To stop this abuse, I have written legislation with Sen. John Edwards (D-NC) to tighten the Hatch-Waxman Act that will lead to more affordable generic drugs, thus saving consumers billions of dollars.
Support legislation to tighten the Hatch-Waxman Act by limiting automatic 30-month stays and closing loopholes that delay generic drug competition.
Occurrences
Evidence
legacy_unverified · Source version not recorded · locator unknown
Collins said the Greater Access to Affordable Pharmaceuticals Act would "limit brand name manufacturers to a single 30-month stay" and prevent stacking multiple automatic stays to keep generics off the market.
unverified · Source version 86681 · locator unknown
On the conference report for H.R. 1, Susan Collins voted Yea; the measure title states it was an act to strengthen and improve Medicare, and the conference report included access-to-affordable-pharmaceuticals provisions.
legacy_unverified · Source version not recorded · locator unknown
Title XI is labeled "Access to Affordable Pharmaceuticals." Section 1101 is "Thirty-Month Stay-of-Effectiveness Period" and amends Hatch-Waxman timing rules; Section 1102 adds forfeiture of the 180-day exclusivity period.
legacy_unverified · Source version not recorded · locator unknown
Public Law 108-173 was approved December 8, 2003. Title XI is Access to Affordable Pharmaceuticals and includes Sec. 1101 on the thirty-month stay-of-effectiveness period and Sec. 1102 on forfeiture of the 180-day exclusivity period. Section 1101 amended 21 U.S.C. 355 so the stay-triggering patent information had to be submitted before the generic application, addressing sequential late-patent stays; Section 1102 added first-filer exclusivity forfeiture events.
legacy_unverified · Source version not recorded · locator unknown
Collins said the compromise amendment would restore Hatch-Waxman and close loopholes delaying generic competition. She described limiting brand manufacturers to a single 30-month stay and adding forfeiture of 180-day exclusivity when the first generic applicant failed to market or entered an anticompetitive agreement.
Assessments
The promise was tied to Collins's 2002 federal Senate campaign and the 2003-2009 Senate term. Public Law 108-173 was enacted on December 8, 2003, during that term, and Title XI included Hatch-Waxman reforms limiting abusive 30-month stays and adding 180-day exclusivity forfeiture mechanisms to reduce generic-delay loopholes. Collins had publicly introduced and supported matching legislation in 2002 and voted for the enacted bill's conference report, so the outcome counts as delivered in the same term.
Collins publicly backed and introduced legislation in 2002 to limit automatic 30-month stays and close generic-delay loopholes, and the Medicare Prescription Drug, Improvement, and Modernization Act enacted in 2003 during her Senate term included those pharmaceutical patent reforms. Because the promised policy was carried into law while she was in office, this is delivered in the same term.
Delivered. During Collins's 2003-2009 Senate term, Public Law 108-173 enacted Hatch-Waxman changes matching the promise's core substance, including limits on 30-month stay timing and forfeiture provisions aimed at delayed generic competition. Collins also supported the enacted conference report and had previously introduced or backed similar legislation, so federal candidate credit is appropriate within the same term.