| Comment Record |
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Commentor |
Mr. Michael Mlodzik |
Date/Time |
2002-03-13 18:00:00 |
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Organization |
Fort Dodge Animal Health |
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Category |
Company |
| Comments for FDA General |
| Questions |
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1. General Comments
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E. Definition of Serious (New Sec. 514.3(h))
Comment: The definition of serious adverse event differs from the VICH definition. The VICH definition is preferred. In addition, the term requires professional interventions is not needed. There are many professional interventions that are commonly utilized for events that are by any definition not serious. An example: A pet suffers from fever post vaccination. A veterinarian examines the pet and decides to administer an anti-pyretic medication by injection. This professional intervention would make the observation of fever a serious adverse event. Therefore this clause should be removed. In addition from a medical perspective the addition of infertility of a serious adverse event is not reasonable. There are many types of infertility that would not be serious. The omission of the VICH sentence about animals that are housed and managed as a group should be returned. Animals housed and managed as a group must be evaluated differently than a collection of individuals. An example: Let's assume that a 3% death rate is normal in a group of housed and managed animals. Then a product is used. Subsequently a death rate of 1% is observed. By the definition proposed this observation would be serious, because fatalities are seen after a product is used. This is contrary to the fact that the death rate has really decreased.
Proposed Sec. 514.80(a) discussed the requirements for establish[ing] and maintain[ing] records and mak[ing] reports in one paragraph. For easier reading, FDA has broken the paragraph down in this interim final rule to discuss the recordkeeping and reporting requirements separately….
Comment: Sec. 514.80(a) states that separate complete set of files containing full records of all information pertinent to safety or effectiveness of drug must be kept, regardless of source. What is meant by and what is the purpose of a separate file. While we recognize the need to have domestic and foreign adverse event information these records are best kept in the offices where these reports are received. How can the creation of duplicate sets of records be of any value to the FDA? If inspected these documents can always be provided.
K. Fifteen-Day Alert Reports (New Sec. 514.80(b)(2))
Comment: 15 day reports must be filed regardless of source of the information. This is a completely new regulation that does not agree with the currently proposed VICH guidelines. The VICH guideline should be used. (Be advised that at this time, the VICH guideline on this issue is still being debated. It will likely say something like expedited reports will be submitted in another region within the time periods specified by that region beginning from the time the report is received in the second region.) Even with current technologies it is impossible for the manufactures to be expected to submit within 15 days reports of adverse events from international areas. There is no objective evidence that such a requirement would improve animal safety.
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