Many industry analysts and journalists are speculating that FDA could approve a fewer number of drugs this year than in years previous. Citing from a recent report from Fitch Ratings, one article entitled “Sharp dip in US drug approvals forecast,” remarks that “the total of 30 new primary care and specialty medicines approved for marketing in the US in 2011 will be hard to beat this year.” With only 14 new approvals in the first half of 2012, FDA is behind its mark of 18 new approvals by the same time in 2011.
However, according to the article entitled “The FDA Will Approve How Many New Drugs?” Fitch believes FDA’s goal of filing for marketing authorization of 12 new medicines is obtainable.
On the other hand, the problem may not be solely driven by FDA. The article in Pharmalot also mentions that there has been a fewer number of drugs being submitted to FDA. The article states, “…drugmakers filed only four NMEs with the FDA and European Medicines Agency, comprising of three new drugs filed in the first quarter and another on the second quarter…”