Report: FDA Drug Approvals to Decline in 2012

Market research from Fitch Ratings indicates the FDA will approve fewer novel drugs in 2012 compared to 2011.

Fitch Ratings expects the Food and Drug Administration (FDA) will approve fewer novel drugs in 2012 as compared to 2011 while the industry faces several ongoing operational risks, according to a new report.

Fitch believes that the total of 30 new primary care and specialty medicines cleared for marketing in the U.S. during 2011 will be difficult to beat this year. Despite a strong first quarter with eight new molecular entities (NMEs) approved, the total of 14 new approvals in the first half of 2012 (1H'12) lags behind the 18 new approvals in the same period of 2011.

These trends come as the global pharmaceutical industry faces several risks over the course of 2012, including a historic zenith in the dollar amount of drug patent expirations. Four of the industry's once top-10 best-selling medications will have lost market exclusivity by the end of 3Q'12. Fitch anticipates little relief from the patent cliff this year, as key drug patents continue to lapse and the industry contends with 2011 losses.

Coupled with pressure from European austerity measures, Fitch-rated drug developers saw average weighted revenues fall modestly in the first quarter after adjusting for currency changes and consolidation activities within the past 12 months.

Fitch-covered pharmaceutical developers returned a total of $22.1 billion to shareholders in 1Q'12, comprising $15.3 billion in dividends and $6.8 billion of share buybacks. Fitch believes that share repurchases will exceed dividends as the year progresses.

The full report 'Global Pharmaceutical R&D Pipeline: First-Quarter 2012' is available on the company website.

Source: Fitch Ratings via BusinessWire

 

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