Lower PRICED Drugs Act

Summary

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 drugs to only those new drugs for which the Secretary of Health and Human Services approves labeling that contains specific, therapeutically meaningful information about the use of the drug product in pediatric patients. Prohibits the Secretary from delaying the approval of a new drug application while a petition is reviewed and considered. Requires the Secretary to take final agency action on a petition within six months 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.

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Timeline

1. 16 February 2006

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S1421-1422)

   Source: IntroReferral

2. 16 February 2006

   Introduced

   Sponsor introductory remarks on measure. (CR S1420-1421)

   Source: IntroReferral

3. 16 February 2006

   Introduced

   Introduced in Senate

   Source: IntroReferral

4. 27 February 2006

   Floor

   Star Print ordered on the bill.

   Source: Floor

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 16 February 2006 · Official file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 16 February 2006

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 16 February 2006

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 16 February 2006

  Open at official source

Sponsors

• Sen. Stabenow, Debbie [D-MI] · D · Sponsor
• Rep. Lott, Trent [R-MS-5] · R · Sponsor
• Sen. Kohl, Herb [D-WI] · D · Cosponsor
• · sshr00 · Standing

Related records

• related to → Lower PRICED Drugs Act