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
This post is the first in a series of three in which we recap the Food and Drug Administration’s somewhat difficult year, having spent the majority of it without a permanent Commissioner and facing a slew of political and...more
12/5/2019
/ 21st Century Cures Act ,
Clinical Laboratories ,
Digital Health ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
Regulatory Agenda ,
Regulatory Oversight ,
Statutory Authority
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/ Draft Guidance ,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 September 26, 2019, FDA released a suite of revised digital health guidances, which includes the following:
- Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act...more
10/10/2019
/ 21st Century Cures Act ,
CDS ,
Comment Period ,
Digital Health ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
International Medical Device Regulators Forum (IMDRF) ,
Medical Devices ,
Medical Software ,
Patients ,
Public Comment ,
Regulatory Requirements ,
Software Developers
On August 8, 2019, FDA issued a notice on its medical device recall database stating that a company called Opternative, Inc. had initiated a recall for the Visibly Online Refractive Vision Test, a software application offered...more
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
Regulation of cannabidiol (CBD) was a hot topic on Day 1 of ACI’s Cosmetics & Personal Care Products conference on March 28, 2019. Attendees asked many questions about legitimate uses of and claims for CBD, but definite...more
4/1/2019
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Cosmetics ,
DEA ,
Dietary Supplements ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Hemp ,
Labeling ,
Legislative Agendas ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Regulatory Oversight
In December, my colleague Aaron Josephson and I described our observations after attending FDA’s public workshop on Medical Device Servicing and Remanufacturing Activities. In this post, I want to share some additional...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
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT for Patients and Communities Act”) – which is intended to combat the spread and pernicious...more
11/13/2018
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Health Care Providers ,
OIG ,
Opioid ,
Pain Management ,
Patient Referrals ,
Regulatory Oversight ,
Regulatory Requirements ,
Remuneration ,
Safe Harbors ,
Secretary of HHS
In this issue, we provide an overview of 62 recently unsealed qui tam cases and take an in-depth look at four of those cases. Two of the featured cases concern alleged schemes to provide unnecessary therapy to residents of...more
11/9/2018
/ Anti-Kickback Statute ,
False Claims Act (FCA) ,
Former Employee ,
Health Care Providers ,
Healthcare ,
Medicare ,
Medicare Part D ,
Physicians ,
Qui Tam ,
Relators ,
Settlement Agreements ,
TRICARE
On October 18, 2018, FDA released a new draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which describes the Agency’s current thinking and recommendations on designing...more
Over the past couple of years, FDA has introduced multiple programs allowing faster review of medical devices in order to get them to market more quickly. Some of the FDA’s efforts have been highly visible, such as the...more
Overview of Qui Tam Activity -
..We identified 60 health care related qui tam cases that were unsealed in December 2017 and January 2018.
..The government intervened in 14% of those unsealed cases, which is consistent...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
On February 22, the Wall Street Journal published an article about the tissue graft manufacturer MiMedx Goup, Inc. and its failure to report payments to physicians under CMS’s Open Payments Program established by the Centers...more
3/8/2018
/ Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Disclosure Requirements ,
Enforcement Actions ,
Failure to Report ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Open Payments ,
Physicians ,
PPSA ,
Regulatory Oversight ,
Reporting Requirements ,
Social Security Act
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