The FDA Will Approve How Many New Drugs?

By Ed Silverman // July 26th, 2012 // 11:02 am

Maybe not as many as last year, at least according to Fitch Ratings. In a new report, the ratings service notes that the FDA is on track to approve fewer drugs than in 2011, when 30 new primary care and specialty medicines were cleared for marketing. And while 2012 started strong with eight new molecular entities endorsed in the first quarter, the total of 14 new approvals in the first half of the year lags behind the 18 new medicines in the same period in 2011.

Meanwhile, new filings by drugmakers covered by Fitch slowed to a trickle in the first half of the year. During this time, drugmakers filed only four NMEs with the FDA and European Medicines Agency, comprising three new drugs filed in the first quarter and another in the second quarter, according to the Fitch report. Specialty medicines represented all of the application registrations made during the first quarter.

In reflecting on the numbers, the Fitch analysts acknowledge that duplicating the output last year, when 18 of 24 novel therapies were submitted for registration, will be hard to accomplish. The brand-name drugmakes watched by Fitch added four novel drug projects to their research programs in the first quarter of 2011 plus another four later on. This compares to five NMEs in the fourth quarter of 2011 and 11 NMEs in the third quarter. Seven of the eight new investigational drugs in 2012 emerged thanks to business development deals in recent years, Fitch writes.

But the rating service also believes the “more modest goal” of filing for marketing authorization of 12 new medicines is obtainable. The drugmakers that Fitch follows, by the way, includes Abbott Laboratories, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, Roche and Sanofi.