ALERT- Legislative Action Needed
Contact Your Senators to Oppose a
Durbin/Hatch DSHEA Amendment
(Links to Petition and Contact List Below)
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 Senator Hatch, in consultation with Durbin, got the amendment withdrawn from consideration for modification.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.
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
(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.
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