1 drug safety oversight board update dia annual meeting philadelphia, pa june 21 st, 2006 susan k....
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Drug Safety Oversight Board UpdateDIA Annual Meeting
Philadelphia, PAJune 21st, 2006
Susan K. Cummins, MD, MPHExecutive Director Drug Safety Oversight Board
Center for Drug Evaluation and Research
Food and Drug Administration
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Today’s Talk
Review the first year’s activities for the Drug Safety Oversight Board
Provide update on other DSB Activities Draft Drug Watch Guidance
Posting of information sheets about emerging important drug safety concerns
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Definition: Important Drug Safety Issue
A Drug Safety issue with the potential to:
Significantly alter the risk-benefit analysis of a drug
Affect physician’s decision to prescribe
Affect patient’s decision to use
Includes and is broader than regulatory definition of “serious and/or life-threatening” adverse event
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Drug Safety Oversight Board
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Definition: Oversight
Oversight1 (n):
1. Watchful care or management; supervision.
2. An unintentional omission or mistake.
1The American Heritage® Dictionary of the English Language, Fourth Edition, 2000 by Houghton Mifflin Company
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Drug Safety Oversight Board Charge
Provide independent oversight and advice to Center Director on:
Management of Important Drug Safety Issues
Adjudication of organizational disputes
Policies about management of drug safety issues
Risk communication about important emerging drug safety concerns
Development of HCP & patient information sheets
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Drug Safety Oversight BoardOperational Principles
Fosters effective CDER management of important emerging drug safety concerns
DOES NOT replace Public Advisory Committees
DOES NOT replace current internal responsibility for Regulatory Decision-making
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Drug Safety Oversight Board: the First Year
Held nine meetings
June 17th 2005 to June 15th 2006
Public Summaries are at: http://www.fda.gov/cder/drug/DrugSafety/DSOBmeetings/default.htm
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Drug Safety Oversight Board: the First Year
Focus of meetings Didactic sessions about CDER processes Defining role within CDER Advising on when and what to communicate
about emerging risk Consider how to track emerging important
drug safety issues Pre-decisional discussions about many drugs
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When does FDA communicate about emerging risk?
Factors that favor early communication:
If a new risk is a “important drug safety concern”
Affects prescribing or monitoring
When there are measures to be taken to prevent harm
If unapproved (off-label) use poses a significant and/or yet undescribed risk
If a specific and/or vulnerable subpopulation may be affected (children or the elderly)
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DSB does Not Replace AC Meetings or Reduce Public Input DSB Meetings :
Many products discussed
Process-oriented
Surfaces & addresses internal conflicts
Discusses confidential commercial information
AC Meetings :
Reviews single drug or drug class
Regulatory action oriented
Venue for obtaining public input
FDA information provided to public
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Drug Safety Oversight Board Staff Activities
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Proposed Drug Watch Draft Guidance
Many comments
Support for early communication; unfavorable comments about Watch concept
Comments have been collated, synthesized & evaluated by team
New draft under development
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Risk Communication Venuesfor Patients and the General Public Plain Language health communication
Public Health Advisory Summarizes the specific public health concern
with actions to take
Patient Information Sheet “FDA Alert” summarizing safety concern
Highlights about product from the approved label
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Risk Communication Venuefor Health Care Professionals
Health Care Professional Information Sheet
“FDA Alert” summarizing the safety concern
Recommendations and Considerations—implications for practice
Information & data that are the basis for concern
Studies being done to better understand the concern
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Drug Safety Alert Challenges Striking the right balance—don’t want to
Over warn OR Under warn
Communicating complex information simply Determining when to inform the public when the
nature of the data is evolving and early Anticipating & managing unintended consequences Balancing the communication of emerging risk with
communication of benefit
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Drug Safety HC Professional and
Patient Information Sheets At least 49 drugs with safety postings through May 31 2006
6 Product class issues 3 Market suspensions
Palladone (hydromorphone hydrochloride ext release) Tysabri (natalizumab) (Return to Market 06/05/06) Neutrospec [Technetium (99m Tc) fanolesomab]
3 Product withdrawals Bextra (valdecoxib) Cylert (pemoline) Tequin (gatifloxin)
40 with added warnings to product label
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Drug Class Risks Described in HC Professional & Patient Information Sheets
Antidepressants—suicidality in adults & children Atypical antipsychotics—increased risk of death in dementia
(unapproved use) Non-steroidal anti-inflammatory drugs—increased
cardiovascular risk Erectile dysfunction drugs—non-arteritic anterior ischemic
optic neuropathy Topical Immunosuppressant calcineurin inhibitors—potential
cancer risk Long-acting beta agonists—increased risk of severe asthma
episodes that may lead to death
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Drug Safety HC Professional & Patient Information Sheets: Examples
Accutane (isotretinoin)—new restricted access program to prevent pregnancy in treated women
Paxil (paroxetine)—Pregnancy Category changed--C to D Strattera (atomoxetine)—increased pediatric suicidality risk Palladone (hydromorphone)— Withdrawn due to dose
dumping with concomitant alcohol exposure Campath (alemtuzumab)—idiopathic thrombocytopenic purpura
in patients with multiple sclerosis (unlabeled use) Neutrospec (99mTechnetium fanolesomab)—serious and life
threatening cardiopulmonary events shortly after administration
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Summary
Drug Safety Oversight Board and its risk communication efforts are a major component of CDER’s effort to strengthen drug safety efforts
Sharing emerging important issues early
Improving management through internal oversight
