List of contacts for our campaign

Endocrinologic & Metabolic Drugs Advisory Committee Roster:

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM225568.pdf.

http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm096416.htm

HHS Employees from Both Advisory Panels (i.e. Meridia and Lorcaserin) –

 

- Curtis J. Rosebraugh, M.D., M.P.H. (Director) - curtis.rosebraugh@fda.hhs.gov

- Mary H. Parks, M.D. (Director) - mary.parks@fda.hhs.gov

- Eric Colman, M.D. (Deputy Director) - eric.colman@fda.hhs.gov

- Monique Falconer, M.D., M.S. (Clinical Reviewer) - monique.falconer@fda.hhs.gov

- David Hoberman, Ph.D. (Statistician, Div. of Biometrics) - david.hoberman@fda.hhs.gov

- Katherine M. Flegal, Ph.D. - katherine.flegal@cdc.hhs.gov

- Edward W. Gregg, Ph.D. - edward.gregg@cdc.hhs.gov

- Michael A. Proschan, Ph.D. - Michael.Proschan@nih.hhs.gov

- Julie K. Golden, M.D. (Clinical Reviewer) - julie.golden@fda.hhs.gov

- Fred K. Alavi (Pharmacology/Toxicology Reviewer) - fred.alavi@fda.hhs.gov

- Todd M. Bourcier, Ph.D. (Pharmacologist Team Leader) - todd.bourcier@fda.hhs.gov

- David D. Waters, M.D. - David.Waters@nih.hhs.gov

- Dennis O. Dixon, Ph.D. - Dennis.Dixon@nih.hhs.gov

- Paul Tran (Designated Federal Official) - Paul.Tran@fda.hhs.gov

 

Others from Board -

mary.kremzner@fda.hhs.gov
cderombudsman@fda.hhs.gov
Lynn@cswd.org
Miriam@cswd.org
paffairs@oig.hhs.gov
president@messages.whitehouse.gov
info@messages.whitehouse.gov
karin.nelson@med.va.gov
info@obesityaction.org
jpratt@obesity.org;fdea@obesity.org
hendersj@wou.edu
info@healthadvocate.com
editors@medicalnewstoday.com
walter@obesitylaw.com
kelley@obesitylaw.com
info@nyccah.org
glennbeck@foxnews.com
cavuto@foxnews.com
ontherecord@foxnews.com
sanjay.gupta@turner.com

********Department of Health & Human Sevices (HHS)********

(click on links below for further leadership contact info)

http://www.hhs.gov/open/contacts/index.html#sd

More info on the officials & the leadership flow can be obtained here: http://www.whorunsgov.com/Profiles/Kathleen_Sebelius

 

- HHS Employee Directory -

http://Dir.y.psc.gov/employee.htm

- Email addresses for officials from the HHS website –

 

Operating Divisions:

1) Kathleen Sebelius (Secretary of the Dept. HHS) - Kathleen.Sebelius@hhs.gov

(Quote by Sebelius on HHS site - “Our Administration is committed to eliminating the barriers between the American people & their government, & we want to ensure government is open & accountable to you.”)

 à TAKE NOTICE of “Accountability”

2) William V. Corr, J.D. (Deputy Secretary HHS) – email N/A

3) Laura Petrou ( Chief of Staff HHS) - COS_info@hhs.gov

4) Dawn L. Smalls (Executive Secretary) - Dawn.Smalls@hhs.gov

5) Oliver Potts (Dir., Office of Documents & Regulations Management HHS) - Oliver.Potts@hhs.gov

6) Counselors to the Secretary - Counselors@hhs.gov

a. Rima Cohen - Counselors to the Secretary for Health Policy

b. Dora L. Hughes, M.D., M.P.H., F.A.C.P. - Counselor for Science & Public Health

c. Sharon Parrott - Counselor to the Secretary for Human Services Policy

7) Margaret A. Hamburg M.D. (FDA Cmsr.)- Margaret.Hamburg@fda.hhs.gov

8) Kathy Greenlee (Assistant Secretary for Aging) - Kathy.Greenlee@aoa.hhs.gov

9) Mary K. Wakefield, Ph.D., R.N. (Administrator HRSA) - Administrator@hrsa.gov

10) Carolyn M. Clancy, M.D. (Agency for Healthcare Research & Quality) - Dir.@ahrq.hhs.gov

11) Thomas Frieden M.D. (Dir. CDC, Administrator Agency for Toxic Substances & Disease Registry) -   Tomfrieden@cdc.gov

12) Francis S. Collins, M.D., Ph.D. (Dir., National Institutes of Health (NIH)) - execsec1@od.nih.gov

13) Daniel R. Levinson (Inspector General, Office of Inspector General) - paffairs@oig.hhs.gov

