Skip to main content
HR 6022 109th Congress House Health Administrative remedies Antibiotics Child health Civil actions and liability Clinical trials Commerce Congressional reporting requirements Consumer education Department of Health and Human Services Discovery (Law) Drug approvals Drug industry Drug utilization Drugs Evidence (Law) Families Generic drugs Government Operations and Politics Government publicity

Lower PRICED Drugs Act

Introduced: July 28, 2006 See on congress.gov
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Aug 1, 2006
Referred to the Subcommittee on Health.
Jul 28, 2006
Referred to the House Committee on Energy and Commerce.
Jul 28, 2006
Introduced in House
 Plain-English summary Congressional Research Service

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.

What's happening now August 1, 2006

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2