Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more
In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA....more
In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA.
Hear from Joanne Hawana and Ben Zegarelli, FDA specialists...more
Welcome to FDA in Flux – A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more
In this episode of Health Law Diagnosed, host Bridgette Keller is joined by Mintz Health Law attorneys Joanne Hawana and Benjamin Zegarelli to discuss the FDA’s long-awaited proposed rules that actively regulate laboratory...more
The U.S. Food and Drug Administration (FDA) announced a new pilot program on June 21, 2023 that gives sponsors of oncology products the opportunity to submit validation and performance data for laboratory developed tests...more
On April 16, 2021, the Food and Drug Administration (FDA) published twin notices in the Federal Register effectively reversing a move by the Trump administration Department of Health and Human Services (HHS) on January 15,...more
On March 3, 2021, FDA issued a statement acknowledging that certain entities produce certificates of registration for medical device manufacturers and clarifying that the agency does not issue such certificates. The agency...more
After exploring some of the ethical questions involved in allocating and distributing a potential COVID-19 vaccine and the basic tenets of bioethics, we continue by delving into the ethical issues relating to the vaccine...more
On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which in part describes reforms to modernize the regulatory framework for over-the-counter (OTC) monograph...more
6/10/2020
/ Abbreviated New Drug Application (ANDA) ,
Administrative Orders ,
CARES Act ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Healthcare Reform ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Rulemaking Process
Since the 21st Century Cures Act became law in December 2016, we have been keeping track of the Food and Drug Administration’s actions to carry out its obligations under the relatively new law. One particular provision of the...more
To anyone who has been following government enforcement and private litigation trends related to the over-the-counter (OTC) homeopathic drug industry over the past several years, the Food and Drug Administration’s (FDA)...more
10/28/2019
/ Draft Guidance ,
Enforcement Actions ,
Enforcement Guidance ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Over The Counter Drugs (OTC) ,
Over-the-Counter Sales ,
Pharmaceutical Industry ,
Public Comment ,
Regulatory Agenda ,
Regulatory Standards
On July 31, 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published a proposal, called the Safe Importation Action Plan, to allow certain entities to import...more
On May 14, FDA announced that it issued five Warning Letters to companies that manufacture and market homeopathic drugs for human use. Four of the letters were issued to four companies that jointly manufacture and package...more
As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs...more
12/31/2018
/ 21st Century Cures Act ,
510(k) RTA ,
Biosimilars ,
CMMI ,
Comment Period ,
Cybersecurity ,
Digital Health ,
Draft Guidance ,
FDA De Novo Clearance ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Regulatory Agenda ,
Software Developers
On December 10-11, 2018, FDA hosted a public workshop, Medical Device Servicing and Remanufacturing Activities, as part of its effort to develop a draft guidance that will distinguish servicing activities from...more
Recently the U.S. Department of Justice (DOJ) issued a statement that it had intervened in a False Claims Act (FCA) case against Insys Therapeutics, Inc. and consolidated five separate qui tam cases into one case, U.S. ex rel...more
5/23/2018
/ Anti-Kickback Statute ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Medicare ,
Off-Label Use ,
Opioid ,
Pharmaceutical Industry ,
Physicians ,
Qui Tam ,
RICO ,
TRICARE
In 2017, FDA issued only 44 Warning Letters to medical device establishments. Of those, 11 were related to pre-market issues, which include investigational device exemption violations or lack of approval or clearance. Only 33...more
This is the third installment of our year-in-review series covering major developments at FDA. While the previous two installments, pertain to FDA actions on drugs and biologics, this post will address developments related...more
12/27/2017
/ 510(k) RTA ,
CLIA ,
De Novo Standard of Review ,
Digital Health ,
Draft Guidance ,
FDA Approval ,
Federal Pilot Programs ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Software ,
Standard of Review
In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice (“DOJ”)...more
10/27/2017
/ Caronia ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Healthcare Fraud ,
Inducements ,
Off-Label Promotion ,
Off-Label Use ,
Pharmaceutical Industry ,
Physicians ,
Universal Health Services Inc v United States ex rel Escobar
This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration (“FDA”) refers to as “mobile apps.” The goal of this post is to provide you...more
10/3/2017
/ 21st Century Cures Act ,
Electronic Medical Records ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Devices ,
Medical Records ,
Mobile Apps ,
Mobile Health Apps ,
Pharmaceutical Industry ,
Regulatory Oversight
Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not...more
8/14/2017
/ Commercial Speech ,
Criminal Prosecution ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Free Speech ,
Off-Label Promotion ,
Off-Label Use ,
OPDP ,
Pharmaceutical Industry ,
Product Safety Labels ,
Warning Labels ,
Warning Letters
This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more
6/22/2017
/ Amarin ,
Caronia ,
Commercial Speech ,
Criminal Convictions ,
FDAMA ,
First Amendment ,
Food and Drug Administration (FDA) ,
Free Speech ,
Misbranding ,
Off-Label Promotion ,
Off-Label Use ,
Pharmaceutical Industry ,
Physicians ,
Prescribing Authority ,
Prescription Drugs ,
Public Health ,
Public Safety ,
Sorrell
In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy...more
As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to...more
4/14/2017
/ Amended Rules ,
Biologics ,
Enforcement Actions ,
Final Rules ,
First Amendment ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Hearing ,
Trump Administration