AER Dietary Supplement Legislation

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AER Dietary Supplement Legislation

S.3546 the Dietary Supplement and Non-Prescription Drug Consumer Protection Act

(the AER bill) is the latest bill impacting dietary supplements.

If S. 3564 becomes law, it will amend the federal Food, Drug and Cosmetic Act to

require the reporting of 1Cserious 1D adverse events for both over the counter

(OTC) drugs and dietary supplements to the U.S. Food and Drug Administration.

While S.3546 was created and introduced by supporters of dietary supplements,

Senators Hatch and Harkin, this is not a bill that should become law.

First, we believe that this bill is a step towards treating dietary supplements

more like pharmaceuticals and not like food. Second, we believe that this bill

will ultimately have a negative impact on the dietary supplement industry and

the consumer. Third and most importantly, a person experiencing an adverse

event (especially one that is serious) from a drug (prescription or OTC), food,

or supplement, should work with their healthcare professional to determine the

cause.

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Dear [ Decision Maker ],

(Edit Letter Below)

As your constituent, voter, and dietary supplement consumer, I urge you to not

vote for the Dietary Supplement and Non-Prescription Drug Consumer Protection

Act (S.3546) or support a House bill if introduced.

The Dietary Supplement Health & Education Act of 1994 (DSHEA) acknowledged that

millions of consumers are using dietary supplements to help augment daily diets

and provide health benefits. Any legislation that treats dietary supplements

more like pharmaceuticals instead of food is one step closer to dismantling

DSHEA.

I appreciate the dietary supplement industry wanting to show that they are a

responsible industry but feel that this bill is

1) Unnecessary - as there are so few serious adverse events to begin with,

2) Confusing - by definition of " serious adverse event " ALL reports should be

directed to a healthcare professional who is already trained to handle AERs and

determine the actual cause,

3) Wasteful - the FDA's recent faltering and systematic setbacks show that it

cannot manage such a bill. The FDA's enforcement reports for drug products show

it to be an agency under increasing pressure to do more with less. The number of

warning letters issued to pharmaceutical companies has dropped over the past 10

years even as product recalls have increased. In other words, the agency is

allowing more manufacturer product mistakes to reach the market. Adding

supplements would further reduce enforcement efficiency for both drugs and

supplements.

I support American Association for Health Freedom in joining other health

freedom groups to oppose this bill. I would however support a mandatory AER for

over-the-counter drugs. I hope that you will agree with my views and will vote

no for S.3546 (or House bill) as it currently stands. I would like to know what

your position is on this legislation.

Thank you.

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see also:

http://ga4.org/campaign/AER_bill/explanation

What's At Stake?

AER Dietary Supplement Legislation

Technical Analysis

Adverse Event Reporting (AER) would be created only for serious adverse events

which is defined as an experience that resulted in

(A) Death

( A life-threatening condition

© An inpatient hospitalization or prolongation of hospitalization

(D) A persistent or significant disability or incapacity

(E) A congenital anomaly, birth defect, or other effect on pregnancy, including

premature labor or low birth weight; or

(F) Based on reasonable medical judgment, required medical or surgical

intervention to prevent one of these outcomes.

Reporting And Manufacturer Compliance

A manufacturer, distributor, or retailer of a dietary supplement would be

required to file an AER incorporated into the existing FDA Med Watch form within

15 days of receiving a consumer notice. Under S 3546, retailers can be exempted,

and distributors can be exempted, if there is agreement among the parties as to

which party's address and 800 phone number is printed on the product label.

Upon receipt of a serious adverse experience from a person having purchased a

product, the 1Cresponsible person 1D/company is required to file with the FDA

within 15 calendar days after initial receipt of an AER.

Having your name on a product label, qualifies as a responsible party, but

distributors and retailers must also have written 1Cexemption 1D agreements to

establish this exclusion, or something to this effect.

The responsible 1Cperson 1D must also develop and comply with written

procedures for receipt, evaluation, and transmittal of AER information to the

FDA. S 3546 requires that the FDA issue an industry GUIDANCE* document within

one year. This Guidance is to explain the minimum data elements that are to be

included, via a revised Med Watch form, in a submitted serious adverse event

report.

Depending upon which entity - manufacturer, distributor, retailer - is listed on

a dietary supplement product label as the 1Cresponsible person', there is a

refined requirement to submit any new 1Cmedical information 1D associated with

a submitted adverse event report, within one year of the initial report. This

must also be done within 15 days of the receipt of any new medical information.

It is unclear as to what would be included. Does this cover patient medical

records and/or published research studies? This would have to be clarified in

the Guidance document.

*Guidance document is not administrative law, nor is it enacted law. In its

literal sense, it is a statement of what the FDA expects, and will be guided by.

By the same token, it also opens up the FDA a more rigorous explanation of its

interpretation of the law, good, bad, or indifferent. In short, drug companies

have been doing a lot of things over the years, based on the argument that an

FDA industry Guidance was not clear, for example.

On the process side, if enacted, there is the matter of integrating the

currently voluntary reporting system into the FDA's Med Watch reporting system

and having this effectively transferred into enforcement actions.

What is clear is that if this Senate bill is approved and enacted into law,

there will certainly be more regulatory confusion and cost associated with

supplements. The cost consideration does not take into account the prospect, if

enacted, of future dietary supplement User Fees being imposed on the industry

and, indirectly, upon dietary supplement consumers.