Docket Management
Docket: 02N-0383 - Agency Info Coll. Act; Veterinary Adverse Drug Reaction, Lack of Effectiveness, Prod. Defect Rp
Comment Number: EC -4

Accepted - Volume 1

Comment Record
Commentor Mrs. Becky Armfield Date/Time 2002-11-04 16:23:44
Organization Novartis Animal Health US, Inc.
Category Company

Comments for FDA General
1. Is the proposed collection of information necessary for the proper performance of FDA's functions? Will the information have practical utility? We believe the general principle that it is the FDAs role to collect and monitor adverse events on FDA approved products. However, we believe that the broad nature in which this rule is written will initiate the reporting of events that are not useful and could potentially, due to sheer volume, cause important events to be lost in the pile. Specifically, the rule essentially eliminates the label as a guideline for drug use when it comes to reporting adverse events. This is in contrast to the many months and man-hours applied by both the pharmaceutical companies and the FDA when it comes to deciding the content and wording of the label. While there is some value in collecting data related to overdoses for the labeled indication, it is unclear how reporting inefficacies when the dosing is not compliant with the label, or inefficacies related to indications that are not labeled, will help the FDA in assessing the drugs performance in the market place. It remains unclear as to the utility of the 15-day reporting requirements as they relate to product defects since the requirement applies to serious, unexpected adverse drug events. It appears this may be an inaccurate reference. Please refer back to our original comment number 9 on docket 88N-0038.
2. What is the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used? We believe FDA’s estimate of the reporting burden for product defects (Form FDA 1932) is underestimated by at least one hour and possibly as much as one hour and 45 minutes. In the interim rule, FDA requests that investigative reports of product defects not be submitted, but the information be included on the 1932 form. This will require laborious hours of typing the data from the investigation onto the 1932 form. We ask that the agency reconsider allowing the investigative report to be attached, or in the least, allow only a brief summary and classification of the defect.
3. What are ways to enhance the quality, utility, and clarity of the information to be collected? We believe that an examination without administration or dispensing of medications does not qualify as professional intervention, and is not appropriate as the sole means to classify an adverse event as serious. If the veterinarian has examined the animal and feels that no treatment is indicated, professional intervention in the outcome of the case has not occurred. Furthermore, if the Center receives the expected tremendous number of reports, it will be extremely difficult to assess trends and truly conduct oversight of pharmacovigilance on marketed products. We interpret the current wording in the interim rule to mean that non-significant defects that may affect physical appearance but not public health or animal safety are not included in the definition of a manufacturing/product defect and therefore are not required to be reported to the FDA at all. Examples of non-significant defects would be a misaligned die-cut of a blister unit that does not affect the integrity of the package seal or labeling, or an empty blister well. If this interpretation is correct, the final rule needs to be clarified to indicate that non-significant defects are not required to be reported in 514.80(b)(4)(iv) but are still required to be handled by the firm as per 211.198. We believe it will enhance the utility of information collected if it is made clear to the public that a report of an event in association with drug administration does not indicate a cause and effect. At present, that information is not clearly understood and leads to unnecessary consternation on the part of the public.
4. What are ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology? We understand that FDA/CVM, with the enactment of the interim rule, requests that all the information must be in the 1932 form. This will add an additional burden if the company has to then extract, summarize and retype all of the investigation information. We estimate that this could add approximately 15 minutes to 1hour to each report, depending on the level of complexity of the individual report. Thus it becomes critical that FDA/CVM clarify that according to the interim rule, non-significant defects that may affect physical appearance but not public health or animal safety are not included in the definition of a manufacturing/product defect and therefore are not required to be reported to the FDA at all. If this interpretation of what must be reported is not correct, then the requirement stated above could add a prohibitive amount of time to the reporting process. In addition, FDA would not be given the ability to evaluate these defects as effectively as when they have access to the full reports.
5. General Comments It is critical that the Agency defines their requirements clearly and concisely if industry is expected to comply in a strictly defined manner. We appreciate your diligence in accepting and responding to industry’s comments.

EC -4