Lower PRICED Drugs Act
Latest action · Aug 1, 2006 Referred to the Subcommittee on Health.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedJul 28, 2006
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
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 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.
Cosponsors 3
Members who signed on, in the order they did. Signatures ran from Jul 28, 2006 to Nov 9, 2006, with 2 there on the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-NJ | Frank Pallone, Jr. | Original | Jul 28, 2006 |
| D-CT | Rosa L. DeLauro | Original | Jul 28, 2006 |
| R-TX | Ron Paul | Nov 9, 2006 |
Actions 3
Everything that happened, newest first.
- Aug 1, 2006Referred to the Subcommittee on Health.
- Jul 28, 2006Introduced in House
- Jul 28, 2006Referred to the House Committee on Energy and Commerce.
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| S 2300 | Lower PRICED Drugs Act | Related bill | Feb 27, 2006 |
Subjects
Assigned by the Library of Congress. Policy area: 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
- Health
- Injunctions
- Intellectual property
- Labeling
- Law
- Marketing
- Patent infringement
- Patents
- Pharmaceutical research
- Prescription pricing
- Public health
- Science, Technology, Communications
Text 1
Each version as it was printed, newest first.
- Jul 28, 2006Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.