Philip Morris
Losing the Edge
Fields
- Area
- NICOLI,DAVID/OFFICE
- Type
- MAGA, MAGAZINE ARTICLE
- Master ID
- 2046936726/6992
- 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
- 2046936784 Feds: Toughen Regulation, Promote Research Improvements Needed, and They Are on the Way
- 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
Related Documents:
Document Images
By pi ttsmburver
` 9ureau i
and Mik. M.yua
HalOmi Ecanorrsica
Corrospandsm
Losing'the edge
Minnesdta medical firms say they
i
must export tecbno1Qgy,; jobs
I
S
usatre, a~c~a3r~r ot' eq~ivme,at used
~to Vett ~d~ disdtta, lus boet: Lhe
R' tnodet of Mittaesoti's UV'nMC4rl hi~hter~ rnedirsl devia com¢aoies-
ia the lata t9S0s, r.alei lus.v ax t darrlia6 rste
of xf pesaent a yzar:ad its ern9loy~ec had
avery rmSOp to tCt4 VlosperdUd asSd itauie.
Bvt not awytacro.
tift mantbss of ivv%glial, Minatr.o Laid off
40 workass last 69 u its Flyntouth tkaorY
tnd noae of theta hive been rs!leci bulc.
Yet Mioatx soon r%,Il be hirin aaaia -- on
the other sido of the Ailtatie aoem The
comAteAy, wEsirh tlrasdy hats a smaly ftetory
in E}emzwy, this year wi11 oqESt aiwr site
in ths Hetberizads or 8slsitcm. The nuuh or
>Eie"W: wil1 be tettinz hio-myin; jobs ia s
to i~ts i~tWttue d U.$.R s~ora.y,ptaaa
A Star 7nbune ttittiey ofs~ln~sots taedicsl
~'ia n~aJcsrs shoWrs tlsss Micuatee is not -
sione. In the yeart zbesd, cnalcen ot *e hiad
of lifeSaxin~ hiYh.teeh deviees th~t bave
~vea Miaaaots a repuutiaa ss * sounce of
inE moit idvaaxd asedinlae in !hu Yerid
will be Grqttas jobs olhhore far fasier tba.n
tbsy a+{ll'hea. ' I
Over the n,qtt fivE yaars, some 1 Co jof~s will
be rraated in other eoc~ntries by iaaa0ta
~rais seeldaz to dsveloF msdi devices th,u
almost aurely M)] be sv,ilxble ' Evrope or
~ tora tder are 'sa use Ut sh Uaited
"Dy the year 2005, E+,rope usd pCrobaDly
ltpaa wiit hsve. !sz up on w," aud Dr.
R.Obort Iituser, cardiolozist at ~he
Miaueat~olis Ma~it tastitcta d former cdirf
ex~ive o3CArdi*a Paae , Ke
qoattads tbat the rnedi4ti deri industsy is
slipiiaalj awxy ia tho Urtitai S w witbout a
~tat~on dab~te,
"Ths woriddeading tanttts (of eatdioloayj
ue slready ia Ewnpc," Hsu:er s.id. "wg ~
to Eurape:o f~d out whit's, gainf ou ... St's
ines~diblo v~lut we'ss dola~ ~oursdves '
Mtdiesi,de.iob coatis~i+ed onnnlllPye 6A
1
lQSfNG"iHE EDGE
Medical devices/
Europe, Asia in l
Long regulatory delays for introduction of new technoiogy.'
Shortages of seed money for startups and expansion,
,A Lawsuits that threaten raw materiaW suppliers.
Scrsmping by insurers over payment for experimental
treatments. This is in contrast to national health plans abroad
that often promote innovation as a matter of national policy.
A r:iviaa et solutions ta prablems raisad in tha
5tu'>7tbuae seriss "L~oa.ttg the Edge" may be
about .saasy as Setttag a doeter to make a
01
Esperu reach i~to t2teir little black bagt for ®kl kitcds of
eliltits to ivstGr the be:t piediW care itt the United
Sttues.
Soma aall for lem relulaticn; tsthtsrs for xaore.
Some waat fewer lawsviu, etld others want mOre eotu-
psay amuatability,
Some favor goret'tt.ment support for expestmental use
of acw todgioloEies, others waztt to stick medical cem
paaies or istdividual patisats with the tab.
