Philip Morris
Feds: Toughen Regulation, Promote Research Improvements Needed, and They Are on the Way
Fields
- Author
- Shalala, D.
- Wolfe, S.
- Area
- NICOLI,DAVID/OFFICE
- Type
- NEWS, NEWS ARTICLE
- Site
- W6
- Named Person
- Hader, R.
- Request
- Stmn/R1-072
- Stmn/R1-079
- Document File
- 2046936725/2046937271/Missing
- Named Organization
- FDA, Food and Drug Administration
- Health Research Group
- Hhs, Dept of Health and Human Services
- Health Research Group
- Author (Organization)
- Health Research Group
- Public Citizen Org
- Litigation
- Stmn/Produced
- Master ID
- 2046936726/6992
Related Documents:- 2046936726 Table of Contents
- 2046936727 A
- 2046936728-6731 FDA's Legally Suspect Actions Invite Challenge
- 2046936732-6735 FDA Paralysis Raises Health Care Costs
- 2046936736-6739 the Real Problem with Health Care in America: While Dr. David Kessler's FDA Fiddles, Medical Approvals Lag and Americans Die
- 2046936740-6743 What the FDA Doesn't Want You to Know Could Kill You
- 2046936744-6751
- 2046936752-6759
- 2046936760-6762 Guide to Medical Device Regulation FDA Issues First Warning Letter Citing Gmp Problems Under New Cpg
- 2046936763-6766 the Vitamin Uprising
- 2046936767-6780 Losing the Edge Overseas Patients Reap the Benefits of U.S.Research While Those Here Wait
- 2046936781-6783 Losing the Edge
- 2046936785-6786
- 2046936787-6789 Challenging FDA Authority
- 2046936790-6793 Speakeasies in A New Age of Prohibition
- 2046936794-6798 Who Is Happiest Politician in Washington Over Whitewater? Alfonse D'amato - Newt Gingrich - David Kessler?
- 2046936799-6800 Pro-Free Enterprise Group Challenges FDA's Authority to Regulate Drug Companies' Speech
- 2046936801-6802 Wlf Off-Label Use Suit Heats Up
- 2046936803-6805 Just Call Me 'doc'
- 2046936806-6810 Food and Drugs and Politics
- 2046936811-6813 Science and Technology Getting the Lead Out
- 2046936814 Forbes Fear of Falling 5 Ways to Protect Yourself in Scary Times
- 2046936815-6816 Book Burning
- 2046936817 If A Murderer Kills You, It's Homicide If A Drunk Driver Kills You, It's Manslaughter If the FDA Kills You, It's Just Being Cautious
- 2046936818-6820 Frustration for Medical Innovators
- 2046936821 Block That Innovation
- 2046936822-6823 Getting Even
- 2046936824-6826 Biotech Pipeline: Bottleneck Ahead
- 2046936827-6829 Consuming Interest Are We Safe From the FDA?
- 2046936830-6839 Saying Yes to Drugs Policy Analysis
- 2046936840-6858 Deadly Overcaution: FDA's Drug Approval Process
- 2046936859 B
- 2046936860-6861 Litigation Update Wlf Wins Suit Against FDA to Stop Overregulation of Heart Valves (Washington Legal Foundation V. Shalala)
- 2046936862-6863 Litigation Update Wlf Opposes FDA Efforts to Dismiss First Amendment Lawsuit (Washington Legal Foundation V. Kessler)
- 2046936864-6867 Dickinson's FDA Review
- 2046936868-6869 Wlf Urges Appeals Court to Enjoin Federal Policy Restricting Human Heart Valve Transplant (Washington Legal Foundation V. Shalala)
- 2046936870-6871 FDA Problems Slow US Andas
- 2046936872-6873 Taking the Heat An Aids Patient Champions A Risky Blood Treatment Banned in the U.S.
- 2046936874-6876 New Study Says Breast Implants Are Not A Health Risk
- 2046936877-6878 Wlf Sues FDA to Overturn Policy Restricting Information on Off-Labels Uses of Approved Drugs and Devices (Washington Legal Foundation V. Shalala)
- 2046936879 Ex-Inspector of F.D.A. Is Convicted of Bribery
- 2046936879A FDA Has No Position Yet
- 2046936880-6881 M-D-D-I Reports - 'the Gray Sheet'
- 2046936882 FDA Halts Test on Device That Shows Promise for the Victims of Cardiac Arrest
- 2046936883 Law Concerning Medical Devices Is Often Ignored
- 2046936884 Dairies, Drugs and Accusations
- 2046936884A FDA to Launch Campaign on New Labels for Food
- 2046936885 Probe of Three FDA Officials Sought Industry Ties Before Approval of Bovine Growth Hormone Are at Issue
- 2046936886-6889 Safety First How A Device to Aid in Breast Self-Exams If Kept Off the Market Other Nations Approved It But U.S. Demands Proof Simple Pad Isn't Risky Nine Year Battle with the FDA
- 2046936890-6892 Who Will Regulate the Regulators? If You Make A Mistake, Shouldn't You Own Up? Not If You're the FDA, Epa, or Ftc
- 2046936893-6894 None - A - Day Is the FDA Out to Take Your Vitamin?
- 2046936895 Will A New Government Program Net the Bad Fish?
