From: Califf, Robert [calif001@mc.duke.edu]
Sent: Tuesday, April 23, 2002 10:15 PM
To: 'FDADockets@oc.fda.gov'
Subject: FW: Notice of Participation; Public Hearing: Risk Management of
P rescription Drugs



> -
> April 23, 2002
> 
> Dockets Management Branch (HFA-305)	(FDADockets@oc.fda.gov)
> Food and Drug Administration
> 5630 Fishers Lane, Rm. 1061
> Rockville, MD  20852
> 
> Dear Sir or Madam:
> 
> The Centers for Education and Research on Therapeutics (CERTs) program,
> administered by the Agency for Healthcare Research and Quality (AHRQ) in
> consultation with the FDA, hereby requests participation in the FDA public
> hearing Risk Management of Prescription Drugs to be held on May 22, 2002
> in Washington, DC.  As Principal Investigator of the CERTs Coordinating
> Center, I will represent the CERTs program at the hearing. 
> 
> The mission of the CERTs program is to conduct research and provide
> education that will advance the optimal use of drugs, medical devices, and
> biological products.  In furtherance of its mission, CERTs investigators
> conduct health services and pharmacoepidemiology research to improve the
> understanding of benefits and risks of drugs, as well as the effectiveness
> of risk management approaches.  As an example, the CERTs Center at Duke
> University has studied the acceptance and effectiveness of the mandatory
> provider education program for the use of Dofetilide. 
> 
> The CERTs program is also collaborating with AHRQ, FDA and the
> Pharmaceutical Research and Manufacturers of America (PhRMA) on a series
> of expert meetings through which recommended priorities will be
> established for the study of current and innovative approaches and tools
> to better understand and manage pharmaceutical risks (Risk Series).  The
> first meeting of the Risk Series was held last year on the topic of risk
> communication.  A manuscript summarizing the meeting discussions has been
> submitted to a peer-reviewed journal.  In addition, an initiative to
> develop a model to depict how information about medical product risk is
> communicated within the health care system is under consideration.  Four
> additional meetings are planned on the topics of risk assessment, benefit
> assessment, risk communication and the media, and risk management.
> 
> A key factor in the success of any risk management program is informed and
> involved health care providers, who administer, dispense or prescribe the
> drug.  Thus, a comprehensive education program for health professional
> students, fellows and practitioners is a critical next step.  The program
> would include, for example, education about how to assess benefits and
> risks of therapies and to communicate in ways to minimize risk to
> patients.  The CERTs has begun to develop a proposed curriculum to
> specifically address this need.
> 
> The CERTs program welcomes additional opportunities to work with FDA and
> others to evaluate tools and programs to better manage pharmaceutical
> risk, recognizing that if risks are not adequately managed patients could
> be harmed.  Conversely, products will continue to be removed from the
> market that could potentially benefit significant individual populations. 
> 
> We would like to request 20 minutes to present information about some of
> the CERTs findings about what works, what doesn't and what questions
> remain relative to managing risk in the use of pharmaceuticals, as well as
> criteria that could be used to evaluate risk management tools and
> approaches.
> 
> I can be reached by mail or phone as follows:
> 
> 	Duke Clinical Research Institute
> 	PO Box 17969 
> 	Durham, NC  27715
> 	(919) 668-8820
> 	
> We appreciate your consideration.
> 
> Sincerely,
> 
> Robert M. Califf, MD
> Associate Vice Chancellor for Clinical Research
> Director, Duke Clinical Research Institute
> Duke University Medical Center
>