HR 386 · 107th Congress 2001–2003, ended

Orphan Drug Program Improvement Act of 2001

Fact sheet

Latest action · Feb 14, 2001 Referred to the Subcommittee on Health.

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.

  1. IntroducedJan 31, 2001
  2. Passed HouseNot reached
  3. Passed SenateNot reached
  4. To the PresidentNot reached
  5. Became lawNot reached

Summary

Orphan Drug Program Improvement Act of 2001 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services, respecting application approval or licensing, to conform the designation of a drug for a rare disease or condition (orphan drug) to reflect such drug's approved labeling.

Exempts clinically superior subsequent orphan drugs from the seven-year prohibition of approval respecting a previously approved or licensed drug.

Cosponsors 3

Members who signed on, in the order they did. Signatures ran from Feb 27, 2001 to Mar 6, 2001.

SeatCosponsorSigned on
R-COBob SchafferFeb 27, 2001
D-GANathan DealFeb 28, 2001
R-COThomas G. TancredoMar 6, 2001

Actions 3

Everything that happened, newest first.

  1. Feb 14, 2001Referred to the Subcommittee on Health.
  2. Jan 31, 2001Introduced in House
  3. Jan 31, 2001Referred to the House Committee on Energy and Commerce.

Subjects

Assigned by the Library of Congress. Policy area: Health.

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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.