The Senate likely will vote on the "Dietary Supplement & Nonprescription Drug Consumer Protection Act" (S 3546) before they adjourn in early October, according to several supplement industry trade groups.

The bill, which requires FDA to establish a system for collecting data on serious adverse events related to the use of OTC drugs and dietary supplements, is likely to be voted on in the Senate by unanimous consent (UC), according to Natural Products Association Executive Director and CEO David Seckman.

Unanimous consent is expected to be the preferred method "simply because there's not a lot of opposition" to the bill in the Senate, Seckman explained.

A bill passed through the UC process would not go to the floor for a physical vote but would instead be placed on a calendar along with other bills being passed in this manner. Periodically, the Senate passes bills on the calendar as a group.

The unanimous consent procedure is fairly common. The Dietary Supplement Health & Education Act of 1994 passed via unanimous consent.

However, one industry insider noted that the procedure, while efficient, is also delicate. If a senator objects to the bill, he or she may put a hold on it as it moves through the calendar, which could kill the bill.

If the bill passes the Senate, it will move to the Rules Committee. Then it will need to go through a House committee, most likely the Energy & Commerce Committee, according to Seckman.

"I would also not be surprised if we see some people now, knowing that this bill's going to pass the Senate, in the House thinking about trying to introduce a House version of the bill as well," he said.

The Senate bill is widely embraced by trade groups in both industries, as well as several consumer groups, and trade groups note they have been meeting with House leaders on the issue of an AER bill (¹ Also see "AER Bill Will Provide Documented History Of Supplement Safety – Industry" - Pink Sheet, 17 July, 2006., p. 3).

However, associations and individuals concerned about the bill are also vocal. Long-time advocate Julian Whitaker, MD, sent a letter Sept. 8 to the Energy & Commerce Committee Chairman Joe Barton (R-Texas) voicing his concern with the bill's lack of a causality requirement for the AERs.

Following favorable reporting of the Senate AER bill by the Health, Education, Labor & Pensions Committee Sept. 5, the Congressional Budget Office published a cost estimate for the bill.

According to the Sept. 12 CBO score, manufacturers, packers and distributors of supplements and OTC drugs should expect a total annual industry-wide cost of less than $2 mil. to implement mandates associated with adverse event reporting. However, according to Seckman, this number may be a little high.

Under the act, nonprescription drug products and supplements are also required to have either a domestic phone number or a domestic address to which an AE can be reported on their products' labels.

According to CBO, the total cost of complying with the new labeling requirements will be "low" since the address requirement would not apply to products with a telephone number on the label.

"Moreover, the requirement would apply only to those products labeled later than one year following enactment of the bill, allowing makers of nonprescription drugs and dietary supplements ample time to add a single line to their labels," the score says.

CBO estimates it will cost FDA $3 mil. to implement the bill in 2007 and $50 mil. between 2007 and 2011.

Federal revenues would increase $2 mil. over the 2008-2011 period and by $5 mil. between 2008 and 2016, due primarily to the payment of criminal fines and firms' reimbursements to the agency for expenses related to products violating the new requirements, according to CBO.

The CBO score also anticipates the new mandatory reporting requirements will result in an additional 10,000 to 15,000 AERs, but notes "significant uncertainty surrounds that estimate."

Sen. Orrin Hatch (R-Utah) noted that "some expressed surprise at the expected number of reports" and pointed out the figures include reports from both supplement and over-the-counter products.

"I worked very closely with the supplement industry to draft the bill, and throughout those discussions the industry indicated they expected only a handful of events," he added.

- Katia Fowler

Senate Vote On Adverse Event Reporting Bill Expected By October

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