Price
Records: 38
Control #

Recd Date /
Due Date

Originator /
Org

2016-6738

11/17/2016

PRICE, TOM

16-DEC-16

HOUSE OF REPRESENATATIVES

To /
Org Abbr

Synopsis

[no person]

CDER(C) Rep. Tom Price writes on behalf
of constituent (b) (6)
, who has
concerns about acquiring the drug Rituxan,
or its alternatives.

Open

CDER-(C) (b) (6)
is requesting
information on when the FDA Pharmacy
Compounding Advisory Committee will
update the list to include capsaicin
palmitate.

Closed

CDRH-(C) (b) (6)
is writing regarding
the classification of Sonablate 450, a
prescription device

Closed

CCT-(C)(b) (6)
is requesting
assistance with a legal matter regarding a
retired FDA Special Agent.

Closed

CDER-PRIORITY-MULTI-MEMBER-(S)
Members are writing to express concern
with the FDA's Implementation of the
Biologics Price Competition and Innovation
Act (BPCIA), and to urge the FDA to solicit
and consider physicians' and patients' views
in its rule-making.

Closed

CDER-(C) (b) (6)
is writing
regarding access to a medication similar to
Sprivia which is made in the US.

Closed

CDER-(c)- Constituent (b) (6)
is
writing regarding the anti-malaria drug
mefloquine.

Closed

FDA CONGRESSIONAL LIASON

(b) (6)

Status /
Status Date
11/17/2016

[no org]
2016-2612

04/27/2016

PRICE, TOM

25-MAY-16

HOUSE OF REPRESENTATIVES

[no person]
FDA CONGRESSIONAL LIASON

(b) (6)
[no org]
2016-2378

04/18/2016
16-MAY-16

(b) (6)
[no org]

[no person]
FDA CONGRESSIONAL LIASON

PRICE, TOM

11/18/2016

05/16/2016

HOUSE OF REPRESENTATIVES
2016-541

02/03/2016

PRICE, TOM

03-MAR-16

HOUSE OF REPRESENATATIVES

[no person]
FDA CONGRESSIONAL LIASON

(b) (6)

06/27/2016

[no org]
2016-463

02/02/2016

WENSTRUP, BRAD

Ostroff, Stephen M

17-FEB-16

House of Representatives

FDA/OC/

Roe, David P. (Phil)
HOUSE OF REPRESENTATIVES
BUSCHON, Mr. LARRY

03/15/2016

[no org]
ELLMERS, RENEE L
HOUSE OF REPRESENATATIVES
HARRIS, ANDY
HOUSE OF REPRESENTATIVES
7 Addtional
2016-148

01/12/2016

PRICE, TOM

10-FEB-16

HOUSE OF REPRESENATATIVES

[no person]
FDA CONGRESSIONAL LIASON

02/17/2016

(b) (6)
[no org]
2015-6239

09/24/2015

PRICE, TOM

23-OCT-15

HOUSE OF REPRESENTATIVES

[no person]
FDA CONGRESSIONAL LIASON

12/30/2015

(b) (6)
[no org]

Page 2 of 7

December 15, 2016 11:59 AM

 Price
Records: 38
Control #

Recd Date /
Due Date

Originator /
Org

To /
Org Abbr

Synopsis

2015-5238

08/04/2015
18-AUG-15

ISAKSON, JOHNNY

Ostroff, Stephen M
FDA/OC/

CCN-CFSAN-CVM-PRIORITY-MULTIMEMBER-(s)- Members are writing
regarding the Proposed Rule for Current
Good Manufacturing Practice (CGMP) and
Hazard Analysis and Risk-Based Preventive
Controls for Animal Food. FSMA

Closed

UNITED STATES SENATE

CDER-PRIORITY-MULTI-MEMBER-(s)Members are expressing their concerns
regarding the implementation of the Drug
Quality and Security Act (DQSA) and
compounded and repackaged drugs.

