Life Sciences

How Drug Cos. Can Adapt To New Reference Pricing Rules

Considering the Trump administration's aggressive drug reference pricing rules, and more price control measures potentially on the horizon, drug and biotech companies should prepare a comprehensive readiness strategy tailored to country-specific considerations, says Meenakshi Datta at Sidley.

Declaratory Judgments Unavoidable For Biosimilar Applicants

Data from recent Biologics Price Competition and Innovation Act litigation suggests that a biosimilar applicant will inevitably face a declaratory judgment action irrespective of the amount and type of information it provides to the brand holder, say attorneys at Morgan Lewis.

Ethics Tips For Attorneys Telecommuting Across State Lines

Attorneys working remotely from jurisdictions in which they are not admitted should take precautionary steps to avoid engaging in unauthorized practice of law, say John Schmidt and Michael Seaman at Phillips Lytle.

6 Ways Legal Employers Can Help Pandemic-Weary Parents

Parenting during the pandemic has introduced a series of competing personal and professional obligations for attorneys and professional staff, and even organizations that are supportive of their parent employees can take steps to do better, says Meredith Kahan at Saul Ewing.

Health Cos. Can Reduce FCA Risk By Leveraging Data

The U.S. Department of Justice's increasing reliance on data analytics for False Claims Act investigations brings new urgency to how health industry participants can defensively deploy data to bolster compliance efforts, says Brenna Jenny at Sidley Austin and Mihran Yenikomshian and Paul Greenberg at Analysis Group.

Questions Loom About DOJ Dismissal Power In FCA Suits

The Second Circuit's recent decision to grant a U.S. Department of Justice motion to dismiss a False Claims Act suit, without weighing in on the standard for assessing the agency’s decision, illustrates a significant trend, given an increase in agency dismissals and the expected uptick in FCA cases amid the pandemic, say attorneys at Baker Botts.

3 Degrees Of Legalization Show True Prevalence Of Cannabis

The three degrees of state marijuana legalization regimes throughout the U.S. show that cannabis is only fully illegal in three U.S. states and one territory — not 14 states as some counts indicate — and even in those places, there are stirrings of change, says Julie Werner-Simon at Drexel University's Thomas R. Kline School of Law.

Remote Working Tips For Lawyer Trainees And Their Firms

The prospect of joining a law firm during the pandemic can cause added pressure, but with a few good practices — and a little help from their firms and supervising attorneys — lawyer trainees can get ahead of the curve while working remotely, say William Morris and Ted Landray at King & Spalding.

EpiPen Ruling Could Embolden Private Anti-Kickback Claims

A Minnesota federal court's recent EpiPen decision, allowing private litigants to assert Anti-Kickback Statute violations, could expose companies to novel and aggressive AKS theories over which federal prosecutors have historically exercised discretion, say Allan Thoen and Callan Stein at Troutman Pepper.

Cos. Should Back Up Sensory Advertising Claims With Data

In order to ensure sense perception claims about products — such as assertions that a brand of contact lenses is more comfortable, or that the taste of a pasta sauce is preferred by consumers — are legally defensible against challenges from competitors, advertisers should substantiate them with hard data, say Barry Benjamin and Bryan Wolin at Kilpatrick.

What Biden's Ethics Pledge Means For Gov't Revolving Door

Attorneys at Nossaman look at how President Joe Biden’s ethics pledge goes beyond those of his predecessors by imposing post-employment shadow lobbying and golden parachute restrictions on his administration’s appointees — and how a House bill proposing expansion of federal ethics law could affect enforcement.

Opinion

Punishing Bar Exam Policies On Menstrual Products Must Go

Law graduates across the states are sitting for the grueling two-day bar exam this week despite menstruation-related barriers, such as inadequate menstrual product and bathroom access, which could be eradicated with simple policy tweaks, say law professors Elizabeth Cooper, Margaret Johnson and Marcy Karin.

Takeaways From DOJ Fraud Section's Pandemic Year

The U.S. Department of Justice's Criminal Division report on the Fraud Section's accomplishments in 2020 reveals impressive enforcement productivity, despite pandemic-related limitations, and we should expect to see a significant increase in prosecution later this year, say Kevin Muhlendorf and Holly Wilson at Wiley.

EPA Hazardous Pharma Waste Rule Has Wide Reach

The U.S. Environmental Protection Agency's soon-to-be-effective rule on hazardous waste pharmaceuticals may seem only relevant to health care entities, but its sweeping definitions could cover any business that dispenses over-the-counter medicines, say Andrew Stewart and Anushka Rahman at Sidley Austin and Renée van de Griend at Ramboll.

It's Time For Law Firms To Start Loving And Leveraging Data

The volume and diversity of data managed by law firms today — from client files to internal financial records — may seem daunting, but when properly organized, good data can help practitioners stay competitive by providing sharper insight into firm resources and cost of work, say Jaron Luttich and Barry Wiggins at Element Standard.