- 2046936896-6897 FDA Responds to Wlf Petition Regarding Off-Label Drug Use by Indefinitely Postponing Issuance of Regulatory Guidelines
- 2046936898-6905 FDA Research: Overview
- 2046936906-6910 Government Report Finds Levels Safe Pesticide Residues in Your Children's Food
- 2046936911-6912 Wlf Urges FDA to Rescind Policy Restricting Information Flow on Off-Label Uses of Approved Drugs and Devices
- 2046936913 Regulatory Chokehold FDA Red Tape Dooms Transplant Drug
- 2046936914 FDA Called Lax in Overseeing Medical Sterilizers, Disinfectants
- 2046936915 FDA Sets Labeling Rules for Dietary Supplements Nutritional Data, Support for Health Claims Required
- 2046936916 Chemicals That Taint Seafood Concerns Continue Over Safety of Methylmercury Inspection Processes
- 2046936917 Lifesaving Devices Languish at the FDA
- 2046936918-6919 Wlf Sues FDA to Enjoin Federal Policy Restricting Human Heart Valve Transplants (Washington Legal Foundation V. Shalala)
- 2046936920 What's in Food? Answers Differ at 2 Agencies Manufacturers Fight to Keep FDA Label Rules From Encroaching on Ftc Ad Rules
- 2046936921 Reform the FDA
- 2046936922 Legal Beat FDA Approval Shield Firms in Injury Suits
- 2046936923 Water From A Bottle
- 2046936924 Commentary FDA and Our Split Medical Persona
- 2046936925-6926 FDA Assailed for Slow Testing of New Drugs
- 2046936927 Andrews Office Products Capitol Heights, Md (K)
- 2046936928-6947 Statement by David A. Kessler, M.D. Commissioner of Food and Drugs Before the Committee on Energy and Commerce Subcommittee on Health and the Environment U.S. House of Representatives
- 2046936948-6961 Filthy Food,Dubious Drugs, and Defective Devices: the Legacy of FDA's Antiquated Statute A Staff Report
- 2046936962-6968 Gao Reports on FDA-Related Topics 860000 to Present
- 2046936969 D
- 2046936970-6985 Statement by Louis W. Sullivan, M.D. Secretary of Health and Human Services Before the Committee on Labor and Human Resources U.S. Senate on the Final Report of the Advisory Committee on the FDA
- 2046936986-6992 Proposed Remarks of Dr. Charles Edwards Before the Senate Committee on Labor and Human Resources
- Date Loaded
- 05 Jun 1998
- UCSF Legacy ID
- znn65e00
Document Images
2 peds:'taughen regulation, promote research
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......././n...NM\.
br. Sidney Wolfe .
llaeiih ltr:pttrcb 6roup (peit of Rziipn lhdcM Pttblia Citizen QrotAlzation)
Me main probiom bave a huge aa~Ity to
with daviee repiirtioa do kartts. Ths F3]A
1a thic C9W3try is there doei more te$tlietioA
fs not eqougln of it. tbaa taost otber coun
Most of'the devices tzies. Svt our view is
tbat arr an tho tnarlust that the FDA doeea't
bars avoided thr rep do aesrly eazxtflt.
Latory p:ecess bmwe
tftey.rept tJuottgh
bifore dtviee reiula
tion was eadified ut
iaw in 19% or beeatse
tttey ase aoasideted a
Mwfftcatica of aa
t~tists46 dttviee.
"I favor more r2BolOLUt
iqti+e3tf~uson aad test-
in~ oi deviea besatsss
t}tta~, tbit ue
itnptaate0 permaaeaely
'-The (adrsstt,r: oaat
;Iai4t t~utbi s±essg isj
Prepasteraus. You
hwe to be sltepticai of
indLtIUYs taaplaiaa,
they oaur
often
becstue tbt Lodustty
doa not werat ta be
openad up to =etvtioy
aad Das eotuaated
~OteatiaWr da~magiaB
sBfCt'IIlttsoA.
"Ovetatl, the lndustry
is ~towiag, and ehey
have tls,tivad iA rhe
Ts~ qf~c~erntDent
re ulatien. sa taet, oae
of~tlse"aroas the
indumy bas tbrived is
beausa of uS.:eSula-
tionc tbat havs beeomE
the ataadard for the
worla
"It's a Sood idea to
eaooutage U.S. to1ula
toce to ba taare tsas}-
tive to intes>jatioaal
deYelopaients and in
novattoDi tA Cara. 8ut
it ii not a substittue for
rijoTous !aw and reeu
Wo11."
.
For ts'aore infonn4or+:
~------
Huifh R11tfate9t GrWp
tOffo r st, ti,w.
Wsshlnpion, D.C. 20238
- Improverrients ne,eded, and they ere on the way
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Donna Shalala
Suntarr o1 the OtQufcaeat st Hialsh ind Humzn Sarfees, which ftteludfs the FOA
"wR've been woaied
fox a lvrit titae (sbaut
Ua. medicai eataPs-
tsiss atovka2 oittborc)
/1Ziat'i wliy , , , ws'vc
Sot a Acw tsatn ia
~bisge tbetc at the
~ it'tt not pa:fcct
but we ~to cestaut
+do':ag better. Of
co3tlis, vye C3L't
apFIrove thinss that ws
ttsmk ase uasffe, to it
tetaaf>ss a balaasiag
act, p ut eettiia ly we
caa do better, Mad
we've titutod, A year
or ro eSo, we taovad to
ttan tta br,ef up both
tho:tiff ad tiAs
pttxets. So we ate
eomiaii alpW=
Fpr R1ote inforrnatiort:
Huith utd !luttntt
aa"ltwe: aeoorunonl
200 tndlpsndottes Afr..
za2 1~ptaa. Q.C.
` - 10MMMMM~
.
