Monday, February 7, 2011

ePharma 2011: What Can You Say? How Can You Say It? Examining FDA/DDMAC Enforcement Trends

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Mark Senak, Fleishman Hillard, Eye on FDA Blog

Two types of regulatory actions: warning letter and NOV – Notice of Violation, injunction/consent decree and seizures/criminal actions. Promotion must be balanced: balancing message of indication/use with safety concerns and risks of its use.
Trouble spots in digital marketing: Better and more effective, safe with fewer side effects, comparative claims, misleading presentations of data and promotion outside of labeled uses. If a company gets the four warning above quite a few times, they are likely flagged and looked at more closely.

Enforcement Trends for 2010: After the 2000 election, there was a drop of enforcement by DDMAC on materials. It went from 156 in 1998, throughout the early 2000s, around 25 a year. A NOV letter is generally perceived as sever than a warning letter. Warning letters show more violations, but they are drastically different from the recommended parameters. Warning letters typically get sent to smaller companies, due to inexperience.

The average letter sent out last year carried 3-4 violations in 2010. Most frequent problem: minimization or omission of risk information. The most prominent vehicles that carried the violations: DTC information, Websites, Sales Aids, and Videos. There was one warning letter issued for Social Media in 2010.

What the FDA is looking at is not only the promotional material or phrases, but they’re more focused looking at its totality and the impression that the promotional material is giving. Always ask what general impression you want consumers to get after you develop a promotional material. If the impression is outside of the FDA guidelines, it is best not to use this material. Do not state that a product is safe and effective before it is approved by the FDA.

2010 Enforcements With Dysport, letter went to a clinical investigator. She made oral statements to reporters, then got an FDA warning letter. Warning letters have also gone out for not clearly indicating the differences between the benefits and risks. Patient videos have also received warning letters, often times takes the promotion outside the label of the drug. It’s hard to send balanced information. The patient videos then turn into the product claims. Senak believes that they are the most dangerous kind of promotional materials.

Internet/Social Media More Americans go to the internet for healthcare than almost anywhere else. The FDA policies are still unclear as to what can be posted. FDA first met in 1996 to set up guidelines. No policy has been released. The podcast in March 2009 by Senak and the FDA captured that “it’s not the medium, it’s the message.” In April of 2009, warning letters were issued to paid search, opposite of their previous claim. Longstanding practices in social media marketing are not necessarily right according the FDA. In July 2010, the FDA issued their only FDA Warning letter to Novartis for their Facebook Share button. The “Share Button” shared information about product, but failed to promote risk information.

Listen to Mark Senak's podcast with the ePharma Summit.

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