Michael Causey, Editor & Publisher, eDataIntegrityReport.com
You’ve got to admit, the FDA certainly seems earnest about its intention to make its operations more transparent. Earlier today (January 12) the agency unveiled the first phase of its “Transparency Initiative,” designed to explain agency operations, how it makes decisions, and the drug approval process.
It’s a timely initiative as the agency has come under fire from some camps for being too lax on the approval process, and too harsh by some others. Another sign that this inititve has struck a nerve: it received more than 900 comments, according to the chair of the FDA’s Transparency Task Force, Principal Deputy FDA Commissioner Joshua Sharfstein. By contrast, the important eMDR initiative drew about 25 comments at last count.
At today’s briefing, Sharfstein outlined a Web-based curriculum called “FDA Basics,” aimed at helping the public better understand what the agency does. “The launch of FDA Basics is our first step towards making FDA a more transparent agency,” he said. It includes:
- Questions and answers about the agency and the products it regulates
- Short videos that explain various agency activities
- Conversations with agency personnel about the work of their office
Going forward, senior officials from FDA product centers and offices will answer questions on various topics during future online sessions. Each session will be announced on the FDA Web site.
In recent months, the Task Force solicited public input on improving agency transparency through a public docket, an online blog, and two public meetings. The Transparency Task Force received hundreds of comments from various stakeholders, including regulated industry, consumers, patients, health care providers, and others. As a result of comments from the public, the Task Force decided to develop its recommendations in three phases. FDA Basics represents the result of the initial phase, to be followed by two additional phases.
In phase two of the initiative, the Task Force intends to make recommendations to the Commissioner regarding how to make information about agency activities more transparent, useful, and understandable to the public, in a manner compatible with the agency’s goal of protecting confidential information, as appropriate. The agency hopes to release those at the end of February.
In the final phase of the initiative, the Task Force intends to make recommendations to the Commissioner regarding FDA’s transparency to regulated industries. They hope to do than in May or June 2010.
We’ve certainly heard some complaints about this initiative, but on balance I think this has to be viewed as an improvement over how the FDA did business in the recent past.
Key will be keeping those comments coming and then waiting to see if the FDA listen to them.
Mike,
Great column; continue to enjoy your work.
So it’s now one year since the new administration took over the FDA and they have finally started something that looks like transparency (though I’ll reserve judgment, thank you). And they’re crowing about this?!? Gimme a break! I have followed the FDA for 20 years, and — as a consumer advocate — I’d say this represents some of the “worst of times.” Was the Bush FDA worse? Sure. How much worse? At this point I’d say Obama’s FDA is giving them a real run for the money.
Is there a transcript or recording? It is desirable for a meeting on transparency to be transparent.
The meeting yesterday was a press briefing open only to credentialed press. It was not a meeting of the commission, per se, but rather an educational session for press designed to help FDA get the word out about the inititative and its progress and timelines for future events and goals.
The official task force meetings are open to the public, and there is a link for each meeting with transcripts and other materials that came out of the meeting. The latest one (for the Nov. 3, 2009 meeting) is at http://www.fda.gov/AboutFDA/WhatWeDo/FDATransparencyTaskForce/ucm189863.htm