14) Dr. Donald M. Berwick Administrator, (Ctr.s for Medicare & Medicaid Services) - AskCMSquestions@cms.hhs.gov

------FDA –--------

List of FDA Leadership Profiles:

http://www.fda.gov/AboutFDA/Ctr.sOffices/ucm193757.htm

 

1) Margaret A. Hamburg M.D. (FDA Cmsr.)- Margaret.Hamburg@fda.hhs.gov

2) Joshua M. Sharfstein, M.D. (Principal Deputy Cmsr.) - joshua.sharfstein@fda.hhs.gov

3) Russell Abbott (Deputy Cmsr. for Administration) - russell.abbott@fda.hhs.gov

4) David Dorsey, J.D. (Acting Deputy Cmsr. for Policy, Planning, & Budget) - david.dorsey@fda.hhs.gov

5) Murray M. Lumpkin, M.D.(Deputy Cmsr. for International Programs) - murray.lumpkin@fda.hhs.gov

6) Ralph S. Tyler, J.D. (Chief Counsel) - ralph.tyler@fda.hhs.gov

7) John M. Taylor III, J.D.(Counselor to the Cmsr.) - john.taylor2@fda.hhs.gov

8) Jeanne Ireland (Assistant Cmsr. for Legislation) - jeanne.ireland@fda.hhs.gov

9) Michael A. Chappell (Acting Associate Cmsr. for Regulatory Affairs) - michael.chappell@fda.hhs.gov

10) Beth Martino (Associate Cmsr. for External Affairs) - beth.martino@fda.hhs.gov

11) Lawrence R. Deyton, M.S.P.H., M.D. (Dir., Ctr. for Tobacco Products) - lawrence.deyton@fda.hhs.gov

12) Bernadette Dunham, D.V.M., Ph.D.(Dir., Ctr. for Veterinary Medicine) - bernadette.dunham@fda.hhs.gov

13) Michael M. Landa, J.D. (Acting Dir., Ctr. for Food Safety & Applied Nutrition) - michael.landa@fda.hhs.gov

14) Karen Midthun, M.D. (Dir., Ctr. for Biologics Evaluation & Research) - karen.midthun@fda.hhs.gov

15) Jeffrey E. Shuren, M.D., J.D.(Dir., Ctr. for Devices & Radiological Health) - jeff.shuren@fda.hhs.gov

16) William Slikker, Jr., Ph.D. (Dir., National Ctr. for Toxicological Research) - william.slikker@fda.hhs.gov

17) Janet Woodcock, M.D (Dir., Ctr. for Drug Evaluation & Research) - janet.woodcock@fda.hhs.gov

18) FDA Ctr. for Drug Evaluation & Research (CDER):

http://www.fda.gov/AboutFDA/Ctr.sOffices/CDER/ucm075128.htm

- Contact FDA Ctr. for Drug Evaluation & Research (CDER) – (Fill out form on Site)

“Information about drug products currently in review at FDA is confidential. If you know the manufacturer/sponsor, please contact them directly.

http://www.accessdata.fda.gov/scripts/email/cder/comment.cfm

19) Cardiovascular & Renal Drugs Advisory Committee:

Elaine Ferguson, M.S., R.Ph., (Designated Federal Official) - Elaine.Ferguson@fda.hhs.gov

http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/default.htm

 

 

20) Office of Compliance - “Vision: Through excellence in risk- and science-based policy, surveillance, and enforcement, we prevent consumer exposure to unnecessary risk from drugs throughout their lifecycle.”

- Deborah Autor, Esq., Director (FDA Office of Compliance) - deborah.autor@fda.hhs.gov

Office of Compliance

10903 New Hampshire Avenue

Bldg. 51, Rm 5271

Silver Spring, MD 20993-0002

21) Office of New Drugs - “Our Mission - To ensure that safe and effective drugs and biologics are available to the American people.”

- John Jenkins, M.D., Director (Office of New Drugs) - john.jenkins@fda.hhs.gov

- Sandra Kweder, M.D., Deputy Director (Office of New Drugs) - sandra.kweder@fda.hhs.gov

Office of New Drugs

301-796-0700

Fax: 301-796-9856

ondeio@fda.hhs.gov

Immediate Office - Mail Stop 6311

10903 New Hampshire Avenue

Silver Spring, MD 20993

22) Office of Oncology Drug Products Divisions & Programs:

- Richard Pazdur, M.D. - Dir., Div. of Oncology Drug Products - richard.pazdur@fda.hhs.gov

Food & Drug Administration

Ctr. for Drug Evaluation & Research

Division of Drug Oncology Products

5901-B Ammendale Road

Beltsville, MD 20705-1266

http://www.fda.gov/AboutFDA/Ctr.sOffices/CDER/ucm093829.htm

23) Division of Drug Oncology Products (DDOP)