Notaetheleas, tpere is toma bipgrtisau agreemect: Sana-
tors fsom Mianesota Itspublicaa Aave Duret-
bergtr te Ma~schu~etts Demoast lydaro,td Katsaedy
hve asked t)ut US.'technoioxy and inaovatioa be
iddroued in the oosoiaa hoaltti refotin debate.
Md leguiators from both parties igree oa Lhe need o
spead sp raval time at the U.S. Focdsed Drug in.
iatradon f ~DA) iad to eaeare the eotttinued flow of
taw mattxuls to mediczl maaufacturer:.
8elow sre'the ideaa of a Ctiatott Cabinet aeeretary,
comumEr sotivist ggoup, an induatry organ~etloa a
Mlatsecetsi em~reuxnta.
. i
If yeu have suggeuioeu, there are places for you to ci{!1
or write, as weli.
=Tam Hamburger
I
ad
FDA and Industry, need to work harder toget
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M.l..11.....IM W\IN..Y.`I..INLML.\
Jim Menson
fmrmer dirrcior of tbm Centu for Devkas rnd utfttp eammEssiOttar ol tlie FGA,
haw-ylce pnudent of the Hetith industy Menatr<elunt: A3gCei? tltnt
"!'ve beea atrucac 6y
the aumber of co,mpa-
L1SEi 3ii'G C0~ C4m
~i' or-
tetruaolou rqviatary
M a, Aad 'm n-ou-
by bum that
comea te cmpuies
boeauso of product ipo sad s~he F~D~A havi~
theix d9tfereacas but
~~i ~dleera~P~
dcrirss to patients and
dieith prtetitioaaatl
QVe waat tc worlc le8islszatm (Sporsaared
tojesbtst.
1f1b improve the sltua-
tian, we encousage:
"7he PDA to doa,plete
;aview.-aad product
spe.
opprovali within a
CST~C l~3C fri~e,lOur orv0 iirduscry te
iatprove the qua* of
gubaaissims to the
FDA.
W Sm 7o~pb
flaluszmsa, D-Coaa
and aurenbisrsorl tbat
wottld prot`et su~pG
er; of raN tnetens~s for
tnedlal devias frosa
tawsuiti.
'7he FDA to estsblish
twaiustiae eppest .nd/
avessidht prooeduras,
)inUh inda" Moaulneluaer: Asgn1
"Caegrecs to pau the 1tG0 6 Zt/ N.W.
Wv maeerieis tUureaae 11lu,hinplan, O,C. ?A00
~
~ New legislation is.needed to reform FDA
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. I,
Asp. Jim Rat»stad
P-Mian., sind iounder eod shelrrtae of ttle Heuse Hfedlra! Teabnofapy Gaoou:
.~ ;Jzetavatian that pra se+d the a=e»cy coatic. '`medklS devicei' iiko
'
'duoee new ways to
dWver ty esro at
iower pneos !g sctytW.y
,f~t~.~yirey~y`to _Lu1n~.Q{~t{'/e~~rm/~~LM
.~M t1YMtrW I ... rY
bitely, the FDAf mSA
7y0IDeIIt ptoblmms aAd
"'I'ttt: seoond would
awlte the ageacy
ditftdy uxauatable fat
ptootpt rovirw of
asviees vitbia s, titae
~es4od to be set by
latirl'
"Zbn masa;va baeklog roliss+e tbt agency OMGe of ditg lkanswd
of eppliaatioat at FLIA froat Muiremaeti ttsst ' 7u Can"t/Houl 041 CE 8alidlltQ
J:not b.lttg reduad it Hriew, rukrtte! WgshlnptOt. D.C. 2055
Ihls would
ues to devote soo mxny bstidageL
staff botsrs to review Siye the FDA ttt,ote
iag riuabtec produuts reeattrses to review
-- tim. taat ootitd be ; deviea tttut raqtira
better spent evtluatktg gzoater ee7vtiay befodt
raors eruieal dev" mukating.
itttttiaasl ro$ttluioa of "I plaa to affer two
taefts1 t3evtt.ai beve uaoedmescs this ium
led to trssa.adent do- mer u Congrue
itye ia dcvioa epprovaL eotssidete whtther to
kerpteg i~k.sev' aad itapose u:er f®tsa cc
'eaias!lsestys taesiltei ths device industry.
dsvttU off the taukea
1 -7%M rt"t wculd
I
