Various FDA Meetings, Events, Advocacy

Ann Fonfa, founder and president of the Annie Appleseed Project said in March 2010 in an email sent to a consumer advocate listserv:

"While FDA does inform the public two days ahead - how useful is that? I have questioned this many times with no good answers. They say it is to 'protect' the submitting company and their data.

But there are no real secrets within an industry so it usually turns out that the only folks who are not clear what is going on are the patient advocates without access to the information behind the invitation.

For example - being told that the drug X is going to be discussed, does not yield any information TO discuss! Further two days is too short to make low-cost travel arrangements in case an advocate wants to comment. I find this very limiting".

* * * * *

Posted 6/08

Your Guide to Reporting Problems to FDA:

http://www.fda.gov/consumer/updates/reporting_guide061008.html

FDA 101: How to Use the Consumer Complaint System and MedWatch

http://www.fda.gov/consumer/updates/reporting061008.html


Sentinel Network for Adverse Event Reporting

March 2007 FDA meeting

Ann Fonfa's comments on Sentinel Network
Maryann Napoli's comments on FDA Issues
FDA 6/8/99 meeting summary

Dietary Supplements

CNN Article 4/12/01
Dietary Supplement Health & Educ Act of 1994
Testimony 6/8/99
In vitro diagnostic multivariate index assays -  FDA

Posted February 2007

Advocate Helen Schiff, NYC

Recommendations on FDA & Drug Safety

Arch Intern Med, 2006

Testimony of Helen Schiff, Advocate on Abraxane

FDA ODAC Hearing, 9/06/06

FDA 6/7/99 Time to Disease Progression as Standard?

Amazing discussion: Time To Progression

Ann's Testimony
Epirubicin and FDA Panel
FDA -Discussion: Drug Approval & Survival

Exerpts from FDA summary www.fda.gov

Reuters Health Coverage of this FDA Meeting
Accelerated Approval-Statement of Maryann Napoli
FDA Advisors Independence Challenged

USA Today reports 54% have interest in drug/topic being evaluated 9/00

Proposals for Public Disclosure of Advisory Panel Members
FDA Scientists Pressured to Exclude, Alter Findings
FDA : Compassionate Use of Drugs

Ann's testimony via letter, 2001

FDA: Patient Use of Non-Approved Oncology Drugs &Biologics

December 14, 2000 Discussion & Patient/Pharmaceutical Testimony

Ann Fonfa's Testimony
Melissa Yazman Testimony
Chelsea Kidd Testimony
FDA and Consumer Advertising

August 2001

FDA Sued for Refusing Labels on Antioxidants/Cancer

July, 2001 Reuters Health

Ann's Comments on Drug User Fee Act

December 2001

FDA Okays Speedier Medication Reviews
FDA Rule Changes: Benefits/Dangers
Patient, Consumer, & Public Health Coalition: Generic Drug UserFee
Ann's Comments on New Bisphosphonates

January 2002

FDA/Industry Guidelines for Disclosure

Boston Globe, 3/21/02

Industry Influence on Federal Advisory Committees
Letter to Dr. Lester Crawford, FDA Acting Commissioner
Dutch & Pharma Ads/Mktg

Press Release Health Action Int'l 6/19/02

Effort to Prohibit Scientists w/Direct Conflicts on Panels

Letter in Support of Senator Durbin, Representative Hinchey June 8, 2005

Expanded Access to Investigational Drugs

FDA Comment period until March 14, 200

Ann Fonfa's Comments to FDA: Access to Drugs
Lilla Romeo, Pt Advocate Quoted on Limits to Anemia Drugs

New York Times, May 9, 2007

Ann Fonfa's remarks on FDA Hearing - Anemia Drugs
Full Text of Lilla Romeo's remarks to FDA Oncologic Drugs Advisory Committee
BCPT1:Tamoxifen hearings 1998

Perspective and summary from Sharon Batt, a Canadian activist

Ann Fonfa's Testimony to the FDA 9/2/98
Washington Post Coverage, 9/98
Oncological Drug Advisory Committee meets on Avastin

July 20, 2010

Testimony of Roberta Gelb SHARELeaders
Fran Visco, President NBCC Letter on Avastin
Concerns: Policies/practices re FDA Advisory Committee meetings.

Letter sent October 26, 2010 Many groups signed on including Annie Appleseed Project


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