H.R.6022 - Lower PRICED Drugs Act109th Congress (2005-2006)
|Sponsor:||Rep. Waxman, Henry A. [D-CA-30] (Introduced 07/28/2006)|
|Committees:||House - Energy and Commerce|
|Latest Action:||08/01/2006 Referred to the Subcommittee on Health. (All Actions)|
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Summary: H.R.6022 — 109th Congress (2005-2006)All Information (Except Text)
Introduced in House (07/28/2006)
Lower Prices Reduced with Increased Competition and Efficient Development of Drugs Act or the Lower PRICED Drugs Act - Amends the Federal Food, Drug, and Cosmetic Act to require an abbreviated application for a new drug containing certain antibiotics, the approved labeling for which includes a method of use that is claimed by a patent, to include a statement: (1) that identifies the relevant patent and the approved use covered by the patent; and (2) that the applicant is not seeking approval of such use.
Requires the court to consider the totality of circumstances and the public interest in deciding whether to shorten the 30-month period that delays the approval of an abbreviated drug application when a patent infringement case is filed against the applicant.
Limits market exclusivity provided for conducting pediatric studies of new or already approved drugs to only those drugs for which the Secretary of Health and Human Services approves labeling that provides specific, therapeutically meaningful information about the use of the drug in pediatric patients.
Sets forth provisions governing petitions seeking any action relating to the approval of certain new drug or abbreviated new drug applications, including the delay of such approval. Allows the Secretary to approve a petition to delay approval only when necessary to protect the public health. Requires the Secretary to take final agency action on a petition within 180 days of receipt, with no extensions allowed.
Extends the 30-month period that the Secretary has to approve or disapprove an abbreviated application for a new drug by the amount of time that lapses from the date the Secretary receives a petition and the date of the final agency action on the petition, without regard to whether the Secretary grants or denies the petition.