Has the Food and Drug Administration (FDA) finally ushered in a new era for the U.S. biosimilar marketplace? Many in the industry are hopeful after the Agency approved its first interchangeable biosimilar, Mylan’s Semglee...more
In our most recent year-end blog post on devices and diagnostic products at the Food and Drug Administration (FDA), we summarized the tumultuous events of 2020 with respect to laboratory developed tests (LDTs) and clinical...more
Although we’ve now entered June of 2021 and President Biden has yet to nominate someone to serve as the Commissioner of Food and Drugs, current Acting Commissioner Janet Woodcock and her Senate-confirmed boss, Department of...more
The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have the authority to regulate clinical trial reporting requirements. Despite this authority, FDA and NIH have scantly enforced this area...more
The U.S. Food and Drug Administration (FDA), industry, policymakers, and consumers share a common goal of ensuring that the foods and beverages Americans eat and drink are safe, and the law has long prohibited the...more
In its first exercise of a newly granted authority, the Federal Trade Commission (FTC or the Commission) on April 15, 2021 charged a St. Louis-based chiropractor and his company (the Defendants) with violating the COVID-19...more
In an unexpected twist to a troubling situation that began over two years ago, U.S. Special Counsel Henry Kerner penned a letter to President Biden on March 31, 2021 questioning the Food and Drug Administration’s (FDA’s)...more
Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings, several...more
1/29/2021
/ Biden Administration ,
CARES Act ,
Coronavirus/COVID-19 ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Care Providers ,
Orange Book ,
PDUFA ,
Pharmaceutical Industry ,
Public Health Service Act ,
Regulatory Agenda
In addition to the incredible work of agency scientists and reviewers to get the first COVID-19 vaccines authorized for emergency use in December (as we covered in Part 2 of our year-end post), the Food and Drug...more
12/28/2020
/ Biologics ,
Center for Biologics Evaluation and Research (CBER) ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Over The Counter Drugs (OTC) ,
Prescription Drugs ,
Vaccinations
Following up on our colleagues’ post earlier this month covering the Food and Drug Administration’s 2020 device law and policy activities, this post will explore prescription drug and biologic law and policy developments over...more
12/22/2020
/ Biologics ,
CDRH ,
Coronavirus/COVID-19 ,
Criminal Investigations ,
Department of Justice (DOJ) ,
Emergency Use Authorization (EUA) ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry
It has been a long time coming. On November 2, 2020, the Drug Enforcement Administration (DEA) released its long-awaited proposed rule to revise the regulations related to suspicious orders of controlled substances. The...more
11/9/2020
/ Controlled Substances ,
Controlled Substances Act ,
DEA ,
Due Diligence ,
Opioid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Recordkeeping Requirements ,
Substance Abuse ,
Wholesale
Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the...more
11/6/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Laboratory Developed Tests ,
Life Sciences ,
Over The Counter Drugs (OTC) ,
Virus Testing
The U.S. Food and Drug Administration (FDA) recently announced what appears to be the first public warning made by the agency to a company promoting an approved prescription drug product for the unapproved use of treating...more
10/7/2020
/ Coronavirus/COVID-19 ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Intended Use ,
OPDP ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules
As previously covered on this blog, in mid-2019 the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump...more
9/28/2020
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Imports ,
Infectious Diseases ,
Medical Supplies ,
New Regulations ,
Pharmaceutical Industry ,
Prescription Drugs ,
Secretary of HHS ,
Supply Chain
Clinical trial sponsors and principal investigators can consider themselves on notice that the Food & Drug Administration (FDA) is poised to ramp up enforcement activity relating to responsible parties’ obligations regarding...more
About a month ago, I predicted on this blog that Food and Drug Administration’s November 2020 enforcement discretion deadline announced as part of its Comprehensive Regenerative Medicine Policy Framework would most likely not...more
As we discussed in our last update on the Food and Drug Administration’s Comprehensive Regenerative Medicine Policy Framework back in December 2019 (during the much simpler, pre-COVID-19 world), this coming November will...more
A panel of federal appellate judges has sided with drugmakers by upholding a lower court ruling from 2019 that struck down a regulation proposed by the Department of Health and Human Services (HHS). In a closely watched case,...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
We have been blogging about the various actions that numerous government agencies were taking to combat COVID-19 fraud. These agencies and their respective law enforcement efforts have yet to slow down and appear to have...more
On May 1, 2020, Blue Bell Creameries L.P. (Blue Bell) agreed to plead guilty to charges that it distributed contaminated ice cream products that were linked to a 2015 listeriosis outbreak. The Blue Bell outbreak made...more
5/12/2020
/ Blue Bell Creameries ,
Corporate Counsel ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
Listeria ,
Settlement Agreements
Responding to increased public and congressional criticism of its arguably too-flexible approach to regulatory oversight of serological tests used to detect COVID-19 antibodies, on May 4, 2020, the Food and Drug...more
Recently, newspapers and television news programs have been full of stories about laboratory testing and the important role it will play in containing the spread of COVID-19 and reopening U.S. economic activity. But these...more
Since our last roundup-style blog post on the response of the Food and Drug Administration (FDA) to the COVID-19 public health emergency, the agency has taken a wide variety of additional actions with the goal of getting...more
We’ve been blogging periodically on the various actions taken and enforcement policies being developed by the Food and Drug Administration (FDA) to support and expand the national response to the declared COVID-19 public...more