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Drug Safety Oversight Board Meeting, March 15, 2012

Public Summary

The following is a list of the Drug Safety Communications (DSCs) posted shortly before or since the January 19, 2012 meeting and relayed to the Drug Safety Oversight Board (DSB or Board) via memorandum:

The DSB discussed three topics:

  1. Commercial Web Sites Accessing and/or Offering FDA Adverse Event Reporting System (AERS) Data
  2. HHS Efforts to Mitigate the Risks Associated with Prescription Drug Abuse
  3. Department of Defense Challenges with FDA Risk Evaluation & Mitigation Strategies (REMS)

Views expressed by non-CDER employees are those of the individual and not necessarily the opinion of their respective federal agency or institution.

Commercial Web Sites Accessing and/or Offering FDA Adverse Event Reporting System (AERS) Data

The Board heard a presentation from Lauren Choi, Pharm.D., Team Leader, Division of Pharmacovigilance II, Office of Surveillance and Epidemiology, CDER, on the proliferation of commercial web sites accessing and/or offering FDA Adverse Event Reporting System (AERS) data.

These sites (for example, www.adverseevents.com disclaimer icon or www.drugcite.com disclaimer icon ) purport to refine and present FDA’s AERS data  in more user-friendly interfaces and platforms than might be available at www.fda.gov.

Dr. Choi reviewed the sites for content options and variations, features, limitations, specific cautions, and implications for the future.

The Board discussed the following:

  • Possible range and breadth of patient use of AE sites and potential impacts on drug safety and medication adherence.
  • Need for more information about public AE sites, some with fee-based options.
  • Concerns about AE information presented without adequate context or explanation.
  • The potential for private AE sites to present new directions for developing accessible health information for consumers that will have relevance with the continued growth of web-based information, tools, and applications.

HHS Efforts to Mitigate the Risks Associated with Prescription Drug Abuse

Peter Lurie, MD, MPH, from the Office of Policy and Planning in the Office of the Commissioner, presented on HHS efforts to mitigate risks associated with prescription drug abuse.

Dr. Lurie introduced the role and goals of the Prescription Drug Abuse Subcommittee of the HHS Behavioral Health Coordinating Committee.  (Dr. Lurie co-chairs the Subcommittee with Dr. Nora Volkow of the National Institute on Drug Abuse, NIH.)

  • Improve federal surveillance capacity
  • Increase provider access to Prescription Drug Monitoring Program data
  • Reduce overdose deaths through secondary prevention strategies
  • Develop educational materials to promote appropriate use/reduce misuse
  • Use electronic medical records as a tool for improved clinical identification of drug abuse

The Board discussed:

  • Prescription drug abuse mitigation efforts currently under consideration in Federal Partner agencies.
  • Potential impacts that new or different requirements might have within Federal Partner agencies.
  • Drug Take-back Programs as a tool for risk mitigation.
  • State-level Prescription Drug Monitoring Programs (PDMPs) as tools for risk mitigation.

Department of Defense (DOD) Challenges with FDA Risk Evaluation & Mitigation Strategies (REMS)

The Board heard a presentation from COL Carol Labadie, PharmD, U.S. Army Pharmacy Consultant.

DOD faces an array of challenges in implementation and compliance with FDA REMS, including acquisition of drug products and related logistical concerns, documentation requirements, facility coordination, and product shipping constraints.  There are also barriers to REMS compliance when using certain products in the field and/or in combat situations.

In general, REMS with ETASU (elements to assure safe use) are the most difficult to implement within DOD, given DOD’s geographically and structurally disparate organizations and missions.

In DOD regions with multiple medical facilities, “cross-pharmacy” use can create organizational and data tracking challenges.

The Board discussed:

  • FDA’s interest in methods to streamline, centralize, and assist all our Federal partners.
  • Alternative approaches to centralize and/or better track REMS requirements for all partners.