By Mike Caiafa
If you hadn’t already noticed, it’s no longer a question of whether or not the winds of regulatory change are coming to professional dental marketing. They’re real. They’re here. And they’re blowing across the professional dental marketing landscape.
These regulatory changes are actually coming from many different directions and they have the force to affect us all. We need to be able to understand and address the ever-increasing impact that regulatory and compliance issues have on our market sector. And we need to be able to monitor the sources of these changes:
- Professional dental associations
- The U.S. Food and Drug Administration (FDA)
- State governments
- Miscellaneous organizations
The following realities are not meant to scare the reader, but imagining these nightmares is enough to keep one tossing and turning throughout the night.
How about the medical device company that’s planning on hosting an event for dental clinicians from throughout the U.S. in less than two months? Food and beverage contracts have been signed. Invitations have been designed and addressed and are ready to be mailed. Hold on. The company’s brand team has just found out that every one of the Massachusetts-licensed dentists on the list cannot be invited.
The Commonwealth of Massachusetts recently enacted a tough new law that prohibits companies like this from inviting state-licensed healthcare providers (including dentists). Penalties are severe … for each infraction. By the way, if the company were to hold the same type of event in Chicago, let’s say, it would not be allowed to invite Massachusetts-licensed dentists, either.
No doubt about it, this new Massachusetts law is tough. Just ask some of the manufacturers who pulled their sponsorships of bags and lanyards for a recent meeting held in Boston. Pharmaceutical and medical device manufacturers cannot even give a clinician a pen with a product logo! And meals can now only be provided at a hospital or clinician’s office. For a much more comprehensive look at the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct, visit www.mass.gov/dph/pharmamed.
And don’t think that Massachusetts is the only state. Other states to watch include California and Vermont, to name just a couple. Legislators are calling some of these potential new laws “clinician sunshine acts.”
If you think because a company isn’t a pharmaceutical or medical device manufacturer marketing and selling in the professional dental sector that it’s free from growing regulatory and compliance challenges … think again.
Let’s look at another potential nightmarish situation that’s arisen from the winds of regulatory change. A company is introducing a new product to the professional dental market sector and is using a major industry trade show as its hard launch point. Months of planning for the big launch culminate on the trade show floor. Expensive new graphics have been designed and produced promoting the new product.
The show has only been open a few hours when a representative of the association that’s sponsoring the show is at the booth looking for a member of the management team to discuss certain graphics. Why? Because the comparative claims that the company has made on its graphics need to be substantiated adequately states the association representative, citing the exhibitor prospectus. The company is given a choice: either provide the necessary documentation or remove the graphics.
Isolated case? No. More and more associations have been beefing up the rules and regulations in this area over the past few years. In several cases, these rules have grown from a single paragraph to one or two full pages.
There are several suggested approaches this company (and others like it) needs to take. First and foremost, carefully read those rules and regulations for every show and meeting on the show schedule … and not just for booth height restrictions and whether sweepstakes are allowed! Equally important, make sure that any product claims that have been made can be substantiated right on the spot. Don’t wait for that tap on the shoulder. It might be too late. Additionally, don’t forget that any sales promotion literature or public relations materials may very well also be covered under an association’s exhibitor rules and regulations.
Let’s look at another potential nightmare that’s related. This same company is also planning a major media presence, with full-page advertisements in several association journals and mainstream publications. The schedule is tight but it looks like the company will just barely make the publication cut-off dates for receiving new ad materials. But, there’s a potential problem. New ad materials were supposed to be sent in for review by the several association journals two weeks prior to the cut-off date. Oops!
How these winds of change will affect future regulation of advertising in mainstream professional dental publications is anyone’s guess. Vigilance is prescribed … today.
Let’s go back to the trade show floor for another potential regulatory nightmare. Here we have a company that is exhibiting an FDA-regulated product at a major industry meeting. During the course of the meeting, company reps have been aggressively promoting the product to booth visitors. But one rep has gotten a little over-zealous and has been promoting “off-label” uses of the product to visitors. Unfortunately, one of the visitors was an FDA representative wearing an attendee badge. This “oopsie” also has serious ramifications, with some pretty serious potential sanctions.
For this company, avoiding the situation wasn’t about neglecting to read and understand the association rules and regulations or making unsubstantiated competitive claims. It was about flying in the face of some very basic FDA rules and regulations. This nightmare could have been avoided, in part, with a disciplined sales team that has been trained, uses a script and a detail aid to work from, and follows and knows the dire consequences of freelancing.
Enough about potential regulatory nightmares and sleepless nights. How do companies marketing and selling in the professional dental sector avoid getting into some of these situations? First of all, it’s not easy. It’s a lot of hard work and paying attention to detail. But here’s a very basic checklist:
- Look to and support your in-house regulatory and compliance team.
- Pay close attention to potential legislation activities at the state and federal levels (set up Google Alerts, for instance).
- Familiarize yourself with some of the voluntary codes of conduct for dealing with healthcare professionals established by organizations such as the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Medical Device Manufacturers Association (MDMA).
- Get comfortable with FDA rules and regulations (check out the FDA advertising and promotion manuals published by Thompson).
- Read those exhibitor rules and regulations in a new light, especially those dealing with product claims and substantiation.
- When developing copy for collateral materials or advertising, think twice about the claims that you’re making.
- Partner with an agency that has an in-house regulatory and compliance team to supplement and complement your own in-house team (nothing like an extra set of eyes working for you!).
There’s one last note for you to consider: Compliance is not a black-and-white issue. There are lots of gray areas. Use all the help and assistance you can get your hands on to avoid any sleepless nights.
Mike Caiafa is the vice president of marketing and regulatory affairs for Lanmark Group, a full-service, advertising, marketing, and public relations agency specializing in the healthcare industry. Caiafa is responsible for managing the agency’s Regulatory Compliance Team. This interdepartmental group is tasked with establishing and maintaining best-practice standards in the regulatory review and approval process for promotional and advertising materials developed for Lanmark Group clients in the pharmaceutical, medical device, and dental industries. His 25 years of experience includes working with companies such as Johnson & Johnson, OralDNA Labs, OraPharma, Pharmacia, and the Perkin-Elmer Corporation.