Adverse Event Requirements for Dietary Supplements

1
Adverse Event Requirements for Dietary
Supplements OTC Monograph Drugs

• Deborah White
• Food Marketing Institute
• October 23, 2007

2
Introduction

• Welcome
• Review of statute and guidance
• Deborah White, FMI
• Q A
• Vasilios Bill Frankos, FDA
• Deborah White, FMI
• Conclusion

3
Basics

• Dietary Supplement and Non-Prescription Drug
  Consumer Protection Act (PL 109-462, 120 Stat.
  3469)
• Effective December 22, 2007
• Guidance documents (October, 2007)
• Dietary Supplements
• Non-Prescription Drugs

4
Which products?

• Certain non-prescription drugs
• Not subject to Section 503(b) or subject to
  approval under Section 505 application
• OTC monograph drugs
• List at http//www.fda.gov/cder/otcmonographs/rule
  making_index.htm
• Examples ibuprofen, antacids, dentifrices (e.g.,
  fluoride containing toothpastes)

5
Which products?

• Dietary supplements
• Products (other than tobacco) intended to
  supplement the diet that contain one or more of
  the following dietary ingredients
• Vitamin
• Mineral
• Herb or botanical
• Amino acid
• Dietary substance for use by humans to increase
  total dietary intake
• Concentrate, metabolite, constituent, extract or
  combination of any ingredient mentioned above

6
Labeling

• Requires labels of covered products to include
  domestic phone number or address thru which
  reports of adverse events may be made
• Applies to products labeled on or after December
  22, 2007

7
Who must comply?

• Responsible person
• Manufacturers, packers, distributors whose name
  appears on the label pursuant to Section
  403(e)(1) or Section 502(b)(1)
• Responsible person includes retailers whose
  name appears on the label as a distributor, e.g.,
  private label products

8
Adverse Event

• Adverse event
• Any adverse health-related event associated with
  use of dietary supplement or drug including (for
  drugs) from
• Overdose
• Abuse
• Withdrawal
• Failure of expected pharmacological effect

9
Serious Adverse Event

• Serious adverse event
• An adverse event that either results in
• Death
• Life-threatening experience
• In-patient hospitalization
• Persistent or significant disability or
  incapacity
• Congenital anomaly or birth defect OR
• Requires medical or surgical intervention to
  prevent any of the above-mentioned outcomes,
  based on reasonable medical judgment

10
Reporting

• Responsible Persons must report all serious
  adverse events associated with products in US
• HOWEVER, retailers may by agreement authorize
  manufacturers or packers to submit reports,
• PROVIDED, retailer sends all reports of any
  adverse event serious or not to the
  manufacturer or packer

11
Agreement

• Statute is silent
• Any agreement should
• Reference statute
• Specify that manufacturer or packer is authorized
  to submit the reports under statute
• State that manufacturer or packer agrees to
  submit all such reports and to keep required
  records
• State that retailer will send any reports that it
  receives of adverse events to the manufacturer or
  packer
• May implement through call centers

12
Reporting

• Use MedWatch form 3500A
• http//www.accessdata.fda.gov/scripts/medwatch/

13
Reporting

• Submit serious adverse event reports within 15
  business days of receipt thru address or phone
  number on label
• FDA recommends same time frame for SAER received
  thru other mechanisms (e.g., e-mail, fax)
• Any new medical information relevant to report
  and received within 1 year of initial report must
  also be submitted within 15 days of receipt by
  responsible person
• FDA encourages voluntary submission of any new
  medical information received after 1 year

14
Reporting

• Data Elements
• Identifiable injured person
• Sufficient to distinguish different events, but
  dont identify person
• Identifiable initial reporter
• Person who notifies the Responsible Person
• Get to person with actual knowledge
• If requests anonymity, say so on report but keep
  enough info to contact
• Identity and contact info for Responsible Person
• Suspect product
• Specify type, form, strength, packaging size, etc
• Serious adverse event
• Specify symptoms, diagnosis, etc

15
Reporting

• Obtaining Information
• Diligent attempts to obtain complete
  information
• Trained healthcare providers
• Targeted questionnaires
• Permission to contact healthcare provider

16
Reporting

• Report must include label on or within dietary
  package
• FDA recommends
• Hospital discharge summaries
• Autopsy reports
• Relevant laboratory data
• Other clinical data
• But NOT sample

17
Exemption

• Statute authorizes FDA to establish exemptions to
  the reporting requirement via notice comment
  rulemaking
• PROVIDED such exemptions wont have an adverse
  effect on public health

18
Submission

• Serious adverse event reports for dietary
  supplements must be submitted by mail to the
  following address
• Food and Drug Administration
• Center for Food Safety and Applied Nutrition
• Office of Food Defense, Communication
  Emergency Response
• CAERS Team HFS-11
• 5100 Paint Branch Parkway
• College Park, Maryland 20740

19
Submission

• Serious adverse event reports for monograph OTC
  drugs may be submitted by postal or electronic
  mail to the following addresses
• Central Document Room
• Center for Drug Evaluation and Research
• Food and Drug Administration
• 5901-B Ammendale Road
• Beltsville, MD 20705-1266
• http//www.fda.gov/medwatch/safety/FDA-3500A_Fill
  able_08-16-2006.pdf

20
Public Availability

• Reports redacted of personally identifiable
  information are subject to release under Freedom
  of Information Act
• Reports may be submitted with a statement that
  denies that the report is an admission that the
  product caused or contributed to the adverse
  event
• Statement will accompany any release of the report

21
Liability

• Statute prohibits submission of report from being
  interpreted as admission of liability

22
Recordkeeping

• Responsible persons must maintain records for 6
  yrs after each adverse event serious or not --
  report received by the RP
• Includes new medical information received more
  than 1 year after SAER submitted

23
Records Access

• FDA officials may inspect records during Section
  704 inspections
• Appropriate credentials
• Duly authorized

24
Statutory Mechanics

• Preemption
• Preempts state laws that are in addition to or
  different than the federal law
• Effective Date December 22, 2007
• Labeling requirement applies to any products
  labeled on or after this date

25
Question Answer

• Dr. Vasilios Bill Frankos, Director
• Dietary Supplements Program Division
• Food and Drug Administration
• Instructions for asking questions
• Press 1 on your telephone
• Turn mute function off
• Press to remove yourself from the queue

26
Conclusion

• Contact Information
• Bill Frankos
• 301.436.2375
• vasilios.frankos_at_fda.hhs.gov
• Deborah White
• 202.220.0614
• dwhite_at_fmi.org