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Will FDA’s SM Guidance Resemble Suggestions Made by Industry Group Back in October?

Yesterday, during a Pharma Marketing Talk live podcast/interview , Cynthia Phillips, who is currently Senior Director of Regulatory Labeling and Promotional Compliance at Millennium Pharmaceuticals, Inc., and spokesperson for an adhoc Social Media Working Group (SMWG), told how her group met with the FDA in October, 2009, and presented the agency with a draft guidance on regulating social media. This draft guidance may be similar to the comments SMWG submitted subsequently to the public docket (see ” A Pharma ‘Social Media Working Group’ Submits Comments to FDA “). Soon after its meeting with the SMWG, FDA held a public hearing on Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools

FDA Should Begin a Collaborative Wiki to Innovate More Quickly

FDA Needs to Tell a Coherent Story on BPA – Bring Back the Talk Paper!

When the new leadership took over at FDA, they inherited one of many problems when it comes to the troubled history of the FDA's response to issues associated with the presence of bisphenol-A (BPA) in or near the foods we consume.

Once again the FDA gets it wrong when it comes to fair balance

“As consumers utilize a wide variety of sources to learn about prescription medications, it may not be optimal for the FDA to require that pharmaceutical companies include the same details in each of the channels they use to communicate information about their prescription drug products,” said Morris S. Whitcup, Ph.

Finally. Individuals Speak Out Pro & Con (Mostly Con) About Online Pharma Marketing

The comments are dribbling in to FDA regarding whether or how it should regulate the use of the Internet by drug companies for promotion of its products.

Would complete disclosure cure the NDA-rejection rash?

John Jenkins, the head of the FDA’s Office of New Drugs, has the perfect cure for a chronic rash of poorly conceived new drug applications: Sunshine. And plenty of it, according to a piece in The RPM Report

Dear FDA: Where Are the Public Comments Regarding Regulation of Internet, Docket FDA-2009-N-0441?

A public service message from FDA Intern: Not only does FDA Intern want to know where all the comments are, I want to know also! It’s been over 2 months since the FDA called for comments and three weeks since the public hearing. But there are NO comments available to view on the www.regulations.gov docket here .

While the FDA listens to presentations on social media a ticking time bomb continues to count down

Make no mistake about it obesity is going to cost us billions in healthcare dollars. What’s so frustrating about this is that it could be totally preventable if the FDA took action and decided to notify the public about the dangers of overeating and obesity

Risk Communication Advisory Committee – That Other FDA Meeting This Week – Don’t Ignore It!

So many people have been laser focused on the FDA's Part 15 Meeting on the use of social media to promote medical products being held this week in Washington, that the meeting on the same two-days of the Risk Communications Advisory Committee has gotten scant attention.  So let's pay attention, shall we?

Social Media Best Practices for Pharma Are Needed, Whatever Happens at FDA

Many pharma eMarketing pundits and FDA policy wonks out there are already predicting that nothing much will come out of the upcoming public hearing on Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (see ” FDA Announces Public Hearing on Promotion of Drugs on Internet & via Social Media. This is NOT a Hoax! “). Rich Meyer, blogger over at World of DTC Marketing , says “So what do I expect from the FDA open hearings?