Durbin/Hatch DSHEA Amendment
(Links to Petition and Contact List Below)
September 2004
Senator Durbin introduced an amendment to the
Dept of Defense Authorization bill that proposed to restrict
access to dietary supplements on military bases, and create
reporting requirements on manufacturers that where stricter than
those for over-the-counter drugs.
Mandatory Adverse Event Reporting (AER) to the FDA would have
applied to some supplement products without regard to whether
the adverse medical experience was known to be related to a
supplement product. Senator Hatch, in consultation with Durbin,
got the amendment withdrawn from consideration for modification.
The major issue was over the definition and application of AER
reporting to the FDA. What follows is an outline of the current
working amendment of Senators Hatch and Durbin, followed by
other issues that may impact Senate passage when Congress
returns in September, or thereafter this year.
Outline of Hatch/Durbin Adverse Event
Reporting Amendment
Adverse Event Reporting would be created, but only for Serious
Adverse Medical Events (SAME). Durbin language in S.722
regarding “without regard to whether the event is known to be
causally related” would not be included. The mandatory
post-market surveillance procedures for manufacturers contained
in S.722 are also proposed to be stricken. However, mandatory
reporting within 15 calendar days of receipt of information by a
covered party on a SAME from a consumer would be established.
The definition of a SAME is under discussion and could be
modified from what has been proposed below.
Definitions
The term ‘adverse dietary supplement experience ’ means an
adverse event associated with the use of a dietary supplement in
a human. A Serious Adverse Dietary Supplement Event could be
defined as an experience that resulted in
(A) Death
(B) A life-threatening condition
(C) An inpatient hospitalization or prolongation of
hospitalization
(D) A persistent or significant disability or incapacity
(E) A congenital anomaly, birth defect, or other effect on
pregnancy, including premature labor or low birth weight; or
(F) Required medical or surgical intervention to prevent one of
the outcomes listed in (A)–(E).
Each manufacturer of a dietary supplement, and each packer or
distributor of a dietary supplement would:
(A) Upon receipt of a serious adverse experience from a person
having purchased their product, file a submission with the FDA
within no more that 15 calendar days after initial receipt of
information. (Reporting limit being discussed and could be
extended to more than 15 calendar days).
(B) Have to develop and comply with written procedures for
receipt, evaluation, and transmittal of information to the FDA.
What does this mean?
In short, depending on the final SAME definition, only if a
consumer had such an experience and filed with a mfg., would
there be a requirement for mandatory reporting to the FDA.
Consumers can report to the FDA voluntarily now. If the final
definition of a serious adverse event/experience is even more
circumspect, the AER reporting requirement will carry even less
impact.
Durbin wants to add AER requirements for over-the-counter drugs,
believing that this will help with Senate passage. Hatch staff
do not agree with doing this. Second, Durbin wants to use S.
2195, the Anabolic Steroid Control Act, currently pending before
the Senate Judiciary Committee, of which Hatch is the Chairman,
as the vehicle for the amendment. Hatch is not on board with
doing this either.
Unless either Senator or their staff changes their minds,
finding a legislative vehicle for a compromise AER amendment for
dietary supplements could be in doubt moving forward. Durbin may
try to add an amendment to any bill up for a vote in the Senate.
As of today, there are only 27 days left before the Senate
adjourns for the elections. There may be a "lame duck" session
after Nov 3rd.
The two most likely legislative vehicles for a compromise
Durbin/Hatch, if one is reached, are the Anabolic Steroid bill
or the FY 2005 USDA appropriations bill, which funds the FDA.
However, going the second route has a bigger legislative process
hurdle - you cannot authorize policy changes on a spending bill
if any one Senator objects.
The realistic prospects for an amendment to be brought up are
slim, but possible. The NHF needs to engage in grassroots
lobbying to help prevent enough support?
If an amendment is NOT considered during the rest of this
session, then there would be some room for claiming success in
blocking it.
