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The importance of FDA approval packages and briefing documents in pharmacy education.

To the Editor. A commentary published in July 8, 2009 Journal of the American Medical Association (JAMA) underscored the importance of Food and Drug Administration (FDA) approval documents in conducting truly independent evaluations of the therapeutic value of new drugs.1 The author concluded “…agency reviews are the most complete and accurate syntheses of clinical trial data available—it is time to make better use of them.” FDA approval packages contain rigorously reviewed data submitted by manufacturers in support of new drug approvals. These documents have been available free of charge on the agency's Web site for over a decade. 
 
Fundamental to the importance of these FDA documents is the evidence that only an estimated 30% to 50% of the randomized clinical trials submitted to the agency are published, and the majority of those that are not published appear to be trials with negative results.2,3 This, of course, may result in an overly optimistic impression of the therapeutic value of new drugs by clinicians. In addition, this raises questions about the validity of the drug information sources we as pharmacy educators traditionally have recommended to our students. These sources would include the published medical literature comprised of systematic reviews; meta-analyses; clinical practice guidelines; and the compendia and databases that depend on the peer-reviewed literature for documentation. 
 
Another important source of rigorously-reviewed, potentially-unpublished clinical trials is FDA briefing documents prepared for agency advisory committee meetings. These documents are reviews of early safety and efficacy data before a drug is approved. They are required to be in the public domain before advisory committee meetings and have been available on the FDA's Web site since 2000. 
 
The value of briefing documents may be best illustrated by the first dual peroxisome proliferator–activated receptor (PPAR) agonist muraglitazar (Pargluva) that was highly touted as a breakthrough by the professional and lay media. Nissen and colleagues using the FDA briefing documents for the muraglitazar advisory committee meeting found that the drug was found to be associated with excess of major adverse cardiovascular events.4 
 
Approval and briefing documents can be difficult to locate due to the nature and size of the FDA Web site.5 The effective utilization of both types of documents requires more than a casual familiarity with drug regulations and a strong background in evaluating clinical research, including observational research. 
 
The importance and utilization of FDA approval and briefing documents have been a part of our 2-course drug information sequence required in the first year of our doctor of pharmacy (PharmD) curriculum for the past 4 years. This year, 2009, we have instituted a Capstone Course for our second-professionalyear students in which they are asked to evaluate the therapeutic value of a drug. Students are required to use approval documents and/or briefing documents in their evaluations. 
 
With potentially as much as half of the available data about new drugs being unpublished, we no longer find it tenable to routinely, and uncritically, teach and recommend the use of traditional drug information sources for our students. 
 
 
Larry D. Sasich, PharmD, MPH 
 
Sana R. Sukkari, BScPharm, MPhil, PharmD 
 
G. Elliott Cook, PharmD 
 
Donald A. Tuttle, PharmD 
 
LECOM School of Pharmacy