Regulatory Coming to Dental

In case it has gone unnoticed, the winds of regulatory change have been making their way into professional dental marketing. These changes are real and they are here.

These regulatory changes are coming from many different sources; they are certainly not limited to what the FDA is doing or planning to do! These changes are coming from, but not limited to, the following:

• Professional dental associations
• State government
• FDA
• Miscellaneous others

Some of the realities of regulatory change?

Massachusetts, along with several other states, including Vermont, has enacted tough laws dealing with how medical device and pharmaceutical companies interact with clinicians—and these include dentists! And there are several other states with similar pending legislation.

More and more peer-reviewed journals in the professional dental space have been instituting a strict review policy for paid advertising. If the company wanting to advertise cannot back up the claims in the ad, the journal will reject that ad.

The FDA has been sending “undercover” representatives to dental meetings to be detailed by a medical device or pharmaceutical manufacturer’s sales rep. Penalties will be assessed should the rep detail any off-label uses of the device or the drug.

And more and more professional dental associations have been beefing up their exhibit rules and regulations pertaining not only to sweepstakes and height restrictions, but also to claims and comparative claims made in graphics within a company’s booth space.

What can we do to be prepared? It takes a lot of hard work, attention to detail, and vigilance. A few suggestions:

• Look to and support your in-house regulatory and compliance team
• Pay attention to existing and pending state legislation
• Familiarize yourself with some of the voluntary codes of conduct for dealing with healthcare professionals established by pharmaceutical and medical device organizations
• Get comfortable with FDA rules and guidance statements

Compliance is not a black-and-white issue. Lots of gray areas exist.