Thursday, September 28, 2017

Does This Email Message from KVK Tech Violate FDA Regulations?

Today, I received an email message from KVK Tech - a generic drug manufacturer located in my my hometown of Newtown, PA - regarding a gift to Stanford's Department of Bariatric and Minimally Invasive Surgery (see below; ignore that the email has the wrong date on it - you can't expect a drug company to have good copy editors, can you?). It talks about obesity in the U.S.

At the end of the email, in the "About KVK Tech" section, it mentions that it manufactures and distributes Lomaira, which is a drug to treat obesity. Unfortunately, KVK Tech does not mention the Important Safety Information (ISI) whenever a drug company mention a brand name drug and its indication in the same communication.

I believe, therefore, that this email violates FDA regulations. I've passed this on via email to the FDA's BadAd program, which I am not sure still exists. Not being a healthcare professional, I don't have much standing with the FDA in any case.

So, what do you think? Violative or not?

Wednesday, September 27, 2017

Is FDA Most Science-Based and Less patient Centric Now that Gottlieb is in Charge?

Last October, FDA caved in to patients lobbying on behalf of Sarepta's Duchenne drug Exondys 51 despite the fact that there was little scientific evidence that it was effective (read "FDA Succumbs to Industry-Sponsored Patient Power & Accelerates Approval of Sarepta's Duchenne Drug").

Now, another company -- PTC Therapeutics -- is seeking approval for a competing drug and the FDA warned in a briefing document that it the company should not depend on the same tactics to get its drug approved. Will paid patient lobbyists sway FDA just like they did for Sarepta? Or is the FDA now more science-based that Gottlieb is in charge? For more, see story embedded below.

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