Closed

CDRH-(c)- Member Tom Price is writing in
support of (b) (4)
, and their
510K pre-submission of a (b) (4)

Closed

CDER: T. Price Communication log

Open

PERDUE, Honorable DAVID A
UNITED STATES SENATE
WESTMORELAND, LYNN A

Status /
Status Date
08/31/2015

HOUSE OF REPRESENTATIVES
BISHOP, SANFORD D
HOUSE OF REPRESENTATIVES
CARTER, EARL L
HOUSE OF REPRESENTATIVES
9 Addtional
2015-4388

06/22/2015

GRIFFITH, H. MORGAN

Ostroff, Stephen M

07-JUL-15

HOUSE OF REPRESENTATIVES

FDA/OC/

ROE, PHIL
HOUSE OF REPRESENTATIVES

07/28/2015

BLACKBURN, MARSHA
HOUSE OF REPRESENTATIVES
Harper, Gregg
HOUSE OF REPRESENTATIVES
NUGENT, RICHARD B.
HOUSE OF REPRESENTATIVES
28 Addtional
2015-2619

2015-1821

03/31/2015

PRICE, TOM

28-APR-15

HOUSE OF REPRESENTATIVES

03/09/2015

PRICE, TOM
HOUSE OF REPRESENTATIVES

2014-7561

[no person]
FDA CONGRESSIONAL LIASON

[no person]
FDA CONGRESSIONAL LIASON

09/23/2014

DEGETTE, DIANA

HAMBURG, M.D., MARGARET

07-OCT-14

HOUSE OF REPRESENTATIVES

Food and Drug Administration

WHITFIELD, ED
HOUSE OF REPRESENTATIVES

08/07/2015

03/09/2015
CDRH - PRIORITY - MULTI-MEMBER(s) Members are concerned about the draft
guidance on blood glucose monitoring test
systems ( BGMS ) and the draft guidance on
Over the Counter ( OTC ) BGMS.

Closed
10/06/2014

AMODEI, MARK
HOUSE OF REPRESENTATIVES
BARROW, JOHN
HOUSE OF REPRESENTATIVES
BERA, AMI
HOUSE OF REPRESENTATIVES
80 Addtional
Page 3 of 7

December 15, 2016 11:59 AM

 Price
Records: 38
To /
Org Abbr

Synopsis

PRICE, TOM

FDA/OL, CONGRESSIONAL LIAISO
OFFICE OF LEGISLATION

CCN-CFSAN-(C) (b) (6)
is asking
the FDA to review the labeling of Food
products.

Closed

HOUSE OF REPRESENATATIVES

CDRH-(C) (b) (6)
writing in
regards to ultrasound or readiology device
safety and support.

Closed

CDER (c) - Ever since (b) (6)
started taking the generic form of Lexapro
(escitalopram), she has experienced side
effects - withdrawl, depression, cognitive
problems, and then later by persistant
genital arousal disorder, which she is
currently seeking treatment for.

Closed

CCN (CFSAN) (s) - MULTI - As concerned
physicians and medical practitioners, they
are concerned about FDA and EPA advising
women who may be come pregnant, are
pregnant, nursing mothers, and children to
reduce the amount of seafood consumption,
but since 2004, there is an Omega 3
deficiency in the United States based on this
reduced consumption.

Closed

CCN-CSFAN-(C)-(b) (6)
is
concerned about Draft Guidance on New
Dietary Supplements.

Closed

CDER (c) -(b) (4)
has varicose veins
which cause excruciating pain. The drug
Detralex 500 mg helps her immensley. The
drug is available in Europe, but not in the
United States or Canada.

Closed

CDER (s) - Feels becuase there is a lack of
framework to bring DESI drugs to market
legally (even though these drugs have been
used for many years), people are begining
to lose access to treatments they have relied
on for decades.

