Drug and Device Accountability Act of 2008
Latest action · Jul 31, 2008 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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 31, 2008
- Passed SenateNot reached
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Drug and Device Accountability Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to deem a drug or device to be misbranded unless certain conditions related to registration of establishments, identification of prior transactions, labeling for country of manufacture, and provision of required information on importation are met.
Includes in the definition of "drug" a precursor ingredient.
Repeals the registration exemption for manufacturers of harmless inactive ingredients that become components of drugs.
Expands the information required to be included for registration of establishments.
Deems a drug to be adulterated if certain conditions related to verification of identity and purity, identification of establishments, consistency with current manufacturing technologies, and conformity with good distribution and import practices are not met.
Sets forth provisions governing importation of a drug.
Sets forth required actions, including cessation of distribution, if there is a reasonable probability that a drug intended for human use would cause serious, adverse health consequences or death.
Establishes actions manufacturers must take regarding any defective drug.
Sets forth additional required certifications for submissions related to drugs and devices regarding accuracy of information submitted and personal knowledge of such information.
Establishes whistleblower protection for employees providing information regarding a drug, biological product, or device.
Directs the Secretary of Health and Human Services to establish and maintain a corps of inspectors dedicated to inspections of foreign establishments and foreign facilities.
Authorizes the Secretary to conduct investigations, subpoena witnesses, and compel attendance of witnesses as necessary to carry out authority under the FFDCA or provisions governing the regulation of biological products.
Requires reports to the Secretary regarding certain civil actions involving a regulated product.
Cosponsors 1
Members who signed on, in the order they did. All signed on Jul 31, 2008.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-IA | Chuck Grassley | Original | Jul 31, 2008 |
Actions 2
Everything that happened, newest first.
- Jul 31, 2008Introduced in Senate
- Jul 31, 2008Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Administrative fees
- Clinical trials
- Commerce
- Communication in medicine
- Damages
- Data banks
- Defective products
- Drug adulteration
- Drug approvals
- Drug industry
- Drugs
- Economics and Public Finance
- Fines (Penalties)
- Foreign Trade and International Finance
- Government Operations and Politics
- Government paperwork
- Governmental investigations
- Health
- Health information systems
- Imports
- Internet
- Labeling
- Law
- Licenses
- Medical technology
- Product safety
- Science, Technology, Communications
- Subpoena
- Wage restitution
- Whistle blowing
Text 1
Each version as it was printed, newest first.
- Jul 31, 2008Introduced in Senate
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.