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The Case for Mandatory Reporting of Adverse Events for Dietary Supplements. Steve Mister President & CEO Council for Responsible Nutrition. What S. 3546 / H.R. 6168 Does:.

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the case for mandatory reporting of adverse events for dietary supplements

The Case for Mandatory Reporting of Adverse Events for Dietary Supplements

Steve Mister

President & CEO

Council for Responsible Nutrition

what s 3546 h r 6168 does
What S. 3546 / H.R. 6168 Does:
  • Requires that manufacturers provide FDA with all reports they receive of serious adverse events associated with their dietary supplements within 15 days of receipt.
  • Dietary supplement labeling must include an address or telephone number through which a report of a serious adverse event may be received.
  • Manufacturers must keep records of all adverse event reports they receive for 6 years.
  • Pre-empts states from enacting their own systems
what is an adverse event
What is an Adverse Event?
  • A negative health-related experience
  • Associated with an FDA regulated product
  • May or may not be caused or connected with the use of the product
a serious adverse event is
A Serious Adverse Event is . . .

… an event that results in:

  • Death,
  • A life threatening experience,
  • Inpatient hospitalization or prolonging of an existing hospitalization,
  • A persistent or significant disability or incapacity, or
  • A congenital anomaly or birth defect,
  • An incident that requires medical or surgical intervention to prevent one of the above.
This legislation is

not about incentivizing consumers to generate more AERs —

it’s about requiring manufacturers

to inform FDA of the serious AERs

that they already receive.

consumers already report adverse events to fda
Consumers Already Report Adverse Events to FDA

FDA Receives AE reports now through:

  • CAERS – CFSAN Adverse Event Reporting System,
  • Medwatch, and
  • FDA District Coordinators

as reported (on a voluntary basis) by

    • Doctors, pharmacists and other healthcare professionals
    • Emergency Rooms
    • Poison Control Centers
    • Manufacturers
    • Consumers
the value of aers
The Value of AERs
  • FDA considers AERs “a monitoring tool to identify potential public health issues that may be associated with the use of a particular product already in the marketplace.”
  • AERs serve as early warning signals of possible problems, not as conclusions (see ephedra).
  • AERs can help to identify concerns with ingredient safety, manufacturing issues, contamination (of either raw ingredients or finished products), tamperings, and bio-terrorism.
the value of aers cont
The Value of AERs (cont.)
  • Review of AERs by a single entity can suggest trends or potential commonalities across brands or companies, identify a common supplier, and define the scope of a problem.
  • Treated as “safety reports,” AERs are protected under the FD&CA and cannot be used in litigation as an admission of causality.
  • FDA emphatically states that AERs are useful for developing hypotheses, they are not meant to prove them.
No one – except possibly the opponents of this bill – has suggested that AERs can, or should, prove causality.
why aers are needed
Why AERs are Needed
  • While many companies report voluntarily, one company making an ephedra supplement allegedly had thousands of AERs that it didn’t report.
  • Many consumers perceive that dietary supplements are not safe and FDA doesn’t know enough about our products.
  • We have a credibility problem as long as a manufacturer can legally receive a serious AER, put in in a locked file cabinet, and pretend it never happened.
mandatory aers are what a responsible industry does
Mandatory AERs are What A Responsible Industry Does
  • It’s the right thing to — responsible manufacturers put their consumers first.
  • It will improve the public health by giving FDA early signals with respect to DS.
  • It will improve public perceptions of DS as a regulated industry.
  • States are increasingly interested in AERs, even if Congress wasn’t.
  • Along with GMPs (coming soon?), AE reporting will help level the playing field; identify issues of quality among fringe players; and provide “bookends” on product quality.
myth 1 the bill should only require reporting of adverse events caused by a dietary supplement

Submission of the report does not involve a judgment call by the mfr.

Gives FDA an earlier signal; may prevent harm had the mfr. waited for proof of causality.

Act of filing of a report can’t be used to lend credence to the report — legislation protects mfrs from inference of causation.

AERs widely-recognized as merely serving as possible warning signal, as with other FDA regulated products.

No admission of a causal connection.

Myth #1: The bill should only require reporting of adverse events caused bya dietary supplement.
myth 2 the law should just require a medwatch phone number on the label instead
Myth #2: The law should just require a Medwatch phone number on the label instead.


