Fitch Report Says NME Approvals Plummet at FDA in Q1, but FDA Data Paint Alternate Picture

Posted 14 May 2014 | By Alexander Gaffney, RAC 

When trying to gauge the success of both the US pharmaceutical sector and the US Food and Drug Administration (FDA), one metric usually reigns supreme: approvals. But despite progress by the latter in shoring up its flagging approval numbers in recent years, a new report indicates the first quarter of 2014 was the worst quarter for approvals in almost 15 years.


FDA approvals over the last decade have experienced their ups and downs.

Consider the following chart from a January 2014 report published by FDA regarding its approvals of New Molecular Entities (NMEs):

Year Applications ReceivedApplications ApprovedApproval Percentage

The number of NME approvals is a powerful metric for both FDA and industry, as it illustrates the number of new and innovative drugs that are being approved by regulators. Because the drugs have never before been approved, it also indicates the ability of regulators to grapple with difficult questions of safety and efficacy.

Troubling Signs Ahead?

But despite the agency approving more drugs in the last three years than in any other period since 2005, there are some troubling indications that this trend might not hold true in 2014.

In a new Fitch Ratings report released on 13 May 2014, the financial analyst group observed that FDA had only approved six NMEs during the first quarter of 2014. That was the fewest number of NME approvals since at least the year 2000, Fitch noted.

FDA approved nine NMEs in the first quarter of 2013, by contrast.

It's notable that Fitch appears to be using a different standard for NME approvals than FDA. Fitch said it counted 27 NME approvals in 2013 and 37 in 2012, while FDA counted 27 and 39 approvals during those respective time periods. 

FDA said it counts eight NME approvals through the first quarter of 2014:

Drug (Brand)Drug (Formal)Date of ApprovalDescription
8.Otezlaapremilast3/21/2014To treat adults with active psoriatic arthritis (PsA)
Press Release
7.Impavidomiltefosine3/19/2014To treat a tropical disease called leishmaniasis
Press Release
6.Neuraceqflorbetaben F 18 injection3/19/2014For Positron EmissionTomography (PET) imaging of the brain
5.Myaleptmetreleptin for injection2/24/2014To treat the complications of leptin deficiency
Press Release
4.Northeradroxidopa2/18/2014To treat neurogenic orthostatic hypotension (NOH)
Press Release
3.Vimizimelosulfase alfa2/14/2014Treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome).
Press Release
2.Hetlioztasimelteon1/31/2014To treat non-24- hour sleep-wake disorder ("non-24") in totally blind individuals. Non-24 is a chronic circadian rhythm (body clock) disorder in the blind that causes problems with the timing of sleep.

Press Release

1.Farxigadapaglifozin1/8/2014To improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. 
Press Release

By FDA's count, it had approved nine drugs through the end of the first quarter in 2013, and eight in 2012 and 2011-not significantly different than the numbers now giving Fitch's analysts pause.

Fitch's report analyst and corporate media relations official were not available for comment at the time this article was published.

An Addendum

But approval numbers don't necessarily tell the whole story, either. FDA can only approve NMEs if it receives an application for approval from a company. A period during which there aren't many innovative products succeeding in late-stage trials might depress FDA's approval numbers, but that isn't necessarily the agency's fault. Additionally, FDA might issue a complete response letter to a company indicating that it has deficiencies in its application which preclude approval. While that drug may not be approved for several more months or years, that may be the result of a sloppy development program, and not FDA.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles