H.R.1862 - Greater Access to Affordable Pharmaceuticals Act of 2001107th Congress (2001-2002)
|Sponsor:||Rep. Brown, Sherrod [D-OH-13] (Introduced 05/16/2001)|
|Committees:||House - Energy and Commerce|
|Latest Action:||05/07/2002 Sponsor introductory remarks on measure. (All Actions)|
|Notes:||On 9/19/2002, a motion was filed to discharge the Rules Committee from consideration of H.Res.517 a resolution providing for the consideration of H.R.1862. A discharge petition requires 218 signatures for further action. (Discharge Petition No. 107-11: text with signatures.)|
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Summary: H.R.1862 — 107th Congress (2001-2002)All Information (Except Text)
Greater Access to Affordable Pharmaceuticals Act of 2001 - Amends the Federal Food, Drug, and Cosmetic Act to provide for an accelerated date of approval for a generic drug application.
Introduced in House (05/16/2001)
Allows a drug to be considered a bioequivalent to a listed drug if the effects of such drug and the listed drug do not show a significant difference based on certain tests or studies.
Sets forth requirements concerning the filing of a citizen petition review.
Revises provisions concerning: (1) abbreviated new drug applications and new drug applications with respect to the time required for approval and the certification that a patent is invalid or will not be infringed; and (2) filing an application.
Requires a report concerning the extent to which this Act has: (1) has enabled products to come to market in a fair and expeditious manner, consistent with the rights of patent owners under intellectual property law; and (2) has promoted lower prices of drugs and greater access to drugs through price competition..