Companies in the life sciences space have a price to pay when caught improperly or illegally promoting a drug or device. Depending on the offense, that price can range anywhere from an FDA-issued warning letter to settlements upwards of tens of millions of dollars. 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 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.”
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. Not every case of improper marketing results in a multi-million dollar settlement or is due to intentional misbranding. More often than not, the FDA issues warning letters for smaller-scale missteps. But regardless of intention, each slip-up has the ability to misinform a healthcare professional and/or the patient.
Below are some common oversights, along with some simple steps to help avoid them:
Omitting Material Facts
In the world of life sciences, omission is misrepresentation. If a company communicates the benefits of their product, the FDA requires that they also thoroughly communicate the risks. This is another measure taken to ensure that the customer, whether a physician or patient, is properly informed on the product. With exhibit banners and tradeshow graphics, there is typically a small amount of space available to convey a big message. In some cases, this can result in leaving out important risk information in order to include eye-catching imagery or an attention-grabbing statement.
How to avoid: One way to avoid this oversight is to work with Regulatory and Compliance teams to develop a required boilerplate for every piece of promotional collateral with the product’s full indication, instantly mitigating major risks. This practice allows Marketing to enforce the right message and Sales to distribute the most compliant content possible—with the further benefit of collaborating with Regulatory/Compliance.
Misbranding the Drug
Whether they’re non-compliant or downright archaic, there is always a lurking fear that a sales aid from 2007 will somehow make its way into a physician’s inbox. This either happens because the rep doesn’t have rapid access to the right piece of content, or marketing isn’t able to easily retire the versions of years’ past and quickly distribute what’s new.
How to avoid: Enabling marketers with the ability to organize, store and distribute collateral in and from centralized repositories offers them ultimate version control, allowing them to always provide sales with the most up-to-date, compliant information and collateral possible. This can be achieved by performing a monthly, quarterly or yearly content audit. The process requires cross-functional collaboration, which helps increase company-wide alignment. Implementing this practice allows both Marketing and Sales to feel confident that the content they are sharing is always in the best interest of the physician and/or the patient.
Making Unsubstantiated Claims
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.
How to avoid: 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.
Marketers in the space are faced with the challenging task of launching brand new products, supporting a growing sales team and keeping up with an evolving market. The constant red tape can be discouraging at times –competition is fierce and companies are expected to frequently develop innovative ways to make their product stand out among the rest. Though sometimes frustrating, it’s important to remember that the parameters serve a purpose. And while profit is important, everyone can agree that patient lives are paramount.
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