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0:\I(ER\K8R04054;LC

DISCUSSION DRAF'T

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108'i'r'r COIiGRESS

2u SnssroN

S.

IN TI.I]' SENATII OF TI{E UNITED

STATES

il{r.

I'nmt (ibr himself

following bill; which was read tvrice and referred to

introduced the the Committee orr

A BILL
'&r require the Foocl qnd Drug Administration to pronrulgate ' .I I' ' regulations establishing an alternative investigational

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stud;r procedure for specified clrugs.

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ihe SsnAi;e und' l:Iouse of Representa: Be 'it enouctbcl by l" ',, - i- ^ -,' t'i,ues r$'th.e, United, Btates of America in Congress a,ssem,bled,,

This Act :ma;' be ,cited as. the ,'lDoctornaut Act :of 4 : J -: 2004".
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6 ssc. z. ALTEFNATTvE fl',{vEsrrGATroNAL sruDY FRocE,. DUnns Fon, SPECTFIED DRUGS: " 7 ,,
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(a) Rncur,r\TroNS.-The Secretary of I{ealth I '
(ret'errecl
-: , :

ancl
:

__-:l__-,__ Services I{uman _ _

to in this Act as the "Sec-

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DISCUSSION DRAFT

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retary") shall promulg'€rte regulations to establish an alter-

2 native investigational stucly proceclure fbr clrugs that con3
tain, as an active ingredient, an ingreclient
deseribecl

in

4 section 201(tf)(1) of the Feclelzrl ltoocl, Drug, anci Cos5 metic r\ct (21 U.S.C. 321(ff)(1)) (b) CoNT ENTS.-The regulations promulgatccl uncler 6 7 subsection (a) shall include the fbllowing:
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(1) .Ari'ftlR.\rvlrvn sTrJDy pll,ocEDUriES FoR st DoIrrrED Dtiucs.-'l'o satisfy the requirements
uncler section 505 of the Fecteral Foocl, Drug,
Cosmetic
ancL

Act (21 U.S.C: 355), an investigaltor-spon-

sor of a clrug that contains, as an active ingretiient,

an ingreclient describeci in section 201(ff)(1) of the
Ii'ederal Foocl, Drug, ancl Cosmetic

r\ct (21

U.S.C.

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321(ffx1)) may either-

(A) concluct investigational studies in
corclance
ofl

ac-

with the regulations uncler section 312

title 21, Cocle of Federal ll,eguiations (or any

corresponding similar regulation or ruling as.in ef'fbct on the clate of enactrnent of this Act); or

(B) conduct investigational studies in
eorcianee

ac-

with the proceclures clescribecl in para-

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sraph (2).

(2) Ar.,'rnnxl'lwn DoctonNr\rir
TroNAJ.r

rNVEs'treA-

sruDy r)RocEDURES.-\Yith respect to the

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DISCUSSION DRAFT
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investigartional stuclies conclucted uncler
grziph, the fbllowing shall apply:

this para-

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a

(A)
volunteer

TR,

n

sutsJucrs.-Physicians may
subjects.

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to be investigationa] study

fmrist ali subjects be physicians?

I believe that
ancl

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this is wirat yolr mean, since ctifferent IRB

informecl consent requirements apply. Do you
'want to define "physician?"]

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(B) INronuno coNSENT
2I,
Cocle

REeLTTRE-

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MlirYls.-Notwithstancling section 50

of

titte

of Fecleral

Regr.rlations

(or any cor'in et'-

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responcling simiiar regulation or ruling as

fect on the clzlte of enactment ofl this -r\ct), a
physician may be a volunteer subject

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in a study

ifl such Ph)rsician has the ability t9 make a reasoned judgement,

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to

communicate, ancl

to

un-

ciei'stancl the risks ancl benefits

of participating

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in the stucly.

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(C)
T,II'ITIT!].-

INs.r'rr:u'r'roNAl, B,EVTE\v coilr-

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(i)

CoivrposrlroN.-Notwithstanding

section 56

of title 21, Cocle of

Federal

Regulations (or any corresponcling sirnilar
regulation or ruiing as in effect on the
ofl ena,ctment of this
d.ate

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Act), an institutional

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DISCUSSTOTI D&AFT
'f
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re\riew comrnrttee under this.'strbsection
shatl be eomposediof plysieians,

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(ii) R,n"** oF PRoPosED rNvtrsflea.

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:I

tional rwiew

colff * *1t4

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(I) 'review the'protocol i"oposed
by an

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investigator.sponsor;' :r (II) reject the proposecl prot6col

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proportional to the projectecl benefit;

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.reject the proposed. protocol ',., , . ' I unlessrthe eory.qittee ean reasonab$
:

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, .l

lu**'th*t'th"
lotiog to the

,i:*oitu:of a study re

l),

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:-.
.

,.:-...

"ffe*ti"*ess

of a drug

tbl T nurretroN oF r-,*'***r*ot oxar,
t,.,

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g1gpv.-ihe Secretary,
:. . .' '
,.

:

the' instiiutlonal review

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eommittee, or th.e investigator-sponsor of an investig4lional' :stucl;r rnay,terminate:, such stuqy

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due

to anl

of

'the,rof11!11
,

tional',stucly:

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t '
,

the investigat', '' .'
,

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,',:,--

'(i),Neg1igence.

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(ii) WiAru miseoncluet,

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(iii)

Significant failure

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to

adhere to

:

appi'oved prctocol.

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(iv) The oceurrence of unexpeeted and

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unacoeptabie adverse events.

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(E)

Irvrrr,ruNlrly pnovrsroNs.--Investigator.

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'sponsors conducting stuclies

in

accordanee lvith

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under this section shail be immune from lcivi]J
.

iiability funder Federal lawJ

exeept

in the

case

of gross negligence or intentional misconduct.

:'

sEC. s. REvIEw

or nneulnrroNs.
b5' section

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Not less than 18 months after the Secretary'promul-:
gzites the

final reguiations as rcquirecl

2, the

L4 Secretary shail contract rn'ith the Institute' of Medicine 15 to-,(1:) concluct a review of jnvestigational stuclies L6 '
pei'formed under this arrthority; and I7 18 , ', ,, (2) provide legal ancl ,aqJministrative ree: 19 ommenclations fbr irnproving the process by whieh 20 investigational studies are performed under this au2L
t,tt'