Closed

Control #

Recd Date /
Due Date

Originator /
Org

2014-2453

03/21/2014
18-APR-14

Status /
Status Date
04/02/2014

(b) (6)
[no org]
2014-2185

03/12/2014

PRICE, TOM

FDA/OL, CONGRESSIONAL LIAISO

09-APR-14

HOUSE OF REPRESENATATIVES

OFFICE OF LEGISLATION

03/28/2014

(b) (6)
[no org]
2013-2872

04/22/2013

PRICE, TOM

FDA/OL, CONGRESSIONAL LIAISO

20-MAY-13

HOUSE OF REPRESENATATIVES

OFFICE OF LEGISLATION

(b) (6)
[no org]

2012-9398

11/20/2012

GINGREY, PHILLIP

HAMBURG, MARGARET

04-DEC-12

HOUSE OF REPRESENTATIVES

Commissioner U.S. Food and Drug
Administration

FLEMING, JOHN
HOUSE OF REPRESENTATIVES
BURGESS, MICHAEL C
HOUSE OF REPRESENTATIVES
BOUSTANY, CHARLES

05/16/2013

02/26/2013

HOUSE OF REPRESENTATIVES
HARRIS, ANDY
HOUSE OF REPRESENTATIVES
4 Addtional
2012-1593

02/23/2012

PRICE, TOM

MASON, STEPHEN R

22-MAR-12

HOUSE OF REPRESENTATIVES

ACTING, ASSISTANT COMMISSIONER
FOR LEGISLATION

(b) (6)

04/11/2012

[no org]
2012-910

02/02/2012

PRICE, TOM

MASON, STEPHEN R

02-MAR-12

HOUSE OF REPRESENTATIVES

ACTING, ASSISTANT COMMISSIONER
FOR LEGISLATION

(b) (6)
[no org]
2011-8428

10/17/2011

PRICE, TOM

HAMBURG, MARGARET

15-NOV-11

HOUSE OF REPRESENATATIVES

Commissioner U.S. Food and Drug
Administration

Page 4 of 7

06/11/2012

01/06/2012

December 15, 2016 11:59 AM

 Price
Records: 38
To /
Org Abbr

Synopsis

GINGREY, PHILLIP

HAMBURG, MARGARET
Commissioner U.S. Food and Drug
Administration

CCN - CFSAN (s) - PRIORITY MULTISIG - MULTI-SIG -Sixteen Members
of Congress want FDA to modify its 2004
advice about eating seafood for women who
are or might become pregnant, nursing
mothers, and young children, to be
consistent with HHS's 2010 Dietary
Guidelines for Americans (DGAs).

Closed

HOUSE OF REPRESENTATIVES

CCN - CFSAN (c) - (b) (6)
is
concerned about FDA's regulation of raw
mi k and the Agency's seizure of cheese
from Morningland Dairy.

Closed

CDER (c) - A constituent is concerned
about FDA not monitoring the safety of
generic drug manufacturing.

Closed

CCN / CFSAN - (c) - Constituent is urging
FDA not to ban the marketing of dietary
supplements containing pyridoxal 5'phosphate (P5P). Constituent asserts that
Medicare wants to ban the marketing of the
supplement, and that P5P is exempt from
the New Dietary Ingredient pre-market
notification requirements because it has
been part of the human diet prior to 1994's
DSHEA.

Closed

CDER (c) - Constituent is concerned about
(1) obtaining Armour Thyroid medicine, and
(2) the use of mail-in pharmacies.

Closed

CBER/CDRH-(c) Constituent is concerned
that FDA Commissioner Dr. Margaret
Hamburg misuses her position at FDA to
keep the truth about the danger of amalgam
(mercury) fillings covered up for personal
gain.

Closed

CDER-(c) Constituent inquires about the
status of a Citizen Petition to reclassify
terbutaline sulfate from pregnancy risk
catergory B to category C, D, or X (Docket
No. 2008-P-0358).

