Drug Safety Oversight Board Meeting, July 16, 2009
The Executive Director updated the Board on risk communications [Public Health Advisories (PHAs), Early Communications about Ongoing Safety Reviews (ECs), and Information for Healthcare Professionals (HCP)] posted and in development since the June 18, 2009 meeting.
The following is a list of the posted risk communications:
- July 1, 2009: Insulin glargine (Lantus) and possible cancer risk
- July 1, 2009: Varenicline/bupropion and suicidality:
- Information for Healthcare Professionals: Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics)
- July 7, 2009: Propoxyphene and Propoxyphene-containing products
- July 14, 2009: Immunosuppressants and BK virus-associated nephropathy
The Drug Safety Oversight Board (DSB) discussed 4 topics: the Freedom of Information Act (FOIA) and how it applies to the DSB; the Veterans Health Administration-FDA collaboration on the propoxyphene issues; an update from the Safe Use Initiative Team on their projects and goals; and follow-up actions to the 21 ECs released since 2007.
Freedom of Information Act
The Director of the Division of Information Disclosure Policy presented on FOIA and how it relates to the DSB. The following issues were clarified and/or noted during the discussion:
- If a meeting was recorded for the purpose of preparing the minutes, and the recording was erased immediately after preparing the draft minutes, then only the written minutes would be subject to FOIA. The retention time for the recording, if not erased prior to meeting minutes being finalized, might be the same as the retention time for other records. To date, no meeting minutes have been recorded.
- If someone requests the details or records for a DSB meeting, the DSB staff should inform the requestor to submit a FOIA request.
- If a research study or project is federally funded, then the final report, regardless of whether the report has been published, is subject to FOIA. A report in draft form may be exempt from FOIA; however, a document can not remain in draft in order to protect it from disclosure.
- FDA may not disclose trade secrets, commercial, financial or personal privacy information without the company’s or individual’s permission.
- It was unclear whether a Board member’s individual vote on an issue would be subject to FOIA. It was noted that votes are rarely taken and counted for specific issues since the Board is not a decision making entity and only serves to inform and advise Dr. Woodcock. When voting situations arise, only the total number of votes for and against a particular issue are typically counted, rather than an individual’s vote.
Veterans Health Administration-FDA Collaboration on the Propoxyphene Issue
The Deputy Director of CDER and Chair of the DSB presented a recent example where FDA partnered with the Veterans Health Administration to help sort through a very complex drug safety issue involving propoxyphene. Although FDA has discussions on a variety of issues with our Federal Partners in other forums, this particular example illustrated how FDA can collaborate and connect with our partners through their participation on the DSB. Moreover, it exemplifies the value of the DSB.
Update from the Safe Use Initiative Team
A representative from the Safe Use Initiative Team provided an overview of the goals and scope of CDER’s Safe Use Initiative. Areas to target for improvement are inappropriate medication use (e.g. misuse, abuse), failure to use, and medical mix-ups. These are preventable errors that cause the majority of harm from approved medications. CDER’s Safe Use Initiative complements and reaches out beyond the regulatory authority of the Center to focus externally on activities within the healthcare community. The Safe Use Initiative Team will collaborate and partner with those involved in healthcare to positively influence the safe use of non-prescription and prescription medications in order to reduce preventable harm. The Board discussed what types of Safe Use projects would be of interest, how Safe Use should define project priorities and boundaries, and what can be used as measures of success.
Follow-up actions to the 21 Early Communications released since 2007
The Executive Director of the DSB presented a follow-up on 21 ECs issued from August 2007 to July 2009. Elements of an EC were given along with a brief description of each EC, the projected date for follow-up, actual date of follow-up, and the follow-up actions. The following lessons were learned:
- The media’s and public’s reaction has been generally positive.
- FDA could improve upon their estimated timeframe for follow-up as it has been imprecise with a few of the issued ECs.
- Companies can be significantly affected by an EC despite FDA’s disclaimer (that states FDA has not reached a conclusion but is studying the potential safety issue) that accompanies the communication.
- The words in our disclaimer are not easily understood and interpreted by some of the public.