Drug and Medical Device Company Gift Disclosure Act

To require the manufacturers, packers, and distributors of prescription drugs and medical devices to disclose certain gifts provided in connection with detailing, promotional, or other marketing activities, and for other purposes.

7/12/2007--Introduced.
Drug and Medical Device Company Gift Disclosure Act - Amends the Federal Food, Drug, and Cosmetic Act to require prescription drug or medical device manufacturers, packers, and distributors to annually disclose to the Commissioner of Food and Drugs the value, nature, and purpose of any :
(1) gift made in connection with detailing, promotion, or other marketing activity to any physician, nurse, therapist, hospital, nursing home, pharmacist, health benefit plan administrator, or any other person authorized to prescribe or dispense prescription drugs; and
(2) cash rebate, discount, or other financial consideration given to any pharmaceutical benefit manager in connection with such marketing activities. Defines "gift" to include any fee, payment, subsidy, amenity, object, service, or other economic benefit, except:
(1) free samples of prescription drugs;
(2) reasonable compensation and reimbursement of expenses in connection with a bona fide clinical trial; and
(3) certain scholarships or other support for medical students, residents, or fellows to attend conferences. Applies such provisions only if the total value of the gift or gifts is $50 or more during the calendar year. Requires the Commissioner to:
(1) make such information available to the public; and
(2) keep confidential any information related to a trade secret. Establishes civil penalties for violations.
Gives the Commissioner authority to investigate compliance with this Act. Authorizes the Commissioner to file a petition in the United States District Court for an order requiring submission of a report or other appropriate relief.


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Sponsor

• Rep. Peter DeFazio [D, OR-4]
• and 4 Co-Sponsors
  • Rep. Ben Chandler [D, KY-6]
  • Rep. Maurice Hinchey [D, NY-22]
  • Rep. Fortney Stark [D, CA-13]
  • Rep. Henry Waxman [D, CA-30]
  close

Committees

• House Energy and Commerce
• 1 more
  • House Energy and Commerce
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Amendments

This bill has no amendments.

Amendments to H.R.3023

Number	Status	Purpose

Bill Status

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Introduced		Voted on by House		Voted on by Senate		Considered By President		Bill Becomes Law
July 12, 2007

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All Bill Actions

• Introduced on Jul 12, 2007.
• Jul 12, 2007: Referred to the House Committee on Energy and Commerce.
• Jul 12, 2007: Referred to the Subcommittee on Health.

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Related Issue Areas:

• Medicine
• Business
• Business records
• Drug industry
• 26 more
• Drugs
• Fines (Penalties)
• Gifts
• Government information
• Government paperwork
• Government publicity
• Governmental investigations
• Health insurance
• Health maintenance organizations
• Health policy
• Hospitals
• Injunctions
• Law
• Marketing
• Medical care
• Medical instruments and apparatus
• Medical personnel
• Nurses
• Nursing homes
• Pharmacists
• Physicians
• Prescription pricing
• Rebates
• Sales promotion
• Trade secrets
• Medical supplies

Data from the Congressional Research Service

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Blog Coverage

October 09, 2008 DownsizeDC.org

Veterans' Benefits Improvement Act of 2008: H.R. 3023, amended, to amend title 38, United States Code, to improve and enhance compensation and pension, housing, labor and education, and insurance benefits for veterans; 6 pages ...

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Source: DownsizeDC.org

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September 25, 2008 Representative DeFazio Sponsors Drug and Medical Device Company ...

On July 12, Representative Peter DeFazio and other co-sponsors introduced HR 3023, also known as the "Drug and Medical Device Company Gift Disclosure Act," which proposes to mandate that drug and medical device companies disclose ...

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Source: Juvan's Health Law Update

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May 20, 2008 FDALegislativeWatch: Grassley, Kohl Retool Physician Gift ...

In the House, the Gift Disclosure Act, H.R. 3023, was introduced March 13 by Rep. Peter DeFazio, D-Ore. (5"The Pink Sheet," March 10, 2008, p. 23). The Medicare Payment Advisory Commission also is considering whether to recommend a ...

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Source: FDALegislativeWatch

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