Law, Penn State Univ.   —   Food Law Cases

■   Michael Helbing, Esquire  —   Associate Chief Counsel for Enforcement, U.S. Food & Drug Administration   —   Enforcement

■   George D. Lapsley  —   Food Safety Expert  —   Court Appointed Expert – Miller’s Organic Farm 

■   Peter Marks, M.D., PhD.,  —   Director, Center for Biologics Evaluation & Research U.S. Food & Drug Administration   —  
COVID-19 Vaccines    and    Alzheimer’s Aduhelm® Approval

■   Matthew Noonan and Lillian Hsu  —   U.S. Food & Drug Administration FDA Preventive Controls (PC) experts in CFSAN Office of Compliance   —   Enforcement

■   Jessica J. Sleater, Esquire  —   Andersen Sleater Sianni LLC, New York,  NY    —   Pet Product Safety

■   Roseann B. Termini, Esquire  —   Food & Drug Law Legal Scholar, Food & Drug Law Courses, Delaware Law School   —  
Symposium Director   —   Year in Review

■   Julia Tierney, Esquire  —   Chief of Staff, U.S. Food & Drug Administration   —   FDA Through the Pandemic: COVID-19 and Beyond 

4 CLE credits (2 Ethics & 2 Substantive) in DE and PA

All Matters FDA March 31 Virtual

Save the Date March 31, 2022

1pm-5pm Virtual

Find out the latest about COVID-19 from FDA’s Biologics Center Director Dr. Marks and other notable speakers. Other topics include criminal and civil enforcement, mandatory food recalls, vaping, e-cigarettes, unsafe pet products in the marketplace.  Invited Speakers/Designees to date include:

Brook Duer, JD, Pennsylvania State Univ., Center for Agriculture Law

Michael Helbing, JD, Office of Chief Counsel, U.S. Food and Drug Administration

Peter Marks, MD, PhD, Director, Center for Biologics, U.S. Food and Drug Administration

Christopher Mondics, Moderator

Matthew Noonan and Lillian Hsu, FDA Preventive Controls (PC) experts in CFSAN Office of Compliance, U.S. Food and Drug Administration  

Jessica Sleater, Esq. Veterinary Medicine, Pet Products

Roseann B. Termini, Esq., Food and Drug Law Cutting Edge Issues including Vaping

Julia C.Tierney, JD, Chief of Staff, U.S. Food and Drug Administration

Further Info. Roseann Termini: rbtermini@widener.edu

COVID-19 Treatment— FDA Issued Emergency Use Authorization to Pfizer

FDA granted the first oral treatment on Dec. 22. The FDA authorized Pfizer’s, Inc.’s (Pfizer) request that the Food and Drug Administration (FDA or Agency) issue an Emergency Use Authorization (EUA) for PAXLOVID (nirmatrelvir co-packaged with ritonavir) for treatment of mild-to-moderate COVID-19 in some adults and pediatric patients under the official Section 564 of the Federal Food, Drug, and Cosmetic Act codified in 21 U.S.C. §360bbb-3).

Here is the direct link to the EUA letter. https://www.fda.gov/media/155049/download

In the press release, Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research remarked:

“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.”

Direct Link to press release: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19

FDA First COVID-19 Vaccine Approval Comirnaty August 23, 2021

Link: https://www.fda.gov/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine

Approval Letter

Package Insert

FAQ for Comirnaty (COVID-19 Vaccine mRNA)

Press Release: https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

Indication and Approval: The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” 

According to FDA “Comirnaty contains messenger RNA (mRNA), a kind of genetic material, used by the body to make a mimic of one of the proteins in the virus that causes COVID-19.” “The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material.” Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart. 

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”