07/24198 FRI 08:50 FAX 301 443,5169

07/24198
FRI 08:50 FAX 301 443,5169
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ON IABOR 4ND
RESOURCES
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hWJW.sennb.gov/-lmbor/
July 23,
1998
Dr. Michael Friedman
Acting Commissioner
Foad and Drug Adminlstmtkm
5600 Fishers Lane (HF-28)
Rockville, MD 20857
Dockets Management
Branch &lFAu306)
Food and Drug Administration
12420
Parklawn Drive, rm, 1-23
Rockville, MD 20857
f)issemination
of Information
on Unapproved/New
Biologics, and Devices; Docket No. 98 N-0222
Uses for Marketed
Drugs,
Dear Dr. Friedm6n,
I am writing to comment on the Food and Drug Administration’s
(FDA) proposed
rule of June 8, 1998, implementing
section 401 of the Food and Drug
Administration
Modernization
Act of 1997.
1 want to commend FDA for its
commitment
to implementing
the Food and Drug Administration
Modernization
Act
of 1997 In a timely manner.
As the ranking member of the Senate Labor and Human
was intimately
invalved in development
of the Food and
Modernization
Act of 1997 (FDAMA)
and specifically of
want to highlight important considerations
and concerns
crucial part of our compromise
an this issue.
.
Resources Committee,
I
Dru~ Admlfiistration
section 401.
As such, I
zhal 1‘believe were a
First, I would like to comment gerterally on the intent of Congress.
Congress
intended this provision to allow dissemination
of information
under specific limited
Congress was par~lcularly concerned tha~ current incentives
for
circumstances.
companies to invest in research and to submit supplemental
applications
be
maintained
and enhanced.
Because dissemination
by drug companies of
information
regarding uses which have not yet been shown to meet FDA’s standard
for sefety and efficacy
raises important’ public health questions,
Congress limited
This provision in duratkm and requm~ed follow up studies to determine the utility of
this provision and its impact on the public health.
In light of these concerns,
FDA’s
should be consistent
with the law and assure that patients be pro~ected.
c 37
07,;24/98
EtJoo3
FRI 08:51
FAX 301--443
5169
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FDA should provide for public access to information
401 to the maximum
extent feasible,
The patients’
41 U.13UL
r.
3~5
made available under section
groups are essential
stakeholders
in the exemptions
granted under section
crucial to successful
implementation
of this provision,
401
and their participation
is
a.r~i&
of
Congress intended for FDA to have a role in assessing the scientific acceptability
journai articles and reference texts distributed pursuant to section 401.
The statute
requires ~hat the information
be a “copy of an article, peer-reviewed
by experts
qualified by scientific training or experience . . . which is about a clinical
sound by such
investigation
- . . and which would be considered to be scientifically
the FDA may require the mwwi%cturer
to disseminate
expems. ” Where appropriate,
additional objective and scientifically
sound information that pertains to the safety
or effectiveness
of the uss and IS necessary to provide objectivity
and belance, or
the Secretary may provide her Own objective statement.
Thus, the statute ciearly
envisions that the Secretary be provided sufficient information
to assess the clinical
investigation.
This opportunity
is especially important in order for the Secretary to
meaningfully
assess the need for balancing
information
is false or misleading.
information
and to ❑ ssess whelher
the
.
fib
suu~iemenk
be predicated
Congressional
intent is ciear. Congress intended that dissemination
Exceptions to this rule we limited
on submission of a supplemental
USEJapplication.
in scope and shouid be infrequent.
Any interpretation
to the contrary would
undermine the essential compromise
reached in this legislation.
As stated in the
when it is appropriate
to
conference
report, “there may be /lmited circumstances
exempt a manufacturer
from the requirement
to fiie a supplemental
application. ”
(emphasis added.)
ns
t=
The au~hority ~ba~ Congress gave to the Secretary regarding factors to be taken
into account in granting exemptions
is permissive, not mandato~.
Congress
intended the Secretary to exercise subs~antiai discretion in granting exceptions
and
that oniy when the interests of pubiic heaith are served by allowing the exemption
and there is no significant
pessibiiity that a supplemental
application
vvili be filed
should FDA grant such an exemption.
Sincerely,
Edward
M. Kenned /