Sherry Feldberg

Top Regulatory Considerations Every Healthcare PR Practitioner Needs to Know

As healthcare PR practitioners, it is natural to get excited upon learning a patient experienced tremendous quality of life benefits after being treated with your client’s technology, but does that mean you are free to promote the heck out of that patient’s experience? What about a physician who is using your client’s technology successfully to treat patients for a condition not indicated as one of the conditions for which the product is FDA approved?

We live in an increasingly regulated environment in which CEOs and physicians can get in serious legal trouble if they fail to follow FDA guidelines regarding public promotion of medical technology. The healthcare practice at Schwartz Communications kicked off 2011 by participating in an extensive training series to stay abreast of the top regulatory considerations our clients need to keep in mind when communicating with the outside world. Here are a few of the top takeaways every healthcare PR practitioner needs to know:

• Physicians and other third parties speaking to media are subject to the same scrutiny as the CEO of the company. When talking about an investigational product or off-label use of an approved product, advise spokespeople NOT to draw conclusions from clinical studies or their own clinical experiences. Rather, they should relay only quantitative and objective information. Citing study results is always a safe approach.

• Promotional materials must be presented in a fair and balanced manner. It’s not OK only to talk about the benefits of a product. Side effects and/or complications must be included in documents such as press releases and press kit documents. Same goes for graphics and videos.

• Always include the indications for use or prescribing label in promotional documents, or at least include a way for people to get that information. A best practice for press releases is to include contact information for Investor Relations to obtain the indications for use of an approved product.

While it’s vital PR practitioners are aware of and alert clients to the regulations as noted above, it is ultimately every company’s decision to determine the level or risk it is comfortable taking. We have done our jobs effectively so long as the company has been informed.

Posted by Sherry Feldberg on March 8, 2011 at 2:42 PM
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