Embed with the FDA

  • by: |
  • 02/28/2008
Blogging to you directly from the glamorous Gaithersburg Hilton and the inaugural meeting of the FDA's Risk Communications Advisory Committee.

Star of the morning was FDA Commissioner von Eschenbach.

Andy pointed out that the committee's work was "central and core" to the mission of the FDA -- specifically because it speaks to how the FDA crafts messages for the general public. And to that end the Commissioner commented that the FDA has to learn "not only what is the right thing to do -- but how to do it the right way."

The Commissioner spent much of his remarks on the general theme of "putting things into the proper context for the patient," pointing out that "trust is built on communication and dialogue." And he acknowledged that this meeting is taking place "at a time when there is an erosion of consumer trust in the FDA."

Sometimes stating the obvious is the best place to start. Confession, after all, is good for the soul.

"Help us dialogue," the Commissioner asked the committee.

Communications hint to Commissioner: "Dialogue" is not a verb.

To that end he shared that he has floated the idea of "embedded" reporters at the FDA -- and shared that the concept "sent shudders" throughout the agency.

He addressed the need to better balance risk communications so as to avoid unintended consequences, specifically the need to better consider the desire to communicate earlier versus communicating with less evidence and certainty.

Andy also announced that the FDA world shortly announce more details on the Sentinel Network on post-market surveillance. That's good news and long overdue.

The Commissioner also staked a claim to FDA's leadership in educating the American public to what he called "the doctrine of risk," calling for a national dialogue.

Amen again-- and God's Speed.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
Better Health
Biotech Blog
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
Envisioning 2.0
FDA Law Blog
Fierce Pharma
Fresh Air Fund
Furious Seasons
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
In the Pipeline
In Vivo
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
More than Medicine
National Review
Neuroethics & Law
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmacology Corner
Pharmaceutical Business Review
Piper Report
Prescription for a Cure
Public Plan Facts
Real Clear Politics
Shark Report
Shearlings Got Plowed
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog