Dietary supplement industry critic Sen. Richard Durbin (D-Ill.) will work alongside congressional industry supporters to develop legislation to create a mandatory serious adverse event reporting system.

Durbin and Sen. Orrin Hatch (R-Utah) agreed June 21 to work together to attach adverse event reporting to a bill sponsored by Hatch and Sen. Joseph Biden (D-Del.) which would make androstenedione and other steroid precursors controlled substances.

The cooperative effort may mark the beginning of an era of compromise for Sen. Durbin and the supplement industry. Durbin has been harshly critical of the Dietary Supplement Health & Education Act and of the industry in general.

The industry and its supporters on Capitol Hill have voiced strong opposition to Durbin's attempts to change DSHEA. In 2003, Durbin introduced the "Dietary Supplement Safety Act" S722, which would require premarket approval for supplements containing stimulants and would establish a mandatory AER system (¹ Also see "Supplements Containing Stimulants Would Need Preapproval Under Durbin Bill" - Pink Sheet, 31 March, 2003., p. 3).

The deal was forged after competing amendments from Durbin and Sen. Tom Harkin (D-Iowa) briefly turned floor debate on the National Defense Authorization Act into an unlikely forum on DSHEA.

Durbin's amendment would have allowed the sale of supplements at military installations only for products whose manufacturers submitted AERs to HHS.

A substitute amendment introduced by Harkin would have "expressed the sense of the Senate" that FDA should make full implementation of DSHEA a priority, and that HHS should develop a plan for mandatory AE reporting within 180 days of enactment.

Some broad areas of disagreement remain. For example, Hatch and Harkin continue to strongly oppose premarket approval.

However, all parties expressed an interest of developing a mandatory AER system. Durbin suggested a goal of finishing this year.

Durbin consented to Hatch's stipulation that industry be included in development of the system. Industry trade groups have been in talks for several months about what models for mandatory AER systems would work (² Also see "Supplement Industry Groups Working To Define AER Plans" - Pink Sheet, 17 May, 2004., p. 18).

Hatch likewise agreed to the inclusion of groups that had endorsed Durbin's amendment, such as the American Medical Association and the Center for Science in the Public Interest.

Harkin and Hatch took issue with Durbin's model for a mandatory AER system. While agreeing that a system is needed, Harkin said during the floor debate that "the issue has to be dealt with in a more comprehensive fashion to be effective and efficient. We need to make sure we have a reporting system that will provide timely, accurate and useful information."

Durbin's proposal is "too limited and does not ensure we will have a workable system," said Hatch, adding he supported a system that would be "broader in scope."

An appropriate system would be national, he said, not limited to army bases.

Harkin advocated a system that would include over-the-counter drugs as well as supplements, saying that inclusion of both is "a matter of fairness and protection of public health."

Hatch also is pushing for inclusion of OTCs. "In 2002, estimates are that 182 persons died from taking acetaminophen as directed," he said. "Yet this is a broadly sold drug, over-the-counter drug. Why should there not be AER requirements for such over-the-counter products as well, or maybe that is where we are headed with this type of amendment."

"If there is a serious problem with an aspirin, a vitamin, an herb, or a cold remedy, should not our policy be the same, that authorities are alerted to a serious problem?" Hatch asked.

Following the agreement, both sides withdrew their amendments.

"I would like nothing more than for us to come up with an appropriate way of handling adverse event reporting that really makes sense, that helps the industry and yet makes sense for the consuming public as well, and to FDA," said Hatch.

Senators Durbin, Hatch To Work Together On AER Plan

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