My friend works as a sales rep for a division of Johnson & Johnson selling medical devices. He and I talked about the recent US Senate Panel hearings over possible new FDA regulations for medical device companies advertising directly to consumers.

These regulations would most likely be similar to what is currently required in the pharmaceutical industry.

My guess is that it’s only a matter of time before the medical device industry is required to follow FDA regulations when it comes to DTC ads. Unless the medical device industry (AdvaMed) took a stronger stance and convinces legislators that self-regulation will work.

This could potentially avoid some of the inevitable delays and incremental costs that going through FDA approvals for advertising would add. I didn’t find AdvaMed’s responses to the Senate Panel to be particularly convincing and I’m on their side.

That reminds me of another industry in a similar situation in the early 90’s. Faced with the possibility of a wide array of federal, state and local government regulations around battery recycling programs, the 5 leading industry players got together and formed a non-profit trade association, the Portable Recyclable Battery Association or PRBA.

At the time I was working for Sanyo Energy USA Corp, one of the five companies that established the PRBA, so I had an insider’s view on how they convinced legislators they were serious about getting things done. They created regional pilot programs and then a national recycling program that the manufacturers agreed to abide by instead of waiting for the government to decide. And it worked.

In my opinion it’s not a matter of if, but when, the government will require medical device manufacturers to follow FDA guidelines for DTC advertising.

How the medical device industry decides to handle this issue could have long-term affects for marketers, their budgets and the timelines required to launch new DTC programs.

This entry was posted on Monday, November 3rd, 2008 at 8:00 am and is filed under Medical Devices. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.