Regulatory Focus™ > News Articles > Is FDA on Pace to Beat Its 2011 Drug Approval Numbers?

Is FDA on Pace to Beat Its 2011 Drug Approval Numbers?

Posted 27 July 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is potentially on pace to approve fewer new drug entities than it did in 2011, according to several sources.

An analysis by The Streetof the remaining 2012 FDA advisory committees-panels of experts who provide non-binding advice to the agency regarding whether to approve a new drug product-shows just 23 more drugs set to go before US regulators before the end of the year.

The list includes Pfizer's anti-rheumatoid arthritis drug tofacitinib, Gilead Sciences' anti-HIV combination drug Quad, and Sanofi's multiple sclerosis drug Aubagio. One drug manufacturer, Regeneron, has three compounds set for possible FDA approval: Eylea for retinal vein occlusion, Zaltrap for colon cancer and Arcalyst for gout flares.

But it is highly unlikely all drug products before the agency will be approved, even if they are not outright denied. Several of the drug products are facing their second and even third attempts at approval-something prior research shows has diminishing returns for companies hoping to obtain approval.

FDA approved only 14 drug products through the first six months of the year, down from 18 in 2011. If the US regulator wants to match its 2011 performance, it will have to approve 13 more drugs before the end of this year-56% of the products currently on its calendar.

Even if FDA does not meet its 2011 performance levels, it would still likely be above prior years, when it approved as few as 17 products (2002). The agency's best year for approvals in the last decade was 2004, when it approved 36 new molecular entities.   The agency has an approval average of 23 drugs per year.

Read more:

The Street - 28 Drugs Facing FDA Approval in 2012-2013

Pharmalot - The FDA Will Approve How Many New Drugs?

Pharma Times - Sharp dip in US drug approvals forecast


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