Patient Choice Act of 2013
Latest action · May 24, 2013 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.
- IntroducedMay 22, 2013
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Patient Choice Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast track products determined by the Secretary of Health and Human Services (HHS) to be adequately safe. Treats provisional approval in the same manner as approval of a drug, except that provisional approval is subject to requirements related to informed consent and continued pursuit of safety and efficacy data for purposes of gaining approval for the drug.
Defines the term “adequately safe” to mean that: (1) for at least one population, the risk of death or morbidity caused directly by an adverse effect of the drug is unlikely to be greater than the combined direct and secondary risks of death or morbidity of the disease and existing therapies; or (2) the drug has had a valid marketing authorization for at least four years in specified countries and data adequate for the approval of such marketing authorization has been submitted to the Secretary.
Prohibits the Secretary from imposing any requirements for safety studies or data in addition to, or different than, the requirements for studies to establish safety for purposes of Phase 1 (initial introduction of an investigational new drug into humans) or Phase 2 (controlled clinical studies to evaluate the effectiveness of the drug for a particular indication in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug).
Applies the provisional approval only to the indication for the drug: (1) which is related to the treatment of the condition with respect to which the drug was designated as a fast track product, and (2) for which the drug is demonstrated to be adequately safety.
Prescribes requirements for termination of provisional approval, withdrawal of such approval, and application of market exclusivity to fast-track approval products.
Cosponsors 3
Members who signed on, in the order they did. Signatures ran from May 22, 2013 to Sep 11, 2013, with 2 there on the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-TX | Michael T. McCaul | Original | May 22, 2013 |
| D-CA | Scott H. Peters | Original | May 22, 2013 |
| R-FL | Ted S. Yoho | Sep 11, 2013 |
Actions 3
Everything that happened, newest first.
- May 24, 2013Referred to the Subcommittee on Health.
- May 22, 2013Introduced in House
- May 22, 2013Referred to the House Committee on Energy and Commerce.
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- May 22, 2013Introduced 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.