- Robert Justice, M.D.(Director) - robert.justice@fda.hhs.gov

- Ann Farrell, M.D. (Deputy Director) - ann.farrell@fda.hhs.gov

- Anthony Murgo, M.D. (Acting Deputy Director) - anthony.murgo@fda.hhs.gov

- Amna Ibrahim, M.D. (Deputy Director of Safety) - amna.ibrahim@fda.hhs.gov

Co-Chiefs, Project Management Staff:

- Frank Cross - frank.crossjr@fda.hhs.gov

- Alice Kacuba, R.N., M.S.N. - alice.kacuba@fda.hhs.gov

Mailing Address:

Food and Drug Administration

Center for Drug Evaluation and Research

Division of Drug Oncology Products

5901-B Ammendale Road

Beltsville, MD 20705-1266

24) Office of Pharmaceutical Science (OPS)

- Helen N. Winkle, (Director) - helen.winkle@fda.hhs.gov

- Keith O. Webber, Ph.D. (Deputy Director) - keith.webber@fda.hhs.gov

25) Office of New Drug Quality Assessment

- Moheb Nasr, Ph.D. (Director) - moheb.nasr@fda.hhs.gov

- Christine Moore, Ph.D. (Acting Deputy Director) - christine.moore@fda.hhs.gov

10903 New Hampshire Avenue HFD-800

Silver Spring, MD 20993

Phone: (301) 796-1900

Fax: (301) 796-9748

26) Office of Biotechnology Products (OBP)

"The mission of the Office of Biotechnology Products is to protect public health by assuring the quality, safety, efficacy, availability and security of therapeutic protein and monoclonal antibody products."

- Steve Kozlowski, M.D. (Director) - steven.kozlowski@fda.hhs.gov

27) Office of Testing and Research Mission

- Vincent L. Vilker, Ph.D. (Director) - vincent.vilker@fda.hhs.gov

The mission of the Office of Testing and Research is to:

* Advance the scientific basis of regulatory policy

* Assure that regulatory policy and decision making are based on the best available science

Federal Research Center

White Oak Office Building #22

10903 New Hampshire Avenue

Silver Spring, MD 20993

Phone: (301) 796-1213 Fax: (301) 796-9859

28) Division of Pharmaceutical Analysis

- Lucinda Buhse, Ph.D. (Director) - lucinda.buhse@fda.hhs.gov

Benjamin Westenberger, Deputy Director

1114 Market St. Room 1002

St. Louis, Missouri 63101

Phone: (314) 539-2135   Fax: (314) 539-2113

29) Office of Translational Sciences

- Shaavhree Buckman, MD, PhD (Acting Director) - shaavhree.buckman@fda.hhs.gov

Overview - "OTS was established to promote efficient and informative study designs and data analysis methods to quantitatively evaluate the efficacy, safety, and dosing of drugs through collaboration among the Office of Biostatistics, Office of Clinical Pharmacology, and other offices in CDER and Centers in FDA. We foster novel drug development strategies through research and application of statistical and mathematical modeling and simulation techniques in the review and analysis of data in the areas of exposure-response, pharmacokinetics, pharmacodynamics, pharmacogenomics, bioequivalence assessment, clinical trials, quantitative risk assessment, toxicology, and product quality assessment."

White Oak Building 22 - Room 5300

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

Phone: 301-796-2600

Fax: 301-796-9907

29) Office of Biostatistics Organization

(http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm166250.htm)

- Robert T. O'Neill, PhD, (Director) - robert.oneill@fda.hhs.gov

- S. Edward Nevius, PhD, (Deputy Director) - sedward.nevius@fda.hhs.gov

- Sue-Jane Wang, PhD, (Associate Director, Pharmacogenomics) - suejane.wang@fda.hhs.gov

- Ram Tiwari, PhD, (Associate Director) - ram.tiwari@fda.hhs.gov

- George Rochester, PhD, (Acting Associate Director) - george.rochester@fda.hhs.gov

*****Public Advocates*******

Below are links to public advocates that need to be informed of the FDA & Advisory Panels questionable actions.

1) The Obesity Society (!!!Meeting in SanDiego Oct 8-12!!!)
http://www.obesity.org/

2) Obesity Action Coalition
http://www.obesityaction.org/advocacy/ge...

3) Council on Size & Weight Discrimination
http://www.cswd.org/

4) New York City Coalition Against Hunger (a must read report)
http://www.nyccah.org/node/92

5) Health Advocate
http://www.healthadvocate.com/
http://www.medicalnewstoday.com/articles...

6) British Columbia Association of Bariatric Advocates
http://www.bcaba.net/

7) Obesity Law & Advocacy Ctr.
http://www.obesitylaw.com/lawyers.php

Links for Poeple to contact there senators:
https://writerep.house.gov/writerep/welcome.shtml
http://www.senate.gov/general/contact_information/senators_cfm.cfm