Docket Management
Docket: 00N-1484 - Safety Reporting Requirements for Human Drug & Biological Products
Comment Number: EC -5

Accepted - Volume 1

Comment Record
Commentor Dr. James Nickas Date/Time 2003-03-17 12:13:21
Organization Genentech, Inc.
Category Health Professional

Comments for FDA General
1. General Comments COMMENTS ON THE QUALITY OF POSTMARKETING SAFETY REPORTS I applaud the Agency's proposed amendments intended to improve the quality of post-marketing safety reports. In particular, the emphasis on serious SADRs, designated medical events, and medication errors will help Pharmacovigilance departments focus their sometimes-limited resources on the most potentially important events. With respect to the Agency's proposed amendment that would require a licensed physician at the company to be responsible for the content of post-marketing safety reports submitted to the FDA, a few comments are being submitted for consideration. The Agency should be aware that some Pharmacovigilance departments effectively and efficiently utilize a mix of healthcare professionals to review, process and submit safety reports. This mix of healthcare professionals may include MDs, PharmDs, PhDs, RNs, and other clinical specialists. Often, healthcare professionals work as teams to ensure that received safety information is triaged, reviewed, and followed up by appropriate personnel. For example, some Pharmacovigilance departments may circulate only serious individual case safety reports to physicians within the company for review and comment in real time. In addition, many companies utilize Product Safety Committees composed of senior management (including physicians) to review important safety findings. If the Agency intends to codify a physician requirement, it probably should be framed differently. It is reasonable to require companies to identify physicians who can speak to individual case safety reports or periodic safety reports submitted to the Agency. What is most important is that companies institute procedures for adequate medical review of acquired safety information. This can be accomplished in a variety of ways. In Pharmacovigilance work, company physicians cannot and do not practice medicine in the traditional sense. This said, diagnostic medical expertise is helpful in evaluating safety reports. Unfortunatley, company physicians who are not directly treating patients rarely receive enough information make diagnoses. All Pharmacovigilance departments should employ and/or have access to licensed physicians. It is absolutely reasonable for the Agency to require companies to list the names and contact information of healthcare professionals (including physicians) who can speak to safety issues in periodic reports. This said, the proposed requirement to print responsible physician names on FDA 3500A forms for individual case safety reports may be more difficult from a practical and systems point of few. It may be easier for companies to identify on FDA 3500A forms a single point of contact for safety-related queries. This person may or may not be a physician. However, the single point of contact can refer the Agency to the appropriate physician if necessary.

EC -5