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U.S. Department of Health and Human Services

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Drug Safety Oversight Board Meeting, January 21, 2010

Public Summary

The Executive Director updated the Drug Safety Oversight Board (DSB or Board) on risk communications [Public Health Advisories (PHA), Early Communications about Ongoing Safety Reviews (EC), and Information for Healthcare Professionals (HCP)] posted and in development since the November 19, 2009 meeting. The following is a list of the posted risk communications:

Risk Communications Posted since the November 19, 2009 DSB meeting:

The DSB heard presentations and discussed three topics:

  1. An update from the Office of Communications
  2. How to communicate FDA’s updated recommendations about long acting beta agonists (LABAs)
  3. Propoxyphene safety issue

The views expressed by non-CDER employees are those of the individual and not necessarily the opinion of their respective government agency.

An update from the Office of Communications

The Director from FDA’s Office of Communications (OCOMM) provided an update on developments over the past year and the many challenges OCOMM faces when writing and issuing risk communications to health care professionals and the public. OCOMM has expanded its vision of how to communicate to the public beyond the traditional ways, including talking directly with health care professionals and the media. Dr. Baruch Fischhoff, a Howard Heinz University Professor at Carnegie Mellon University and Chair of FDA’s Risk Communications Advisory Committee attended as a guest speaker. He provided an overview of the issues involved when communicating risks and benefits to the public.

The Board discussed the following:

  • The many factors that are considered when writing risk communications, such as who is the audience; what does the audience want; and what is the best way to deliver information to them
  • Challenges FDA encounters when communicating risks to the public, including legal and regulatory constraints, emerging science, the audiences’ needs, and helping the public understand FDA’s role in overseeing drug safety throughout the product’s life cycle
  • What is the most effective approach for communicating messages to the public (e.g. multiple, multi-tiered, or single communications)
  • Different social media and communication products that FDA is using or may use in the future to disseminate messages to the public, such as texting, facebook, twitter, widgets, RSS feed, and other social media products
  • Methods for testing the impact of safety communications

How to communicate FDA’s updated recommendations about long acting beta agonists (LABAs)

LABAs are FDA-approved medications used to treat adult and pediatric patients with asthma, chronic obstructive pulmonary disease, or exercise-induced bronchospasm. LABAs work by relaxing muscles in the airways in the lungs allowing for better airflow for up to 12 hours. The DSB heard presentations and discussed how FDA might communicate FDA’s updated recommendations when LABAs are used to treat patients with asthma.

Board members from the Department of Defense, Veterans Health Administration, and the Indian Health Service provided information on LABA usage patterns including LABA combination products (with an inhaled corticosteroid) used in their hospitals and clinics. They also provided input on how the updated recommendations might affect their health systems.

The Board discussed the following:

  • The pathophysiology of asthma and the risks and benefits of LABAs
  • The National Asthma Education and Prevention Program’s (NAEPP) published asthma treatment guidelines for patients 12 years of age and older
  • The Serevent Nationwide Surveillance (SNS) study, the Salmeterol Multicenter Asthma Research Trial (SMART), and FDA’s 2008 LABA meta-analysis
  • Recommendations for LABA use from the Advisory Committee meeting held in December 2008
  • FDA’s updated recommendations for using LABAs in patients with asthma
  • Specific labeling concepts, goals, and rationale for each labeling change
  • Key messages regarding LABAs that should be included in a communication to healthcare professionals and consumers
  • The importance for FDA to discuss the updated recommendations with stakeholders, professional societies and healthcare professionals to help disseminate the message

Propoxyphene Issue

The Board discussed whether and how additional safety data from the Drug Abuse Warning Network-Medical Examiner (DAWN-ME) and the Florida Department of Law Enforcement (FDLE) could impact the risk-benefit assessment for propoxyphene. Propoxyphene is an opioid analgesic used to relieve mild to moderate pain.

The Board discussed the following:

  • The regulatory history of propoxyphene products
  • Efficacy and safety of propoxyphene products
  • Non-clinical toxicology safety issues associated with propoxyphene
  • Propoxyphene’s receptor activity and cardiotoxicity in relationship to other opiates
  • An overview of propoxyphene pharmcokinetics, including the effect of food, hepatic and renal impairment, and age on its metabolism
  • Safety findings from FDA’s Propoxyphene Working Group, including data from the DAWN-ME and FDLE
  • Propoxyphene drug utilization trends in the US
  • The use of summary safety data (overall data rather than individual patient data) from a large database when making regulatory decisions; and what standards should FDA use to make regulatory decisions using summary safety data