FDA takes microsite back to 'Basics'

Share this article:
The FDA unveiled the first fruit of its transparency initiative with FDA Basics, a microsite aimed at demystifying the agency's workings for the public.

“We'd like to see this pull people into the process we have at FDA for developing policy,” said principal deputy commissioner Joshua Sharfstein, who chairs the agency's Transparency Task Force. “This may be one avenue to catch people who ordinarily wouldn't be able to find the way to comment on something.”

FDA Basics (www.fda.gov/AboutFDA/Basics) will feature FAQs and Q&As about the agency, short videos explaining agency activities, conversations with agency personnel about their work and a series of monthly webinars by senior officials from different FDA centers starting this month. Topics to be covered include access to investigational drugs, the inspection process and safeguarding against BSE (mad cow disease).

It's the first of a three-phase transparency initiative launched by commissioner Margaret Hamburg last spring as part of the Obama administration's broader commitment to openness. Phase 2, which will deal with disclosure of sensitive information like clinical trials and postmarket surveillance data, will likely be completed by the end of February, Dr. Sharfstein said, and Phase 3, dealing with the agency's transparency to regulated industries, will probably wrap up “maybe a couple months after that.”

Share this article:
You must be a registered member of MMM to post a comment.

Next Article in Features

Email Newsletters


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Read the complete September 2014 Digital Edition

Read the complete September 2014 Digital Edition

Click the above link to access the complete Digital Edition of the August 2014 issue of MM&M, with all text, charts and pictures.

Medical marketing needs mainstream Mad Men

Medical marketing needs mainstream Mad Men

Agencies must generate emotional resonance with the target audience, not unlike Apple, Pepsi or Nike

Are discounts cutting out co-pays?

GSK's decision to cut Advair's price spurred some PBMs to put it back on formulary. Will drugmaker discounts diminish the need for loyalty programs? How can these programs stay relevant beyond giving co-pay assistance?