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Supplement Industry-backed Adverse Events reporting (AER) Bill Passes Congress PDF Print E-mail
Written by John Weeks   

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.
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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.

ImageEarly 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.

Image 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.
The NPA, formerly the National Nutritional Foods Association, has actively supported the bill (see NPA notice here) as has the American Herbal Products Association (see AHPA notice here). The NPA's briefing on the bill notes that there would be a new layer of paperwork for its members in the bill's mandatory reporting requirements. Yet the benefits are viewed as worth it for these reasons as stated in the December 7, 2006 e-bulletin:

  • "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."

Image
US Sen. Orrin Hatch, longtime natural products industry backer
The bill, sponsored by Orrin Hatch (R-Utah)
, requires adverse events reporting in the instances of death, life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect or a situation which "requires medical or surgical intervention to prevent any of the above outcomes." Among the co-sponsors are Tom Harkin (D-IA), Ted Kennedy (D-MA) and, more important, the incoming power on this issue when the Democrats take over in 2007, Richard Durbin (D-Il).

The NPA has bent over backwards to educate its members to its views that there is nothing in this bill that support the view of those "fear-mongering and sending alarmist messages" that AER will result in supplements being "removed from the marketplace and healthfood stores closing."

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.

ImageShe 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
, AHPA, expressed the dominant view in the industry: "We have worked diligently over the last several years to get this law passed, and we will continue to work hard in the remaining days of this Congress to ensure that this good legislation, which includes important safeguards for companies that sell supplements, makes its way through the House."

 Party

Yes     No    Not
Voting 
 Republican

    66       94   67 
 Democrat

     134        64
 Independent

               1
 Total

 203

 98
132 
Addendum (Monday, 11 December)  According to a note just forwarded from Loren Israelson, industry expert and executive director of the Utah Natural Products Alliance, the last act of the US House of Representatives in the 109th Congress was to pass an AER bill at 3:09 AM on Saturday, December 9th.

Israelson shared a note from former Harkin staffer and lobbyist Peter Reinecke
which noted that on a "motion to suspend the rules and pass" the AER legislation, 203 voted for and 98 against, just more than was needed for the 2/3 majority. Congressman Chris Canon (R-UT) was singled out for being "a big help." The vote was as is noted in the table. Israelson, an attorney and natural products policy maven who is a long-time advocate of more stringent self-regulation by the industry, is offering a seminar on the bill in early January. Contact if you wish to be linked to information on that meeting.

In a e-note to industry-interested people later in the day, Israelson stated that the Center for Science in the Public Interest (CSPI) had a positive statement on the AER passage. Said Israelson: "It's a rare day when the CSPI and the industry agree on anything." Then he added: "
This legislation is a top example of how industry, Congress and historic critics of the industry can work together. I expect that as the national media reports on this legislation we will see equally helpful and positive comments that the supplement industry (despite some internal opposition) supported mandatory AERs."

Comment
: The natural products community can remind one of the boy who cried wolf, screaming at every turn, that an action is going to kill their industry. This act, if it does, probably should. If there is real harm, it needs to be outed. We need to know if a wolf exists. Why? The good money is with the NPA and AHPA's advocacy of the bill. Requiring such reporting is likely to help slay the phantasm of a wolf-like animus that anti-supplement interests have conjured about the frequency of nasty events associated with taking natural products. Good for the industry to have been pushing this.

Disclosure note: In the late 1980s I worked closely with the AHPA leadership and served, briefly, on AHPA's board.

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