FDA issues generic drug final rules
FDA issues generic drug final rules
ROCKVILLE, MD., June 13, 2003 - The FDA announced June 12 that it would publish a final rule in the June 18 Federal Register, streamlining the generic drug process by limiting a drug company to only one 30-month stay of a generic drug's entry into the market for resolution of a patent challenge.
The FDA also is changing its review procedures to speed and reduce the cost of determining that a new generic drug is safe and effective.
The new rule, which becomes effective Aug. 18, follows an October 2002 draft rule released by the FDA and the Department of Health and Human Services (HHS). In its prepublication notice, the FDA said that "the final rule maintains a balance between the innovator companies' intellectual property rights and the desire to get generic drugs on the market in a timely fashion."
The regulation also clarifies the types of patents innovators must submit for listing in the "Orange Book" to reduce confusion and help curb attempts to take advantage of the process. The new rule prohibits the submission of patents claiming packaging, intermediates or metabolite innovations. Patents claiming a different polymorphic form of the active ingredient described in the new drug application (NDA) must be submitted if the NDA holder has test data demonstrating that a drug product containing the polymorph will perform in the same way as the drug product described in the NDA. The changes are consistent with concerns raised last year by the Federal Trade Commission in its report on generic drugs.
The final rule also will change the patent information required to be submitted and will provide declaration forms for submitting that information to the agency, both with the NDA and after NDA approval, and does not require claim-by-claim listing on the declaration form except for method-of-use patents claiming approved methods of use.
"These changes will enable consumers to save billions of dollars each year by making it easier for generic drug manufacturers to get safe and effective products on the market when the appropriate patent protection expires," HHS Secretary Tommy Thompson said in a statement. Commissioner of Food and Drugs Dr. Mark B. McClellan added the following: "Our new rule and our new procedures are important steps in making more generic drugs available more quickly."
The final rule, along with background documents, are available at: www.fda.gov/oc/initiatives/generics
Detailed information regarding the final rule will appear soon on www.warningletters.com
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