FDA approved drug products from Drugs@FDA

last decade (2000-2011)


Everybody related to the healthcare sector in USA is aware of the Food and Drug Administration (FDA) - an agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the regulation and supervision of prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, dietary supplements and other relevant products.

The FDA regulates more than $1 trillion worth of consumer goods, about 25% of consumer expenditures in the United States. This includes $466 billion in food sales, $275 billion in drugs, $60 billion in cosmetics and $18 billion in vitamin supplements [1].

Currently information about pharmaceutical drugs products required FDA approval is available on-line to public through FDA web site (http://www.fda.gov) and Drugs@FDA database, which provides monthly updates on new coming products approvals.

iicoll llc collected and processed data for last decade approvals and would like to share its findings and analysis.

Overall data are available for more than 30 different kind of approvals where 5 most frequent in the last decade are:

labeling revision

16851 cases

chemistry

14617

control supplement

12239

approval

9111

labeling

8233

We looked for how the overall number of approvals (all) and number of original approvals (original) varied year-over-year in the last decade and compare the results for different companies, different ingredients, new ingredients and total:






for different companies

for different ingredients

for new ingredients

year

filings

approvals

%

filings

approvals

%

filings

approvals

%

filings

approvals

2000

5886

435

7.39

371

138

37.2

990

208

21.01

55

64

2001

5759

395

6.86

365

132

36.16

990

200

20.2

45

55

2002

6560

503

7.67

384

149

38.8

1064

223

20.96

38

57

2003

1933

473

24.47

273

150

54.95

675

231

34.22

46

64

2004

2099

617

29.39

328

197

60.06

659

285

43.25

56

68

2005

1800

562

31.22

321

176

54.83

594

262

44.11

39

46

2006

1811

689

38.05

331

199

60.12

611

295

48.28

51

66

2007

2135

817

38.27

371

221

59.57

666

299

44.89

39

44

2008

1944

706

36.32

360

205

56.94

681

323

47.43

41

54

2009

3848

1442

37.47

378

231

61.11

666

321

48.2

46

55

2010

1908

705

36.95

388

232

59.79

711

339

47.68

48

59

2011

2406

734

30.51

430

241

56.05

759

335

44.14

54

63


As one can see in the table above, all approvals had fairly close values for 2000-2003 then 3 times drop in 2003 and again close values till end of the decade except sharp almost 2 times increase in 2009. Number of original approvals had a positive trend till 2010 with almost 2 times sharp increase in 2009 and the same amplitude drop in 2010. Considering original approvals relative to all one can see sharp increase from 2002 to 2006 (from about 7% to about 38%), through 2006-2010 the fraction settled on the same (~38%) level and decreased to ~30% in 2011.

Number of approvals issued to different companies increased over the decade as for all as for original filings. But one has to note a significant drop in 2003 in all (but not original) approvals. Relative fraction increased in 2003 from about 38% to about 58% where it settled till end of the decade.

Number of approvals issued for different ingredients dropped significantly in 2003 then slowly decreased to its minimum in 2006 and grew thereafter to the end of the decade. Number of original approvals issued for different ingredients steadily increased through the decade.

Novel ingredients approvals number (both all and original) fluctuates year over year and doesn't show any trend. As a novel ingredient we consider one which has not been met in prior (up to 01/01/1990) approvals (for all) in prior original approvals (for original).

So, the data show that something happened in 2003.

Speculations: FDA approval process has been altered to omitting some kind of approvals (not for original drugs but rather some of their derivative products/supplements or labeling) and now FDA is more focused on new products.

Overall tendency is positive - more new FDA approved drugs year over year.


If we look at leading companies in number of overall and original approvals and compare changes over the decade and the last year. One can note that for overall approvals over the decade top 10 list changed by 70% (only 3 companies remained in the list from 2000 to 2011), while in the last year only one new top performer was added to the list. Also one can note significant gap between the over decade top performer Novartis and others.


overall approvals

2011


2010


2000


Novartis

151

Pfizer

102

Novartis

382

Pfizer

114

Novartis

95

Teva pharm.

353

GlaxoSmithKline

89

GlaxoSmithKline

62

Baxter intl

292

Abbott

83

Merck

58

Mutual pharma

237

Merck

76

Abbott

52

Watson pharms

235

Johnson and Johnson

68

Mylan

50

Ivax pharms

214

Sanofi

61

Johnson and Johnson

34

Hospira

213

Mylan

61

Eli Lilly and co

33

Bausch and Lomb

149

Eli Lilly and co

60

Astrazeneca

30

Johnson and Johnson

141

Astrazeneca

56

Bristol Myers Squibb

30

GlaxoSmithKline

135



Watson pharms

30



green - companies stayed at the top performer list through 2000-2011

blue - went out of the list

pink - newly appeared on the list

Looking at the original approvals list one can see significant difference from the overall top list. Here were more companies stayed in the top list over the decade. Besides the top lists have only 2 companies in common (Novartis and Mylan) or 20% at the end of the decade and about 70% at the beginning.


original approvals

Mylan

50

Mylan

46

Teva pharm.

31

Novartis

34

Novartis

35

Novartis

31

Teva pharm.

28

Watson pharms

28

Mylan

25

Dr Reddys labs

27

Glenmark pharms

25

Hospira

20

Watson pharms

25

Aurobindo pharma

23

Watson pharms

20

Sun pharma

24

Teva pharm.

22

Bedford labs

15

Lupin pharms

21

Sun pharma

20

Baxter intl

10

Aurobindo pharma

20

Lupin pharms

18

Ranbaxy

10

Strides arcolab

15

Zydus pharms

17

GlaxoSmithKline

9

Glenmark pharms

14

Dr Reddys labs

17

Ivax pharms

9



Torrent pharms

17

Sanofi

9

green - companies stayed at the top performer list through 2000-2011

blue - went out of the list

pink - newly appeared on the list

Another interesting regularity of the list - while most of the companies (70% at the beginning and 60% at the end of the decade) in overall approval list are US companies. For original approvals only about a half of the companies in 2000 and only 2 or 20% in 2011 are domestic, moreover, 60% of the top list as in 2011 as in 2010 are Indian companies. The question arise why novel drugs development in US becomes less and less efficient?

Ibuprofen appeared to be the most common ingredient of FDA approved drug products over the last decade. For original approvals cetirizine hydrochloride took the leader role.


Ibuprofen


Cetirizine

In the last year levofloxacin was the most common ingredient of FDA approved drug products, donepezil hydrochloride - one for original approvals.




Levofloxacin


Donepezil

[1] http://en.wikipedia.org/wiki/Fda