Recognition of online reality will help FDA stay relevant

The Food & Drug Administration (FDA) held public hearings in mid-November with industry leaders to gather information about using social media and the Web to promote FDA-regulated medical products.

The Food & Drug Administration (FDA) held public hearings in mid-November with industry leaders to gather information about using social media and the Web to promote FDA-regulated medical products.

The federal agency has insisted for years that regulations for print, radio, and TV communications also apply to online marketing, frustrating many of the companies and agencies that work in the pharma, biotech, and medical-device industries.

By not acknowledging the game-changing way that social networking sites and search engines have revolutionized how patients seek information, the FDA had made itself obsolete as a regulator for this rapidly growing online space.

Holding the hearings is the first major step that the FDA has made in recognizing that the way people communicate has drastically changed in the past decade. The last time the agency addressed the Web and advertising and promotion of medical products was in 1996.

Not only do consumers use the Web to search for information about drugs and diseases, they also turn to online forums, blogs, and social networking sites to share what they find, whether that information is accurate or inaccurate, positive or negative.

For this industry, the challenges are many. A company will face an uphill battle with the legal department to get a Web-related initiative off the ground. In addition, there is always a chance that the FDA could interfere in a communications program it deems "misleading."

At the hearings in November, FDA officials heard from reps at Google, Yahoo, WebMD, Sanofi-Aventis, PatientsLikeMe, the Word of Mouth Marketing Association, and several PR firms. How the FDA will use this information and whether it will develop guidance for online communications is unknown, but putting into place sound guidelines developed in conjunction with the industry would keep everyone on the same page.

In the past, the pharmaceutical industry has received its fair share of criticism for its lack of transparency and misleading marketing tactics. However, just as the pharma industry has evolved in recent years, the FDA must follow suit.

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