Council for Responsible Nutrition Supplyside West, October 19, 2006 The Case for Mandatory Reporting...

Council for Responsible Nutrition Supplyside West, October 19, 2006

The Case for Mandatory ReportingThe Case for Mandatory Reporting of Adverse Events of Adverse Events

for Dietary Supplements for Dietary Supplements

Steve MisterSteve Mister

President & CEOPresident & CEO

Council for Responsible NutritionCouncil for Responsible Nutrition

22 22Council for Responsible Nutrition Supplyside West, October 19, 2006

What S. 3546 / H.R. 6168 Does:What S. 3546 / H.R. 6168 Does:

Requires that manufacturers provide FDA with all Requires that manufacturers provide FDA with all reports they receive of reports they receive of seriousserious adverse events adverse events associated with their dietary supplements within 15 associated with their dietary supplements within 15 days of receipt.days of receipt.

Dietary supplement labeling must include an address Dietary supplement labeling must include an address or telephone number through which a report of a or telephone number through which a report of a serious adverse event may be received.serious adverse event may be received.

Manufacturers must keep records of Manufacturers must keep records of allall adverse event adverse event reports they receive for 6 years. reports they receive for 6 years.

Pre-empts states from enacting their own systemsPre-empts states from enacting their own systems


What is an Adverse Event?What is an Adverse Event?

A negative health-related experienceA negative health-related experience

Associated with an FDA regulated productAssociated with an FDA regulated product

May or may not be caused or connected with May or may not be caused or connected with the use of the productthe use of the product


A A SeriousSerious Adverse Event is . . . Adverse Event is . . .

… … an event that results in:an event that results in:– Death,Death,– A life threatening experience,A life threatening experience,– Inpatient hospitalization or prolonging of an existing Inpatient hospitalization or prolonging of an existing

hospitalization,hospitalization,– A persistent or significant disability or incapacity, orA persistent or significant disability or incapacity, or– A congenital anomaly or birth defect,A congenital anomaly or birth defect,– An incident that requires medical or surgical An incident that requires medical or surgical

intervention to prevent one of the above.intervention to prevent one of the above.


This legislation is This legislation is

notnot about about incentivizingincentivizing consumers to consumers to generate more AERs — generate more AERs —

it’s about it’s about requiringrequiring manufacturers manufacturers

to inform FDA of the serious AERs to inform FDA of the serious AERs

that that they already receivethey already receive..


Consumers Consumers AlreadyAlready Report Report Adverse Events to FDAAdverse Events to FDA

FDA Receives AE reports now through: FDA Receives AE reports now through: CAERS –CAERS – CFSAN Adverse Event Reporting System, CFSAN Adverse Event Reporting System,

Medwatch, and Medwatch, and FDA District CoordinatorsFDA District Coordinators

as reported (on a voluntary basis) byas reported (on a voluntary basis) by– Doctors, pharmacists and other healthcare professionalsDoctors, pharmacists and other healthcare professionals– Emergency RoomsEmergency Rooms– Poison Control CentersPoison Control Centers– Manufacturers Manufacturers – ConsumersConsumers


The Value of AERsThe Value of AERs

FDA considers AERs “a monitoring tool to identify potential FDA considers AERs “a monitoring tool to identify potential public health issues that may be associated with the use of a public health issues that may be associated with the use of a particular product already in the marketplace.”particular product already in the marketplace.”

AERs serve as early warning signals of possible problems, not AERs serve as early warning signals of possible problems, not as conclusions (as conclusions (see ephedrasee ephedra).).

AERs can help to identify concerns with ingredient safety, AERs can help to identify concerns with ingredient safety, manufacturing issues, contamination (of either raw ingredients manufacturing issues, contamination (of either raw ingredients or finished products), tamperings, and bio-terrorism.or finished products), tamperings, and bio-terrorism.


The Value of AERs (The Value of AERs (contcont.).)

Review of AERs by a single entity can suggest trends or Review of AERs by a single entity can suggest trends or potential commonalities across brands or companies, identify a potential commonalities across brands or companies, identify a common supplier, and define the scope of a problem.common supplier, and define the scope of a problem.

Treated as “safety reports,” AERs are protected under the Treated as “safety reports,” AERs are protected under the FD&CA and cannot be used in litigation as an admission FD&CA and cannot be used in litigation as an admission of causality.of causality.

FDA emphatically states that AERs are useful for developing FDA emphatically states that AERs are useful for developing hypotheses, they are not meant to prove them.hypotheses, they are not meant to prove them.


No one No one – except possibly the opponents – except possibly the opponents

of this bill – of this bill – has suggested that AERs can, or should, has suggested that AERs can, or should,

prove causality.prove causality.