Closed

Control #

Recd Date /
Due Date

Originator /
Org

2011-2160

03/17/2011
31-MAR-11

WASSERMAN SCHULTZ, DEBBIE
HOUSE OF REPRESENTATIVES
BOUSTANY, CHARLES
HOUSE OF REPRESENTATIVES

Status /
Status Date
04/11/2011

BURGESS, MICHAEL C
HOUSE OF REPRESENTATIVES
CASSIDY, BILL
HOUSE OF REPRESENTATIVES
11 Addtional
2010-7285

10/13/2010

PRICE, TOM

MASON, STEPHEN R

10-NOV-10

HOUSE OF REPRESENATATIVES

ACTING, ASSISTANT COMMISSIONER
FOR LEGISLATION

(b) (6)

01/24/2011

[no org]
2010-3666

05/21/2010
21-JUN-10

PRICE, TOM

MASON, STEPHEN R

HOUSE OF REPRESENATATIVES

ACTING, ASSISTANT COMMISSIONER
FOR LEGISLATION

(b) (6)

08/24/2010

[no org]
2010-2287

03/30/2010
27-APR-10

PRICE, TOM

MASON, STEPHEN R

HOUSE OF REPRESENATATIVES

ACTING, ASSISTANT COMMISSIONER
FOR LEGISLATION

(b) (6)
[no org]

2010-254

01/09/2010

PRICE, TOM

MASON, STEPHEN R

08-FEB-10

HOUSE OF REPRESENATATIVES

ACTING, ASSISTANT COMMISSIONER
FOR LEGISLATION

(b) (6)

05/12/2010

03/05/2010

[no org]
2009-6906

10/14/2009

PRICE, TOM

MASON, STEPHEN R

12-NOV-09

HOUSE OF REPRESENATATIVES

ACTING, ASSISTANT COMMISSIONER
FOR LEGISLATION

(b) (6)
[no org]
2009-6714

10/06/2009

PRICE, TOM

MASON, STEPHEN R

04-NOV-09

HOUSE OF REPRESENATATIVES

ACTING, ASSISTANT COMMISSIONER
FOR LEGISLATION

(b) (6)
CONSTITUENT

Page 5 of 7

11/23/2009

10/29/2009

December 15, 2016 11:59 AM

 Price
Records: 38
To /
Org Abbr

Synopsis

PRICE, TOM

MASON, STEPHEN R
ACTING, ASSISTANT COMMISSIONER
FOR LEGISLATION

CDER-(c) Constituent states that FDA has
ordered the supplier (of her desiccated
thyroid hormone) to cease production, and
that there is a massive, nationwide shortage
of dessicated thyroid hormone. Constituent
cannot take synthetic hormones and
depends on the dessicated thyroid to live.

Closed

HOUSE OF REPRESENATATIVES

CBER/CDRH-(c) Fertility Technology
Resources markets medical products to
fertility specialists. The company asks that
their product, the Sperm Class Analyzer, be
classified as a sperm analysis device just as
three similar products have been.

Closed

CDER (C) RE: ACCUTANE

Closed

Control #

Recd Date /
Due Date

Originator /
Org

2009-5824

09/02/2009
01-OCT-09

(b) (6)
CONSTITUENT

2009-4929

07/27/2009

PRICE, TOM

MASON, STEPHEN R

24-AUG-09

HOUSE OF REPRESENATATIVES

ACTING, ASSISTANT COMMISSIONER
FOR LEGISLATION

(b) (6)
Fertility Technology Resources
2008-4710

07/17/2008

PRICE, TOM

MASON, STEPHEN R

14-AUG-08

HOUSE OF REPRESENATATIVES

ACTING, ASSISTANT COMMISSIONER
FOR LEGISLATION

(b) (6)

Status /
Status Date
10/30/2009

01/09/2010

09/10/2008

Constituent
2007-5124

07/26/2007

PRICE, TOM

Mason, Stephen R

23-AUG-07

HOUSE OF REPRESENATATIVES

OC/OPPL/

(b) (6)
Constituent
2007-3550

05/20/2007

Doyle, Mike

von Eschenbach, Andrew C

18-JUN-07

HOUSE OF REPRESENTATIVES

Commissioner of Food and Drugs

SESSIONS, PETE
HOUSE OF REPRESENTATIVES

CDRH (C) CONCERNS RE: REQUEST
FOR FDA TO ISSUE A NUMERIC CODE
FOR A TRANSMITTER OR SENSOR THAT
WORKS WITH MEDTRONICS' INSULIN
PUMP.

