DTC in Perspective: FDA New Guidance

The FDA is slowly trying to deal with Internet reality with two new guidance documents. One guidance is an attempt to deal with what happens when social media gets factually incorrect postings. How can a drug company respond if it has to provide fair balance and risk/side effect information? Well, it could not under the regulations in any real sense. The new guidance allows such corrections without requiring the litany of fair balance and side effects.

"These guidances help the drug industry..." - Bob Ehrlich

FDA said the correction must be from the label and cannot use advertising slogans used in its responses. The effect is positive in that so many bloggers and people who comment give so much false information and try scare tactics to malign a drug.

The second guidance is how to do a promotional blurb in a medium like twitter without having to do a full disclosure of fair balance. FDA gave an example of a fictitious drug for memory loss. The drug company would have to give the exact indication approved and the main risks. In their example ?No-focus for mild to moderate memory loss; may cause seizures in patients with a seizure disorder www.nofocus.com/risk.? FDA would not accept a shorter version of the indication like memory loss.

Both these guidances help the drug industry discuss their products in the real world of social media. Correcting the many incorrect posts is an important tool for drug companies whose reputation can be shattered by bloggers. Being able to use the approved label in a short factual reply was needed. To force the drug company to provide a full page answer to a factually wrong short blog post was effectively preventing the drug company from replying.

The guidance that allows brand name and indication in ads is a great step. No consumer needs a full
fair balance discussion in the two line type ad for a drug online. These online users are well equipped to click through for more information. Preventing a drug from saying its indication was silly in the world of massive information with a mouse click. FDA properly recognized the need for some flexibility. Their No-focus example is a good one and allows drug makers to use social media. While it took a long time for these sensible steps, it is appreciated by the DTC community.

Bob Ehrlich

Chairman & Chief Executive Officer at DTC Perspectives

Bob Ehrlich has over 20 years marketing experience in pharmaceutical and consumer products. Bob is the CEO of DTC Perspectives, Inc., a DTC services company founded in 2000. DTC Perspectives, Inc. developed the DTC National Conference, the largest DTC conference in the industry. DTC Perspectives, Inc. also publishes DTC Perspectives, a quarterly journal dedicated to DTC issues and practices. In addition DTC Perspectives, Inc. does DTC consulting for established and emerging companies, and provides DTC marketing plans for pharmaceutical companies.