Why AERs are NeededWhy AERs are Needed

While many companies report voluntarily, one While many companies report voluntarily, one company making an ephedra supplement allegedly had company making an ephedra supplement allegedly had thousands of AERs that it didn’t report.thousands of AERs that it didn’t report.

Many consumers perceive that dietary supplements Many consumers perceive that dietary supplements are not safe and FDA doesn’t know enough about are not safe and FDA doesn’t know enough about our products.our products.

We have a credibility problem as long as a We have a credibility problem as long as a manufacturer can legally receive a serious AER, put in manufacturer can legally receive a serious AER, put in in a locked file cabinet, and pretend it never happened.in a locked file cabinet, and pretend it never happened.


Mandatory AERs are Mandatory AERs are What A Responsible Industry DoesWhat A Responsible Industry Does

It’s the right thing to — responsible manufacturers put their It’s the right thing to — responsible manufacturers put their consumers first.consumers first.

It will improve the public health by giving FDA early signals with It will improve the public health by giving FDA early signals with respect to DS.respect to DS.

It will improve public perceptions of DS as a regulated industry.It will improve public perceptions of DS as a regulated industry.

States are increasingly interested in AERs, even if States are increasingly interested in AERs, even if Congress wasn’t.Congress wasn’t.

Along with GMPs (coming soon?), AE reporting will help level Along with GMPs (coming soon?), AE reporting will help level the playing field; identify issues of quality among fringe players; the playing field; identify issues of quality among fringe players; and provide “bookends” on product quality.and provide “bookends” on product quality.


Status of the LegislationStatus of the Legislation


Ten Myths & the FactsTen Myths & the Facts About AERs About AERs


Myth #1: The bill should only require Myth #1: The bill should only require reporting of adverse events reporting of adverse events caused caused

byby a dietary supplement.a dietary supplement.Facts: Facts:

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

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

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

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

No admission of a causal connection.No admission of a causal connection.


Myth #2: The law should just require a Myth #2: The law should just require a Medwatch phone number on the Medwatch phone number on the

label instead.label instead.

Facts:Facts:Consumers would call FDA Medwatch directly.Consumers would call FDA Medwatch directly.Would likely encourage over-reporting.Would likely encourage over-reporting.Even non-serious AEs would be reported directly to FDA.Even non-serious AEs would be reported directly to FDA.FDA would know before the mfr does — mfr may not even know FDA would know before the mfr does — mfr may not even know that report has been filed.that report has been filed.Mfrs would lose the ability to make quick corrections to Mfrs would lose the ability to make quick corrections to address concerns.address concerns.Mfrs want to interface with their consumers and know the most Mfrs want to interface with their consumers and know the most about their products.about their products.


Myth #3: Myth #3: Plaintiffs’ attorneys can use AERs Plaintiffs’ attorneys can use AERs to develop class action law suits.to develop class action law suits.

Facts:Facts:

AERs are subject to nondisclosure of private information provisions of AERs are subject to nondisclosure of private information provisions of the Privacy Act and HIPPA.the Privacy Act and HIPPA.

– All personal or identifying information is redacted.All personal or identifying information is redacted.

– Two courts of appeals have specifically denied plaintiffs’ attorneys Two courts of appeals have specifically denied plaintiffs’ attorneys access to this information with respect to drug AERs.access to this information with respect to drug AERs.

Along with the AER, a manufacturer may submit a statement denying Along with the AER, a manufacturer may submit a statement denying that the report constitutes an admission.that the report constitutes an admission.

Legislation directs FDA to avoid duplicate reports of the same event.Legislation directs FDA to avoid duplicate reports of the same event.

AERs are considered a “safety report” under section 756 of the AERs are considered a “safety report” under section 756 of the FD&C Act.FD&C Act.


Liability ProtectionLiability Protection

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

FD&C Act §756 (21 U.S.C. §379v )FD&C Act §756 (21 U.S.C. §379v )


Myth #4:Myth #4: Mandatory reporting will provide Mandatory reporting will provide a roadmap to plaintiffs’ attorneys of the a roadmap to plaintiffs’ attorneys of the

“next big case.”“next big case.”

Facts:Facts:

Mfrs may submit additional information that negates the AE or Mfrs may submit additional information that negates the AE or exculpates the product. Any exculpatory information becomes exculpates the product. Any exculpatory information becomes part of the report and must be provided when the report part of the report and must be provided when the report is disseminated.is disseminated.

Attorneys already have access to Medwatch reports today. That Attorneys already have access to Medwatch reports today. That already gives them signals of AE reported directly to FDA. already gives them signals of AE reported directly to FDA.

