Dietary Supplement and Nonprescription Drug Consumer Protection Act

Bill: 109-s-3546
Sponsor: Sen. Hatch, Orrin G. [R-UT]
Introduced: 2006-06-21 in the Senate
Policy area: Health
Subjects: Agriculture and Food
Birth defects
Business records
Civil Rights and Liberties, Minority Issues
Commerce
Crime and Law Enforcement
Death
Dietary supplements
Drug abuse
Drug adulteration
Drug industry
Federal preemption
Food safety
Foreign Trade and International Finance
Fraud
Freedom of information
Government Operations and Politics
Government paperwork
Import restrictions
Labeling
Local laws
Nonprescription drugs
Right of privacy
State laws

Summary:
action_date: 2006-06-21
text: 
Dietary Supplement and Nonprescription Drug Consumer Protection Act - 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 received of a serious adverse event associated with such drug or supplement when used 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.
 
Requires the Secretary to develop systems to ensure that duplicate reports of a serious adverse event are consolidated into a single report.
 
Allows the Secretary to establish an exemption from such reporting that would have no adverse effect on public health.
 
Prohibits any state or local government from establishing or continuing any requirement related to a mandatory system for adverse event reports for nonprescription drugs or dietary supplements that is not identical to 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 an address or phone number for the reporting of a serious adverse event.

action_date: 2006-09-05
text: 
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.

action_date: 2006-12-22
text: 

(This measure has not been amended since it was reported to the Senate on September 5, 2006. The summary of that version is repeated here.)

 
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.


Legislative actions:
action_date: 2006-12-22
text: Became Public Law No: 109-462.
action_date: 2006-12-22
text: Became Public Law No: 109-462.
action_date: 2006-12-22
text: Signed by President.
action_date: 2006-12-22
text: Signed by President.
action_date: 2006-12-20
text: Presented to President.
action_date: 2006-12-20
text: Presented to President.
action_date: 2006-12-09
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2006-12-09
text: On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 203 - 98 (Roll no. 543). (text: CR 12/8/2006 H9243-9245)
action_date: 2006-12-09
text: Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 203 - 98 (Roll no. 543).(text: CR 12/8/2006 H9243-9245)
action_date: 2006-12-09
text: Considered as unfinished business. (consideration: CR 12/8/2006 H9303-9304)
action_date: 2006-12-09
text: At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.
action_date: 2006-12-09
text: DEBATE - The House proceeded with forty minutes of debate on S. 3546.
action_date: 2006-12-09
text: Considered under suspension of the rules. (consideration: CR 12/8/2006 H9243-9246)
action_date: 2006-12-09
text: Mr. Barton (TX) moved to suspend the rules and pass the bill.
action_date: 2006-12-07
text: Held at the desk.
action_date: 2006-12-07
text: Received in the House.
action_date: 2006-12-07
text: Message on Senate action sent to the House.
action_date: 2006-12-06
text: Passed Senate with an amendment by Unanimous Consent. (consideration: CR  S11376-11381; text as passed Senate: CR  S11377-11378)
action_date: 2006-12-06
text: Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.(consideration: CR  S11376-11381; text as passed Senate: CR  S11377-11378)
action_date: 2006-09-05
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 586.
action_date: 2006-09-05
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Enzi with an amendment in the nature of a substitute. With written report No. 109-324.
action_date: 2006-09-05
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Enzi with an amendment in the nature of a substitute. With written report No. 109-324.
action_date: 2006-06-28
text: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
action_date: 2006-06-21
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2006-06-21
text: Sponsor introductory remarks on measure. (CR S6285-6287)
action_date: 2006-06-21
text: Introduced in Senate

Enacted as: number: 109-462