When we discussed the Public Readiness and Emergency Preparedness (PREP) Act earlier this year, we predicted that its tort liability protections would reassure manufacturers and distributors of novel COVID-19 drugs and...more
FDA is actively “monitor[ing] the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic.” The agency says it has discovered hundreds of fraudulent COVID-19 products,...more
Serology tests could play a critical role in the fight against COVID-19. Serology tests may help determine who can donate convalescent plasma—a part of the blood containing antibodies—which is currently being explored as an...more
FDA has been actively working to accelerate access to diagnostic tests for COVID-19 through its extension of Emergency Use Authorizations (EUAs). According to FDA Commissioner Stephen M. Hahn, M.D., “The FDA’s...more
A federal court in Florida has entered a temporary restraining order against the Genesis II Church of Health and Healing (Genesis) and four principals associated with the entity. The order requires defendants to immediately...more
On April 14, the U.S. Department of Health and Human Services (HHS) issued an advisory opinion on the Public Readiness and Emergency Preparedness (PREP) Act to clarify the scope of immunity that accompanies developing and...more
The Consumer Product Safety Commission (CPSC) recognizes that companies everywhere are in the midst of responding to the impact of COVID-19 on business operations, including government stay-at-home orders that could see some...more
As the number of COVID-19 cases in the U.S. grows, the potential shortage of ventilators has become an increasing concern. This week, the U.S. Food and Drug Administration (FDA) took two important steps to keep medical...more
A number of startups announced they would begin selling at-home COVID-19 testing kits this week. These startups included: Carbon Health, a tech-enabled healthcare network that combines virtual and in-person care, Everlywell,...more
Last week, the U.S. Food and Drug Administration (FDA) took yet another step to encourage production of basic medical supplies in the battle against COVID-19. On Friday, March 20, FDA published two new guidance documents...more
COVID-19 is, quite literally, putting the medical supply industry to the test. Manufacturers are being pushed to develop novel products like therapies and vaccines to combat the disease as quickly as possible. The Public...more
The rapid spread of coronavirus has spawned prolific marketing claims that any number of products can treat or prevent coronavirus. It comes as no surprise then that the Food and Drug Administration (FDA) and Federal Trade...more
3/19/2020
/ Coronavirus/COVID-19 ,
Deceptively Misdescriptive ,
Enforcement Actions ,
False Advertising ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Fraud ,
FTC Act ,
Unfair or Deceptive Trade Practices ,
Warning Letters
This week, President Trump announced that he intends to nominate Nancy Beck as Chair and Commissioner of the Consumer Product Safety Commission (CPSC). The five-person CPSC has been short a member since the end of September...more
Last month, Dr. Stephen Hahn was officially sworn in as the new commissioner of the U.S. Food and Drug Administration (FDA). The Senate confirmed him by a 73-17 vote. Hahn became the fourth leader of FDA in 2019 and the first...more
The U.S. Consumer Product Safety Commission (CPSC) recently elected Commissioner Robert Adler to serve as vice-chair of the CPSC. Commissioner Adler, a Democrat who has served on the CPSC since 2009, is a surprising choice...more
On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.” This report describes updates to FDA’s Medical Device Reporting...more
This week, Acting Chairman Ann Marie Buerkle withdrew her nomination to serve as Chairman of the U.S. Consumer Product Safety Commission (CPSC). She will wrap up her tenure as Acting Chairman, a position she has held since...more
The United States Supreme Court finally clarified its 11-year-old “clear evidence” standard for pharmaceutical preemption. In its much-anticipated opinion delivered by Justice Breyer, the Court unanimously reversed the Third...more
6/6/2019
/ Agency Disapproval ,
Clear Evidence Standard ,
Failure To Warn ,
FDA Approval ,
Federal v State Law Application ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Jury Trial ,
Manufacturers ,
Merck Sharp & Dohme Corp. v. Albrecht ,
Preemption ,
Prescription Drugs ,
Question of Fact ,
Question of Law ,
Remand ,
SCOTUS ,
State Law Claims ,
Vacated ,
Warning Labels
Consumer products companies are familiar with the reporting requirement under Section 15(b) of the Consumer Products Safety Act (the Act), but when does that obligation kick in for statute of limitations purposes? The...more
At a recent product safety conference, Ann Marie Buerkle, Acting Chair of the U.S. Consumer Product Safety Commission (CPSC), announced CPSC’s priorities for 2019. These include technology—both for consumers and within the...more
Safety standards for booster seats will no longer be a polite suggestion. On June 26, 2018, the U.S. Consumer Product Safety Commission (CPSC) voted 4-0 to approve a new mandatory safety standard for children’s booster seats....more
Developing and maintaining consumer trust is central to operating a successful consumer products company. Product recalls, contamination issues, product defects, privacy violations and data breaches can all undermine consumer...more
Running a successful consumer products company has never been easy. Rapidly evolving technologies, an uncertain economy and changing government regulations appear primed to complicate the already challenging task of...more
On June 4th, President Trump nominated Peter Feldman to fill the fifth seat on the U.S. Consumer Product Safety Commission (CPSC) and serve out the remainder of prior Commissioner Joe Mohorovic’s vacated seven-year term...more
After months of anticipation, the U.S. Senate finally confirmed Dana Baiocco as a Commissioner of the U.S. Consumer Product Safety Commission (CPSC) on May 22, 2018. President Trump first nominated Commissioner Baiocco on...more