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New Pharmaceutical Agreement Notification Filing Requirements
As of Jan. 7, 2004, pursuant to Section 1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, agreements between brand-name and generic pharmaceutical companies regarding the manufacture, marketing, and sale of generic versions of brand-name drug products are required to be filed with the Federal Trade Commission and the U.S. Department of Justice. In addition, certain agreements between generic drug manufacturers, each of which have filed certain types of applications with the FDA for the same brand-name drug product, must also be filed. However, agreements that concern only purchase orders for raw materials, equipment and facility contracts, employment or consulting contracts or packaging and labeling contracts need not be reported. The filing requirements cover agreements executed on or after Jan. 7, 2004.
Any agreement subject to the new law must be within 10 business days of the date the agreement was executed. The penalty for failure to file can be up to $11,000 per day.
The new requirements are being implemented because the FTC believes that agreements between brand-name and generic drug companies can have the effect of delaying entry to the market of generic drugs. Using these filings, the anti-trust agencies will be able to monitor the effects of these agreements on trade.
Copies of the new filing requirements can be found at www.ftc.gov.
As of Jan. 7, 2004, pursuant to Section 1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, agreements between brand-name and generic pharmaceutical companies regarding the manufacture, marketing, and sale of generic versions of brand-name drug products are required to be filed with the Federal Trade Commission and the U.S. Department of Justice. In addition, certain agreements between generic drug manufacturers, each of which have filed certain types of applications with the FDA for the same brand-name drug product, must also be filed. However, agreements that concern only purchase orders for raw materials, equipment and facility contracts, employment or consulting contracts or packaging and labeling contracts need not be reported. The filing requirements cover agreements executed on or after Jan. 7, 2004.
Any agreement subject to the new law must be within 10 business days of the date the agreement was executed. The penalty for failure to file can be up to $11,000 per day.
The new requirements are being implemented because the FTC believes that agreements between brand-name and generic drug companies can have the effect of delaying entry to the market of generic drugs. Using these filings, the anti-trust agencies will be able to monitor the effects of these agreements on trade.
Copies of the new filing requirements can be found at www.ftc.gov.
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