S.754 - Drug Competition Act of 2002107th Congress (2001-2002)
|Sponsor:||Sen. Leahy, Patrick J. [D-VT] (Introduced 04/06/2001)|
|Committees:||Senate - Judiciary | House - Energy and Commerce; Judiciary|
|Committee Reports:||S. Rept. 107-167|
|Latest Action:||House - 11/22/2002 Referred to the Subcommittee on Health. (All Actions)|
This bill has the status Passed Senate
Here are the steps for Status of Legislation:
- Passed Senate
Summary: S.754 — 107th Congress (2001-2002)All Information (Except Text)
Drug Competition Act of 2002 - (Sec. 5) Requires a generic drug applicant that has submitted an Abbreviated New Drug Application (ANDA) and a brand name drug company that enter into an agreement, prior to the generic drug entering the market, regarding the manufacture, marketing, or sale of the brand name or the generic drug, or regarding the 180-day semi-exclusivity period referred to in the Federal Food, Drug, and Cosmetic Act as it applies to such ANDA or any other ANDA based on the same brand name drug, to each file such agreement and any related agreements with the Assistant Attorney General and the Federal Trade Commission (FTC). Makes an exception for agreements that solely concern purchase orders for raw material supplies, equipment and facility contracts, or employment or consulting contracts. Requires such agreements to be filed not later than ten business days after the date they are executed.
Passed Senate amended (11/18/2002)
(Sec. 7) Exempts any such information or documentary material filed from disclosure under the Freedom of Information Act. Prohibits such information or material from being made public, except as relevant to any administrative or judicial action or proceeding.
(Sec. 8) Subjects an applicant or company to a civil penalty of up to $11,000 for each day such entity fails to comply with this Act, recoverable in a civil action brought by the United States or the FTC. Authorizes a U.S. district court to order compliance and grant equitable relief.