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Given that the FDA Amendments Act of 2007 (FDAAA) took effect in late March 2008, the 2008 class of approved NMEs offered an early glimpse into how anxiously the FDA would wield its newly found powers regarding postmarketing requirements and risk evaluation and mitigation strategies (REMS). Even before FDAAA took effect, however, few observers assumed that a new drug would gain FDA approval unless it was encumbered by one or more postmarketing commitments that a sponsor agreed to fulfill following approval.
Of the 21 NMEs cleared in 2008, all but two (Adre View and Rapaflo) had some form of postmarketing requirement associated with them. For a handful of NMEs approved in 2008 (Cleviprex, Relistor, and Toviaz), the only postmarketing requirements were deferred pediatric assessments.
Interesting, the three NMEs approved before FDAAA took effect on March 25, 2008, had some of the more numerous postmarketing commitments – Intelence (9), Pristiq (5, including a long-term efficacy study), and Treanda (7).
The FDA invoked its new FDAAA authorities to mandate postmarketing requirements for 11 of the 18 NMEs approved in the FDAAA era. The approval letter for one NME approved in the FDAAA era, Durezol, included postmarketing commitments, although it specified no FDAAA-related postmarketing requirement.
Only six of the 18 FDAAA-era NMEs cleared in 2008 included REMS.
| Percent of NMEs Approved with Postmarketing Commitments, 2001-2008 % of NMEs with Postmarketing Commitments |
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2008 |
91% |
(19/21) |
2007 |
88% |
(14/16) |
2006 |
94% |
(17/18) |
2005 |
72% |
(13/18) |
2004 |
74% |
(23/31) |
2003 |
86% |
(18/21) |
2002 |
82% |
(14/17) |
2001 |
75% * |
(18/24) |
| *Drops to 67% if two extremely minor postmarketing commitments not included, one to revise a method to improve specificity and another to provide histopathological exams for animals in a rat carcinogenicity study. Source: PAREXEL’s Bio/Pharmaceutical R&D Statistical Sourcebook 2009/2010 |
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