Why should mfr-reported cases be any different that those Why should mfr-reported cases be any different that those reported directly to FDA?reported directly to FDA?


Myth #5:Myth #5: Consumers Will Overwhelm FDA Consumers Will Overwhelm FDA With Adverse Event Reports.With Adverse Event Reports.

Facts:Facts:Consumers can already report AEs to FDA via Medwatch now.Consumers can already report AEs to FDA via Medwatch now.Many mfrs already report serious AEs to FDA now.Many mfrs already report serious AEs to FDA now.Many OTCs are already subject to mandatory AERs.Many OTCs are already subject to mandatory AERs.We’ve been telling the world about the wide margins of safety of We’ve been telling the world about the wide margins of safety of our products for years. Are we telling the truth?our products for years. Are we telling the truth?So why isn’t FDA being overwhelmed now?So why isn’t FDA being overwhelmed now?The opposition’s math is misguided.The opposition’s math is misguided.There is no “flashing neon sign” for consumers in the legislation. There is no “flashing neon sign” for consumers in the legislation.


Myth #6: Myth #6: AERS Will Prevent Mfrs from AERS Will Prevent Mfrs from Getting Product Liability Insurance.Getting Product Liability Insurance.

Facts:Facts:Underwriters already ask about claims histories and any AERs Underwriters already ask about claims histories and any AERs the mfr is aware of.the mfr is aware of.Insurance carriers can review AERs that FDA already receives.Insurance carriers can review AERs that FDA already receives.Mandatory reporting will give insurance carriers more confidence Mandatory reporting will give insurance carriers more confidence they are getting the whole story.they are getting the whole story.Mandatory reporting creates more transparency in the insurance Mandatory reporting creates more transparency in the insurance marketplace and more accurate information on which to marketplace and more accurate information on which to base premiums.base premiums.


Myth #7: Myth #7: Even if the bill is limited to Even if the bill is limited to “serious” AERs, mfrs will need to report “serious” AERs, mfrs will need to report

everything to be safe.everything to be safe.

Facts:Facts:

The legislation defines “serious AERs” using existing The legislation defines “serious AERs” using existing criteria for drugs.criteria for drugs.

The definition provides concrete parameters for what The definition provides concrete parameters for what is “serious.”is “serious.”

Why take on more responsibility that you need to? Why take on more responsibility that you need to?


Myth #8: Myth #8: We don’t need AERs if FDA We don’t need AERs if FDA would just promulgate GMPs.would just promulgate GMPs.

Facts:Facts:Rx drugs have both GMPs and mandatory AERs.Rx drugs have both GMPs and mandatory AERs.We don’t know when/if FDA will release the GMPs.We don’t know when/if FDA will release the GMPs.If the ingredient is unsafe, no amount of GMPs If the ingredient is unsafe, no amount of GMPs will solve that problem.will solve that problem.GMPs and AERs provide bookends of safety:GMPs and AERs provide bookends of safety:– GMPs help assure quality products under quality conditions.GMPs help assure quality products under quality conditions.– AERs provide post-market surveillance in case an unsafe AERs provide post-market surveillance in case an unsafe

product slips through. product slips through.


Myth #9:Myth #9: Mandatory AE reporting will Mandatory AE reporting will drive up the cost of DS.drive up the cost of DS.

Facts:Facts:

Many OTCs (including ibuprofen, naproxen, and Many OTCs (including ibuprofen, naproxen, and hydrocortisone) have been living under this model hydrocortisone) have been living under this model for years.for years.

Many mfrs routinely maintain a call center or get AEs Many mfrs routinely maintain a call center or get AEs now; how are they handled now.now; how are they handled now.

Legislation permits contracts with call center vendors.Legislation permits contracts with call center vendors.

How many serious adverse event reports do you really How many serious adverse event reports do you really receive in a year?receive in a year?


Myth #10: Myth #10: AER Legislation Will Deny AER Legislation Will Deny Consumers Access to Dietary Consumers Access to Dietary

Supplements.Supplements.

Facts:Facts:

Nothing in the legislation limits access to dietary Nothing in the legislation limits access to dietary supplements.supplements.

Mandatory AERs will demonstrate to FDA the safety Mandatory AERs will demonstrate to FDA the safety of supplements.of supplements.

If anything, AERs will lead to more-informed If anything, AERs will lead to more-informed consumers, able to make smarter supplement choices.consumers, able to make smarter supplement choices.


Questions? Questions?

Contact me at: (202) 776-7929Contact me at: (202) 776-7929

[email protected]@crnusa.org

Council for Responsible Nutrition Supplyside West, October 19, 2006 The Case for Mandatory Reporting...

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