After ‘Clean’ User Fee Renewal, Will Programs Held Hostage Be Enough To Drive A Broader Reform Bill?

Continuing resolution will force lawmakers back to the bargaining table before year end. Orphan grants and pediatric exclusivity are among the programs left out of the short-term spending measure as Congressional Democrats seek leverage to add more policy riders.

New life — Some policy riders that had been in the FDA user fee package may find new life in post-election end-of-year legislation. • Source: Shutterstock

Congress may be gambling with the extensions of programs that fund orphan drug and pediatric clinical trials by only extending them a few weeks in the upcoming continuing resolution, but advocate Nancy Goodman sees the odds in her favor.

Goodman, executive director of the pediatric cancer advocacy group Kids v Cancer, is not a fan of the Best Pharmaceuticals for Children program, which offers six months of exclusivity to sponsors that conduct clinical trials of

After ‘Clean’ User Fee Renewal, Will Programs Held Hostage Be Enough To Drive A Broader Reform Bill?

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