In the past several months, the life sciences industry has seen its fair share of headlines. They’ve shined a spotlight on everything from multi-million dollar settlements to a handful of active lawsuits – many related to how the company in question is marketing their drug or device. One of the world’s largest contributors to the advancement of human healthcare, Johnson & Johnson, has been the lead in quite a few of them.
- In July, Johnson and Johnson’s Acclarent unit paid more than $18 million to resolve U.S. claims of illegally marketing a medical device. Two former executives at Acclarent, a medical device startup purchased by Johnson and Johnson in 2010, “directed salespeople to promote one of its products as a drug delivery device even though U.S. health regulators had rejected the use.”
“Former executives Acclarent were found guilty of 10 misdemeanor counts for illegally marketing a medical device”
- That same case that led to those two former executives being convicted of related charges. The charges included ten misdemeanor counts, each carrying a maximum prison sentence of one year.
- In August, The Kentucky Attorney General announced a suit against Johnson and Johnson and its subsidiary, Ethicon, for millions of dollars. The Kentucky AG says the company “concealed and misrepresented” the risk of its transvaginal mesh products to doctors and patients.
Why the Red Tape?
Companies in the life sciences space live in an environment of strict regulation. The constant red tape can be discouraging at times – believe me, I understand the pain. As a former medical device marketer, I recognize the challenges that come with launching a new product, supporting a growing sales force and keeping up with an evolving market. Sometimes simultaneously. The competition is fierce and companies are expected to frequently develop innovative ways to make their product stand out among the rest. But after countless tradeshows, ad campaigns and PR pitches, it can feel like you’ve exhausted every single FDA-compliant option.
However, the industry is regulated for a reason – and when those regulations aren’t met, there is a price to pay. Depending on the offense, that price can range anywhere from an FDA-issued warning letter to, in Johnson and Johnson’s case, an $18 million settlement and a handful of active lawsuits. An FDA-issued warning letter can incur costs associated with process overhaul, damage control and employee dissatisfaction. A multi-million dollar settlement costs exactly that.
But everyone in the industry can agree that the risk of putting a patient in harm’s way due to misinformation is even costlier. That risk is one of the reasons why the Food, Drug and Cosmetic Act allows the FDA to regulate how organizations in the life sciences industry are able to promote their products. In fact, the FDA’s Office of Prescription Drug Promotion’s (OPDP) sole mission is to “protect the public health by ensuring that prescription drug information is truthful, balanced, and accurately communicated.”
Avoid the Oversights
When it comes to promoting a product within the healthcare and life sciences industries, any piece of collateral that makes a claim can be under the surveillance of the FDA. With numerous product lines, countless indications and multiple regions around the globe, companies inevitably make oversights.
One of the most common of those oversights is making unsubstantiated claims.
For example: Because this webpage made claims that it did not support, the FDA deemed it misbranded within the meaning of the Federal Food, Drug and Cosmetic Act. It landed the company an FDA warning letter.
The healthcare and life sciences industries are becoming more and more crowded – and it’s becoming more and more challenging for companies to differentiate their product over a competitor’s. As a result, marketers are getting bolder and louder.
But when phrases like “new and improved” and “fast-acting results” start getting thrown around without any data to back them up, they can be considered misleading to a physician and/or the patient.
In many cases, the data to back the claim exists. But the process of locating the clinical paper that proves it can be lengthy and arduous. A good practice to avoid unsubstantiated claims is for companies to provide Marketing and Sales with access to clinical data from one single source. With all of the information in one repository, teams always have what they need to make strong, data-backed claims. This can be achieved using platforms like Box, SharePoint or Seismic.
To take a closer look at some of those oversights, along with a handful of simple solutions to avoid them, take a look through the guide below: