Supplement Industry-backed Adverse Events Reporting (AER) Bill Passes Congress

Summary: In the waning days of the 109th Congress, the US Senate passed a bill requiring adverse events reporting (AER) for the dietary supplement industry and the over-the-counter (OTC) drug industry. Though supported by the Natural Products Association and the American Herbal Products Association, the bill has also generated opposition from some parts of the broader natural health world, including the American Association for Health Freedom. If AER doesn't pass, a similar bill is expected to be back before the Democratic 110th Congress next year. The Democrats would be expected to produce a bill that is more stringent.

UPDATE:  On December 9, 2006, at 3:01 AM, the last act of the House of Representatives before the 109th Congress adjourned was to pass the AER bill. See addendum, below for details.

Early morning on Pearl Harbor Day, December 7, the Natural Products Association (NPA) sent out an e-message to its friends announcing that the US Senate had passed S. 3546, the Dietary Supplement and Non-Prescription Drug Consumer Proterction Act. The bill passed by unanimous consent. NPA was calling on its affiliates to contact their representatives, in the waning days of the 109th Congress, to pass the House version, H. 6168.

The bills, if they become law, would amend the Food, Drug and Cosmetic Act to require the reporting of "serious" adverse events for both over the counter (OTC) drugs and dietary supplements.

• "Helping to change the perception by critics of the dietary supplement industry that it is not well regulated.
• "Second, over time, the recordkeeping and reporting requirements will substantiate what many in the industry have been saying all along – that the safety record of dietary supplements is exemplary, especially when compared to other health-related products."

US Sen. Orrin Hatch, longtime natural products industry backer

The bill, sponsored by Orrin Hatch (R-Utah)

Health Freedom Group Opposes

Clearly, support for AER is not unanimous in the broader natural health care and alternative medicine community. The American Association for Health Freedom (AAHF) has been as actively urging its supporters to oppose AER as the NPA and AHPA have pushed support. Brenna Hill, executive director for AAHF told the Integrator that AAHF thinks the AER activity represents "bills in search of a problem." She says that whenever there are adverse events, they are already reported because medical practitioners are involved and they are already required to make such reports.

She noted two other reasons to oppose. The top for AAHF is that, if passed, the bill would "give an already broken FDA another responsibility." Linked to this, in AAHF's view, is that "this bill is a step closer to treating supplements like pharmaceuticals and less like food.'" She noted that AAHF would support the bill if it was limited to the other OTC medicines.

Hill notes that one reason some proponents of the bill are pushing it now, in the 109th Congress, is to keep it out of the hands of the 110th Congress which will be controlled by Democrats and expected to be more supportive of stiffer regulation.

Says Hill: "I'd like to see it re-introduced in the 110th, with more than Pharma-owned dietary supplement industry members involved. They were shaping (the current bill) for industry, not consumers." Asked what kind of changes the AAHF would propose to clarify a consumer interest, Hill stated that "we have begun talking about this" but that AAHF does not have a formal position at this time.

Hill is confident that the bill will not pass prior to the end of the session this week: "Congress only had zero working days in October, 5 in November and 5 in December. I don't think this will be their priority."

Michael McGuffin, executive director of the herbal products group