| Comment Record|
Mr. Michael Mlodzik ||
2002-01-09 11:58:04 |
Fort Dodge Animal Health |
| Comments for FDA General |
1. General Comments
Per the 13 December 2001 Federal Register Notice, DOCID:fr13de01-61, below are Fort Dodge Animal Health's comments to the Draft Guidance for Industry on ``Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs)'' (VICH GL29), [Docket No. 01D-0501].
The current document only says that Periodic Summary Updates (PSU) are a good idea and they should be filed as the regional authority wants them to be filed. That is NOT harmonization.
1) The document does not determine if a PSU is a regional document or a global document.
A regional document would be one where the PSU would only review issues from that region versus a global document where the PSU would review the product in all regions where it is marketed. Fort Dodge Animal Health feels it is in all manufacturer's best interest to create as few PSU as possible, as they can be very time consuming. This means that if a manufacturer sells a product on in all three regions (EU, Japan, and USA), they would want to create a single global PSU, that is filed with each of the regulators. Fort Dodge Animal Health believes this is easier than three separate PSU created three different times.
2) For global PSU's to work, there needs to be International Birth Date (IBD), standard frequency of submitting PSU's, and the definition of what is and what is not a similar product.
Fort Dodge Animal Health agrees with the IBD; the date of the first marketing authorization for the product granted in any country in the VICH region. For administrative convenience, if desired by the Marketing Authorization Holder (MAH), the IBD can be designated as the last day of the same month. VICH should insist all three regulators agree to standard PSU submission frequencies, and similar products that should be lumped into a single report.
3) Standard submission frequency - Below is an example caused by inconsistent standard submission frequencies: A product is approved in the three regions. Three years apart. Region number 1 requires new products to have a PSU every 6 months for two years, then annually for years 3,4, and 5, and then every 5 years. Region 2 requires a report at 6 months then annually forever. Region number 3 every year for 6 years then every 6 years. Even if you assume Country 1 and 2 agree on a standard birthday you will file a PSU:
Year Region 1 Rgion 2 Region 3
Year 1 every 6 months not approved not approved
Year 2 every 6 month not approved not approved
Year 3 annual every 6 months not approved
Year 4 annual annual not approved
Year 5 annual annual not approved
Year 6 not submitted annual annual
Year 7 not submitted annual annual
Year 8 not submitted annual annual
Year 9 not submitted annual annual
Year 10 for past 5 year annual annual
Year 11 not submitted annual annual
Year 12 not submitted annual not submitted
VICH needs to agree on a set frequency for first approval, then any additional approval will get PSU on the frequency already determined by the first approval. Fort Dodge Animal Health believes that submitting annual reports for the life of the drug do not increase patient safety for well established drugs. Fort Dodge Animal Health suggests a standard be set at every 6 months for a very short period, then annually for another short period, then every 5 years for the life of the drug. With this suggestion, if there is an approval in Region 3 in year 6, they would receive all previous PSU's as part of the registration process. Region 3 would not then get its first PSU until the next PSU was due based on the approval in Region 1.
4) Similar products. This is not discussed, but should be defined. All regulators need to agree on what is or is not a similar product. I suggest that for finished dosage forms, two similar products are where each has the same generic equivalent active, at pharmacologically similar concentrations, with similar formulations, administered to the same species of animals by medically similar routes. The guideline should be written so the manufacturer can combine similar products, if they want or split if that is more appropriate. The decision should be the manufacturer's, however the regulator always hold veto power.
5) The document fails to standardize what adverse event information is reported. We need to have either a line listing with a set of fields or complete reports, not both as currently described. Fort Dodge Animal Health prefers line listings.