Clerk session vote number: 543
Description: Dietary Supplement and Nonprescription Drug Consumer Protection Act
Bill summary: Dietary Supplement and Nonprescription Drug Consumer Protection Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to require a manufacturer, packer, or distributor whose name appears on the label of a nonprescription drug or dietary supplement marketed in the United States to: (1) submit to the Secretary of Health and Human Services within 15 business days any report of a serious adverse event associated with use of such drug or supplement in the United States; (2) submit within 15
business days any related medical information that is received within one year of the initial report; (3) maintain records related to each report for six years; and (4) permit inspection of such records. Allows a retailer whose name appears on the label as a distributor to authorize the manufacturer or packer to submit the required reports so long as the retailer directs all reported adverse events to such manufacturer or packer.
Requires the Secretary to develop systems to ensure that duplicate reports of a serious adverse event are consolidated.
Allows the Secretary to establish an exemption from such reporting that would have no adverse effect on public health.
Considers a serious adverse event report to be: (1) a safety report that may be accompanied by a statement, which shall be included in any public disclosure of the report, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and (2) a record about an individual and a medical or similar file the disclosure of which violates the Freedom of Information Act unless all personally identifiable information is redacted.
Provides that the submission of any adverse event report shall not be construed as an admission that the drug or supplement involved caused or contributed to the adverse event.
Prohibits any state or local government from establishing or continuing any requirements related to a mandatory system for adverse event reports for nonprescription drugs or dietary supplements that are not identical to the requirements of this Act.
Prohibits the responsible person from: (1) refusing to permit access to any required record; or (2) failing to establish or maintain any record, or make any report, required under this Act.
Deems a nonprescription drug or dietary supplement that is marketed in the United States to be misbranded unless its label includes a domestic address or phone number for the reporting of a serious adverse event.
(Sec. 4) Prohibits the falsification of a serious adverse event report.
(Sec. 5) Prohibits the importation of a drug or supplement subject to this Act if the Secretary has credible information indicating that the responsible person has not complied with the requirements of this Act or has not allowed access to its records.
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Bill titles: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to serious adverse event reporting for dietary supplements and nonprescription drugs, and for other purposes.
Links for more info on the vote: congress.gov