FDA Proposes New Rules for the Pharmaceutical Supply Chain

In February 2022, FDA proposed new rules for the licensure of wholesale drug distributors (WDDs) and third-party logistics (3PL) providers. These rules, if approved, would amend 21 CFR parts 10, 12, 16, and 205. Click here for the text. If approved in their current form, FDA’s new rules would not only expand the class of persons subject to licensure, but also preempt many state and local licensure requirements, Read More

Not Just a Pretty Face: Some Tips on Protectable Marks in a World of Copycats and Grifters

Most people are familiar with the trademark symbol (™), registered trademark symbol (®), and their service mark equivalents. But most people are likely unfamiliar with the Lanham Act, which is the law behind those symbols. Enacted just a few months after the end of WWII, the Lanham Act established a number of the intellectual property protections upon which businesses depend today to signal and promote the quality Read More

The Peculiar Case of the Cease & Desist

“Stranger Things” was all the rage In 2017. Looking to cash-in on the popularity, a couple of friends launched a “Stranger Things” pop-up bar in Chicago. The bar was a hit with locals. But it was less so with the legal team at Netflix. It wasn’t long before Netflix sent the bar owners a cease and desist letter, threatening to call the bar owners’ moms and citing the horrors of Demogorgon if the bar lingered beyond Read More

Who Do You Think You’re Talking To?

Whether you can sell something as “skim milk” would seem quite straightforward. After all, according to Merriam Webster’s it’s just milk without the cream. But not according to the FDA and even some competitors in the dairy industry, which require the incorporation of additives to enhance vitamin A and D content before a product can be sold as skim milk. A producer who omits these additives in an effort to create a Read More

Avoid Getting Caught in the Middle

Businesses that are reliant on contractors, suppliers, experts and vendors to complete and deliver goods and services to their upstream customers or clients can face unique challenges. These challenges, however, can quickly multiply when contractual obligations the business owes to its upstream customers or clients aren’t harmonized with the obligations owed to the business by its downstream relationships. There are, Read More

Part II: Avoiding the “Contract Killers”

Beyond the more technical advice we provide our clients on their various business and intellectual property needs, we also counsel them to beware of “contract killers” that often lurk beneath the surface of a deal. These “contract killers” can range from entire provisions to one-word expressions. Examples include: Bad choice of law and forum. What law applies? And, if you sue or get sued, where does a lawsuit Read More

Part I: Making your Contracts Pull Their Weight

Contracts are, in a word, expensive. You have to pay a lawyer to help you draft them, especially for more complex deals. Also, you have to dedicate the time and attention of your employees, customers, vendors, and other parties in negotiating, marking priorities, and dedicating internal resources to their performance. Because of this investment, each contract you enter into should be practical and Read More

The Third Degree: Options When Presented With a Fiduciary Breach That Harms Your Business

Last month, Baker Jenner LLLP published a blog detailing the limited rights of pharmaceutical companies to market products for non-FDA-approved uses, which is still an open question in many courts. The FDA’s authority notwithstanding, companies operating in the FDA space occasionally see it in their best interests to challenge a claim (implied or express) made by a competitor in interstate commerce. The Read More

Off-Label Drug Promotion: a Right or a Crime?

The U.S. Food and Drug Administration (FDA) enjoys broad regulatory authority to police the approved-products market to protect public health. This authority is backed by an array of civil and criminal penalties FDA can impose to deter manufacturers from promoting products for intended uses outside of those which FDA has previously approved. This practice is commonly known as “off-label” promotion. More recently, Read More

Biden’s Executive Order Targeting Non-Competes—How Scary is its Bite?

With consolidation looming large in health care, tech, social media, internet platform providers, and other industries, non-compete agreements are receiving renewed scrutiny at the political and regulatory levels. This renewed scrutiny coincides with recent bad press concerning some national employers’ injudicious uses of non-competes to restrict low-wage and rank-and-file employees.  President Biden has now Read More