Pharmaceutical Market Access Act of 2003

Bill: 108-hr-2427
Sponsor: Rep. Gutknecht, Gil [R-MN-1]
Introduced: 2003-06-11 in the House
Policy area: Health
Subjects: Administrative procedure
Commerce
Congress
Congressional reporting requirements
Consumer protection
Counterfeiting
Crime and Law Enforcement
Department of Health and Human Services
Drug industry
Drugs
Foreign Trade and International Finance
Government Operations and Politics
Government paperwork
Governmental investigations
Identification devices
Import restrictions
Imports
Labeling
Law
Packaging
Prescription pricing
Product safety
Science, Technology, Communications
Sunset legislation

Summary:
action_date: 2003-06-11
text: Pharmaceutical Market Access Act of 2003 - Amends the Federal Food, Drug and Cosmetic Act to direct the Secretary of Health and Human Services to promulgate regulations allowing qualifying individuals to import covered products (in addition to pharmacists and wholesalers, whom current law authorizes to import such products).
Amends provision pertaining to record keeping regarding imported covered products. States that the Secretary shall not have to store records in cases in which qualifying individuals have imported a covered product. 
Amends provisions regarding the testing of imported covered products. Declares that specified tests, including ones involving authenticity and degradation of products, shall not be required unless the importer is a wholesaler. Requires such tests to be conducted by the importer unless a product is a prescription drug subject to the provisions of this Act pertaining to counterfeit-resistant packaging. (Currently either the importer or the manufacturer may conduct such tests). 
Eliminates the sunset date current law establishes for the provisions pertaining to the importation of covered products.
Classifies prescription drugs as misbranded if they do not incorporate specified counterfeit -resistant technologies in packaging.
action_date: 2003-07-25
text: 

(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)

 
Pharmaceutical Market Access Act of 2003 - (Sec. 4) Amends the Federal Food, Drug and Cosmetic Act to direct the Secretary of Health and Human Services to promulgate regulations allowing qualifying individuals to import covered products (in addition to pharmacists and wholesalers, whom current law authorizes to import such products).
 
Amends provision pertaining to record keeping regarding imported covered products. States that the Secretary shall not have to store records in cases in which qualifying individuals have imported a covered product.
 
Amends provisions regarding the importation of covered products, including to remove language directing the Secretary to require that a foreign seller specify the original source of the product and the amount of each lot of the product originally received. 
Amends provisions regarding the testing of imported covered products. Declares that specified tests, including ones involving authenticity and degradation of products, shall not be required unless the importer is a wholesaler. Requires such tests to be conducted by the importer unless a product is a prescription drug subject to the provisions of this Act pertaining to counterfeit-resistant packaging. (Currently either the importer or the manufacturer may conduct such tests). 
Eliminates the sunset date current law establishes for the provisions pertaining to the importation of covered products. 
(Sec. 5) Classifies prescription drugs as misbranded if they do not incorporate specified counterfeit-resistant technologies in packaging.

Legislative actions:
action_date: 2003-07-25
text: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2003-07-25
text: On passage Passed by recorded vote: 243 - 186 (Roll no. 445).
action_date: 2003-07-25
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2003-07-25
text: Passed/agreed to in House: On passage Passed by recorded vote: 243 - 186 (Roll no. 445).
action_date: 2003-07-25
text: On motion to recommit Failed by voice vote.
action_date: 2003-07-25
text: The previous question on the motion to recommit was ordered without objection.
action_date: 2003-07-25
text: Mr. Dingell moved to recommit to Energy and Commerce. (consideration: CR H7610; text: CR H7595-7596)
action_date: 2003-07-25
text: The previous question was ordered pursuant to the rule.
action_date: 2003-07-25
text: DEBATE - The House proceeded with one hour of debate on H.R. 2427.
action_date: 2003-07-25
text: Rule provides for consideration of H.R. 2427.
action_date: 2003-07-25
text: Considered under the provisions of rule H. Res. 335. (consideration: CR H7595-7611)
action_date: 2003-07-24
text: Rule H. Res. 335 passed House.
action_date: 2003-07-24
text: Rules Committee Resolution H. Res. 335 Reported to House. Rule provides for consideration of H.R. 2427.
action_date: 2003-06-24
text: Referred to the Subcommittee on Health.
action_date: 2003-06-11
text: Referred to the House Committee on Energy and Commerce.
action_date: 2003-06-11
text: Introduced in House
action_date: 2003-06-11
text: Introduced in House