Tuesday, June 23, 2009

Pop Open A Window -- Watch the FDA Transparency Webcast -- LIVE, Right Here!

This all has become so easy -- there was a time when it actually took some coding abilities and "skillz" to offer up live webstreams from remote sites. No longer.

So, thankfully -- all you now need do is click this FDA link, after 7:30 am EDT, on Wednesday, June 24, 2009.

. . . .The FDA will hold a public meeting on Wed., June 24, 2009, from 8 a.m. to 5 p.m. to solicit input from interested persons on ways the agency can make useful and understandable information about FDA activities and decision making more readily available to the public in a timely manner and in a user-friendly format. The public meeting will be held in downtown Washington, DC at the National Transportation Safety Board (NTSB) Conference Center, 429 L'Enfant Plaza, SW. Those who cannot attend the meeting may view the proceedings via webcast. . . .


8:00 am Welcome and Introductory Comments
Joshua Sharfstein, MD, Principal Deputy Commissioner
Afia Asamoah, JD, MPP, Special Assistant to Principal Deputy Commissioner

8:15 am Panel 1
Gregory Meyer, Compliance Media Inc.
Janet Trunzo, AdvaMed (Advanced Medical Technology Association)
David Lim, Independent Consultant

8:45 am Panel 2
Francesca T. Grifo, Ph.D., Union of Concerned Scientists
Jeffrey Francer, PhRMA
Kristi Zonno, MS, CGC, Genetic Alliance

9:15 am Panel 3
Steven Findlay, Consumers Union
Bray Patrick-Lake, Consumer
Allan Coukell, Pew Prescription Project

9:45 am Panel 4
Daniel Fabricant, Ph.D, Natural Products Association
Sarah Janssen, MD, Ph.D, Natural Resources Defense Council
Kathy Means, Produce Marketing Association

10:15 am Break

10:30 am Panel 5
Bob Kelser, IDSN, Inc.
Kathryn Foxhall, Freelance Reporter

11:00 am Panel 6
Shannon Benton, The Senior Citizens League
Peter Lurie, MD, MPH, Public Citizen
Diana Zuckerman, Ph.D., Nat’l Research Center for Women &

11:30 am Panel 7
Mark B. Leahey, Medical Device Manufacturers Association
Nancy Beck, Ph.D., Physicians Committee for Responsible Medicine
Sin Hang Lee, MD, Milford Medical Laboratory

12:00 pm Lunch

1:15 pm Panel 8
Emily Claire Napalo, Breast Cancer Fund
William H. Maisel, MD, MPH, Medical Device Safety Institute
Andrew Emmettt, Biotechnology Industry Organization (BIO)

1:45 pm Panel 9
Sarah Klein, The Center for Science in the Public Interest
Kiyo Oden, The Tatia Oden French Memorial Foundation
Carolyn Brubaker, Microsoft

2:15 pm Break

2:30 pm Open Comment Session

5:00 pm Meeting Adjourns

1 comment:

Anonymous said...

Most of the comments as they came from outside the agency were fairly consistent and limited. I didn't pay attention to the non-drug portions so I'll stay focused on comments related to drugs especially as this blog focuses on SP.

Many comments related to difficulties with FOIA, the methods used to redact documents (white out and then scan into pdf image files so they can't be searched). Not including reviews consistently in Drugs@fda. Also not releasing reviews of supplemental indications that have not been approved due to lack of efficacy or safety because companies still promote these uses off-label. One ex-FDA reviewer pointed out the FDAAA 2007 requires release of the action package but not IND reviews which may be pertinent but even so with the very first one under this law there was inappropriate redaction of drug metabolism information and >90% or market withdrawals are due to drug metabolite toxicities. One mother of a boy who died didn't understand why numbers of patients taking a drug should be redacted as it's needed to assess adverse event rates.

Industry comments were pretty much as expected. Don't release stuff because they're trade secret or commercial secret. There were several comments debating the extent of redaction.

However several people indicated that this could be overcome by simply not releasing information until either approval, nonapproval, or prior to an advisory committee and not during the review process.

There were also a number of people who said FDA needs to release all the raw data because analysis by FDA reviewers or analysis of avandia data that came out under discovery showed very different safety risks than admitted to by companies or the FDA.

One ex-FDA reviewer recommended that all new molecular entities have advisory committee meetings in spite of their problems. Dr. Sharfstein probed this and it was suggested that when FDA reviewers can't speak and all the questions are answered by industry or FDA senior people a different picture may emerge. However when reviewers who know the data are allowed to speak the committee members can get more nuanced and detailed answers which they can probe and in that reviewer's experience this in one case he was involved in changed the likely AC yes vote to a no vote by the AC.

Another unique comment by this ex-reviewer was the need to change the FDAAA of 2007 and the Good Review Management Practices/Good Review Practices (GRMPs or GRPs), because they were allowing insider trading.

Off line this ex-reviewer was passing out statements because he had originally been scheduled to speak and when FDA saw his comments he was removed (based on the claim that they were off topic). I have the package which includes the scope of the topics to be discussed and the rules for the meeting and they certainly seem within topic to me, embarassing to FDA yes, but still within the scope.

One of the draft statements is particulary interesting for this blog as it refers to possible insider trading and knowledge of internal FDA information regardig asenapine and possibly the sale of SP to Merck.