  • Consumers would call FDA Medwatch directly.
  • Would likely encourage over-reporting.
  • Even non-serious AEs would be reported directly to FDA.
  • FDA would know before the mfr does — mfr may not even know that report has been filed.
  • Mfrs would lose the ability to make quick corrections to address concerns.
  • Mfrs want to interface with their consumers and know the most about their products.
myth 3 plaintiffs attorneys can use aers to develop class action law suits
Myth #3: Plaintiffs’ attorneys can use AERs to develop class action law suits.


  • AERs are subject to nondisclosure of private information provisions of the Privacy Act and HIPPA.
    • All personal or identifying information is redacted.
    • Two courts of appeals have specifically denied plaintiffs’ attorneys access to this information with respect to drug AERs.
  • Along with the AER, a manufacturer may submit a statement denying that the report constitutes an admission.
  • Legislation directs FDA to avoid duplicate reports of the same event.
  • AERs are considered a “safety report” under section 756 of the FD&C Act.
liability protection
Liability Protection

“. . . such report or information shall not be construed to reflect necessarily a conclusion by the entity or the Secretary [of HHS] that the report or information constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or otherwise caused or contributed to death, serious injury or serious illness. Such an entity need not admit, and may deny, that the report or information submitted by the entity constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or otherwise caused or contributed to death, serious injury or serious illness.”

FD&C Act §756 (21 U.S.C. §379v )

myth 4 mandatory reporting will provide a roadmap to plaintiffs attorneys of the next big case
Myth #4: Mandatory reporting will provide a roadmap to plaintiffs’ attorneys of the “next big case.”


  • Mfrs may submit additional information that negates the AE or exculpates the product. Any exculpatory information becomes part of the report and must be provided when the report is disseminated.
  • Attorneys already have access to Medwatch reports today. That already gives them signals of AE reported directly to FDA.
  • Why should mfr-reported cases be any different that those reported directly to FDA?
myth 5 consumers will overwhelm fda with adverse event reports
Myth #5: Consumers Will Overwhelm FDA With Adverse Event Reports.


  • Consumers can already report AEs to FDA via Medwatch now.
  • Many mfrs already report serious AEs to FDA now.
  • Many OTCs are already subject to mandatory AERs.
  • We’ve been telling the world about the wide margins of safety of our products for years. Are we telling the truth?
  • So why isn’t FDA being overwhelmed now?
  • The opposition’s math is misguided.
  • There is no “flashing neon sign” for consumers in the legislation.
myth 6 aers will prevent mfrs from getting product liability insurance
Myth #6: AERS Will Prevent Mfrs from Getting Product Liability Insurance.


  • Underwriters already ask about claims histories and any AERs the mfr is aware of.
  • Insurance carriers can review AERs that FDA already receives.
  • Mandatory reporting will give insurance carriers more confidence they are getting the whole story.
  • Mandatory reporting creates more transparency in the insurance marketplace and more accurate information on which to base premiums.
myth 7 even if the bill is limited to serious aers mfrs will need to report everything to be safe
Myth #7: Even if the bill is limited to “serious” AERs, mfrs will need to report everything to be safe.


  • The legislation defines “serious AERs” using existing criteria for drugs.
  • The definition provides concrete parameters for what is “serious.”
  • Why take on more responsibility that you need to?
myth 8 we don t need aers if fda would just promulgate gmps
Myth #8: We don’t need AERs if FDA would just promulgate GMPs.


  • Rx drugs have both GMPs and mandatory AERs.
  • We don’t know when/if FDA will release the GMPs.
  • If the ingredient is unsafe, no amount of GMPs will solve that problem.
  • GMPs and AERs provide bookends of safety:
    • GMPs help assure quality products under quality conditions.
    • AERs provide post-market surveillance in case an unsafe product slips through.
myth 9 mandatory ae reporting will drive up the cost of ds
Myth #9: Mandatory AE reporting will drive up the cost of DS.


  • Many OTCs (including ibuprofen, naproxen, and hydrocortisone) have been living under this model for years.
  • Many mfrs routinely maintain a call center or get AEs now; how are they handled now.
  • Legislation permits contracts with call center vendors.
  • How many serious adverse event reports do you really receive in a year?
myth 10 aer legislation will deny consumers access to dietary supplements
Myth #10: AER Legislation Will Deny Consumers Access to Dietary Supplements.


  • Nothing in the legislation limits access to dietary supplements.
  • Mandatory AERs will demonstrate to FDA the safety of supplements.
  • If anything, AERs will lead to more-informed consumers, able to make smarter supplement choices.


Contact me at: (202) 776-7929