Monday, September 11, 2006

The latest about the AER Bill

S.3546 the Dietary Supplement and Non-Prescription Drug Consumer Protection Act (the AER bill) is the latest bill impacting dietary supplements.

If S. 3546 becomes law, it will amend the federal Food, Drug and Cosmetic Act to require the reporting of “serious” adverse events for both over the counter (OTC) drugs and dietary supplements to the U.S. Food and Drug Administration.

We have just heard that the AER bill has been added to the Senate calendar, and staff expect it to be considered this week. What is unknown is whether it will be a roll call vote (recorded) or under unanimous consent*. Recorded is preferable and is expected.

*unanimous consent - A Senator may request unanimous consent on the floor to set aside a specified rule of procedure so as to expedite proceedings. If no Senator objects, the Senate permits the action, but if any one Senator objects, the request is rejected. Unanimous consent requests with only immediate effects are routinely granted, but ones affecting the floor schedule, the conditions of considering a bill or other business, or the rights of other Senators, are normally not offered, or a floor leader will object to it, until all Senators concerned have had an opportunity to inform the leaders that they find it acceptable.

There is still time to halt this bill if we make our voice heard today and encourage others to contact Congress as well. Contact Congress through our online action center.

We are reading the bill report now and will post more shortly. At first glance it appears that importation will be affected, private labeling will most likely disappear, and third-party vendors will be created to handle the AER process for the manufacturers.

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