Big Companies Driving FDA Fast Lanes

President Trump has suggested that the FDA process for drug approval is slow and burdensome. Yet use of the FDAs options for speedier regulatory approval applied to more than half of novel drug approvals in recent years, but just what drugs – and from which companies – are being approved faster? In another of a series to explore expedited FDA approvals, Leela Barham takes a look.

Drugs and companies

Between 2015 to 2017, 71 novel drugs from 49 companies were approved using one or more of the FDAs expedited options (see Appendix 1).

The majority of companies who have successfully secured faster approval have done so only once in the last three years: 37 companies have secured just the one faster drug approval. There are though, companies who have done so more than once, and even as many as five times in the last three years. The league table (Table 1) is topped by Genentech, a subsidiary of Roche.

Table 1: League table of companies securing novel drug approvals using FDA expedited development and review methods, 2015 – 2017

Number of expedited novel drug approvals

Global position*

Genentech

5

3

Merck

4

4

Novartis

4

2

AstraZeneca

3

11

Eli Lilly

3

13

Gilead

3

9

AbbVie

2

8

Alexion

2

39

Bristol-Myers Squibb

2

12

Janssen

2

5

Pfizer

2

1

Takeda

2

20

Acadia Pharmaceuticals

1

Actavis Pharma

1

Advanced Accelerator Applications

1

Allergan

1

17

Amgen

1

10

Asklepion Pharmaceuticals

1

Astellas

1

23

Bayer

1

15

Biogen

1

24

BioMarin

1

Blue Earth Diagnostics

1

Boehringer Ingelheim

1

19

Celgene

1

21

Chemo Research

1

Clovis Oncology

1

Eisai

1

32

Elysys Therapeutics

1

EMD Serono

1

Intercept Pharmaceuticals

1

Jazz Pharmaceuticals

1

La Jolla Pharmaceutical Company

1

Lexicon Pharmaceuticals

1

Marathon Pharmaceuticals

1

Melinta Therapeutics

1

Neurocrine Biosciences

1

Portola Pharmaceuticals

1

Regeneron Pharmaceuticals

1

Rempex Pharmaceuticals

1

Sarepta

1

Shire

1

18

Symbiomix Therapeutics

1

Taiho Oncology

1

Tesaro

1

Ultragenyx

1

United Therapeutics

1

Vertex

1

Wellstat Therapeutics

1

*Based on 2017 revenue and listed at PharmExec’s Top 50 Companies 2018. Subsidiaries have been classed according to their parent company position.

It’s clear that it’s not just the big companies have been successful in getting faster FDA approval, although the top ten companies (in terms of 2018 revenue) have achieved 1 in 5 of the expedited approvals and 43 per cent have been secured by companies who are in the top 50 (Figure 1).

Figure 1: Companies by global revenue who have novel drugs approved using FDA expedited development and review methods, 2015 to 2017

Source: Analysis of data from FDAs novel drug approvals 2015, 2016 and 2017.

Digging a little more deeply though, it’s the big companies who have managed to secure multiple expedited novel drug approvals. Only twelve companies have more than one expedited novel drug approval in the last three years, and seven (58%) of those are in the top ten companies. All twelve companies are in the top 50. Big companies will not only have bigger portfolios - so more candidates for the FDA to look at - but presumably have the in-house resources and know-how to successfully work with the FDA on expedited development and review methods.

It’s not just getting the novel drug approval but also in getting a combination of the expedited development and review options. Here the big companies do better too; the average number of options used per novel drug approved is 2.2 for both the top 10 companies, and for the top 50, whereas it’s 2 for the companies outside of the top 50.

Big companies have big know how on using FDA expedited options

Based on FDA's data - up to the end of 2017 - shows that its both big and small companies that have been able to use the FDA options for faster approval. It’s the big companies who have the greatest experience - both in terms of the number of approvals and the number of expedited development and review options used - and it’s therefore those companies that presumably have the insights on just how best to speed up what Trump has described as slow and burdensome regulation.  They’ll be the ones to talk to on just how much further, and faster, the FDA can go.

Leela Barham is a freelance health economist and policy expert. You can reach her on leels@btinternet.com. She is providing input as a subject matter expert into medicines pricing policy development with a UK government client and for the duration of her involvement in that project, she is restricted on what she can write about.