Closed

CDRH - MULTI-SIG - RE: REQUEST FDA
TO REQUIRE A NATIONAL UNIQUE
DEVICE IDENTIFICATION (UDI) SYSTEM
FOR MEDICAL DEVICES AS SOON AS
POSSIBLE.

Closed

CDER (S) RE: AN APPLICATION FOR A
NATURALLY OCCURRING FORM OF
PROGESTERONE - 17 ALPHAHYDROXPROGESTERONE CAPROATE
(17P)

Closed

CDER (C) CONCERNS RE: INQUIRY
ABOUT BIO-IDENTICAL HORMONES

Closed

09/20/2007

11/01/2007

GORDON, BART
HOUSE OF REPRESENTATIVES
TERRY, LEE
HOUSE OF REPRESENTATIVES
BRADY, ROBERT A
HOUSE OF REPRESENTATIVES
21 Addtional
2006-6897

09/01/2006

GINGREY, PHILLIP

Von Eschenbach, Andrew C

02-OCT-06

HOUSE OF REPRESENTATIVES

FDA/OC/

PRICE, TOM
HOUSE OF REPRESENATATIVES
2006-1872

03/09/2006
06-APR-06

PRICE, TOM

FDA/OL, *

HOUSE OF REPRESENATATIVES

OFFICE OF LEGISLATION

09/08/2006

03/27/2006

(b) (6)
Constituent

(b) (6)
Constituent
Page 6 of 7

December 15, 2016 11:59 AM

 Price
Records: 38
To /
Org Abbr

Synopsis

PRICE, TOM

FDA/OL, *
OFFICE OF LEGISLATION

CDRH (C) CONCERNS RE: AWAITING
APPROVAL OF "RESTOR" IOL LENSES
TO BE AVAILABLE IN A STRONGER
PRESCRIPTION STRENGTH

Closed

HOUSE OF REPRESENATATIVES

CDER (C) CONCERNS RE: IMPORTED
MEDICATIONS BEING HELD BY
CUSTOMS

Closed

CCN/CFSAN (C) CONCERNS RE: FREE
SAMPLE OF DIAL SPRING WATER,
ANTIBACTERIA, CLEAN RINSING BODY
WASH.

Withdrawn

CBER (S) RE: EXPRESSES CONCERNS
ABOUT THE DISRUPTION IN THE
AVAILABILITY OF CRYOLIFE
SYNERGRAFT TISSUE

Closed

CDER (C) RE: COSMETIC PRODUCT
COMPLAINT - DIAL SPRING WATER
BODY WASH

Closed

Control #

Recd Date /
Due Date

Originator /
Org

2006-1274

02/16/2006
17-MAR-06

(b) (6)

Status /
Status Date
03/10/2006

CONSTITUENTS
2006-1223

02/15/2006

PRICE, TOM

FDA/OL, *

16-MAR-06

HOUSE OF REPRESENATATIVES

OFFICE OF LEGISLATION

03/15/2006

(b) (6)
Constituent

(b) (6)
Constituent
2005-8395

12/13/2005

PRICE, TOM

Ronan, Patrick

11-JAN-06

HOUSE OF REPRESENATATIVES

FDA/OPPLA/OL/

(b) (6)

01/06/2006

CONSTITUENTS
2005-5874

2005-4672

09/08/2005

PRICE, TOM

Crawford, Lester M

06-OCT-05

HOUSE OF REPRESENATATIVES

FDA/OC/

07/29/2005

PRICE, TOM

Ronan, Patrick

26-AUG-05

HOUSE OF REPRESENATATIVES

FDA/OPPLA/OL/

12/07/2005

12/07/2005

(b) (6)
Constituent

Page 7 of 7

December 15, 2016 11:59 AM